The VersaJet II Hydrosurgery System is intended for wound debridement (acute and chronic wounds, burns), soft tissue debridement, and cleansing of the surgical site in applications in which, in the physicians judgment, require sharp debridement and pulsed lavage irrigation.

Device Description

The VersaJet II Hydrosurgery System uses 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 device provides cutting, irrigation and evacuation in the same tool. The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from 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 system employs two basic system components: the reusable power console and the single-use, sterile handpiece and tubing assembly. The primary change to the system is the design of the interface of the handpiece into the console. The new design is a simple, intuitive "key lock mechanism" design that improves the ease of connection of the handpiece to the console.

AI/ML Overview

The provided text describes a 510(k) summary for the VersaJet II Hydrosurgery System. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, primarily concerning design changes to the device's interface and performance specifications.

Therefore, it is not a study that assesses a device's performance against clinical acceptance criteria using patient data, nor does it involve ground truth established by experts or human readers.

The information requested in your prompt (e.g., sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable to this type of regulatory submission and the non-clinical testing described.

The device is a medical instrument (hydrosurgery system) for wound debridement, and the "acceptance criteria" here refer to engineering design specifications and performance benchmarks established for the device itself, rather than clinical outcomes or diagnostic accuracy.

Here's the information that can be extracted or inferred based on the provided text, structured to address your points as much as possible, with explanations for why certain points are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are effectively the "Design Input Description" and the reported device performance is the "Result" from the "Summary of Non-Clinical Testing."

Acceptance Criteria (Design Input Description)	Reported Device Performance (Result)
No increase in weight when compared to current console.	Passed
Ability to load pump cartridge up or down (0° or 180°) without affecting performance and/or damaging pump or console.	Passed
Low noise level.	Passed
Easy insertion and removal in a single attempt with positive feedback to user that the handpiece is engaged in the console.	Passed
Force to load and unload disposable mechanism should be no greater than current VERSAJET loading.	Passed
Effective Cutting levels (1 to 10) - console operation must provide equivalent pressures to the new handpiece cutting window equal to existing handpiece models and console.	Passed
The VersaJet II handpiece will operate using the footswitch when correctly connected to the console. Transmission design provides reciprocating axial force to cartridge.	Passed
LED indicators on front panel are visible under normal OR conditions.	Passed
Footswitch provides the control signal to the console to activate the handpiece when depressed and deactivate when released.	Passed
The footswitch will provide the capabilities to control the (up/down) power level setting functions using designated push buttons on the footswitch.	Passed
Handpiece capable of completing 30 minutes average debridement procedure.	Passed
Handpiece is effective at all cutting power levels.	Passed

Biocompatibility testing was also conducted with the following results:

Evaluation Tests Conducted	Result
Cytotoxicity	Passed
Sensitization	Passed
Irritation	Passed

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

Sample Size for Test Set: Not applicable in the context of patient data or diagnostic accuracy. The "test set" here refers to the physical units of the VersaJet II system and its components subjected to engineering design verification tests. The exact number of units tested is not specified but would be typical for product validation (e.g., a batch of handpieces, a console, etc.).
Data Provenance: Not applicable in the context of clinical data. This is non-clinical engineering testing.

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

Number of Experts: Not applicable. The "ground truth" for these tests are objective engineering measurements and functional checks (e.g., measuring weight, force, pressure, noise level, confirming LED visibility, switch functionality, procedure duration, and cutting effectiveness). These are typically performed by trained engineers or technicians in a laboratory setting.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. The results are typically based on objective measurements meeting predefined engineering specifications.

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:

MRMC Study: No. This is a physical medical device, not an AI or imaging diagnostic tool.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is not an algorithm. Its performance is inherent to its physical operation and is always used by a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Engineering specifications and objective physical measurements. For example, a "low noise level" would have a defined decibel limit as its ground truth; "equivalent pressures" would be measured against the predicate device; "30 minutes average debridement procedure" indicates a performance endurance test against a set time.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable. This is not an AI/machine learning device that requires a training set of data.

