COBRA BIPOLAR CLAMP, MODEL 15902

K023288 · Boston Scientific EP Technologies · GEI · Apr 2, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023288
• Device Name: COBRA BIPOLAR CLAMP, MODEL 15902
• Applicant: Boston Scientific EP Technologies
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

Device Story

Cobra Bipolar System consists of reusable surgical clamp and sterile, single-use Bipolar Insert. Device connects to Cobra Electrosurgical Unit (ESU) to deliver 460 kHz radiofrequency (RF) energy. ESU modulates RF energy to maintain uniform temperature across selected clamp electrodes and adjusts power output to reach set point. Used in general surgery by clinicians to coagulate soft tissue and blood for hemostasis. System provides controlled thermal coagulation via RF energy delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System comprises reusable surgical clamp and single-use Bipolar Insert. Operates via 460 kHz radiofrequency (RF) energy. Features temperature-controlled RF delivery to maintain uniform electrode temperature. Class II device (21 CFR 878.4400).

Indications for Use

Indicated for coagulation of soft tissue and hemostasis during general surgery.

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

• Cobra Electrosurgical Probe (K013783)

Submission Summary (Full Text)

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# 510(K) SUMMARY

| Category: | Comments |
|--------------------------------------|---------------------------------------------------------------------------------------------------|
| Sponsor: | Boston Scientific Corporation/EP Technologies, Inc.<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Correspondent: | April Malmborg<br>Specialist II, Regulatory Affairs<br>2710 Orchard Parkway<br>San Jose, CA 95134 |
| Contact Numbers: | Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Common Name | Electrosurgical Probe |
| Device Proprietary Name | Cobra Bipolar System |
| Device Classification | 21 CFR 878.4400; Class II |
| Predicate Device | Cobra Electrosurgical Probe |
| Predicate Device Manufacturer(s) | BSC/ EP Technologies, Inc. |
| Predicate Device Proprietary Name(s) | Eelectrosurgical Probes |
| Predicate Device Classification(s) | 21 CFR 8778.4400; Class II |

### Date Summary Was Prepared:

April 3, 2003

### Description of the Device:

The Cobra Bipolar System device is comprised of two components; a reusable surgical clamp and an associated coagulating device BSC/ EP Technologies has named the Cobra Bipolar Insert. The Bipolar Insert is a sterile, single use device that transmits radiofrequency (RF) energy to coagulate soft tissues. The Bipolar Clamp will be used with a Cobra Electrosurgical Unit (ESU). The ESU delivers 460 kHz RF energy to selected Bipolar Clamp electrodes, modulates the RF energy to keep all selected Bipolar Clamp electrodes' temperatures essentially the same, and adjusts the power output to maintain the maximum temperature of all selected electrodes close to the set point.

### Intended Use:

The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

### Comparison to Predicate Devices:

CONFIDENTIAL

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K023288 – Response to FDA Questions - April 2, 2003
Cobra Bipolar System

| | Predicate Device | Modified Device |
|--------------------------|---------------------------------|-----------------|
| 510(k) Reference | K013783 | K023288 |
| Intended Use | Coagulation of soft tissues | Same |
| Device Description | Electrosurgical Probe | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
| Manufacturer | BSC/ EP Technologies | Same |
| Device<br>Classification | Class II, GEI; 21 CFR §878.4400 | Same |

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APR - 2 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. April Malmborg Regulatory Affairs Specialist II Boston Scientific 2710 Orchard Parkway San Jose, California 95134

Re: K023288

Trade/Device Name: Cobra Bipolar System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 30, 2002 Received: January 2, 2003

Dear Ms. Malmborg:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. April Malmborg

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K023288 - Response to FDA Questions - April 2, 2003 Cobra Bipolar System

#### INTENDED USE STATEMENT

510(k) Number: K023288

Device Name: Cobra Bipolar System

## Indication for Use:

្រុះបា

The Cobra Bipolar System (System) is intended for the coagulation of soft tissue during general surgery. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the Counter Use_ (Per 21 CFR \$801.109)

Miriam C. Provost

Division of General, Restorative and Neurologica! Devices

510(k) Number K023288