K202228 - Kit Cariquitan - Accessdata.fda.gov

1 avr. 2021 — Omron Model BP7900 Blood Pressure. Monitor EKG (K182579) and AliveCor, Inc. KardiaMobile System (K191406). 39. K202228. Page 1 of 10. Page 5 ...

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K202228

April 1, 2021
Omron Healthcare, Inc. Kit Cariquitan Chief Regulatory Officer Experien Group 224 Airport Parkway Suite 250 San Jose, California 95110
Re: K202228 Trade/Device Name: Omron Model BP7900 Blood Pressure Monitor + EKG Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXH, DPS, QDA Dated: February 26, 2021 Received: March 2, 2021
Dear Kit Cariquitan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov

Doc ID# 04017.04.23

K202228 - Kit Cariquitan

Page 2

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Stephen C. Browning -S
LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics
and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure

510(k) SUMMARY

K202228

510(k) Notification K_______________________
GENERAL INFORMATION [807.92(a)(1)]
Applicant: Omron Healthcare, Inc. 1925 West Field Court Lake Forest, IL 60045 USA Phone: 847-247-5626 Fax: 847-680-6269

Correspondent: Kit Cariquitan Chief Regulatory Officer Experien Group, LLC 224 Airport Parkway, Suite 250 San Jose, CA 95110 USA

Date Prepared: August 06, 2020

DEVICE INFORMATION [807.92(A)(2)]

Classification: 21 CFR 870.1130, Noninvasive blood pressure measurement system

Product Code: DXN, System, Measurement, Blood-Pressure, Non-Invasive DXH, Transmitters and Receivers, Electrocardiograph, Telephone DPS, Electrocardiograph QDA, Electrocardiograph Software for Over-The-Counter Use

Trade/Proprietary Name: Omron Model BP7900 Blood Pressure Monitor + EKG

Generic/Common Name: Noninvasive Blood Pressure Monitor and Electrocardiograph

PREDICATE DEVICE(S) [807.92(A)(3)]
The Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the Omron Healthcare, Inc. Omron Model BP7900 Blood Pressure Monitor + EKG (K182579) and AliveCor, Inc. KardiaMobile System (K191406).

Page 1 of 10

K202228
510(k) SUMMARY
DEVICE DESCRIPTION [807.92(A)(4)]
The Omron Model BP7900 Blood Pressure Monitor + EKG ("BP7900") is a battery-powered automatic, non-invasive blood pressure (BP) and electrocardiography (ECG) measurement system intended for home use.
The BP7900 is intended for use in adult patients with arm circumferences between 17cm and 42cm. The device can be used with two different arm cuffs, the HEM-CS24-B and HEMRML31-B which are adjustable to ranges of 17-22cm and 22-42cm, respectively. Other than the difference in circumference, the two cuffs function in the same manner.
The device inflates the arm cuff with an integral pump, then deflates the cuff via an electric valve. During inflation, the arm cuff pressure is monitored, and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/minute. The results of the BP and pulse rate analysis are displayed on the front of the BP7900 for the user. In order to utilize the device, the user must also pair the BP7900 to a smartphone which employs the "Omron Connect" app. This app is intended to display trend graphs of measured systolic and diastolic blood pressure, and pulse rate. This app makes use of the cleared software of the AliveCor, Inc. KardiaMobile System (K191406) to analyze recorded ECGs and identify abnormal heart rhythms based upon the cleared algorithm parameters. Readings can be stored in the app for archiving and review by the user.
In addition to the BP measurement capabilities, the BP7900 also incorporates electrodes capable of gathering ECG data from the user. This can be done either concurrently with BP measurement, or as a separate function. To initiate the ECG, the user places a thumb on each of the right and left electrodes on the top face of the BP7900 and places two or more fingers in contact with the electrodes on the right and left side of the BP7900. The thumb electrodes measure at a rate of 300 samples/second as a single-lead ECG between left and right thumbs. The two remaining finger electrodes on the sides of the BP7900 are used for noise reduction purposes. The single-lead ECG data is transmitted via ultrasonic acoustics to the nearby smartphone with the cleared Kardia App (part of the KardiaMobile System, K191406) or Omron Connect App (Omron functional equivalent). The cleared app, which is incorporated from the KardiaMobile (K191406), allows the user to view their ECG and the results of analysis using the AliveCor's KardiaAI platform (K181823) which detects the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others.
The operation of the device is intended for home use. Functions and other features that are controlled by the end user include: applying the arm cuff to the arm, powering on/off the system, starting or stopping the blood pressure (BP) and pulse measurement cycle, and replacing the batteries as needed. Unlimited readings can be stored in the app for archive and review by the user.

