The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The P50 and P90 Electrodes when used with Mitek VAPR Electrosurgical Systems are intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The VAPR CP90 Electrodes when used with Mitek VAPR VUE Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.

The DePuy Mitek VAPR Electrodes for use with all VAPR Electrosurgical Systems 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.

The DePuy Mitek 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 tissue in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow, and wrist.

Device Description

The VAPR VUE Radiofrequency System is DePuy Mitek's next generation of VAPR Radiofrequency Systems. The system consists of a generator, wired or wireless footswitch and electrodes. The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes.

As with its predicate devices including the VAPR 3 generator, this electrosurgical system 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 VUE system offers five output types of operation: Vaporization (ablation), Coagulation, CP Vaporization (ablation), Blended Vaporization (ablation and coagulation) and temperature control coagulation. All types are present in the predicate device (VAPR3 generator) except the CP Vaporization (ablation).

The VAPR P50 and P90 Electrodes are an addition to the family of LPS Electrodes. These Suction Electrodes are soft tissue ablation and coagulation devices intended for use with the VAPR Electrosurgical Systems. They extend the utility of the system by removing bubbles created during activation from the operating site.

The VAPR CP90 Electrodes are identical in technological characteristics as the P90 electrode only it is intended to be run only off the VAPR VUE platform at pre-determined default settings specific for the device. The CP90 with Handcontrols offers the integration of handcontrol capabilities via three buttons molded on the existing one-piece handles. Those buttons control ablation, coagulation and the generator mode functions.

AI/ML Overview

The information provided describes the DePuy Mitek VAPR VUE Radiofrequency System and associated electrodes, which is a medical device for electrosurgical cutting and coagulation. The submission is a 510(k) premarket notification, aiming to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or detailed reported device performance in terms of clinical metrics (e.g., success rates, complication rates, accuracy). Instead, it relies on demonstrating compliance with recognized electrical safety and software standards and asserting comparable RF performance.

The device's performance is generally stated as:

RF Performance: "The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes."
Safety and Performance Testing: "In addition safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices."
Verification Testing: "Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions."

Acceptance Criteria (Implied by Standards & Equivalence):

Acceptance Criteria Category	Specifics (Implied by Standards/Assertions)	Reported Device Performance
Electrical Safety	Compliance with EN 60601-1: 1995 (General requirements for safety), EN60601-2-2:2007 (Particular requirements for the safety of high-frequency surgical equipment), EN60601-1-2: 2006 (Electromagnetic compatibility).	"Verification of the VAPR VUE System and Electrodes includes electrical, Safety... tests to show that the device meets its product Performance specifications over a range of operating conditions." "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."
Software Safety/Quality	Compliance with EN 60601-1-4/A1:2005 (Programmable electrical medical systems), ISO 62304 (Medical device software-software life cycle process), FDA Guidance for Premarket Submission for Software, General Principals of Software Validation, Guidance Off-The-Shelf Software Use.	"Verification of the VAPR VUE System and Electrodes includes ... software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions." "Results of performance and safety testing have demonstrated that the modified device is suitable for its intended use."
RF Performance Comparability	Expected to provide comparable RF performance to predicate devices (VAPR IIITM).	"The VAPR VUE generator was designed to provide comparable RF performance with legacy VAPR electrodes."
Functional Performance	Device meets product performance specifications over a range of operating conditions.	"Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions." "Validation testing for the VAPR VUE includes testing to show the device meets user needs."
Substantial Equivalence	Demonstrates equivalence in intended use, essential components, materials, performance specifications, and technology characteristics to predicate devices.	The conclusion states: "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 VUE Radiofrequency System, along with the Premiere50, Premiere90 and CP90 Electrodes are shown to be substantially equivalent to the predicate devices..."

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

The document does not specify sample sizes for "test sets" in the context of clinical performance or accuracy in a medical imaging or diagnostic sense. The testing mentioned (electrical, safety, software, performance) would typically involve engineering verification and validation on the device itself and its components, rather than patient data test sets.

