The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

Device Description

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery. The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device. It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device. The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort. In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

AI/ML Overview

This document describes the VAPR® Tripolar 90™ Suction Electrode developed by DePuy Mitek Incorporated. The device is a single-use, one-piece bipolar RF suction electrode intended for resection, ablation, and excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues in patients requiring arthroscopic surgery.

The acceptance criteria for the VAPR® Tripolar 90™ Suction Electrode and the study that proves the device meets these criteria are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the battery of tests conducted. For all tests, the reported device performance was "Acceptable."

Test Category	Specific Test	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Cytotoxicity	Pass	Acceptable
	Sensitization	Pass	Acceptable
	Irritation	Pass	Acceptable
	Systemic toxicity	Pass	Acceptable
Electrical Safety	IEC 60601-1 Compliance	Compliant	Complies
	IEC 60601-2-2 Compliance	Compliant	Complies
Software Status	System Compatibility	Generator recognizes device	No software update required
Performance Data	Tissue Tests	Acceptable	Acceptable
	Saline Outflow Temp Test	Acceptable	Acceptable
	Fingerswitching Tests	Acceptable	Acceptable
	Suction Control	Acceptable	Acceptable
	Area of Thermal Margin	Acceptable	Acceptable
	Clogging Frequency	Acceptable	Acceptable
	Active Tip Compression	Acceptable	Acceptable
	Active Tip Side Load	Acceptable	Acceptable
	Three Point Bend Test	Acceptable	Acceptable
	Fluid Ingress	Acceptable	Acceptable
	System Compatibility	Acceptable	Acceptable
	Thermal Shock	Acceptable	Acceptable
	In-joint Temperature Test	Acceptable	Acceptable
	Surface Contact Temp Test	Acceptable	Acceptable

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each individual test. The tests were performed to demonstrate substantial equivalence to predicate devices for regulatory clearance. The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data provided, though it can be inferred that the testing was conducted by or on behalf of DePuy Mitek, Inc. (a U.S. company) to meet FDA requirements.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The tests seem to be primarily engineering and bench-top evaluations, rather than clinical studies requiring expert interpretation of results for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the tests (biocompatibility, electrical safety, performance testing), an adjudication method in the context of expert consensus on medical image interpretation or clinical outcomes is not applicable here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states that "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance." Therefore, there is no effect size of human readers improving with or without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device does not involve an algorithm or AI. It is a physical medical device. Therefore, a standalone performance study in this context is not applicable. The performance tests evaluate the device's physical and electrical characteristics and its interaction with biological tissues in a controlled environment.

7. The Type of Ground Truth Used

The "ground truth" for the various tests appears to be established by:

Biocompatibility: Conformance to recognized international standards (ISO-10993).
Electrical Safety: Conformance to recognized international electrical safety standards (IEC 60601-1, IEC 60601-2-2).
Performance Data: Acceptable outcomes based on internal engineering specifications and testing protocols, designed to demonstrate the device performs as intended and is substantially equivalent to predicate devices.

8. The Sample Size for the Training Set

This information is not applicable. The VAPR® Tripolar 90™ Suction Electrode is a physical medical device, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for this device.

Summary

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

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked slightly offset from each other. The profiles are simple and abstract, with a flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

April 3, 2015

DePuy Mitek Incorporated Ms. Susan Kagan Project Manager 325 Paramount Drive Raynham, Massachusetts 02067

Re: K143475

Trade/Device Name: VAPR® Tripolar 90" Suction Electrode Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 5, 2015 Received: March 6, 2015

Dear Ms. Kagan:

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 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

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

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.

Sincerely yours.

Jennifer R. Stevenson -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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K143475

Device Name VAPR® Tripolar90™ Suction Electrode

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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

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."

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

510(k) SUMMARY

l. SUBMITTER

DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767

Telephone: 508-880-8097 Facsimile: 508-977-6955 e-mail: skagan@its.jnj.com

Susan Kagan Project Manager, Requlatory Affairs

Date Prepared: December 4, 2014

II. DEVICE

Name of Device:	VAPR® TRIPOLAR 90™ Suction Electrode
Common/Usual Name:	Electrosurgical cutting and coagulation device and accessories
Classification Name:	Electrosurgical cutting and coagulation device and accessories:21 CFR 878.4400
FDA Classification:	II
FDA product code:	GEI

PREDICATE lll.

Primary Predicate: CoolPulse 90 Electrode-K113545/ K100638 Reference Device: ArthroCare Super Turbovac-K120791

These predicate devices have not been the subject of a design related recall.

DEVICE DESCRIPTION IV.

The VAPR TRIPOLAR 90 Suction Electrode is a single use, one-piece bipolar RF suction electrode for use in a surgical setting by a surgeon trained in arthroscopic surgery.

The VAPR TRIPOLAR 90 Suction Electrode is an RF device which incorporates 3 electrodes in the probe tip: one active electrode and two return electrodes. This configuration optimizes ablation and coagulation in a single device.

{5}------------------------------------------------

It has been designed to facilitate access and control the delivery of RF energy to the joint space. The connector plug of the VAPR TRIPOLAR 90 Suction Electrode is designed to interface only with the VAPR VUE Radiofrequency Generator. It has an internal identification code which automatically adjusts the VAPR VUE Generator to the optimal default and accessible powers and waveforms. If required, the settings for the VAPR TRIPOLAR 90 Suction Electrode can be modified within safe pre-determined limits by accessing the generator or footswitch control. It is intended to be only operated with the VAPR VUE generator at pre-determined default settings specific for this device.

