CODMAN ISOCOOL BIPOLAR FORCEPS

K023566 · Codman & Shurtleff, Inc. · GEI · May 22, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K023566
• Device Name: CODMAN ISOCOOL BIPOLAR FORCEPS
• Applicant: Codman & Shurtleff, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures. Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

Device Story

ISOCOOL Bipolar Forceps are electrosurgical instruments used for tissue cauterization, coagulation, grasping, and manipulation. The system comprises an insulated, reusable handle (irrigating or non-irrigating) and sterile, disposable tips. Operated by surgeons in clinical settings (OR), the device connects to a bipolar electrosurgical generator. The generator delivers electrical energy through the forceps tips to the target tissue to achieve hemostasis or tissue destruction. The surgeon manually manipulates the forceps to grasp tissue and activates the generator via foot pedal or hand switch. The device provides a non-stick interface for surgical procedures, reducing tissue adhesion during coagulation.

Clinical Evidence

No clinical data. Substantial equivalence established via comparison to predicate device characteristics and bench performance testing.

Technological Characteristics

Electrosurgical bipolar forceps consisting of reusable insulated handles and sterile, disposable tips. Operates via bipolar electrosurgical generator. Designed for tissue grasping and coagulation.

Indications for Use

Indicated for cauterizing, coagulating, grasping, and manipulating tissue in general, neuro, ENT, OB/GYN, and maxillofacial/plastic surgery. Excludes contraceptive coagulation of fallopian tube tissue.

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

• Codman Mirror Finish Bipolar Forceps
• Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes
• Cool-Tec Bipolar Electrodes
• Link Technology Non-Stick Bipolar Forceps

Submission Summary (Full Text)

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## EXHIBIT A

#### K023566

## 510(k) Summary CODMAN ISOCOOL Bipolar Forceps

## Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, MA 02767-0350

#### Contact Person

Elizabeth Dolan Regulatory Affairs Specialist Telephone Number: [phone] Fax Number: [phone]

#### Name of Device

| Proprietary Name: | CODMAN ISOCOOL Bipolar Forceps |
|----------------------|------------------------------------------------|
| Common Name: | Bipolar Forceps |
| Classification Name: | Electrosurgical Cutting and Coagulation Device |

#### Device Classification

Electrosurgical Cutting and Coagulation Device and Accessories are Class II devices per 21 CFR § 878.4400 (79 GEI).

#### Statement of Substantial Equivalence

CODMAN ISOCOOL Bipolar Forceps are substantially equivalent to Codman Mirror Finish Bipolar Forceps, Seedling Enterprises, LLC, Cool-Tec Reusable Bipolar Electrodes and Cool-Tec Bipolar Electrodes, and Link Technology Non-Stick Bipolar Forceps based on the subject device's similarity to the predicate devices in intended use, materials, design, and principles of operation.

#### Indications for Use

The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing. coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.

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Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

## Physical Description

ISOCOOL Bipolar Forceps consist of an insulated, reusable handle in irrigating and non-irrigating styles and sterile, disposable tips.

# Device Testing________________________________________________________________________________________________________________________________________________________________

Substantial equivalence for this device was based upon comparison to predicate device characteristics and performance testing. All testing results demonstrated the substantial equivalence of the product to commercially distributed devices for the same intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

MAY 22 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Dolan Regulatory Affairs Specialist Codman & Shurtleff, Inc. 325 Paramount Drive Raynham, Massachusetts 02767-0350

Re: K023566

Trade/Device Name: Codman IsoCool Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 1, 2003 Received: May 2, 2003

Dear Ms. Dolan:

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. Elizabeth Dolan

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 vours.

Mark N. Millman

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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510(k) Number (if known):

K023566

Device Name:

CODMAN ISOCOOL Bipolar Forceps

. . . . . .

Indications For Use:

The ISOCOOL Bipolar Forceps (handles and tips) when used as part of a system including a bipolar electrosurgical generator are indicated for cauterizing, coagulating, grasping and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial/plastic surgery procedures.

Indications for use in OB/GYN surgery exclude contraceptive coagulation of fallopian tube tissue.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

leo Charles N. Mellem

(Division Sign-Off) Dision of General, Restorative and Neurological Devices

510(k) Number K023566

Prescription Use
(Per 21 CFR §801.109)

OR

Over-the-Counter Use