ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR

K973159 · Oratec Interventions, Inc. · GEI · Sep 25, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K973159
• Device Name: ORATEC INTERVENTIONS MODEL ORA 40 ELECTROTHERMAL GENERATOR
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Oratec Interventions™ Model ORA 40 Electrothermal Generator, in combination with Oratec thermal/coagulating probes, is designed for general surgical use, including orthopaedic and arthroscopic applications, in coagulating soft tissues. This device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

The Oratec Interventions Model ORA 40 Electrothermal Generator is an electrosurgical unit designed for use in clinical settings, including operating rooms, by trained medical personnel. The device functions by providing electrical energy to compatible Oratec thermal/coagulating probes. The system is used to coagulate soft tissues during general, orthopaedic, and arthroscopic surgical procedures. The physician operates the generator to control the delivery of thermal energy to the target tissue via the probe, facilitating hemostasis or tissue modification. The device provides a therapeutic benefit by enabling controlled thermal coagulation of soft tissues during surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrosurgical generator; provides energy for thermal/coagulating probes; intended for soft tissue coagulation; class II device; product code GEI.

Indications for Use

Indicated for general surgical use, including orthopaedic and arthroscopic applications, for soft tissue coagulation. Contraindicated when electrosurgical procedures are deemed contrary to the patient's best interest by the physician. Intended for use by trained medical personnel.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

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

SEP 2 5 1997

Re: K973159

Trade Name: Oratec Interventions Model ORA 40 Electrothermal Generator Regulatory Class: II Product Code: GEI Dated: August 20, 1997 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 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 (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 [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,

Aoseef

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):

Device Name: Oratec Interventions™ Model ORA 40 Electrothermal Generator

## Indication For Use:

The Oratec Interventions™ Model ORA 40 Electrothermal Generator, in combination with Oratec thermal/coagulating probes, is designed for general surgical use, including orthopaedic and arthroscopic applications, in coagulating soft tissues.

This device is intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

## Contraindications for Use:

The use of the Oratec Interventions™ Model ORA 40 Electrothermal Generator is contraindicated when, in the judgment of the physician, electrosurgical procedure would be contrary to the best interest of the patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division Sign-Off | <div> <img alt="signature" src="signature.png"/> </div> |
|-------------------|---------------------------------------------------------|
| Division of | |
| 510(k) Number | 14973159 |

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (Per 21 CFR 801.109) | | (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.