The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

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

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

The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

Device Description

The VAPR system is electrosurgical system that utilizes bipolar technology specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the joint space. and accessories such as a footswitch and electrodes.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the DePuy Mitek VAPR® VUE™ Radiofrequency System, VAPR III Electrode Surgical System, VAPR II Electrode Surgical System, and various VAPR electrodes (P90, CP90, CP90 with Handcontrol, LDS, LPS Electrode). The purpose of the submission is to add hip arthroscopy to the existing indications for use.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implicit)	Reported Device Performance
Device Insertion	No visible cracks or missing portions at the distal tip of the electrodes after insertion.	Pass: No visible cracks or missing portions at the distal tip of the electrodes.
Shaft Bending	No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft.	Pass: No visible splitting of heatshrink after one cycle of bending and straightening of the electrode handle and shaft.
Active Tip Engagement	Electrodes withstand use without breakage at the active tip.	Pass: The electrodes withstood with no breakage at the active tip.

Study Description:

The document states: "Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1."

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

Sample Size: The document does not specify the exact number of devices tested for each performance test (Device Insertion, Shaft Bending, Active Tip Engagement). It only states "performance testing."
Data Provenance: The data provenance is not explicitly stated. However, given that this is a premarket notification to the FDA, the testing was presumably conducted by the manufacturer, DePuy Mitek, a Johnson & Johnson company, in a controlled laboratory environment. It is not clinical data; it's device performance testing.

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

This type of information is not applicable to the provided study. The study involves engineering performance tests (e.g., physical integrity of the electrodes) rather than assessments requiring expert medical interpretation of images or patient outcomes. The "ground truth" for these tests is based on objective pass/fail criteria for physical characteristics.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiographic readings). The disclosed study involves objective engineering performance tests with clear pass/fail criteria, not subjective interpretations.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, particularly in diagnostic imaging. The current submission is for electrosurgical devices and does not involve AI or human reading tasks.

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

A standalone performance study of an algorithm was not done. The VAPR system and electrodes are electrosurgical devices, not AI algorithms.

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

The ground truth for this performance testing is based on objective engineering and physical integrity criteria. For example, for "Device Insertion," "Pass" means "No visible cracks or missing portions at the distal tip of the electrodes." This is a directly observable and measurable physical attribute, not requiring expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable. This is not an AI/machine learning study, so there is no training set mentioned or implied.

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

This information is not applicable for the same reason as point 8. There is no training set in this context.

In summary, the provided document describes a premarket notification for electrosurgical devices, specifically seeking to add hip arthroscopy to their indications. The "study" described involves engineering-based performance verification and validation of the device's physical integrity and functionality, rather than clinical trials or AI performance evaluations.

Summary

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

		FEB 27 2012 K113545
		Pg 1 of 4
Date Prepared	November 30, 2011
Submitter's Name and Address:	DePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767
Contact Person	Susan KaganProject Manager, Regulatory AffairsDePuy Mitek, Inc.a Johnson & Johnson company325 Paramount DriveRaynham, MA 02767, USATelephone: 508-880-8097Facsimile: 508-977-6911e-mail: skagan@its.jnj.com
Name of Medical Device	Classification Name: Electrosurgical cutting and coagulation device and accessories: 21 CFR 878.4400
	Common/Usual Name: Electrosurgical cutting and coagulation device and accessories: Arthroscope
	Proprietary Name: VAPR® VUE™ Radiofrequency SystemVAPR III Electrode Surgical SystemVAPR II Electrode Surgical SystemP90 ElectrodeCP90 ElectrodeCP90 Electrode with HandcontrolLDS ElectrodeLPS Electrode
	FDA Classification: II
	FDA product code: GEI

.. r

・

、

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

The VAPR system is electrosurgical system that utilizes bipolar technology Device Description specifically designed to provide a range of arthroscopic surgical treatments including soft tissue ablation, contouring, cutting and coagulation and temperature control. The VAPR system includes a generator, electrodes which facilitate access and control the delivery of energy to the ioint space. and accessories such as a footswitch and electrodes. This premarket notification is submitted to add HIP arthroscopy to the Description of indication for use for the VAPR Generators and VAPR Electrodes listed in Change this section. As a result, the Instructions for Use (IFU) will be updated to add the hip indication. In addition the following modifications have also been made to the VAPR system Manuals and Electrode IFU's: . Removing Arthroscopic joint surgery examples from VAPR VUE, VAPR II and VAPR III manuals. Add an electrode shaft bending caution. � There have been no changes to the devices which are the subject of this submission. The purpose of this submission is to evaluate the performance testing to support the addition of hip indication. Indications for Use VAPR VUE Radiofrequency system The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR II Electrosurgical system The Mitek VAPR II Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery. VAPR 3 Electrosurgical system The VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

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

K113545
Pg 3 of 4

VAPR CoolPluse Electrodes

VAPR Suction Electrodes (P90, CP90, CP90 with Handcontrol) The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.