The VAPR TRIPOLAR 90 Suction Electrode has three sets of buttons to address surgeon preference when holding the electrode. Each pair of buttons offers the same functionality and are ergonomically positioned for surgeon comfort.

In addition the VAPR TRIPOLAR 90 Suction Electrode features vacuum fluid extraction which enhances the efficiency of the electrode and assists in the removal of bubbles and debris created during activation within the operating site. The design includes the ability to vary flow rate to allow the surgeon to make adjustments depending on particular procedural requirements.

V. INDICATION FOR USE

The VAPR Electrodes, for use with the VAPR VUE Radiofrequency System, are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coaqulation of soft tissues in patients requiring arthroscopic surgery.

The Indication for Use statement for the VAPR TRIPOLAR 90 Suction Electrode is not identical to the predicate devices however both the subject device and the predicates devices are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine. The logo features a circular graphic in gold on the left, followed by the text "DePuy Synthes" in a dark blue sans-serif font. Below that, "MITEK SPORTS MEDICINE" is written in smaller, uppercase letters. At the bottom, it says "COMPANIES OF Johnson & Johnson" in a smaller font.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PRIMARY PREDICATE DEVICE

Component	VAPR CoolPulse90 Electrode	VAPR TRIPOLAR 90Suction Electrode
FDA Clearance	Predicate Device K100638/K113545	Subject Device
Indication for Use	The VAPR Electrodes for use with theVAPR VUE Radiofrequency Systemare intended for resection, ablationand excision of soft tissue,hemostasis of blood vessels andcoagulation of soft tissue in patientsrequiring arthroscopic surgery of theknee, shoulder, hip, ankle, elbow,and wrist.	The VAPR Electrodes, for usewith the VAPR VUERadiofrequency System, areintended for resection,ablation and excision of softtissue, hemostasis of bloodvessels and coagulation ofsoft tissues in patientsrequiring arthroscopicsurgery.
Working Length	160mm	155mm
Tip Geometry	oval tip w/suction slot & partialperipheral suction	near oval tip w/suction &partial peripheral suction
Integrated Cable andPlug	Yes	Yes
Integrated HandControl	Yes	Yes
Integrated Suction	Yes	Yes
RF Energy	Bipolar	Bipolar
Sterilization	Gamma Irradiation	Gamma Irradiation

PERFORMANCE DATA VII.

Biocompatibility

The biocompatibility evaluation of the VAPR TRIPOLAR 90 Suction Electrode was conducted in accordance with FDA Blue Book Memorandum # G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
. Sensitization
. Irritation
Systemic toxicity ●

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image displays the logo for DePuy Synthes Mitek Sports Medicine, a company of Johnson & Johnson. The DePuy Synthes logo is in a dark blue font, with the words "Mitek Sports Medicine" in a smaller font below. The Johnson & Johnson logo is in red and is located below the DePuy Synthes logo. To the left of the DePuy Synthes logo is a circular graphic with overlapping shapes.

The VAPR TRIPOLAR 90 Suction Electrode is considered an external communicating device used for a duration of less than 24 hours.

Electrical safety

Electrical Safety was conducted on the VAPR TRIPOLAR 90 Suction Electrode when used with the VAPR VUE generator. The system complies with IEC 60601-1 "Medical electrical equipment -- Part 1: General requirements for safety and IEC 60601-2-2 "Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories"

Software Status

The VAPR TRIPOLAR 90 Suction Electrode is compatible only with the VAPR VUE generator. The generator was previously programed to recognize the VAPR TRIPOLAR 90 Suction Electrode so no software update was required.

Performance Data

The following performance data were provided in support off the substantial equivalence determination.

TEST	RESULTS
• Tissue Tests	Acceptable
• Saline Outflow Temperature Test	Acceptable
• Fingerswitching Tests	Acceptable
• Suction Control	Acceptable
• Area of Thermal Margin	Acceptable
• Clogging Frequency	Acceptable
• Active Tip Compression	Acceptable
• Active Tip Side Load	Acceptable
• Three Point Bend Test	Acceptable
• Fluid Ingress	Acceptable
• System Compatibility	Acceptable
• Thermal Shock	Acceptable
• In-joint Temperature Test	Acceptable
• Surface Contact Temperature Test	Acceptable

Animal Study

No animal studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR TRIPOLAR 90 Suction Electrode does not differ from the predicate device in fundamental scientific technology or intended use.

Clinical Study

No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR TRIPOLAR 90 Suction Electrode does not differ from the predicate device in fundamental scientific technology or intended use.

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image contains the logo for DePuy Synthes Mitek Sports Medicine. The logo consists of a circular design on the left, followed by the text "DePuy Synthes" in a bold, sans-serif font. Below that, the text "MITEK SPORTS MEDICINE" is displayed in a smaller, sans-serif font. At the bottom, the text "COMPANIES OF Johnson & Johnson" is displayed.

VIII. CONCLUSION

Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use.

Based on the indications for use, fundamental scientific technology, and comparison to the predicate devices, the VAPR TRIPOLAR 90 Suction Electrode is shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.