The Versalet 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 consists of two basic system components: the reusable power console and the single-use, sterile (Ethylene Oxide) handpiece and tubing assembly. A footswitch is also available for operating the system. 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 high velocity stream of saline simultaneously washes the tissue surface and vacuums away foreign material from the wound. The 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 footswitch or a sealed membrane switch on the front panel of the power console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on user preference and the needs of a particular application. Associated accessories include: VERSAJET EXACT Handpieces, single-use, sterile, in three configurations . . VERSAJET PLUS Handpieces, single-use, sterile, in three configurations Footswitch

AI/ML Overview

The document provided is a 510(k) premarket notification for the VERSAJET™ II Hydrosurgery System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove a device meets specific acceptance criteria in the manner typically seen for novel AI/diagnostic devices.

Therefore, the information required to populate the fields of your request (acceptance criteria, specific study details for performance metrics, sample sizes, expert involvement, ground truth, etc.) is largely not present in this type of regulatory submission for this particular device.

Here's an explanation of why and what information is available:

Type of Device: The VersaJet II Hydrosurgery System is a physical medical device (jet lavage system) used for wound debridement. It's not a diagnostic AI or imaging device where performance metrics like sensitivity, specificity, or accuracy are typically reported for clinical decision-making.
Regulatory Pathway (510(k)): A 510(k) submission aims to prove that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves demonstrating that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is often demonstrated through bench testing and comparisons to the predicate, rather than large-scale clinical trials establishing novel performance criteria.

Based on the provided document, here's what can be extracted or inferred, and what cannot be:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance
Functional Equivalence: Device performs its intended function (cutting, irrigation, evacuation) similar to the predicate.	- Environmental testing successfully completed. - Reliability testing demonstrated improved reliability of modified components. - Performance testing demonstrated: - Effective cutting pressure range per console power setting is substantially equivalent to the predicate. - System priming is substantially equivalent to the predicate. - Console cut off pressure function is substantially equivalent to the predicate. - Handset insertion, removal, engagement and disengagement forces are substantially equivalent to the predicate.
Safety: Device is safe for its intended use, particularly after modifications.	- Biocompatibility testing on handpieces successfully completed per ISO 10993 (Cytotoxicity, Skin Irritation, Sensitization). - Device complies with IEC 60601-1 (3rd edition) electrical safety standards. - Modifications addressed "electrical issues of not turning on," "oil leakage," and "corrosion."
Biocompatibility: Materials in contact with the patient are biocompatible.	- Biocompatibility on the VersaJet Handpieces has been successfully completed in accordance with applicable parts of ISO 10993.
Sterilization: Device can be effectively sterilized.	- Method of Sterilization: Identical to predicate. Implied validation through standard compliance (ISO 11135).
Compliance with relevant standards.	- Device complies with ISO13485, ISO 14971, ISO 15223-1, ISO 15223-2, BS EN 980, BS EN 1041, IEC 60601-1-2, IEC 60601-1, ISO 11135, ISO 11607-1, ISO 10993-1, ISO 10993-10.

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

Not Applicable / Not provided in detail. The document describes "bench testing" and "environmental testing," "reliability testing," and "performance testing" but does not specify the sample sizes (e.g., number of devices tested, number of simulated procedures) or data provenance (e.g., specific country of origin or whether data simulates real-world use) for these tests in a way that would be relevant for an AI/diagnostic device. The testing described focuses on engineering validation rather than clinical efficacy.

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

Not Applicable. This type of information is not relevant for this device's regulatory submission. There is no concept of "ground truth" derived from expert consensus in the context of validating a jet lavage system's physical performance or safety.

4. Adjudication method for the test set:

Not Applicable. No expert adjudication is described or required for this type of device validation.

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 a physical device, not an AI or diagnostic tool that assists human readers.

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

No. This device does not involve an algorithm with standalone performance.