VAPR Suction Electrodes (LDS and LPS Electrode)

Substantial Equivalence

With the addition of the Hip indication, the VAPR Systems and electrodes which are the subject of this submission will have the same indication as the following electrodes currently on the market:

A Serfas RF System: K041810
Safety and Performance Verification and Validation of the VAPR Electrodes included performance testing to demonstrate that the device is appropriate for hip arthroscopy. A summary of testing is provided in Table 1.

T	able	1
---	------	---

Testing	Results
Device Insertion	Pass: No visible cracks or missing portions at thedistal tip of the electrodes.
Shaft Bending	Pass: No visible splitting of heatshrink after one cycleof bending and straightening of the electrode handleand shaft.
Active Tip Engagement	Pass: The electrodes withstood with no breakage atthe active tip.

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

Pg 4 of 4
Clinical Testing	No clinical studies are required to demonstrate safety and efficacy of thedevice in support of an application for premarket clearance. The VAPRSystem and Electrodes, when used for hip arthroscopic surgeries, do notdiffer from the predicate devices in fundamental scientific technology.
Conclusion	Results of safety and performance and testing have demonstrated that themodified device is suitable for its intended use.Based on the indications for use and fundamental scientific technology, theVAPR System, along with the VAPR Electrodes are shown to be appropriatefor arthroscopy of the hip as well as substantially equivalent to thepredicate devices under the Federal Food, Drug and Cosmetic Act.

Pg 4 of 4

Clinical Testing

No clinical studies are required to demonstrate safety and efficacy of thedevice in support of an application for premarket clearance. The VAPRSystem and Electrodes, when used for hip arthroscopic surgeries, do notdiffer from the predicate devices in fundamental scientific technology.

Conclusion

Results of safety and performance and testing have demonstrated that themodified device is suitable for its intended use.Based on the indications for use and fundamental scientific technology, theVAPR System, along with the VAPR Electrodes are shown to be appropriatefor arthroscopy of the hip as well as substantially equivalent to thepredicate devices under the Federal Food, Drug and Cosmetic Act.

. . . . . .

દ્વાર (1135.45

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

Public Health Service

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

FEB 2 7 2012

Depuy Mitek, a Johnson & Johnson Company % Ms. Susan Kagan Project Manager, Regulatory Affairs 325 Paramount Drive Raynham, Massachusetts 02767

Re: K113545

Trade/Device Name: VAPR VUE Radiofrequency System

VAPR II Electrosurgical System

VAPR III Electrosurgical System

VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)

VAPR Suction Electrodes (PD90, LDS, and LPS Electrode)

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI, HRX

Dated: November 30, 2011

Received: December 1, 2011

Received. December 1, 2011

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. Iisting 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.

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

Page 2 - Ms. Susan Kagan

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 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,

Mark N. Melkerson
Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K 113545

Pg 1. of 2

Indications for Use

510(k) Number (if known):

Device Name: VAPR Generator

Indications for Use:

VAPR VUE Radiofrequency system

VAN TV CE Radionequency System is intended for resection, ablation, excision of soft tissue, r ne micel v .. 11 10 U nearly and coagulation of soft tissue in patients requiring arthroscopic surgery.

VAPR II Electrosurgical system

VAPR'II Liectrode System, when used with a VAPR™ Electrode, is intended for resection, r he miles will in it it it it is a coasis of blood vessels and coagulation of soft tissue in patients requiring arthroscopic surgery.

VAPR III Electrosurgical system

VAPR 3 Electrode System, when used with a VAPR™ Electrode, is intended for resection, ablation, rne VAI it 3 Licetious bystems of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery.

Prescription Use (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)

Page 1 of 1

(Division Sign-O Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113545

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

Indications for Use

K113545
PS 2 of 2

510(k) Number (if known):

Device Name: VAPR Electrodes

Indications for Use:

VAPR CoolPulse Electrodes (CP90, CP90 with Handcontrol)

VAPR Suction Electrodes (P90, LDS and LPS Electrode)

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)

signature

Page 1 of 1

(Division Sign-Oir)
Division of Surgical, Orthopedic, Division of Restorative Devices

510(k) Number K113545

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.