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510(k) SUMMARY

K202228

INDICATIONS FOR USE [807.92(a)(5)]
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
The proposed BP7900 incorporates a software update to the cleared BP7900 primary predicate device (K182579), with no change in principles of operation, hardware components, or key specifications; to bring the proposed device's onboarding procedure for accessing ECG functionalities in alignment with the secondary predicate, the AliveCor KardiaMobile System (K191406). The proposed device is substantially equivalent to both predicate devices with regard to intended use, product labeling, anatomical sites, patient population, performance testing, technological characteristics, and safety characteristics.
With respect to technological characteristics, there are no differences between the proposed and primary predicate devices with respect to the key functionalities blood pressure measurement, ECG recording, or ECG analysis. The main difference between the devices, which prompted this 510(k) submission, is a change in the onboarding procedure to access the ECG features. The "unlock overread" restriction has been removed for the first use of the product. This change matches the proposed device's first-use onboarding procedure for accessing ECG functionalities with that of the secondary predicate device. Omron has conducted software testing to demonstrate that the updated onboarding procedure, which is identical to that of the secondary predicate device, has been successfully implemented in the updated software. The removal of the unlock overread restriction for first ECG use does not introduce any new risks or significantly modify existing risks, nor does it remove mitigations of risk as compared with the predicate device. This technological difference therefore does not raise different questions of safety or effectiveness from the predicate devices and supports that the proposed device is substantially equivalent to both predicate devices.
Table 1 presents a tabular substantial equivalence comparison between the proposed device and both predicate devices.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison
Proposed Device: Omron Healthcare, Inc. Omron BP7900 Blood Pressure
Monitor + EKG

CFR Classification

21 CFR§870.1130, Noninvasive blood pressure measurement system.

Primary Predicate: Omron Healthcare, Inc. Omron BP7900 Blood Pressure
Monitor + EKG (K182579)
21 CFR§870.1130, Noninvasive blood pressure measurement system.

Regulatory Class

Product Codes Indications for Use
Environment of Use

DXN - Noninvasive blood pressure measurement DXH - Telephone electrocardiograph transmitter and receiver DPS - Electrocardiograph QDA - Electrocardiograph Software for Over-The-Counter Use
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and the output of ECG analysis including detecting the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm, and others. The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use.
Home Use

DXN - Noninvasive blood pressure measurement DXH - Telephone electrocardiograph transmitter and receiver DPS - Electrocardiograph
The device is intended to measure blood pressure only, electrocardiogram (ECG) only or blood pressure and ECG simultaneously.
The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult population.
The device is intended to record, store, and transfer single-channel electrocardiogram (ECG) rhythms. The device also displays ECG rhythms and detects the presence of atrial fibrillation, bradycardia, tachycardia and normal sinus rhythm (when prescribed or used under the care of a physician). The device is intended for use by healthcare professionals, patients with known or suspected heart conditions, and health-conscious individuals. The device has not been tested and it is not intended for pediatric use. Home Use

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
21 CFR§870.2920, Telephone electrocardiograph transmitter and receiver. II
DXH - Telephone electrocardiograph transmitter and receiver DPS - Electrocardiograph QDA - Electrocardiograph Software for Over-The-Counter Use
The KardiaMobile System is intended to record, store and transfer singlechannel electrocardiogram (ECG) rhythms. The KardiaMobile System also displays ECG rhythms and output of ECG analysis from AliveCor's KardiaAI platform including detecting the presence of normal sinus rhythm, atrial fibrillation, bradycardia, tachycardia, and others. The KardiaMobile System is intended for use by healthcare professionals, patients with known or suspected heart conditions and health conscious individuals. The device has not been tested and is not intended for pediatric use.
Home Use

SE Assessment to Predicate Devices
Same. Unchanged from the cleared predicate device. Same. Unchanged from the cleared predicate device. Product codes include those for predicates.
Similar. The Intended Use of the proposed device is the same as the predicate device. The wording of the Indications for Use statement with respect to ECG analysis has been updated to reflect the updated onboarding procedure which is consistent with that of the secondary predicate device.
Same as both predicate devices.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison (Cont.)

Proposed Device: Omron Healthcare, Inc. Omron BP7900 Blood Pressure
Monitor + EKG

Primary Predicate: Omron Healthcare, Inc. Omron BP7900 Blood Pressure
Monitor + EKG (K182579)

Type of Use

OTC: blood pressure features and ECG OTC: blood pressure features and ECG

recording, display, and analysis

recording

Rx: overread unlock restriction for ECG display and analysis features

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
OTC: ECG recording, display, and analysis

Patient Population

Adults

Adult (non-pediatric)

Key Contraindications/ Contraindicated against use in

Contraindicated against use in

Warnings/Precautions ambulatory environments and aircraft. ambulatory environments and aircraft.