Test Set Sample Size: Not applicable/not specified in the provided text for clinical performance. The testing mentioned is for engineering verification and validation.
Data Provenance: Not applicable, as no clinical/patient data test sets are described. The testing is device-centric.

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

This information is not provided because 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."
Therefore, there were no "ground truth" derived from expert review of clinical cases.

4. Adjudication Method for the Test Set

This information is not applicable as there were no clinical test sets 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

No MRMC study was done. This device is an electrosurgical tool, not an AI-assisted diagnostic or imaging device. The concept of "human readers improve with AI vs without AI assistance" is not relevant to this type of device.

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

Not applicable. This is a hardware-based electrosurgical system, not an algorithm, and does not operate in a standalone diagnostic capacity.

7. The Type of Ground Truth Used

No clinical grand truth was used. The "ground truth" for the device's performance is its compliance with engineering specifications, electrical safety standards, software standards, and its ability to achieve its intended physical effects (resection, ablation, coagulation) in laboratory or simulated environments, as demonstrated through non-clinical performance and safety testing.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" of data.

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

Not applicable. As no training set was used, no ground truth needed to be established for it.

Summary

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KC100638

JUN 1 8 2010

510(k) SUMMARY

Date Prepared March 4, 2010 Submitter's Name and DePuy Mitek, Inc. Address: a Johnson & Johnson company 325 Paramount Drive · Raynham, MA 02767 Contact Person Susan Kagan Project Manager, Regulatory Affairs DePuy Mitek, Inc. a Johnson & Johnson company 325 Paramount Drive Raynham, MA 02767, USA Telephone: 508-880-8097 Facsimile: 508-977-6955 e-mail: skagan@its.jnj.com Name of Medical Classification Name: Electrosurgical cutting and coagulation device Device and accessories: 21 CFR 878.4400 Electrosurgical cutting and coagulation device Common/Usual Name: and accessories: Arthroscope VAPR® VUE™ Radiofrequency System Proprietary Name: P50 Electrode P90 Electrode CP90 Electrode CP90 Electrode with Handcontrol FDA Classification: ll FDA product code: GEI The proposed VAPR VUE Radiofrequency System is substantially Predicate Device(s) equivalent to: K041135: VAPRIIITM (May 10, 2004) 트 The proposed VAPR VUE Radiofrequency System is also similar to: K031085: Gyrus SuperPulse Electrosurgical Generator (July 21, I 2003)

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	The proposed Wireless Footswitch is substantially equivalent to:
	K083161: ConMed Linvatc Zen Wireless Footswitch K053510: Linemaster IR Wireless Footswitch System K033135: Stryker Wireless Universal Footswitch
	The proposed P90 and CP90 Electrodes are substantially equivalent to:
	K002422: VAPR 90° Suction Electrode (August 31, 2000) K041135: VAPR LPS Electrode (May 10, 2004) K082643: VAPR Electrodes with Handpieces (December 19, 2008)
	The proposed P50 Electrode is substantially equivalent to:
	K992876: The 2.3 Wedge Effect Electrode (September 24, 1999) K041135: VAPR LPS Electrode (May 10, 2004) K082643: VAPR Electrodes with Handpieces (December 19, 2008)
Device Description	The VAPR VUE Radiofrequency System is DePuy Mitek's next generationof VAPR Radiofrequency Systems. The system consists of a generator,wired or wireless footswitch and electrodes. The VAPR VUE generatorwas designed to provide comparable RF performance with legacy VAPRelectrodes.
	As with its predicate devices including the VAPR 3 generator, thiselectrosurgical system utilizes bipolar technology specifically designed toprovide a range of arthroscopic surgical treatments including soft tissueablation, contouring, cutting and coagulation and temperature control.
	The VAPR VUE system offers five output types of operation: Vaporization(ablation), Coagulation, CP Vaporization (ablation), Blended Vaporization(ablation and coagulation) and temperature control coagulation. Alltypes are present in the predicate device (VAPR3 generator) except theCP Vaporization (ablation).
	The VAPR P50 and P90 Electrodes are an addition to the family of LPSElectrodes. These Suction Electrodes are soft tissue ablation andcoagulation devices intended for use with the VAPR ElectrosurgicalSystems. They extend the utility of the system by removing bubblescreated during activation from the operating site.
	The VAPR CP90 Electrodes are identical in technological characteristicsas the P90 electrode only it is intended to be run only off the VAPR VUEplatform at pre-determined default settings specific for the device. TheCP90 with Handcontrols offers the integration of handcontrol capabilitiesvia three buttons molded on the existing one-piece handles. Those

