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 Description

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. 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. 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.

AI/ML Overview

Here's an analysis of the provided text regarding the CooperSurgical InfraRed Coagulator, focusing on acceptance criteria and the supporting study information.

Executive Summary:

The provided document (a 510(k) Summary) for the CooperSurgical InfraRed Coagulator (IRC) does not describe an independent study to establish specific acceptance criteria for performance metrics or to directly prove device performance against such criteria. Instead, the basis for finding substantial equivalence – and thus, acceptance – is primarily reliance on previously cleared predicate devices and bench testing demonstrating similar performance in photocoagulation and non-stick characteristics.

Here’s a breakdown of the requested information, highlighting what is (and isn't) present in the text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance metrics.	The device performs similarly to the Redfield IRC in terms of photocoagulation and non-stick characteristics.

Explanation: The document states that the CooperSurgical IRC is "essentially the same device" as the Redfield Corporation's InfraRed Coagulator and "identical" to a previously cleared CooperSurgical IRC for other indications, with minor differences. The "performance" is implicitly deemed acceptable because it is considered equivalent to devices already found safe and effective. No specific numeric thresholds for depth of coagulation, tissue necrosis, or other functional metrics are provided as acceptance criteria, nor are corresponding quantitative results from a study.

Study Details

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The document explicitly states 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." It also mentions bench testing for photocoagulation and non-stick characteristics. This means no clinical "test set" (e.g., patient data) was used in a new clinical study described in this 510(k) summary for the indication of chronic rhinitis. The data provenance would be from the predicate device clearances.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No new clinical study with a "test set" requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no new clinical test set was used, no adjudication method is relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This device is an infrared coagulator, not an AI or imaging device. Therefore, a MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Implicitly: The "ground truth" for the device's safety and effectiveness relies on the prior FDA clearances of the predicate devices. These clearances would have been based on clinical data, performance data, and potentially pathology or outcomes data from the predicate devices. For the CooperSurgical IRC itself, the bench testing provides "ground truth" on its physical performance characteristics (photocoagulation and non-stick) in comparison to the predicate.

8. The sample size for the training set

Not Applicable. No machine learning or AI model is described, thus no "training set."

9. How the ground truth for the training set was established

Not Applicable. As there is no training set mentioned.

Summary

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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 (203) 929-6321 Phone: Facsimile: (203) 925-0135

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

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

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

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
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.(b)
Classification. Class II (performance standards).