DEFLECTABLE ELECTROSURGICAL PROBES

K991190 · Oratec Interventions, Inc. · GEI · Jun 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991190
• Device Name: DEFLECTABLE ELECTROSURGICAL PROBES
• Applicant: Oratec Interventions, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices intended for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to be used with ORATEC ElectroThermal generators.

Device Story

Disposable, monopolar electrosurgical probe; used for coagulation and cutting of soft tissues. Device consists of insulated shaft with RF-energized tip, handle with cable connector, and proximal deflecting mechanism. Operated by physician in surgical setting; used in conjunction with ORATEC ElectroThermal generators to deliver monopolar radiofrequency (RF) energy. Controllable, deflectable distal tip allows access to various tissue surfaces; provides minimally invasive access. Output is thermal energy for tissue effect; enables precise surgical intervention. Benefits include improved access to targeted tissues compared to manually malleable probes.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Disposable monopolar electrosurgical probe. Features insulated shaft, RF-energized tip, and proximal handle with deflecting mechanism. Energy source: ORATEC ElectroThermal generator (monopolar RF). Materials: unspecified tip and insulating materials. Form factor: handheld, deflectable distal tip. No software or algorithm components.

Indications for Use

Indicated for general surgical use in patients requiring electro-coagulation and cutting of soft tissues. 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

• ORATEC Interventions, Inc., Electrosurgical Probes (K965007)

Submission Summary (Full Text)

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

JUN 2 3 1999

# 510(k) Summary

# ORATEC Interventions, Inc. Deflectable Electrosurgical 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: _______________________________________________________________________________________________________________________________________________

A. Submitter:

ORATE ("

Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

[phone] phone: [phone] fax:

Contact: Sheila Ramerman Date Prepared: June 18, 1999

- B. Device Names:
ORATEC® Interventions, Inc., Deflectable Electrosurgical Proprietary Name: Probes Common/usual Name: Electrosurgical Accessory Electrosurgical Device Classification Name:

C. Predicate Device: ORATEC® Interventions, Inc., Electrosurgical Probes, K965007

### D. Device Description:

The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices designed to coagulate or to cut tissues. They provide minimally invasive access to the targeted tissues. The Deflectable Electrosurgical Probes are used in conjunction with ORATEC ElectroThermal generators to deliver monopolar radiofrequency (RF) energy for electro-coagulation and cutting of soft tissues.

ORATEC Interventions, Inc.

3700 Haven Court Menlo Park. CA 94025

- The Deflectable Electrosurgical Probes incorporate:
- A shaft with an RF energized tip to perform tissue coagulation; .
- · Optional tip configurations for various general tissue coagulation and cutting uses;

Phone: [phone] Fax: [phone]

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

Additional Information, K991190 ORATEC Deflectable Electrosurgical Probes

- A controllable, deflectable tip at the distal end of the probe to allow easier access to . all tissue surfaces;
- A handle, with cable connector and deflecting mechanism at the proximal end. .

#### Intended Use: E.

The Deflectable Electrosurgical Probes are disposable electrosurgical devices designed for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to be used with ORATEC ElectroThermal generators.

#### Comparison with the Predicate Device: F.

The ORATEC Interventions Deflectable Electrosurgical Probes and the ORATEC Interventions Electrosurgical Probes are the same in that:

- both provide minimally invasive access to targeted tissues; .
- both deliver monopolar radiofrequency energy for electro-coagulation and cutting of . soft tissues;
- both consist of an insulated shaft with an RF energized tip; .
- both are designed to be used with ORATEC radiofrequency generators. .

The Deflectable Electrosurgical Probes and the Electrosurgical Probes differ in that:

- the Deflectable Probes may have different physical dimensions than the . Electrosurgical Probes;
- . the Deflectable Probes may use different tip or insulating materials than the Electrosurgical Probes;
- . the Deflectable Probes have a controllable, deflectable distal tip to allow orientation of the tip during use, whereas the Electrosurgical Probes have a malleable distal tip that must be manually bent before use.

Based on the information presented here, the ORATEC Interventions Inc., Deflectable Electrosurgical Probes are substantially equivalent to the Electrosurgical Probes manufactured and distributed by Oratec Interventions, Inc.