Single Use

There are no known contraindications. No

Sterility

External contacting device, nonsterile External contacting device, nonsterile External contacting device, nonsterile

Specifications/Features
Measurement Method / BP measurement: Principal of Operation Cuff oscillometric method
ECG recording: User completes circuit with skin contact and hardware transmits audio signal to MCP to convert and display ECG

BP measurement: Cuff oscillometric method ECG recording: User completes circuit with skin contact and hardware transmits audio signal to MCP to convert and display ECG

User completes circuit with skin contact and hardware transmits audio signal to MCP to convert and display ECG

SE Assessment to Predicate Devices
Same as the primary predicate device for blood pressure features and ECG recording. Same as the secondary predicate device for ECG display and analysis. As the "overread unlock" restriction has been removed from the proposed device for the ECG functionalities, as is consistent with the secondary predicate device; the proposed device is no longer indicated as a Rx (prescription use) device. Same as both predicate devices. Unchanged from the cleared predicate device. Same as both predicate devices. Unchanged from the cleared predicate device. Same as both predicate devices. Unchanged from the cleared predicate device. Same as both predicate devices. Unchanged from the cleared predicate device.
Same as primary predicate. No change from cleared BP7900 device.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison (Cont.)

Proposed Device:

Primary Predicate:

Omron Healthcare, Inc.

Omron BP7900 Blood Pressure

Monitor + EKG

(K182579)

Measurement Range

BP measurement:

Pressure: 0 to 299mmHg

Pulse Rate: 40 to 180 beats/min.

ECG recording:

Pulse Rate: 30 to 300 beats/min.

Pressure Sensor

Semiconductor pressure sensor

Applicable cuff (Arm Circumference) Accuracy of pressure indicator Accuracy of pulse rate

17-22cm (HEM-CS24-B) 22-42cm (HEM-RML31-B) Within ±3mmHg or 2% of reading
Within 5% of reading

Inflation Method

Automatic inflation by electric pump Automatic inflation by electric pump

Deflation Method

Automatic pressure release valve

Display Power Source

LCD digital display on device and Smartphone display 4 AA" batteries

Operating Conditions Storage Conditions Dimensions (mm)

10 to 40°C 15 to 90% RH -20 to 60°C 10 to 95% RH 231 (W) × 98 (D) × 123 (H) mm

Weight

Approximately 21oz (600g) (not including batteries)

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
Pulse Rate: 30 to 300 beats/min.
None None None Unknown None None Smartphone display 1 Lithium Manganese Dioxide Coin Cells 10 to 40°C -20 to 60°C 118 (W) × 62 (D) × 16.5 (H) mm
40g

SE Assessment to Predicate Devices
Same as primary predicate. No change from cleared BP7900 device.
Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison (Cont.)

Proposed Device:

Primary Predicate:

Omron Healthcare, Inc.

Omron BP7900 Blood Pressure

Monitor + EKG

(K182579)

ECG Detectors

Provided by KardiaAI platform

(K181823):

· Normal Sinus Rhythm

· Atrial Fibrillation

· Bradycardia

· Tachycardia

· Unclassified

· Unreadable

Body Movement

Yes, for BP measurement

Detection

Communications
Data Acquisition for ECG recording:
Frequency Response ECG channels Resolution Sample Rate Memory Capacity
Technology/Features Power Supply

BP measurement: Bluetooth ECG recording: Ultrasonic Acoustics acquired by phone
0.67 - 40Hz Single Channel 16-bit 300 samples/second BP measurement: 90 BP readings can be stored in the internal memory ECG recording: Essentially unlimited due to real-time transmission to MCP memory (size of ECG file is miniscule kilobytes compared to device memory capacity gigabytes)
Regulates power voltage regardless of battery voltage.

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
Provided by KardiaAI platform (K181823):
· Normal Sinus Rhythm · Atrial Fibrillation · Bradycardia · Tachycardia · Unclassified · Unreadable No
Ultrasonic Acoustics acquired by phone

SE Assessment to Predicate Devices
Same as both predicate devices with respect to the use of the cleared AliveCor, Inc. KardiaAI (K181823) analysis functionalities. No change from cleared BP7900 device.
Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device.

0.5 - 40Hz Single Channel 16-bit 300 samples/second
Essentially unlimited due to real-time transmission to MCP memory (size of ECG file is miniscule kilobytes compared to device memory capacity gigabytes)

Same as primary predicate. No change from cleared BP7900 device.
Same as primary predicate. No change from cleared BP7900 device.

Regulates power voltage regardless of Same as primary predicate. No

battery voltage.

change from cleared BP7900 device.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison (Cont.)

Proposed Device:

Primary Predicate:

Omron Healthcare, Inc.

