The VERSAJET III Hydrosurgery System cuts, ablates and foreign matter from wounds via pressurized saline. The system is intended for applications that in the physician's judgment, require sharp debridement:

wound debridement (acute and chronic wounds, burns),
soft tissue debridement and cleansing of surgical sites.

Device Description

The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.
The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.
The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the VERSAJET III Hydrosurgery System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study with quantitative performance metrics for AI applications. The device described (a hydrosurgery system) is a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically relies on algorithms and data for its function.

Therefore, many of the requested categories in your prompt related to AI/algorithm performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this traditional medical device submission.

However, I can extract information related to the device's "performance" in the context of a 510(k) (which means demonstrating safety and effectiveness compared to a predicate) and non-clinical testing.

Here's a summary based on the provided text, addressing the applicable points and indicating when information is not present or relevant to this type of device:

Device: VERSAJET III Hydrosurgery System

Predicate Device: VERSAJET II Hydrosurgery System (K143115)

Regulation Number: 21 CFR 880.5475 (Jet lavage)

Regulatory Class: Class II

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance results in the way one would for an AI diagnostic algorithm (e.g., sensitivity, specificity thresholds). Instead, "performance" in this context refers to the device's functional integrity, safety, and equivalence to the predicate device through non-clinical testing.

Test Conducted	Objective/Acceptance Criteria (Implied)	Reported Device Performance/Conclusion
Pressure, Flow Rate and Hand Piece Reliability	(Implied) To ensure the device delivers consistent and appropriate pressure and flow rates as designed and that the handpieces are reliable during intended use, matching or exceeding predicate performance for debridement.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.
Hand Piece Aerosolization & Bacterial Transmission	(Implied) To assess and prevent unacceptable levels of aerosol generation or bacterial transmission during use, ensuring user and patient safety and infection control.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.
Console Cut-Off Pressure	(Implied) To verify the console's safety mechanism for pressure control, ensuring it operates within safe parameters and cuts off pressure appropriately to prevent injury or device malfunction.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.
Console Reliability	(Implied) To assure the console's durability and consistent performance over its expected lifespan under various operational conditions.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.
Operating Environment	(Implied) To confirm the device functions correctly and safely within its specified environmental conditions (e.g., temperature, humidity) and is resistant to typical operational stresses.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.
Human Factors Summative Testing	(Implied) To evaluate the user interface and device interaction to ensure it is safe and effective for use by intended users, identifying and mitigating potential use errors. Acceptance criteria would involve demonstrating usability and safety per applicable human factors guidance.	Testing was completed consistent with IEC 62366, IEC 60601-1-6, and FDA Guidance Document: Applying Human Factors and Usability Engineering to Medical Devices. Results support that the VERSAJET III is substantially equivalent.
Electrical safety	(Implied) To demonstrate compliance with electrical safety standards, preventing electrical hazards to both patients and operators. Acceptance criteria would be adherence to specific clauses of IEC 60601-1.	Performed per IEC 60601-1. Results support that the VERSAJET III is substantially equivalent.
EMC (Electromagnetic Compatibility)	(Implied) To ensure the device operates without causing or being susceptible to electromagnetic interference, preventing functional disruption or safety issues. Acceptance criteria would be adherence to specific clauses of IEC 60601-1-2.	Performed per IEC 60601-1-2. Results support that the VERSAJET III is substantially equivalent.
Bench top performance testing including challenge conditions	(Implied) To evaluate the device's functional performance under various simulated conditions, including worst-case scenarios, to ensure it meets design specifications for cutting, ablating, and removing tissue and foreign matter. This likely includes mechanical and fluid dynamics performance.	Testing was completed to prove safety and effectiveness, and to demonstrate substantial equivalence in performance to the predicate device. Results support that the VERSAJET III is substantially equivalent.

The overall conclusion for all tests is that they were completed to prove safety and effectiveness and to demonstrate substantial equivalence in performance to the predicate device. The submission states, "Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use."

2. Sample size used for the test set and the data provenance

Not Applicable. This is a physical device, and the testing described is non-clinical bench testing, electrical safety, EMC, and human factors. There is no "test set" of patient data in the context of an AI algorithm evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. As above, no patient data test set requiring expert ground truth for an algorithm. Human factors testing would involve user interaction, but this is different from establishing ground truth for diagnostic imaging.

4. Adjudication method for the test set

Not Applicable. No test set of patient data requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This is not an AI-powered diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This is a physical, manually operated medical device tool; it does not have an algorithm that performs a standalone function for diagnosis or intervention without human control.

7. The type of ground truth used

Not Applicable. Ground truth, in the context of AI, refers to the verified correct output for a given input. For this device, "ground truth" would relate to engineering specifications, safety standards, and functional performance benchmarks (e.g., a handpiece reliably delivers X pressure, a safety cutoff activates at Y point, components withstand Z cycles). The document does not detail specific "ground truth" methods beyond adherence to standards and demonstrating equivalence to predicate performance.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI model that requires a training set of data.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set for an AI model.