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

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol consisting of three curved lines that resemble a person or a flame.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

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

Re: K991190

Trade Name: Deflectable Electrosurgical Probes Regulatory Class: II Product Code: GEI Dated: April 7, 1999 Received: April 8, 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 (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.

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

### 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,

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

11: 11:1

Enclosure

{4}------------------------------------------------

JUN 2 3 1999

# 510(k) Summary

# ORATEC Interventions, Inc. Deflectable Electrosurgical 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: _______________________________________________________________________________________________________________________________________________

A. Submitter:

ORATF

Oratec Interventions, Inc. 3700 Haven Court Menlo Park, CA 94025

[phone] phone: [phone] fax:

Contact: Sheila Ramerman Date Prepared: June 18, 1999

- B. Device Names:
ORATEC® Interventions, Inc., Deflectable Electrosurgical Proprietary Name: Probes Common/usual Name: Electrosurgical Accessory Electrosurgical Device Classification Name:

C. Predicate Device: ORATEC® Interventions, Inc., Electrosurgical Probes, K965007

### D. Device Description:

The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices designed to coagulate or to cut tissues. They provide minimally invasive access to the targeted tissues. The Deflectable Electrosurgical Probes are used in conjunction with ORATEC ElectroThermal generators to deliver monopolar radiofrequency (RF) energy for electro-coagulation and cutting of soft tissues.

ORATEC Interventions, Inc.

Menlo Park, CA

94025

The Deflectable Electrosurgical Probes incorporate:

- 3700 Haven Court A shaft with an RF energized tip to perform tissue coagulation; .
- · Optional tip configurations for various general tissue coagulation and cutting uses:

Phone: [phone] Fax: [phone]

{5}------------------------------------------------

### Additional Information, K991190 ORATEC Deflectable Electrosurgical Probes

- A controllable, deflectable tip at the distal end of the probe to allow easier access to . all tissue surfaces;
- A handle, with cable connector and deflecting mechanism at the proximal end. .

#### Intended Use: E.

The Deflectable Electrosurgical Probes are disposable electrosurgical devices designed for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to be used with ORATEC ElectroThermal generators.

#### Comparison with the Predicate Device: F.

The ORATEC Interventions Deflectable Electrosurgical Probes and the ORATEC Interventions Electrosurgical Probes are the same in that:

- both provide minimally invasive access to targeted tissues; .
- . both deliver monopolar radiofrequency energy for electro-coagulation and cutting of soft tissues:
- both consist of an insulated shaft with an RF energized tip; .
- both are designed to be used with ORATEC radiofrequency generators. .

The Deflectable Electrosurgical Probes and the Electrosurgical Probes differ in that:

- the Deflectable Probes may have different physical dimensions than the . Electrosurgical Probes;
- the Deflectable Probes may use different tip or insulating materials than the . Electrosurgical Probes:
- . the Deflectable Probes have a controllable, deflectable distal tip to allow orientation of the tip during use, whereas the Electrosurgical Probes have a malleable distal tip that must be manually bent before use.

Based on the information presented here, the ORATEC Interventions Inc., Deflectable Electrosurgical Probes are substantially equivalent to the Electrosurgical Probes manufactured and distributed by Oratec Interventions, Inc.

{6}------------------------------------------------

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three overlapping wing shapes, symbolizing health and human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1999

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

K991190 Re:

Trade Name: Deflectable Electrosurgical Probes Regulatory Class: II Product Code: GEI Dated: April 7, 1999 Received: April 8, 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.

{7}------------------------------------------------

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

{8}------------------------------------------------

510(k) Premarket Notification ORATEC Deflectable Electrosurgical Probes

Page _________________________________________________________________________________________________________________________________________________________________________

k991190 510(k) Number (if known): _

Device Name: _ Oratec™ Interventions Deflectable Electrosurgical Probes

Indications for Use:

The Deflectable Electrosurgical Probes are disposable, monopolar electrosurgical devices intended for general surgical use in procedures where electro-coagulation and cutting of soft tissues is desired. They are designed to be used with ORATEC ElectroThermal generators.

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

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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Division of General Restorative Devices K991190
510(k) Number