Omron BP7900 Blood Pressure Monitor + EKG

(K182579)

Microprocessor

BP measurement:

· Determines blood pressure and pulse rate

· Controls the pump, the valve, and the display

· Detects switch operations

· Stores measurement results

· Manages date and time

ECG recording:

None. ECG rhythm is analyzed by AliveCor engine.

Pressure Sensor

Semiconductor pressure sensor

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
None (ECG rhythm is analyzed by AliveCor engine)
None

Rapid Exhaust/Deflation Valve
Inflation Source

Active electronic control valve that

performs cuff air bleeding and release performs cuff air bleeding and release

DC rolling diaphragm pump

None None

Display

BP measurement: LCD (Liquid Crystal Display) displays; · Current cuff pressure · Systolic blood pressure · Diastolic blood pressure · Pulse rate · Error messages
ECG recording: Smartphone (App) displays; · ECG rhythm · ECG detectors (Normal / Possible
Atrial Fibrillation / Bradycardia / Tachycardia Unclassified / Unreadable) · Past ECG recording in the memory · Some other user convenient information

BP measurement: LCD displays;
· Current cuff pressure · Systolic blood pressure · Diastolic blood pressure · Pulse rate · Error messages
ECG recording: Smartphone (App) displays;
· ECG rhythm · ECG detectors (Normal / Possible
Atrial Fibrillation / Bradycardia / Tachycardia Unclassified / Unreadable) · Past ECG recording in the memory · Some other user convenient information

Smartphone (App) displays;
· ECG rhythm · ECG detectors (Normal / Possible
Atrial Fibrillation / Bradycardia / Tachycardia Unclassified / Unreadable) · Past ECG recording in the memory · Some other user convenient information

SE Assessment to Predicate Devices
Same as primary predicate. No change from cleared BP7900 device.
Same as primary predicate. No change from cleared BP7900 device. Same as primary predicate. No change from cleared BP7900 device.
Same as primary predicate. No change from cleared BP7900 device. BP measurement: Same as primary predicate. No change from cleared BP7900 device. ECG recording: Same as both predicate devices with respect to types of information displayed. The specific content displayed to the user within the software (e.g., on-screen text and user interface) has been updated from the primary predicate device to be consistent with that of the secondary predicate device.

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510(k) SUMMARY

K202228

Table 1: Substantial Equivalence Comparison (Cont.)

Proposed Device:

Primary Predicate:

Omron Healthcare, Inc.

Omron BP7900 Blood Pressure

Monitor + EKG

(K182579)

Controls

· START/STOP Button

· Connection Button

Number of ECG Leads Single lead, 4 electrodes (2 neutral

Single lead, 4 electrodes (2 neutral

electrodes)

Anatomical sites

BP measurement:

Upper arm

ECG recording:

Left hand fingers to right hand fingers Left hand fingers to right hand fingers

User Interface for ECG

recording:

Primary Lead

Lead , Left to right

Data Acquisition

Ultrasonic acoustics

Hardware

Universal module

Software interface

Apple iOS-based or Google Android- Apple iOS-based or Google Android-

based software

Materials

Patient contact materials of the cuff

have been tested in accordance with

have been tested in accordance with ISO

ISO 10993 and FDA guidance

10993 and FDA guidance

Secondary Predicate: AliveCor, Inc.
KardiaMobile System (K191406)
None (When electrode is held by users it starts recording) Single Lead, 2 electrodes
Left hand fingers to right hand fingers
Lead , Left to right Ultrasonic acoustics iPhone case and Universal module Apple iOS-based or Google Androidbased software Patient contact materials of the cuff have been tested in accordance with ISO 10993 and FDA guidance

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510(k) SUMMARY (CONT.)

K202228

SUBSTANTIAL EQUIVALENCE
The proposed Indications for Use for the proposed device, the Omron BP7900 Blood Pressure Monitor + EKG, is substantially equivalent to the Indications for Use for the predicate devices. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the Omron BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(b)]
All necessary performance testing was conducted on the proposed Omron Model BP7900 Blood Pressure Monitor + EKG to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)] Nonclinical Testing Summary:
All necessary bench testing was conducted on the proposed device to support a determination of substantial equivalence to the predicate device. The same test standards and methods used to support the cleared BP7900 primary predicate device were employed for this proposed device. To support the minor changes, additional software verification and validation was performed to confirm the minor change in onboarding procedures were successfully implemented, and that the device continues to perform as intended in accordance with its proposed intended use.
[807.92(b)(2)] Clinical Testing Summary:
No clinical testing was conducted in support of this 510(k) Premarket Notification.
CONCLUSIONS [807.92(b)(3)]
Based on the results from the nonclinical tests performed in support of the updated BP7900, it is concluded that the proposed device performs at least as safely and effectively as the legally marketed predicate devices.
SUMMARY The Omron Model BP7900 Blood Pressure Monitor + EKG is substantially equivalent to the predicate devices.

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