FDA Notification of Substantial Equivalence
The U.S. Food & Drug Administration (FDA) has reviewed the Premarket Notification (510(k)) for the VERSAJET III Hydrosurgery System (K220964) submitted by Smith & Nephew Medical Limited. The FDA has determined that the device is substantially equivalent to legally marketed predicate devices. This determination allows Smith & Nephew to market the device under the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act).
Key regulatory information and requirements include:
- Device Name: VERSAJET Hydrosurgery System (III)
- Regulation Number: 21 CFR 880.5475 (Jet lavage)
- Regulatory Class: Class II
- Product Code: FQH
The Act mandates general controls such as annual registration, device listing, adherence to good manufacturing practices, proper labeling, and prohibitions against misbranding and adulteration. Device labeling must be truthful and not misleading. The FDA also notes that while this letter refers to the product as a device, some cleared products may be combination products. The 510(k) Premarket Notification Database can be accessed at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm.
Further details on regulatory requirements, including medical device reporting (MDR) and postmarketing safety reporting, are available via FDA resources. For comprehensive regulatory information, users are directed to Device Advice and CDRH Learn. The Division of Industry and Consumer Education (DICE) can be contacted for specific inquiries.
510(k) Summary Details
Submitter Information
| Owner Name: | Smith & Nephew Medical Ltd |
| Address: | 101 Hessle Road, Hull, HU3 2BN, United Kingdom |
| Registration Number: | 8043484 |
| Contact Name: | Zoe Smith |
| Telephone Number: | +447583672659 |
| Date Prepared: | May 15, 2023 |
Device Information
| Device Name (Trade/Proprietary Name): | VERSAJET III Hydrosurgery System |
| Common Name: | Hydrosurgery System |
| Review Panel: | General and Plastic Surgery |
| Regulation Number: | 21 CFR 880.5475 |
| Regulatory Class: | Class II |
| Product Code: | FQH |
Predicate Device
| 510(k) Number: | K143115 |
| Device Name: | VERSAJET II Hydrosurgery System |
Device Description
The VERSAJET III Hydrosurgery System consists of a reusable console, a foot pedal, and single-use, sterile handpieces. It is designed to cut, ablate, and remove tissue and foreign matter from wounds, and to resect material in various surgical applications. The system functions as a debridement tool for wound and soft tissue debridement, and for surgical site cleansing.
The mechanism involves delivering a pressurized stream of sterile saline fluid. This fluid stream tangentially ablates tissue surfaces and propels excised material and debris away from the wound. The effluent is collected via the handpiece through a flexible tube leading to a drain or collection canister.
Pressure can be adjusted from 1 to 10 using factory pre-set increments, controlled either by the foot switch or the console's touchscreen front panel.
Intended Use / Indications for Use
The VERSAJET III Hydrosurgery System is indicated for applications that, in the physician's judgment, require sharp debridement. Specific uses include:
- Wound debridement (for acute and chronic wounds, and burns)
- Soft tissue debridement and cleansing of surgical sites
Comparison of Technological Characteristics
The technological principle for debridement and cleansing is identical to the predicate device, the VERSAJET II Hydrosurgery System. Both systems utilize a pressurized stream of sterile fluid for tissue and foreign matter removal.
Key shared technological elements include:
- A mains-powered, reusable console.
- Single-use, sterile disposable handpieces with tubing and pump cartridges.
- A pressurized stream of sterile fluid for cutting, ablating, and removing tissue.
- Adjustable pressure settings (1-10) at factory pre-set increments.
The indications for use are similar, with minor clarifications in the mechanism of action for the VERSAJET III. There are no technological differences that introduce new questions of safety or efficacy; modifications primarily enhance reliability and quality.
Nonclinical Tests and Standards
The submission references completed nonclinical tests to demonstrate safety, effectiveness, and substantial equivalence, including:
- Pressure, Flow Rate and Hand Piece Reliability
- Hand Piece Aerosolization & Bacterial Transmission
- Console Cut-Off Pressure and Reliability
- Operating Environment and Human Factors Summative Testing
Tests were conducted adhering to standards such as IEC 60601-1 (Electrical safety), IEC 60601-1-2 (EMC), and human factors guidelines. Bench top performance testing was also performed.
Clinical Tests
No clinical data were provided to support the demonstration of substantial equivalence.
Conclusions
Smith & Nephew Medical Ltd has established substantial equivalence by evaluating the device's indications for use, principle of operation, materials, technology, product specifications, and energy requirements. Performance testing, software verification, electromagnetic compatibility, and electrical safety testing confirm the VERSAJET III Hydrosurgery System's substantial equivalence to the predicate device for its intended use.
