DEFLECTABLE TAC ELECTROTHERMAL PROBE

K990859 · Oratec Interventions, Inc. · GEI · Jun 14, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990859
• Device Name: DEFLECTABLE TAC ELECTROTHERMAL PROBE
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 14, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Deflectable TAC ElectroThermal probe is a disposable electrosurgical device intended to be used for electro-coagulation of soft tissues in arthroscopic procedures. It is designed to be used with ORATEC ElectroThermal generators.

Device Story

Disposable, monopolar electrosurgical probe; used for controlled coagulative lesions in soft tissues. Input: RF energy from ORATEC ElectroThermal generator. Device features: insulated shaft with RF-energized tip; distal thermocouple for temperature monitoring; proximal handle with cable connector and mechanical deflection mechanism. Operation: physician-controlled tip deflection allows access to tissue surfaces during arthroscopic/endoscopic procedures. Output: thermal energy for tissue coagulation. Benefit: minimally invasive access and precise tissue coagulation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Monopolar electrosurgical probe; disposable; insulated shaft; RF-energized tip; integrated thermocouple for temperature feedback; mechanical tip deflection mechanism; compatible with ORATEC RF generators.

Indications for Use

Indicated for electro-coagulation of soft tissues during arthroscopic procedures. Prescription use only.

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

• TAC-S™ Monopolar Cautery Probe (K963157, K984185)

Submission Summary (Full Text)

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JUN 1 4 1999

.

### 510(k) Summary

# ORATEC Interventions, Inc. Deflectable TAC ElectroThermal™ Probe

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

The assigned 51((k) number is: _______________________________________________________________________________________________________________________________________________

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

phone: [phone] [phone] fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax: fax:

Contact: Sheila Ramerman Date Prepared: June 11, 1999

- B. Device Names:

| Proprietary Name: | Deflectable TACTM ElectroThermal Probe |
|----------------------|----------------------------------------|
| Common/usual Name: | Electrosurgical Accessory |
| Classification Name: | Electrosurgical Device |

- TAC-S™ Monopolar Cautery Probe, K963157, K984185 C. Predicate Device:
#### D. Device Description:

The Deflectable TAC ElectroThermal Probe is a disposable, monopolar electrosurgical device designed 10 create controlled coagulative lesions in tissues. It provides minimally invasive access to the rargeted tissues. The Deflectable TAC probe is used in conjunction with ORATEC ElectroThermal RF generators to deliver monopolar radiofrequency (RF) energy for electro-coagulation of soft tissues.

The Deflectable TAC probe incorporates:

- A shaft with .in RF energized up for percuraneous or arthroscopic access to perform ● tissue coagulation;

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S10(k) Premarket Notification ORATEC Deflectabl : TAC ElectroThermal Probe - Summary of Safety and Effectiveness

- A thermocouple at the distal end of the shaft for measuring tip temperature during RF . energy delivery;
- A controllable, deflectable tip at the distal end of the probe to allow easier access to ● all rissue surfaces;
- A handle, with cuble connector and deflecting mechanism at the proximal end. ●
- E. Intended Jse:

The Deflectable TAC ElectroThermal probe is a disposable electrosurgical device intended to be used for electro-coagulation of soft tissues in arthroscopic procedures. It is designed to be used with ORATEC ElectroThermal generators.

Comparison with the Predicate Device: r.

The ORATEC Ir terventions Deflectable TAC probe and the ORATEC Interventions TAC-S probe are the same in that:

- both provide minimally invasive access to targeted tissues; .
- both deliver inonopolar radiofrequency energy for electro-coagulation of soft tissues; .
- both consist of an insulated shaft with an RF energized up; ●
- both contain a thermocouple in the distal end for measuring tip temperature during . RF delivery;
- . both are designed to be used with ORATEC radiofrequency generators.

The Deflectable TAC und the TAC-S differ in that:

- the Deflectal te TAC probe has different physical dimensions than the TAC-S probe; .
- the Deflectat le TAC may use different tip or insulating materials than the TAC-S . probe;
- the Deflectat le TAC has a controllable, deflectable distal tip to allow orientation of ● the tip during use, whereas the TAC-S has a malleable distal tip that must be manually bent before use;
- the Deflectal le TAC can be used in endoscopic and arthroscopic surgical sertings, ● whereas the TAC-S is designed for arthroscopic surgical settings.

Based on the information presented here, the Deflectable TAC ElectroThermal Probe is substantially equivalent to the TAC-S Monopolar Cautery Probe manufactured and distributed by Oratec Interventions, Inc.

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JUN 1 4 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

> K990859 Trade Name: Deflectable TAC Electro Thermal Probe Regulatory Class: II Product Code: HRX and GEI Dated: March 15, 1999 Received: March 16, 1999

Dear Ms. Ramerman:

Re:

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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K990859

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Deflectable TAC ElectroThermal probe is a disposable, monopolar electrosurgical I he Delicenders Trice used for electro-coagulation of soft tissues in arthroscopic procedures. It is designed to be used with ORATEC® ElectroThermal generators.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K990859 |

Prescription Use __ (Per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Formar 1-2-96)

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