COOPERSURGICAL INFRARED COAGULATOR

K990852 · CooperSurgical, Inc. · KNS · Jun 11, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K990852
• Device Name: COOPERSURGICAL INFRARED COAGULATOR
• Applicant: CooperSurgical, Inc.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Jun 11, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

Device Story

The CooperSurgical InfraRed Coagulator (IRC) is a medical device used by physicians to treat hemorrhoids via thermal coagulation. The device consists of a console, handpiece, light guide, and disposable contact tip. The physician applies the contact tip to the target tissue with light mechanical pressure and activates the device. The system delivers short pulses of visible and infrared light to the tissue, inducing controlled coagulative necrosis. A built-in digital timer automatically deactivates the lamp based on a preselected pulse duration, which determines the depth of tissue necrosis. The device is used in a clinical setting to achieve hemostasis or treat hemorrhoids by routine excision. By providing precise, controlled thermal energy, the device facilitates tissue destruction and hemostasis, potentially reducing bleeding and improving patient outcomes during hemorrhoid treatment.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the predicate devices' established safety and effectiveness and bench testing of the contact tips.

Technological Characteristics

System includes console, handpiece, light guide, and disposable PVC contact tips. Operates via visible and infrared light pulses for thermal coagulation. Features a digital timer for automatic pulse duration control. Device is a Class II medical device (21 CFR 876.4300).

Indications for Use

Indicated for treatment of hemorrhoids, including bleeding, non-prolapsed internal hemorrhoids, and external thrombotic hemorrhoids that have been removed, in patients requiring hemostasis or coagulative necrosis of mucosa.

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 (for genital condylomas and general warts)

Submission Summary (Full Text)

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## JUN 11 1999

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

K990852

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

CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484

| Contact: | Deb Pekar<br>Manager, Regulatory Affairs, CooperSurgical, Inc. |
|------------|----------------------------------------------------------------|
| 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 hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed; and
- (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas (condyloma accuminata) and general warts.

#### Intended Use

The CooperSurgical IRC is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed ("collectively referred to as hemorrhoids") through the coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

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#### 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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K990852

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, waiting at least five seconds between exposures. 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.

#### 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. 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 hemorrhoids. 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 hemorrhoids is based on FDA's clearance of: (1) Redfield's Infrared Coagulator for the treatment of hemorrhoids; (2) CooperSurgical's InfraRed Coagulator for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 1999

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

Re: K990852 CooperSurgical InfraRed Coaqulator Dated: March 15, 1999 Received: March 15, 1999 Requiatory Class: II 21 CFR §876.4300/ Procode : 78 KNS

Dear Mr. Kahan:

We have reviewed vour 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 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). 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 regult 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.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compiance 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/dsma/dsmamain.html".

Sincerely yours.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological 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

Indications for Use:

The CooperSurgical InfraRed Coagulator is indicated for the treatment of hemorrhoids, especially bleeding, non-prolapsed internal hemorrhoids, as a means of hemostasis in the treatment of hemorrhoids by routine excision, or to coagulate external thrombotic hemorrhoids that have been removed through coagulative necrosis of the mucosa proximal to the base of the hemorrhoid.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use | (Per 21 C.F.R. 801.109)

(Division Sign-Off)

and Radiological Dev 510(k) Number.

Division of Reproductive, Abdominal, B

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)