COOPERSURGICAL INFRARED COAGULATOR FOR ENT

K990855 · CooperSurgical, Inc. · KNS · Mar 30, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990855
• Device Name: COOPERSURGICAL INFRARED COAGULATOR FOR ENT
• Applicant: CooperSurgical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Mar 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.

Device Story

Device delivers short pulses of visible and infrared light to tissue via contact tip applicator; causes thermal coagulation and tissue necrosis. Physician selects pulse duration to control necrosis depth. Used in clinical setting by physician; area may be locally anesthetized. Physician applies mechanical pressure to optical window against tissue; depresses activation trigger. Built-in digital timer automatically deactivates lamp based on preselected duration. Overlapping exposures used for larger sites. Benefits patient by providing controlled thermal treatment for chronic rhinitis.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Consists of console unit, hand piece, removable light guide, and disposable contact tip. Operates via visible and infrared light pulses for thermal coagulation. Includes digital timer for pulse duration control.

Indications for Use

Indicated for patients with chronic rhinitis requiring treatment via coagulative necrosis of the inferior turbinate submucosal tissue.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Redfield Corporation's Redfield Infrared Coagulator
• CooperSurgical's InfraRed Coagulator (K974168)

Submission Summary (Full Text)

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3/30/99

990855

## 510(K) SUMMARY FOR COOPERSURGICAL, INC.'S INFRARED COAGULATOR

# Submitter's Name, Address, Telephone Number, And Contact Person

CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484

Debra Pekar Contact: Manager, Regulatory Affairs [phone] Phone: Facsimile: [phone]

Date Prepared: March 15, 1999

#### Name of the Device

CooperSurgical InfraRed Coagulator

#### Common or Usual Name

Infrared Coagulator

#### Predicate Devices

- (1) Redfield Corporation's Redfield Infrared Coagulator for the treatment of chronic rhinitis; and
- CooperSurgical's InfraRed Coagulator for the treatment of genital (2) condylomas (condyloma accuminata) and general warts.

#### Intended Use

The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.

#### Principles of Operation

The Cooper IRC delivers short pulses of visible and infrared light through a small contact tip applicator that is applied to the tissue. This light causes thermal coagulation that results in tissue necrosis. The user sets the pulse duration control knob depending on the depth of the tissue necrosis required. The depth of coagulation is directly related to the pulse length delivered to a given area of tissue. The area(s) to be treated may be locally anesthetized at the physician's discretion.

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Contact photocoagulation requires direct contact of the entire optical window of the disposable contact tip. The physician applies light mechanical pressure to the optical window against the tissue to be treated before depressing the activation trigger of the hand piece. To achieve coagulation, the user depresses the activation trigger. A built-in digital timer deactivates the lamp automatically according to the pulse duration setting preselected by the physician. If the desired treatment site is larger than the optical window, the physician may use overlapping exposures until the entire area is coagulated. waiting at least five seconds between exposures.

### Technical Characteristics

The CooperSurgical IRC consists of the following main components: (1) a console unit: (2) a hand piece: (3) a removable light guide; and (4) a disposable contact tip. With the exception of four minor differences, the CooperSurgical IRC is essentially the same device as Redfield Corporation's InfraRed Coagulator that has already been cleared by FDA for the treatment of chronic rhinitis. In addition, with the exception of four features, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts.

## Summary of the Basis for the Finding of Substantial Equivalence

The safety and effectiveness of the CooperSurgical IRC for the treatment of chronic rhinitis is based on: (1) Redfield IRC's premarket clearances for the treatment of chronic rhinitis; and (2) CooperSurgical IRC's clearance for the treatment of genital condylomas and general warts.

The CooperSurgical IRC is substantially equivalent to Redfield Corp.'s Infrared Coagulator and is essentially the same device in all but four minor features. In addition, bench testing demonstrates that the CooperSurgical performs similarly to the Redfield IRC in terms of photocoagulation and non-stick characteristics.

Additionally, the CooperSurgical IRC is substantially equivalent to the CooperSurgical IRC which has already been cleared by FDA for the treatment of genital condylomas (condyloma accuminata) and general warts (K974168). With the four minor exceptions, the device is identical to the CooperSurgical device that has been cleared for genital condylomas and general warts. These differences do not raise new questions of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 30 1999

CooperSurgical, Inc. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004-1109

Re: K990855

> Trade Name: CooperSurgical InfraRed Coagulator Regulatory Class: II Product Code: KNS Dated: March 15, 1999 Received: March 15, 1999

Dear Mr. Kahan:

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 (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 - Mr. Jonathan S. Kahan

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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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: CooperSurgical InfraRed Coagulator ("IRC")

Indications for Use:

The CooperSurgical InfraRed Coagulator ("IRC") is indicated for the treatment of chronic rhinitis through the coagulative necrosis of the submucosal tissue of the inferior turbinate.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use _ 3 (Per 21 C.F.R. 801.109)

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)