ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES

K991140 · Oratec Interventions, Inc. · GEI · Oct 25, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991140
• Device Name: ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes. The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Device Story

The Vulcan EAS is a 200-watt, single-channel radiofrequency (RF) generator used in arthroscopic surgery. It operates by delivering controlled RF energy to soft tissues via specialized ORATEC probes for coagulation, cutting, and ablation. The system monitors tissue impedance and temperature, automatically adjusting energy delivery to maintain effective heating. It includes features such as auto-probe recognition, remote control/display of settings, and auxiliary thermocouple support. Operated by trained medical personnel in clinical settings, the device provides real-time feedback to the surgeon, enabling precise tissue management and potentially improving surgical outcomes through controlled thermal effects.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

200-watt single-channel RF generator; software-controlled; impedance and temperature monitoring; auto-probe recognition; auxiliary thermocouple input; remote control/display interface; neutral electrode monitoring circuit; accessories include footswitch and probe extension cables.

Indications for Use

Indicated for general surgical purposes, including orthopedic and arthroscopic applications, for coagulation, ablation, and hemostasis of soft tissues. 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

• ValleyLab Force FX Electrosurgical Generator (K944602)

Submission Summary (Full Text)

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OCT 2 5 1999

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- 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.
510(k) Summary

K991140 The assigned 510(k) number is:

- A. Submitter: ORATEC Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025
Phone: [phone] [phone] Fax:

Sheila Ramerman Contact: Date Prepared: October 7, 1999

- B. Device Names: ORATEC Interventions, Inc., VULCANTM EASTM Proprietary Name: ElectroThermal Arthroscopy System and Accessories Common Name: Electrosurgical generator and accessories Electrosurgical and Coagulation Unit and Accessories Classification Name:
- C. Legally Marketed Device:

The ORATEC Vulcan EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator (K944602), currently manufactured and distributed by ValleyLab Inc.

- D. Device Description:
The ORATEC Interventions, Inc., VULCAN EAS ElectroThermal Arthroscopy System generator is a single channel, 200-watt, electrothermal generator that offers finely controlled radiofrequency output for the electrocoagulation, cutting, and ablation of soft tissue during a variety of arthroscopic procedures. The unit is specifically designed to be used with ORATEC electrothermal, electrosurgical, and ablation probes. Temperature and impedance monitoring are provided to assist the surgeon by automatically adjusting energy delivery to maintain effective tissue heating during temperature controlled applications.

Accessories provided with the Vulcan EAS include:

- AC power cord .
- Probe extension cable .
- Dual-pedal footswitch control .

Phone: Each generator is also accompanied by Instructions for Use and a warranty registration card. [phone] fax: [phone]

## ORATEC Interventions, Inc.

3700 Haven Court Menlo Park, CA 94025

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Vulcan EAS Premarket Notification 510(k) Summary of Safety & Effectiveness Page 2

- E. Intended Use:
The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment of the physician, an electrosurgical procedure would be contrary to the best interest of the patient.

- F. Comparison with the Predicate Device:
The Vulcan EAS and the ValleyLab Force FX are similar in that:

- Both can be used for coagulation (fulguration), cutting, or ablation (dessication) of . tissues
- . Both can be used with monopolar and bipolar electrosurgical devices;
- Both measure impedance (resistance) to control power output; .
- . Both offer preset temperature and power combinations;
- . Both offer neutral electrode monitoring circuits;
- Both are software-controlled RF generators. .

The Vulcan EAS and the ValleyLab Force FX differ in that:

- The Vulcan offers temperature control, whereas the Force FX does not .
- The Vulcan offers auto probe recognition, whereas the Force FX does not; .
- The Vulcan offers a remote control of generator settings, whereas the Force FX does . not:
- . The Vulcan offers a remote display of generator settings, whereas the Force FX does not:
- . The Vulcan can accommodate an auxiliary thermocouple, whereas the Force FX cannot;
- . The Vulcan is designed for electrosurgery only, whereas the Force FX is also capable of ultrasonic surgery.

Based on the data and information presented here, the ORATEC VULCAN EAS ElectroThermal Arthroscopy System and Accessories are substantially equivalent to the ValleyLab Force FX Electrosurgical Generator manufactured and distributed by Valley Lab Inc.

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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 1999

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

Re: K991140

Trade Name: VULCAN™ EASTM ElectroThermal Arthroscopy System and Accessories Regulatory Class: II Product Code: GEI Dated: July 26, 1999 Received: July 27, 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 (OS) 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 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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K991140 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The Vulcan EAS ElectroThermal Arthroscopy System and Accessories are intended to be used for general surgical purposes, including orthopedic and arthroscopic applications, in coagulation, ablation, and hemostasis of soft tissues in combination with ORATEC temperature controlled, cutting, and ablation probes.

The VULCAN EAS ElectroThermal Arthroscopy System and Accessories are intended for use by qualified medical personnel trained in the use of electrosurgical equipment.

Contraindications for Use:

The use of the VULCAN EAS ElectroThermal Arthroscopy System and Accessories are contraindicated, when in the judgment 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)

*[Signature]*

| (Division Sign-Off) | |
|-----------------------------------------|--------|
| Division of General Restorative Devices | |
| 510(k) Number | 991140 |

Prescription Use
(Per 21 CFR 801.109) X

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)