ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE by ORATEC INTERVENTIONS, INC.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the comprehensive study you've requested regarding a medical device. The document is an FDA 510(k) clearance letter for the "Oratec Interventions Model Orastat Electrothermal Coagulator" from 1997.

It states that the device is "substantially equivalent" to predicate devices, which means it met the regulatory requirements at that time for market clearance based on its similarity to existing devices. However, this letter does not include performance data, study designs, sample sizes, ground truth establishment, or expert qualifications that would typically be part of a detailed study report.

The information I can extract directly from the provided text is:

Device Name: Model Orastat Electrothermal Coagulator
Intended Use: For hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.
Regulatory Clearance: FDA 510(k) clearance (K973158) in 1997 based on substantial equivalence to predicate devices.

Therefore, I cannot fulfill your request for the specific details outlined in your points 1-9 using only the provided text, as this information is not present. This document is a regulatory approval letter, not a detailed scientific study report.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 5 1997

Michael Kwan, Ph.D. Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

Re: K973158

Trade Name: Oratec Interventions Model Orastat Electrothermal Coagulator Regulatory Class: II Product Code: GEI Dated: August 21, 1977 Received: August 22, 1997

Dear Dr. Kwan:

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 mayor 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 requirements , as set forth in the Quality System Regulation (QS) 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 - Michael Kwan, Ph.D.

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 yours,

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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INDICATIONS FOR USE

	k97 3158
510(k) Number (if known):	Not yet assigned
Device Name:	Model Orastat TM Electrothermal Coagulator

Indication For Use:

Model Orastat™ Electrothermal Coagulator is designed for hemostasis, and for coagulation of soft tissues during general arthroscopic procedures.

Contraindications for Use:

None known.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973158

Prescription Use(Per 21 CFR 801.109)	X	OR	Over-The-Counter Use
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(Optional Format 1-2-96)Proprietary Data: This document and the Information contained herein may not be reproduced, used or disclosed without prior written consent of Orace Interventions, Inc.

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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.