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 tattoo removal. With the exception of four minor changes, the CooperSurgical IRC is identical to the CooperSurgical IRC that is cleared for the treatment of genital condylomas and general warts.

AI/ML Overview

The provided text is a 510(k) summary for the CooperSurgical InfraRed Coagulator (IRC) for tattoo removal. It does not include a study that proves the device meets specific acceptance criteria. Instead, it relies on substantial equivalence to predicate devices already cleared by the FDA. Therefore, many of the requested sections regarding acceptance criteria and performance studies cannot be extracted from this document.

Here's a breakdown of what can be extracted and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document does not specify quantitative acceptance criteria (e.g., specific coagulation depth, treatment efficacy percentages, safety margins) or report performance metrics from a dedicated clinical study for tattoo removal. The basis for clearance is substantial equivalence to existing devices, not a study demonstrating new performance metrics against predefined criteria.

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

Cannot be provided. No specific test set or clinical study for the CooperSurgical IRC for tattoo removal is mentioned in the document. Its clearance is based on the predicate devices.

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)

Cannot be provided. As there is no specified test set or clinical study for the CooperSurgical IRC for tattoo removal, there's no mention of experts establishing ground truth for such a set.

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

Cannot be provided. No test set or clinical study is described.

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

Cannot be provided. This device is an infrared coagulator, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI performance metrics are not applicable and not mentioned.

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

Cannot be provided. This device is a medical instrument used directly by a physician, not an algorithm. Standalone performance is not applicable.

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

Cannot be provided. No new clinical data or ground truth establishment is described for theCooperSurgical IRC regarding tattoo removal. The regulatory approval is based on the previously established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Cannot be provided. This is a hardware medical device, not an AI model. Therefore, the concept of a "training set" in the AI sense does not apply.

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

Cannot be provided. Not applicable (see point 8).

Summary of what the document does provide regarding its basis for substantial equivalence:

The safety and effectiveness of the CooperSurgical IRC for tattoo removal is based on:

Predicate Device 1: Redfield Corporation's Infrared Coagulator, which was already cleared by FDA for tattoo removal.
Predicate Device 2: CooperSurgical's IRC, which had previously received clearance for the treatment of genital condylomas and general warts.
Additional Testing: CooperSurgical's testing of the PVC contact tips (presumably for biocompatibility and function, though details are not provided).

Essentially, the document states that the CooperSurgical IRC is "essentially the same device" as Redfield Corporation's Infrared Coagulator for tattoo removal, with "four minor changes" that are not detailed but are presumably considered insignificant enough not to require new extensive clinical trials for this specific indication.

Summary

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

N99085D

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

CooperSurgical, Inc. 15 Forest Parkway Shelton, Connecticut 06484

Contact:	Debra Pekar
	Manager, Regulatory Affairs
	CooperSurgical, Inc.
Phone:	(203) 929-6321
Facsimile:	(203) 925-0135

March 15, 1999 Date Prepared:

Name of the Device

CooperSurgical InfraRed Coagulator

Common or Usual Name

Infrared Coagulator

Predicate Devices

(1) Redfield Corporation's Redfield Infrared Coagulator for tattoo removal; and
CooperSurgical, Inc.'s InfraRed Coagulator for the treatment of (2) genital condylomas (condyloma accuminata) and general warts.

Intended Use

The CooperSurgical InfraRed Coagulator ("IRC") is indicated for tattoo removal through the coagulative necrosis of tattoo pigmented tissue.

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

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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 lesion is coagulated, waiting at least five seconds between exposures.

Technical Characteristics

Summary of the Basis for the Finding of Substantial Equivalence

The safety and effectiveness of the CooperSurgical IRC for tattoo removal is based on: (1) Redfield Corporation's Infrared Coagulator that has already been cleared by FDA for tattoo removal; (2) CooperSurgical's IRC that has already received clearance for the treatment of genital condylomas and general warts; and (3) CooperSurgical's testing of the PVC contact tips.

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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 depiction of an eagle or bird-like figure with three overlapping, curved lines forming its body and wings. The bird faces to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1999 JUN

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

Re: K990850

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 (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 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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K990850 510(k) Number (if known):___

Device Name: CooperSurgical InfraRed Coagulator

Indications for Use:

The CooperSurgical InfraRed Coagulator is indicated for tattoo removal through coagulative necrosis of tattoo pigmented tissue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

to alee

(Division Sign-Off)
Division of General Restorative Devices / 6990850
510(k) Number.

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

· OR

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).