ORATEC MODEL ENDOTAC PROBE

K972358 · Oratec Interventions, Inc. · GEI · Jan 23, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K972358
• Device Name: ORATEC MODEL ENDOTAC PROBE
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.

Device Story

The EndoTAC Monopolar Cautery Probe is a surgical instrument used for hemostasis, coagulation, and desiccation of disc material. It is intended for use in treating disc annulus disruption and degenerative disc diseases involving contained herniated discs. The device functions as a monopolar cautery probe, delivering energy to target tissues to achieve the desired therapeutic effect. It is operated by a physician in a clinical or surgical setting. By coagulating and desiccating disc material, the device assists in the management of disc-related pathologies.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Monopolar cautery probe; designed for hemostasis, coagulation, and desiccation of disc material. Operates via electrical energy delivery.

Indications for Use

Indicated for patients with disc annulus disruption and degenerative disc diseases of contained herniated disc requiring hemostasis, coagulation, and desiccation of disc material. No known contraindications.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

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

K972358 Re:

> Trade Name: Oratec Model Endotac Probe Regulatory Class: II Product Code: GEI Dated: October 30, 1997 Received: October 31, 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 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 requirements , 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

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Page 2 - Dr. Kwan

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

510(k) Number (if known): __________________ Not yet assigned

Device Name:

Indication For Use:

Model EndoTAC™ Monopolar Cautery Probe is designed for hemostasis, and for coagulation and desiccation of disc material to treat disc annulus disruption and degenerative disc diseases of contained herniated disc.

## Contraindications for Use:

None known.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | 2972358 |

| Prescription Use<br>(Per 21 CFR 801.109) | X |
|------------------------------------------|---|
|------------------------------------------|---|

OR
Over-The-Counter Use
(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 Oratec Interventions, Inc.