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

Ground Truth for Training Set Establishment: Not applicable.

Summary

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510(k) Summary VersaJet II Hydrosurgery System

AUG - 1 2011

1. Submitter: Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716
1. Contact: Laura D. Reynolds Director, Regulatory Affairs 727-329-7702
1. Date Prepared: April 4, 2011
Device Name: VersaJet™ II Hydrosurgery System র্বা Common Name: Pulse lavage with sharp debridement Classification Name: Jet Lavage, 21 CFR 880.5475 Product Classification/Code: Class II / FQH

5. Predicate Device Information:

VersaJet Hydrosurgery System 510(k) # K060782 Smith & Nephew, Inc. 970 Lake Carillon Drive, Suite 110 St. Petersburg, FL 33716

6. · Device Description:

200

The stream of saline simultaneously washes the tissue surface and vacuums away foreign material, including contamination and infected and necrotic tissue from 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 system employs two basic system components: the reusable power console and the single-use, sterile handpiece and tubing assembly.

The primary change to the system is the design of the interface of the handpiece into the console. The new design is a simple, intuitive "key lock mechanism" design that improves the ease of connection of the handpiece to the console.

7. Intended Use:

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Summary of Non-Clinical Testing: 8.

There have been no changes to the patient contacting components of the disposable handpiece. Biocompatibility has previously been completed in accordance with ISO 10993 and is on file at Smith & Nephew:

Evaluation Tests Conducted	Result
Cytotoxicity	Passed
Sensitization	Passed
Irritation	Passed

Design verification testing has been completed to document that all performance specifications have been met. The following table summarizes the testing that has been successfully completed.

Design Input Description	Result
No increase in weight when compared to currentconsole.	Passed
Ability to load pump cartridge up or down (0° or 180°)without affecting performance and/or damaging pumpor console.	Passed
Low noise level	Passed
Easy insertion and removal in a single attempt withpositive feedback to user that the handpiece isengaged in the console.	Passed
Force to load and unload disposable mechanismshould be no greater than current VERSAJET loading.	Passed
Effective Cutting levels (1 to 10) - console operationmust provide equivalent pressures to the newhandpiece cutting window equal to existing handpiecemodels and console.	Passed
The VersaJet II handpiece will operate using thefootswitch when correctly connected to the console.Transmission design provides reciprocating axial forceto cartridge.	Passed
LED indicators on front panel are visible under normalOR conditions.	Passed
Footswitch provides the control signal to the console toactivate the handpiece when depressed and deactivatewhen released.	Passed
The footswitch will provide the capabilities to control the(up/down) power level setting functions usingdesignated push buttons on the footswitch.	Passed
Handpiece capable of completing 30 minutes averagedebridement procedure.	Passed
Handpiece is effective at all cutting power levels.	Passed

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U110958

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g. Conclusions Drawn:

Based on the results of design verification testing, it is concluded that the new VersaJet II system meets all defined performance specifications and is substantially equivalent to the currently marketed VersaJet Hydrosurgery System. The VersaJet II Hydrosurgery System is safe and effective for the intended use.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Smith & Nephew, Inc. % Ms. Laura Reynolds Director Regulatory Affairs 970 Lake Carillon Drive, Suite 110 St. Petersburg, Florida 33716

AUG - 1 2011

Re: K110958

Trade/Device Name: VersaJet II Hydrosurgery System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: II Product Code: FQH Dated: July 15, 2011 Received: July 19, 2011

Dear Ms. Reynolds:

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. 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 requirements, including, but not limited to: registration and listing (21

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Page 2 - Ms. Laura Reynolds

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Muh A. Millkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K110958

Device Name: VersaJet II Hydrosurgery System

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MXM
(Division Sign-Off)

Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K110958

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.