In summary, the provided document details a 510(k) submission for a conventional medical device (hydrosurgery system). The "acceptance criteria" and "study" refer to non-clinical engineering and performance testing aimed at demonstrating the device's safety, effectiveness, and substantial equivalence to a predicate device, rather than the performance metrics and ground truth methodologies typically associated with AI/SaMD products.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 16, 2023

Smith & Nephew Medical Limited Zoe Smith Regulatory Affairs Specialist 101 Hessle Road Hull, HU3 2BN United Kingdom

Re: K220964

Trade/Device Name: VERSAJET Hydrosurgery System (III) Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: Class II Product Code: FQH Dated: March 2, 2023 Received: March 2, 2023

Dear Zoe Smith:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

{1}------------------------------------------------

requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 (OS) 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 531-542 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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-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,

David Krause -S

for Julie A. Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220964

Device Name VERSAJET III Hydrosurgery System

Indications for Use (Describe)

soft tissue debridement and cleansing of surgical sites.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Traditional 510(k) Premarket Notification - K220964

510(k) Summary (K220964)

21 CFR 807.92 (a)(1): Submitter's Information
510(k) OwnerName	Smith & Nephew Medical Ltd
Address	101 Hessle Road, Hull, HU3 2BN, United Kingdom
EstablishmentRegistration Number	8043484
Contact Name	Zoe Smith
Telephone Number	+447583672659
Date Prepared	15th May 2023
21 CFR 807.92 (a)(2): Device Information
Device Name(Trade/ProprietaryName)	VERSAJET III Hydrosurgery System
Common Name	Hydrosurgery System
Review Panel	General and Plastic Surgery
RegulationNumber	21 CFR 880.5475
Regulatory Class	Class II
Product Code	FQH
21 CFR 807.92(a)(3): Legallymarketed device towhich equivalenceis claimed	510(k) Number: K143115Device Name: VERSAJET II Hydrosurgery System

21 CFR 807.92 (a)(4): Device Description

The VERSAJET III Hydrosurgery System consists of a reusable console, foot pedal and single-use, sterile hand pieces.

The VERSAJET III Hydrosurgery System can be used to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications. This is a debridement system intended for wound and soft tissue debridement, and cleansing of the surgical site. This is achieved yia the delivery of a pressurized stream of sterile saline fluid acts to tangentially ablate the surface of the tissue and propel excised tissue and debris out of the wound. The debris and fluid are directed into the handpiece into a flexible tube, which carries the effluent to the drain or collection canister.

The pressure can be adjusted using either the foot switch or on the touchscreen front panel of the console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on the needs of a particular application.

21 CFR 807.92 (a)(5): Intended Use / Indications for Use

wound debridement (acute and chronic wounds, burns),
soft tissue debridement and cleansing of surgical sites.

{4}------------------------------------------------

Traditional 510/k) Premarket Notification - K220

21 CFR 807.92 (a)(6): Comparison of Technological Characteristics between the Subject and Predicate Devices

The technological principle for debridement and cleansing of the surgical site for the VERSAJET III Hydrosurgery System is identical to the predicate device, the VERSAJET II Hydrosurgery System. Both the subject and predicate devices use a pressurized stream of sterile fluid to cut, ablate and remove tissue and foreign matter from wounds and to resect and remove material in a variety of surgical applications.

The subject and predicate devices are based on the following same technological elements:

Consists of two primary components: an electrically (mains) powered console that is reusable equipment, and single-use, sterile disposable handpieces with tubing and pump cartridge.
-Uses a pressurized stream of sterile fluid to cut, ablate and remove tissue
-The pressure settings can be adjusted from 1-10 at factory pre-set increments.

The indications for use are similar for the subject and predicate device, although the phrase "pulse lavage irrigation" is removed and the mechanism of action is clarified by the addition of "The VERSAJET III Hydrosurgery System cuts, ablates and removes tissue and foreign matter from wounds via pressurized saline".

There are no technological differences between the subject and predicate devices that raise new questions o safety or efficacy. Only minor modifications have been made to the device to improve reliability and enhance quality.

21 CFR 807.92 (b)(1): Brief discussion of nonclinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence

The following tests were completed to prove safety and effectiveness of the subject device, as well as demonstrate substantial equivalence in performance to the predicate device:

Pressure, Flow Rate and Hand Piece Reliability -
-Hand Piece Aerosolization & Bacterial Transmission
-Console Cut-Off Pressure
-Console Reliability
-Operating Environment
-Human Factors Summative Testing

Guidance and Standards Used

Electrical safety per IEC 60601-1 -
EMC per IEC 60601-1-2 -
Human factors per IEC 62366, IEC 60601-1-6 and applicable guidelines listed in FDA Guidance -Document: Applying Human Factors and Usability Engineering to Medical Devices (FDA 2011-D0469)
-Bench top performance testing including challenge conditions

21 CFR 807.92 (b)(2): Brief discussion of clinical tests submitted/referenced/ relied on in this submission to determine substantial equivalence

No clinical data were provided to support the demonstration of substantial equivalence.

21 CFR 807.92 (b)(3): Conclusions drawn

In establishing substantial equivalence to the predicate device, Smith & Nephew Medical Ltd evaluated the indications for use, principle of operation, materials, technology, product specifications and energy requirements of the device. Performance testing, software verification testing, electromagnetic compatibility testing and electrical safety testing has been completed to demonstrate that the VERSAJET III Hydrosurgery System is substantially equivalent to the predicate device for the intended use.

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.