The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

Device Description

The HeatWave™ Electrode is a sterile, single-use, monopolar electrode designed to be used in conjunction with an electrosurgical generator via an electrosurgical pencil and a dispersive pad. The HeatWave Electrode will be sold individually and/or in a kit containing an electrode, electrosurgical pencil and an electrosurgical dispersive pad.

AI/ML Overview

The provided document describes a 510(k) submission for the HeatWave™ Electrode. A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission relies on demonstrating substantial equivalence, rather than conducting new clinical studies with defined acceptance criteria and performance outcomes.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or specific performance metrics from a comparative effectiveness or standalone study.

Instead, the submission focuses on:

Device Description: A sterile, single-use, monopolar electrode for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures.
Intended Use: As stated above.
Substantial Equivalence: Claimed to be substantially equivalent in design, function, and intended use to the TAC™ Probes (ORATEC Interventions, Inc.) and ArthoWand CAPS (ArthroCare Corporation).
Testing for Safety and Effectiveness: The document briefly states, "Testing has been done to prove safety and effectiveness of the devices," but it does not provide details of this testing, including acceptance criteria or results. It is typical for 510(k) submissions to rely on non-clinical bench testing, biocompatibility testing, and electrical safety testing, but specific results are not included in this summary.
Comparison to Predicate Devices: A table highlights similarities and dissimilarities in materials, dimensions, and sterilization methods between the HeatWave Electrode and its predicate devices.

In summary, none of the specific details about acceptance criteria, study design, statistical analysis, or expert involvement for proving device performance are present in this 510(k) summary. The FDA's clearance (K991830) is based on a finding of "substantial equivalence" to existing, legally marketed devices, not on a new clinical study demonstrating specific performance against predefined acceptance criteria.

Summary

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K991830

、元 20 103

August 5, 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the HeatWave™ Electrode, 510(k) Number K991830.

A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

C. Device Name

Trade Name:	HeatWave™ Electrode
Common Name:	Electrode
Classification Names:	Electrosurgical cutting and coagulation deviceand accessories, 878.4400
Proposed Class/Device:Product Code	Class II, 79 JOS, Electrode,Electrosurgical

D. Predicate/Legally Marketed Devices

TAC™ Probes ORATEC Interventions, Inc.

ArthoWand CAPS ArthroCare Corporation

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Summary of Safety and Effectiveness HeatWave Electrode 510(k) # K991830 August 5, 1999 Page 2 of 3

E. Device Description

F. Intended Use

The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

G. Substantial Equivalence

The HeatWave Electrode is substantially equivalent in design, function and intended use to the TAC™ Probes (ORATEC Interventions, Inc.)and the ArthoWand CAPS (ArthroCare Corporation).

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness HeatWave Electrode 510(k) # K991830 August 5, 1999 Page 3 of 3

CHART OF SIMILARITIES AND DISSIMILARITIES

Company	Device Name	Intended Use	Material	Single-UseReusableMethod ofSterilization	Design/Dimensions
NEW PRODUCTLinvatec	HeatWaveTMElectrode	Electro-coagulation of softtissue in shoulder, ankle,wrist, elbow and kneearthroscopic procedures	Tip/Shaft: 303 Stainless SteelShrink Tube: KynarHub: Polystyrene	Single-UseETO	Diameter: 2.3mm3.0mm4.0mmWorking length: 4-8½in.Monopolar
PREDICATEORATECInterventions, Inc.510(k)#K984185	TAC-STMMonopolarCautery Probe	Electro-coagulation of softtissue in shoulder, ankle,wrist, elbow and kneearthroscopic procedures	Tip/Shaft: 303 Stainless SteelShrink Tube: TeflonHub/Connector: ABS Plastic	Single UseSterilizationMethod Unknown	Diameter: 2.0mmWorking Length: 6 in.Monopolar
PREDICATEArthroCareCorporation510(K) #Unknown	ARTHROWANDCAPS	Electro-coagulation of softtissue during arthroscopicprocedures	Shaft: 300 Series Stainless SteelTip: CeramicHub/Connector: ABS Plastic	Single-UseSterilizationMethod Unknown	Degree/Diameter:25°/3.0mm35°/3.0mmWorking length: 5.0 in.Bipolar

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 20 1999

Ms. Laura Seneff Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

K991830 Re: Trade Name: HeatWave™ Electrode Regulatory Class: II Product Code: JOS Dated: August 5, 1999 Received: August 10, 1999

Dear Ms. Seneff:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Laura Seneff

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours.

Ser

Plumell J. Rayer

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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August 5, 1999

Page 1 of 1

510(k) Number (if known): K991830

Device Name: HeatWave™ Electrode

Indications for Use:

The HeatWave Electrode is intended to be used for electro-coagulation of soft tissue in shoulder, ankle, wrist, elbow and knee arthroscopic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-the-Counter Use

(Per 21 CFR 801.109)

Thunell V. Hagen for Jas

(Division Sign-Off Division of General Res 510lk) Number

(Optional Format 1-2-96)

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.