The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S0 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR TC Electrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Device Description

The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitek VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (S00 and S50) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.

AI/ML Overview

The provided text is a 510(k) summary for DePuy Mitek's VAPR Electrodes. This document is a premarket notification for a medical device that aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing entirely new performance criteria or conducting a comprehensive study to prove novel efficacy or diagnostic performance. Therefore, many of the requested categories for AI/diagnostic device performance studies are not applicable to this type of submission.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) submission like this, "acceptance criteria" are typically met by demonstrating that the new device performs as safely and effectively as its predicate devices. The performance is "accepted" if it is substantially equivalent to devices already on the market. There aren't specific numerical performance metrics in the way one would see for machine learning models.

Acceptance Criteria (Implied by 510(k) process for substantial equivalence)	Reported Device Performance
Safety and Effectiveness	The VAPR Electrodes underwent "validation testing (performance testing) for the device modification." The specific results are not detailed in this summary document, but the FDA concluded they met requirements.
Technological Characteristics	The new VAPR electrodes conform to the same intended use and operating principles as their predicate devices (various existing VAPR electrodes). Differences, if any, are not so significant as to raise new questions of safety or effectiveness.
Indications for Use	The stated Indications for Use for the new electrodes are identical or very similar to the predicate devices, specifically for resection, ablation, excision of soft tissue, hemostasis, and coagulation in arthroscopic surgery of various joints.
Compliance to Design Control Requirements	Mitek provided "certification of compliance to 21 CFR 820.30 Design Control requirements."
Risk Analysis	Mitek provided "descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures."

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

Not applicable. This is a medical device (electrosurgical electrodes), not a diagnostic or AI device that processes patient data. The "test set" would refer to the physical electrodes themselves and their performance in laboratory or simulated surgical environments, not a dataset of patient information. The document refers to "validation testing (performance testing) for the device modification," but does not specify sample sizes for these tests, which would typically involve testing a specific number of manufactured units according to established test protocols.

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

Not applicable. This is not a diagnostic device. "Ground truth" in this context would relate to the physical performance of the electrodes (e.g., cutting efficacy, coagulation, temperature control), which is measured by engineering and biomechanical tests, not expert interpretation of patient data.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" requiring adjudication by experts.

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

Not applicable. This is an electrosurgical device, not an AI-assisted diagnostic tool.

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

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used

For a device like this, the "ground truth" for performance would be based on:

Engineering specifications and standards: Performance criteria derived from industry standards (e.g., electrical safety, material biocompatibility, structural integrity, thermal performance) and internal design specifications.
Biomechanical studies/bench testing: Measurements of tissue cutting, coagulation, and ablation efficacy using ex vivo or in vitro tissue models.
Predicate device performance: The established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set

Not applicable. This is not a machine learning device.

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

Not applicable. There is no training set for an algorithm.

Summary

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K082643

DEC 1 9 2008

510(k) Summary

VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short), VAPR TC Electrode and VAPR Suction Electrodes (S00 and S50) with Integrated Handpiece

Submitter's Name andAddress:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USA
Contact Person	Zheng LiuRegulatory Affairs SpecialistDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-977-3966Facsimile: 508-977-6955e-mail: zliu8@its.jnj.com
Name of Medical Device	Classification Name:	Electrosurgical cutting and coagulating deviceand accessories
	Common/Usual Name:	Electrosurgical System and Electrodes
	Proprietary Name:	VAPR S90 Electrode
		VAPR 3.5 mm Side effect Electrode withIntegrated Handpiece
		VAPR 3.5 mm Hook Electrode withIntegrated Handpiece
		VAPR 3.5 mm Angled Side Effect Electrodewith Integrated Handpiece
		VAPR 2.3 mm Wedge Electrode withIntegrated Handpiece
		VAPR 2.3 mm Wedge Electrode (Short) withIntegrated Handpiece
		VAPR S50 Electrode

Premarket Notification: Special VAPR Electrode with Integrated Handpiece Confidential :

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VAPR 3.5 mm Flex Side Effect Electrode with Integrated Handpiece

VAPR 2.3 Side Effect Electrode (Short) with Integrated Handpiece, 85 mm

VAPR 2.3 End Effect Electrode with Integrated Handpiece, 140 mm

VAPR Temperature Control (TC) End Effect Electrode with Integrated Handpiece, 2.3 mm x 140 mm

The VAPR S 00 Electrode is substantially equivalent to the VAPR LPS Substantial Equivalence (Low Profile Suction) Electrode (K041135, 05/10/2004).

