ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)

K992805 · Oratec Interventions, Inc. · GEI · Feb 4, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K992805
• Device Name: ORATEC ABLATOR-S PROBES (MONOPOLAR ABLATION SUCTION PROBES)
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 4, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EASTM generator.

Device Story

The ORATEC Ablator-S Probe is a sterile, disposable, monopolar electrosurgical device used in arthroscopic procedures. It functions by delivering radiofrequency (RF) energy to soft tissue to perform ablation and hemostasis. The device is designed for use exclusively with the ORATEC Vulcan EAS RF generator. It is operated by a surgeon in an arthroscopic clinical setting. The probe includes a suction feature to assist in the removal of debris or fluids during the procedure. By providing controlled tissue ablation and coagulation, the device aids the surgeon in managing soft tissue during minimally invasive joint surgery, potentially reducing procedure time and improving surgical outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrosurgical probe; disposable; sterile. Designed for use with ORATEC Vulcan EAS RF generator. Features integrated suction capability. Operates via RF energy for tissue ablation and hemostasis.

Indications for Use

Indicated for ablation and hemostasis of soft tissues during arthroscopic procedures.

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

• ORATEC Electrosurgical Probes (K965007)
• ORATEC Electrosurgical Probes (K992408)
• ORATEC Bipolar Ablation Suction Probes (K991218)
• ArthroCare Ablation Probes (K943450)
• ArthroCare Ablation Probes (K961747)
• ArthroCare Ablation Probes (K962321)

Submission Summary (Full Text)

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FEB 4 2000

## 510(k) Summary ORATEC Interventions, Inc. Monopolar Suction Ablation Probes

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: | K992805 |
|--------------------------------|-------------------------------------------------------------|
| 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: | October 18, 1999 |
| Device Names: | |
| Classification Name: | Electrosurgical device |
| Common/usual Name: | Electrosurgical accessory |
| Proprietary Name: | ORATEC® Ablator™-S Probe (Monopolar Ablation Suction Probe) |
| Predicate Devices: | ORATEC Electrosurgical Probes (K965007 and K992408) |
| | ORATEC Bipolar Ablation Suction Probes (K991218) |
| | ArthroCare Ablation Probes (K943450, K961747, and K962321) |

## Device Description:

The devices described in this 510(k) are sterile, disposable devices designed for use with the ORATEC Vulcan™ EASTM RF generator.

## Intended Use:

The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EASTM generator.

## Conclusion:

Based on the information provided the Ablator™-S Probe is substantially equivalent to the predicate devices: ORATEC Electrosurgical Probes, ORATEC Bipolar Ablation Suction Probes, and ArthroCare Ablation Probes under the Federal, Food, Drug and Cosmetic Act. The Ablator™ S Probe is manufactured and distributed by ORATEC Interventions, Inc.

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Image /page/1/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" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract caduceus or a representation of human figures, with three wavy lines emanating from the right side of the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 4 2000

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

Re: K992805

> Trade Name: ORATEC® Ablator™ Suction Probes Regulatory Class: II Product Code: GEI, HRX Dated: December 28, 1999 Received: December 29, 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 maior 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 (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 devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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,

Stupka Purdy

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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Additional Information, K992805 ORATEC Monopolar Suction Probes

__ of _ l ---Page _

510(k) Number (if known): K992805

Device Name: ORATEC Interventions Monopolar Suction Ablation Probes

Indications for Use:

The ORATEC® Ablator-S Probes are disposable, monopolar electrosurgical devices intended to be used for ablation, and hernostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | |
|------------------|--|
| 801.109) | |

OR

| Over-The-Counter Use | |
|----------------------|--------------------------|
| | (Per 21 CFR |
| | (Optional Format 1-2-96) |

(Division Sign-Off)

Division of General Res

| 510(k) Number | K992805 |
|---------------|---------|
|---------------|---------|