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

Not Applicable. The "ground truth" for this device's validation is adherence to engineering specifications, safety standards, and performance equivalence to a predicate device, as demonstrated through various bench tests and material analyses.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" in the machine learning sense.

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

Not Applicable. This device does not involve a "training set."

In summary: The provided document is a 510(k) submission for a physical medical device. It focuses on demonstrating "substantial equivalence" through engineering and biocompatibility testing, rather than reporting on the performance metrics (like sensitivity, specificity, or reader studies) typically associated with AI or diagnostic devices that would require detailed acceptance criteria, sample sizes, and ground truth methodologies.

Summary

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

Smith and Nephew Incorporated Ms. Laura Reynolds Director Regulatory Affairs 970 Lake Carillon Drive, Suite 110 Saint Petersburg, Florida 33716

Re: K143115

Trade/Device Name: The VersaJet II Hydrosurgery System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet lavage Regulatory Class: Class II Product Code: FQH Dated: June 11, 2015 Received: June 12, 2015

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.

July 15, 2015

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 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

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerelv vours.

Joshua C. Nipper -S

For

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143115

Device Name The VersaJet II Hydrosurgery System

Indications for Use (Describe)

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)

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Image /page/3/Picture/0 description: The image shows the text "K143115" in black font at the top. Below that is the Smith & Nephew logo, with the words "We are" in gray and "smith&nephew" in orange. The logo is a stylized flower with orange petals.

Wound Management Smith & Nephew, Inc. 970 Lake Carillon Drive Suite 110 St. Petersburg, FL 33716 F 727 392-1261 F 727 392-6914 or 727 392-0797 Customer Care Center: 1 800 876-1261 www.smith-nephew.com

510(k) Summary

General Information
Submitters Name/Address:	Smith & Nephew, Inc.970 Lake Carillon DriveSuite 110St. Petersburg, FL 33716
Establishment Registration Number:	3006760724
Contact Person:	Laura ReynoldsDirector Regulatory Affairs
Phone Number:	(727) 329-7702
Date Prepared:	July 8, 2015
Device Description
Trade Name:	VERSAJET™ II Hydrosurgery System
Generic/Common Name:	Jet Lavage
Classification Name:	Jet Lavage, 21 CFR 880.5475
	Product Code: FQH

Predicate Device Information

Current Device	Predicate Device	510k#	Clearance Date
VERSAJET™ II HydrosurgerySystem	VERSAJET™ II HydrosurgerySystem	K110958	08/01/2011

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 high velocity stream of saline simultaneously washes the tissue surface and vacuums away foreign material from the wound. The fluid acts to tangentially ablate the surface of the tissue and

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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 footswitch or a sealed membrane switch on the front panel of the power console. Pressure settings range from 1-10 in factory pre-set increments, with the pressure increasing with each higher setting number, depending on user preference and the needs of a particular application.

Associated accessories include:

VERSAJET EXACT Handpieces, single-use, sterile, in three configurations .
. VERSAJET PLUS Handpieces, single-use, sterile, in three configurations
Footswitch

Indications for Use

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.

	New Device:	Predicate Device:
		510(k)# K110958
Trade Name:	VERSAJET™ IIHydrosurgery System	VERSAJET™ IIHydrosurgery System
Indications for Use:	Identical	Identical
Environment of use	Identical	Identical
VersaJet II Handpiece	Substantially Equivalent	Substantially Equivalent
Console case	Identical	Identical
Power Supply	Substantially Equivalent	Substantially Equivalent
Motor	Identical	Identical
Transmission	Substantially Equivalent	Substantially Equivalent
User Interface PCB	Substantially Equivalent	Substantially Equivalent
User Interface Housing	Substantially Equivalent	Substantially Equivalent
User Interface Chamber	Substantially Equivalent	Substantially Equivalent
Method of Sterilization:	Identical	Identical
Biocompatibility	Identical	Identical
Software	Identical	Identical