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buttons control ablation, coagulation and the generator mode functions.

Indications for Use

Comparison to Predicate Device

This submission is intended to demonstrate that the VAPR VUE Radiofrequency System, P50, P90 and CP90 Electrodes 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. All of the electrodes which are the subject of this submission have the same Indications for Use and technology characteristics. Changes include:

The P50 electrode is identical to its predicate with the exception . of default power which falls within the generator specification.
P90 and CP90 active tip and suction electrode material change. .
. The CP90 Electrodes is provided with non- handcontrol version as well a handcontrol capability which uses the same fundamental technology as the wired footswitch.

The VAPR VUE Radiofrequency System has been compared to legally marketed devices with respect to intended use, performance and technology characteristic. The VAPR VUE has the same Indications for Use and technology characteristics.

. . Enhancements on the VAPR VUE generator include:
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O CP output type
Open the range of Peak power output O

In addition safety and performance testing have been done to validate the performance and safety of the device. It has been demonstrated that these device modifications will not affect safety and effectiveness of the subject devices.

Verification of the VAPR VUE System and Electrodes includes electrical, Safety and software and performance tests to show that the device meets its product Performance specifications over a range of operating conditions. Validation testing for the VAPR VUE includes testing to show the device meets user needs. Verification testing conform to the following Standards and Guidance documents:

Standard/Guidance	Description
EN 60601-1: 1995	Medical electrical equipment -- Part 1: Generalrequirements for safety
EN60601-2-2:2007	Medical electrical equipment -- Part 2-2:Particular requirements for the safety of highfrequency surgical equipment
EN60601-1-2: 2006	Medical electrical equipment -- Part 1-2:General requirements for safety - Collateralstandard: Electromagnetic compatibility -Requirements and tests.
EN 60601-1-4/A1:2005	EN 60601-1-4/A1 2005 electrical equipment -Part 1-4: general rules of security - CollateralStandard: electrical systems programmable
ISO 60601-1-4	Medical Electrical Equipment: Part 1-4 Generalrequirements for collateral standard:Programmable electrical medical systems.
ISO 62304	Medical device software-software life cycleprocess
Guidance for the Content of Premarket Submission for SoftwareContained in Medical Devices: 2005
General Principals of Software Validation; Final Guidance forIndustry and FDA Staff: 2002
Guidance Off-The-Shelf Software Use in Medical Devices: 1999

TABLE 1 Standards & Guidance Documents

Clinical Testing

No clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance. The VAPR

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VUE Radiofrequency System and Electrodes 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 VUE Radiofrequency System, along with the Premiere50, Premiere90 and CP90 Electrodes are shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.

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Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

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

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

Re: K100638

Trade/Device Name: VAPR Electrodes

VAPR VUE Radiofrequency System including wireless footswitch and electrodes

JUN 1 8 2010

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 15, 2010 Received: June 17, 2010

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

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Page 2 - Ms. Susan Kagan

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

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Indications for Use

510(k) Number (if known):

Device Name: VAPR Electrodes

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

יי

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-Off

(Division Sig Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100638

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Indications for Use

510(k) Number (if known):

Device Name: VAPR VUE Radiofrequency System including Wireless Footswitch and Electrodes

Indications for Use:

The Mitek VAPR VUE Radiofrequency System is intended for resection, ablation and 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.

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)

signature

Page 1 of 1

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100638

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.