ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002

K993967 · Oratec Interventions, Inc. · GEI · Dec 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993967
• Device Name: ORATEC SPINECATH INTRADISCAL CATHETER, MODEL 920002
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 17, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORATEC SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH™ Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

Device Story

Sterile, disposable intradiscal catheter; used with ORATEC ElectroThermal Spine System Generator. Device delivers thermal energy to disc material for coagulation and decompression. Used in clinical settings by physicians to treat symptomatic patients with annular disruption of contained herniated discs. Output is thermal energy applied to target tissue; clinical decision-making based on patient symptoms and imaging of contained herniated discs. Benefits include minimally invasive treatment of disc-related pain.

Clinical Evidence

Bench testing only; no clinical data provided. Validation testing performed to support device modification.

Technological Characteristics

Sterile, disposable electrosurgical accessory. Operates with ORATEC ElectroThermal Spine System Generator. Intended for thermal coagulation and decompression of disc material.

Indications for Use

Indicated for symptomatic patients with annular disruption of contained herniated discs requiring coagulation and decompression of disc material.

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.

Predicate Devices

• SpineCATH™ Intradiscal Catheter (K974664)

Submission Summary (Full Text)

{0}------------------------------------------------

#### 510(k) Summary DEC 1 7 1999 ORATEC® SpineCATH™ Intradiscal Catheters

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| The assigned 510(k) number is: | K993967 |
|--------------------------------|-----------------------------------------|
| Submitter: | ORATEC® Interventions, Inc. |
| | 3700 Haven Court |
| | Menlo Park, CA 94025 |
| | Establishment Registration # 2953127 |
| Contact: | Jennifer Brennan |
| | Regulatory Affairs Associate |
| | Telephone: [phone] |
| | Fax: [phone] |
| Date Prepared: | November 22, 1999 |
| Device Names: | |
| Classification Name: | Electrosurgical device |
| Common/usual Name: | Electrosurgical accessory |
| Proprietary Name: | ORATEC® SpineCATH™ Intradiscal Catheter |

Predicate Device: SpineCATH™ Intradiscal Catheter, K974664

## Device Description:

The devices described in this 510(k) are sterile, disposable devices intended for use with the ORATEC ElectroThermal Spine System Generator.

## Intended Use:

The ORATEC SpineCATH Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH™ Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

## Safety and Performance:

치

This submission is a Special 510(k): Device Modification as described in FDA's Guidance document "The New S10(k) Paradigm- Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications. " In support of this 510(k), ORATEC has provided certification of compliance to 21 CFR 820.30 Design Control requirements, and the results of validation testing (performance testing) for the device modification.

## Conclusion:

Based on the indications for use, fundamental scientific technology characteristics, performance, and comparison to the predicate device, the modified SpineCATH Intradiscal Catheter is substantially equivalent to the predicate SpineCATH Intradiscal Catheter under the Federal, Food, Drug and Cosmetic Act. The SpineCATH Intradiscal Catheter is manufactured and distributed by ORATEC Interventions, Inc.

Proprietary information: This document and the information contained herein may not be reproduced, used, or disclosed without prior written consent of Oratec Interventions, Inc.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of a stylized eagle with three heads.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 7 1999

Ms. Jennifer Brennan Regulatory Affairs Associate ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

K993967 Re:

> Trade Name: ORATEC® Spine CATH™ Intradiscal Catheter Regulatory Class: II Product Code: GEI Dated: November 22, 1999 Received: November 23, 1999

Dear Ms. Brennan:

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 (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.

{2}------------------------------------------------

# Page 2 - Ms. Jennifer Brennan

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,

Hamelin Laja

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Page

Device Name: ORATEC® SpineCATH™ Intradiscal Catheters

Indications for Use:

The ORATEC® SpineCATH™ Intradiscal Catheter is intended for use for the coagulation and decompression of disc material to treat symptomatic patients with annular disruption of contained herniated discs. The ORATEC SpineCATH Intradiscal Catheter is intended for use with ORATEC ElectroThermal™ Spine System Generator.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rune/i/iyan

(Division Sign-Off)
Div. General Restorative Devices
510(K) Number 455 3467

OR

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)