ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES

K993854 · Oratec Interventions, Inc. · GEI · Dec 6, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993854
• Device Name: ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 6, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

ORA-50 S AutoTemp is a 50-watt, single-channel radiofrequency (RF) electrosurgical generator; designed for soft tissue coagulation in spine procedures. Device inputs include real-time temperature and impedance data from compatible ORATEC spine probes. Generator software automatically adjusts energy delivery to maintain target tissue heating; includes preset temperature/power configurations and a specific programmed temperature profile mode for the SpineCATH intradiscal catheter. Used in clinical settings by trained medical personnel. Output is controlled RF energy; assists physicians in achieving effective thermal coagulation. Benefits include automated energy management for consistent tissue heating.

Clinical Evidence

No clinical data provided; substantial equivalence is based on hardware identity and software modification to the predicate device.

Technological Characteristics

50-watt radiofrequency electrosurgical generator. Features temperature and impedance monitoring sensors. Software-controlled energy delivery with preset profiles. Standalone unit. Sterilization not specified for the generator unit (accessories are typically sterile).

Indications for Use

Indicated for general surgical coagulation of soft tissues using ORATEC thermal/coagulating probes. Intended for use by qualified medical personnel trained in electrosurgical equipment. Contraindicated when, in the physician's judgment, an electrosurgical procedure is contrary to the patient's best interest.

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

• ORA-50 S Programmable Spine System (K990474)

Reference Devices

• SpineCATH Intradiscal Catheter (K974464)

Submission Summary (Full Text)

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# DEC -6 1999

510(k) Summary

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: | K993854 |
|--------------------------------|---------|
|--------------------------------|---------|

- Submitter: A.
Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

[phone] phone: [phone] fax:

Contact: Sheila Ramerman

Date Prepared: November 10, 1999

- B. Device Names:

| Classification name | Electrosurgical and Coagulation Unit and Accessories |
|---------------------|----------------------------------------------------------------|
| Common/usual name | Electrosurgical generator and accessories |
| Proprietary name | ORA-50 S AutoTemp™ ElectroThermal Spine System and Accessories |

ORA-50 S Programmable Spine System and Accessories, C. Predicate Device: K990474

#### D. Device Description:

The ORATEC Interventions ORA-50 S AutoTemp ElectroThermal Spine System ("ORA-50 S") is a single channel, 50-watt, electrothermal generator that offers finely controlled radiofrequency output for the coagulation of soft tissue during a variety of spine procedures. The ORATEC ORA-50 S is specifically designed for use with ORATEC spine probe devices, although it may be used with any ORATEC electrosurgical or electrothermal probe.

Temperature and impedance monitoring are provided to assist the physician by automatically adjusting energy delivery to maintain effective tissue heating during temperature-controlled applications. Preset temperature and power settings in the generator software offer the convenience of quickly configuring the generator for use. A programmed temperature profile mode specifically designed for use with the ORATEC SpineCATH™ device ("SpineCATH Intradiscal Catheter", K974464) offers the convenience of selecting a treatment profile.

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

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- E. Intended Use:
The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use: The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

### Comparison with the Predicate Device: F.

The ORA-50 S AutoTemp Spine System is a software modification of the ORA-50 S Programmable Spine System (K974464). The ORA-50 S AutoTemp Spine System and the ORA-50 S Programmable Spine System have the same intended use, use the same operating principle, and are identical in their hardware configuration.

Based on the data and information presented here, the modified ORA-50 S AutoTemp Spine System and Accessories are substantially equivalent to the currently legally marketed ORA-50 S Programmable Spine System and Accessories manufactured and distributed by ORATEC Interventions, Inc.

\$\underline{IV}\$-2

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 6 1999

Ms. Sheila Ramerman Director, Regulatory and Clinical Affairs Oratec Interventions, Inc. 3700 Haven Court Menlo Park, California 94025

K993854 Re:

> Trade Name: ORA-50 S Auto Temp Electro Thermal System and Accessories Regulatory Class: II Product Code: HRX and GEI Dated: November 12, 1999 Received: November 15, 1999

Dear Ms. Ramerman:

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.

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## Page 2 - Ms. Sheila Ramerman

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 vour 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.

Hija Plurke

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

Enclosure

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Page of of of

# 510(k) Number (if known): _K 99 3854

Device Name: _________________________________________________________________________________________________________________________________________________________________ System and Accessories

Indications for Use:

.

The ORA-50 S AutoTemp ElectroThermal Generator ("ORA-50 S") and Accessories are intended to be used for general surgical purposes in coagulation of soft tissues, in combination with ORATEC thermal/coagulating probes. The ORA-50 S ElectroThermal Generator and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use: The ORA-50 S AutoTemp ElectroThermal Generator and Accessories are contraindicated, when in the judgement of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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