The DePuy Mitek VAPR Electrodes for use with the VAPR System are intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Device Description

The VAPR Electrodes with Handcontrol are similar in technological characteristics, geometry and materials, as their predicated except they will now be available with integrated handcontrol capabilities via three buttons mounted on the existing one-piece handles. These buttons control ablation, coagulation and the generator mode functions. The plug of the electrode is designed to fit the VAPR VUE generator (K100638: June 18, 2010) socket only and houses the components for ID recognition. They are intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control in addition to the buttons on the handpiece. There are no changes being made to the fundamental technology of the electrode with the exception of the addition of handcontrol functionality.

AI/ML Overview

The provided document describes the predicate device and the new features of the VAPR Electrodes with Handcontrols, primarily the addition of integrated handcontrols. The study conducted to demonstrate the device's conformance to acceptance criteria is detailed as performance testing, summarized in Table 1 on page 2.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria (Implied "Pass")	Reported Device Performance
One Piece Cantilever Handle Separation Test	The handle must remain intact and functional under specified cantilever forces.	Pass
One Piece Handle Retention Test	The handle must remain securely attached to the electrode under specified retention forces.	Pass
Fluid Ingress Test for Finger switches	The finger switches must prevent fluid ingress to maintain functionality and safety.	Pass
System Compatibility Test	The device must function correctly and safely when integrated with the VAPR VUE generator.	Pass
Capacitance Test	The device's capacitance must fall within specified safety and performance ranges.	Pass

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

Sample Size: The document does not specify the exact sample size for each test conducted. It only reports "Pass" for each test.
Data Provenance: The document does not provide details on the country of origin of the data. The data is retrospective in the sense that the testing was performed on the modified electrodes before submission, but it's not a clinical study involving patients or real-world data collection in a longitudinal manner. It's laboratory-based performance testing.

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

Not applicable. The tests performed are engineering and performance validation tests, not clinical evaluations requiring expert interpretation for ground truth establishment in the traditional sense (e.g., image analysis, disease diagnosis). The "ground truth" for these tests would be the pre-defined engineering specifications and safety requirements the device must meet to function as intended.

4. Adjudication Method for the Test Set:

Not applicable. The tests are pass/fail based on objective measurements against engineering specifications, not subjective interpretation requiring an adjudication method.

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

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR Electrodes with handcontrols do not differ from the predicate device in fundamental scientific technology or intended use." Therefore, there is no mention of "human readers" or "AI assistance" in this context, nor an "effect size."

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

Not applicable. This device is an electrosurgical electrode with integrated handcontrols, not an AI algorithm. The performance described is the standalone function of the physical device and its integrated electronic controls, without an AI component or a human-in-the-loop performance study in the context of diagnostic AI.

7. The Type of Ground Truth Used:

The "ground truth" for these tests is based on engineering specifications, safety standards, and predefined performance criteria for the electrosurgical device. These are objective, measurable outcomes (e.g., does the handle separate at a certain force? Is there fluid ingress?). It is not expert consensus, pathology, or outcomes data related to disease.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm or a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this device.

Summary

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APR - 6 2012

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510(k) SUMMARY

Date Prepared	January 11, 2012
Submitter's Nameand Address:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Susan KaganProject Manager, Regulatory AffairsTelephone: 508-880-8097Facsimile: 508-977-6911e-mail: skagan@its.jnj.com
Name of MedicalDevice	Classification Name: Electrosurgical cutting and coagulation deviceand accessories: 21 CFR 878.4400Common/Usual Name: Electrosurgical cutting and coagulation deviceand accessories: ArthroscopeProprietary Name: Side Effect with Hand controlsHook Electrode with Hand controls2.3 Wedge Electrode with Hand controlsS90 with Hand controlsP50 with Hand controlsFDA Classification: IIFDA product code: GEI
PredicateDevice(s)	The proposed P50 Electrode with Handcontrols is substantiallyequivalent to:

K002422: VAPR 90º Suction Electrode (August 31, 2000) ■
K082643: VAPR Electrodes with Handpieces (December 19, 2008) .
K100638: VAPR VUE including CP90 Handcontrol (June 18, 2010) ■

Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols

ﻤﺴﺮ . "

Page 1

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The proposed S90 Electrode with Handcontrols is substantially equivalent to:

1 K041135: VAPR LPS Electrode (May 10, 2004)
K082643: VAPR Electrodes with Handpieces (December 19, 2008) 트
피 K100638: VAPR VUE including CP90 Handcontrol (June 18, 2010)

The proposed Side Effect, Hook and Wedge Electrode with Handcontrols are substantially equivalent to:

K963783 Mitek Electrosurgical System (December 25, 1996) 트
. K082643 VAPR Electrode with Integrated Electrode (December 19, 2008)
: K100638 VAPR VUE including CP90 with handcontrols (June 18, 2010)

Device Description

These buttons control ablation, coagulation and the generator mode functions. The plug of the electrode is designed to fit the VAPR VUE generator (K100638: June 18, 2010) socket only and houses the components for ID recognition. They are intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. If required, the settings for the device can be modified within safe pre-determined limits by accessing the generator or footswitch control in addition to the buttons on the handpiece.

There are no changes being made to the fundamental technology of the electrode with the exception of the addition of handcontrol functionality.

Indications for Use

Comparison to Predicate Device This submission is intended to demonstrate that the VAPR Electrodes with handcontrols are substantially equivalent to their legally marketed devices.

The Electrodes have been carefully compared to legally marketed devices with respect to intended use, essential components and material, performance specifications and technology characteristics.

Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols

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All of the electrodes which are the subject of this submission have the same Indications for Use and technology characteristics. The change to these electrodes is the addition of handcontrol capability which uses the same fundamental technology as the CP90 Electrode and VAPR footswitch.

In addition, safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that the addition of handcontrol capability to their predicate electrodes will not affect safety and effectiveness of the subject devices.

Verification of the VAPR Electrodes with handcontrols includes performance testing to show that the device meets its product specifications. Results of performance testing are summarized in Table 1.

Table 1.

Test	Results
One Piece Cantilever Handle Separation Test	Pass
One Piece Handle Retention Test	Pass
Fluid Ingress Test for Finger switches	Pass
System Compatibility Test	Pass
Capacitance Test	Pass

Clinical Testing

Safety and Performance

No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR Electrodes with handcontrols do not differ from the predicate device in fundamental scientific technology or intended use.

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 Electrodes with handcontrols which are the subject of this submission are shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

Premarket Notification: Traditional 510(k) VAPR Electrodes with Handcontrols

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DEPARTMENT OF HEALTH & HUMAN SERVICES .

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, with three curved lines forming the body and head.

Public Health Service

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

APR - 6 2012

DePuy Mitek % Ms. Susan Kagan 325 Paramount Drive Raynham, MA 02767

Re: K120095

Trade Name: VAPR electrodes with Hand Controls Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: March 22, 2012 Received: March 23, 2012

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. 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 corply 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 Of K F at 607), aboning (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Susan Kagan

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark A. Millkus

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): K120095

Device Name: VAPR Electrodes with Handcontrols

Indications for Use:

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

Over-The-Counter Use (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)

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signature

(Division ign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120095

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.