The VAPR 3,5 mm Side effect Electrode with Integrated Handpiece is substantially equivalent to the Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).

The VAPR 3.5 mm Hook Electrode with Integrated Handpiece is substantially equivalent to the 90° Hook Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).

The VAPR 3.5 mm Angled Side Effect Electrode with Integrated Handpiece is substantially equivalent to the Angled Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).

The VAPR 2.3 mm Wedge Electrode with Integrated Handpiece is substantially equivalent to the 2.3mm Wedge Electrode (K000936, 04/19/2000).

The VAPR 2.3 mm Wedge Electrode (Short) with Integrated Handpiece is substantially equivalent to the 2.3mm Wedge Electrode Short (K000936, 04/19/2000).

The VAPR S60 Electrode is substantially equivalent to the VAPR LPS (Low Profile Suction) Electrode (K041135, 05/10/2004).

The VAPR 3,5 mm Flex Side Effect Electrode with Integrated Handpiece is substantially equivalent to the Flex Side Effect Electrode (K963783, 09/19/1996 & K974022, 01/12/1998).

The VAPR 2.3 Side Effect Electrode (Short) with Integrated Handpiccc, 85 mm is substantially equivalent to the 2.3 VAPR Side Effect Electrode (Short) (K992876, 09/24/1999).

The VAPR 2,3 End Effect Electrode with Integrated Handpiece, 140 mm is substantially equivalent to the 2.3 VAPR End Effect

Premarket Notification: Special VAPR Electrode with Integrated Handpiece

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Electrode (K992406, 08/06/1999). The VAPR Temperature Control (TC) End Effect Electrode with Integrated Handpiece, 2.3 mm x 140 mm is the VAPR TC Electrode (K002402, 08/31/2000). Device Classification Electrosurgical cutting and coagulating device and accessories have been classified as Class II, GEI (21 CFR 878.4400). Device Description The device description of the VAPR 3.5 mm and 2.3 mm Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) with Integrated Handpiece is as follows. The DePuy Mitck VAPR System is designed for arthroscopic surgical procedures. The System consists of a high frequency Electrosurgical Generator, disposable Electrodes with integrated Handpiece, and a Footswitch. The components are designed and intended to be operated as a single unit. The device description of the VAPR TC Electrode with Integrated Handpiece is as follows. The VAPR Temperature Control Electrode is a soft tissue desiccation device intended for use with the VAPR Systems. Utilization with a VAPR System allows the tip temperature of the electrode to be indicated on the generator display. The device description of the VAPR Suction Electrodes (Sm and S60) is as follows. The VAPR Suction Electrodes are soft tissue ablation and desiccation devices intended for use with the VAPR System. Thev extend the utility of the system by removing bubbles created during activation from the operating site. Indications for Use The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (S20 and S50) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist. The VAPR TC Elcctrode with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgiçal System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Premarket Notification: Special VAPR Electrode with Integrated Handpiece

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Safety and Performance

In support of the 510(k), Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing (performance testing) for the device modification.

Based on the Indications for Use, technological characteristics and safety and performance testing, the VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short), VAPR TC Electrode and VAPR Suction Electrodes (S0 and S50) with Integrated Handpiece have been shown to be substantially cquivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Special VAPR Electrode with Integrated Handpiece

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circle around the eagle. The logo is black and white.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Depuy Mitek % Ms. Zheng Liu Regulatory Affairs Specialist 325 Paramount Drive Raynham, Massachusetts 02767

DEC 1 9 2008

Re: K082643

Trade/Device Name: VAPR Electrodes with Integrated Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 24, 2008 Received: November 26, 2008

Dear Ms. Liu:

We have reviewed your Scction 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Zheng Liu

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Protmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: VAPR Electrodes with Integrated Handpiece

Indications For Use:

The VAPR Electrodes (end effect, side effect, wedge, angled, hook, flex, side effect short and wedge short) and VAPR Suction Electrodes (Sº and S56) with Integrated Handpiece with Integrated Handpiece, when used with the DePuy Mitek VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR TC Electrode with Integrated Handpicce, when used with the DePuy Mitek VAPR Electrosurgical System, is intended for coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden Sir mkm

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number K082643

Page 1 of 1

Premarket Notification: Special VAPR Electrode with Integrated Handpiece

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.