Summary Comparison between New and Predicate Devices

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Table of Modifications

Modification	Reason For Change	Verification TestingPerformed
Saline Bag Spike resin	Obsolete material	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance;retested biocompatibility
Retainer Fitting-changedfrom a metal injectionmolded part to amachined part; nospecification changes	Improve manufacturability of thepart	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
Body Pump with Chamfer- increase length of dowelpin component	Length of the dowel pin wasincreased to assure fullengagement between the pumpbody and retaining fitting;improve manufacturability	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance
High Pressure Hose -nylon material resinchange	Obsolete material	Comprehensive verificationwas completed whichdemonstrated acceptabledevice performance;retested biocompatibility
Change to power supplyPrinted Circuit Board(PCB) layout	Address electrical issues of notturning on	Comprehensive verificationand reliability wascompleted whichdemonstrated acceptabledevice performance
Changes to the oil seals,gasket and compressionspring in the transmission	Increase reliability and addressoil leakage	Comprehensive verificationand reliability wascompleted whichdemonstrated acceptabledevice performance
Replacing passivationprocess with electro-polishing of the userinterface components	Increase their corrosionresistance	Comprehensive verificationand reliability wascompleted whichdemonstrated acceptabledevice performance
Replace a bronze bushingin the user interfacechamber, with a Rulon™bushing	Eliminate galvanic corrosion	Comprehensive verificationand reliability wascompleted whichdemonstrated acceptabledevice performance
Minor modifications tocomply with IEC 60601-13rd Edition safetystandards	Compliance with safety standard	Device complies with theIEC 60601-1 3rd Editionseries of electrical safetystandards

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Non-Clinical Tests (Bench)

Testing has been conducted to verify the modifications to the VERSAJET™ II Hydrosurgery System meet design specifications and demonstrate substantial equivalence to the predicate device.

The list below summarizes the bench testing undertaken and successfully completed for the VERSAJET™ II Hydrosurgery System device:

Environmental testing of the device including the extremes of the operating range and under general operating room conditions.
Reliability testing demonstrating that the modified components improved the reliability of ● the device.
. Monitoring of aerosols generated through the use of the device outside of the operating room in conditions such as out-patient surgery.
. Performance testing demonstrating that the effective cutting pressure range per console power setting, system priming, console cut off pressure function, and handset insertion, removal, engagement and disengagement forces are substantially equivalent to the predicate.

Biocompatibility on the VersaJet Handpieces has been successfully completed in accordance with applicable parts of ISO 10993 as follows:

Cytotoxicity
Skin Irritation
Sensitization

Device complies with the following standards:

. ISO13485:2003, Medical Devices - Quality Management Systems
ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices ●
ISO 15223-1:2012 Medical devices Symbols to be used with medical device labels, . labelling, and information to be supplied Part 1: General requirements.(General)
. ISO 15223-2:2010 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied-Part 2: Symbol development, selection and validation. (General)
BS EN 980:2008 Graphical Symbols for use in the labeling of Medical Devices
BS EN 1041:2008 +A1:2013 Information Supplied by the Manufacturer with Medical Devices
IEC 60601-1-2:2007(3rd edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, Interpretation Sheet
. IEC 60601-1:2005 (3rd edition). Medical Electrical Equipment - Part 1: General Requirements for Safety
ISO 11135: 2014 Medical Devices - Validation and routine control of ethylene oxide sterilization
ISO 11607-1:2006 Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems
. ISO 10993-1:2009 Biological evaluation of medical devices Part 1: Evaluation and testing with a risk management process

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ISO 10993-10:2010 Biological evaluation of medical devices- Part 10:Tests for irritation and skin sensitization

Conclusions

In establishing substantial equivalence to the currently marketed predicate devices, Smith & Nephew, Inc. evaluated the indications for use, materials, technology, product specifications and energy requirements of the device. Performance testing, biocompatibility testing and electrical safety testing has been successfully completed to demonstrate that the VERSAJET™ II 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.