The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.

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 lesion is coagulated, waiting at least five seconds between exposures. The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CooperSurgical Infrared Coagulator. It focuses on demonstrating substantial equivalence to predicate devices and does not contain detailed acceptance criteria, a specific study design to prove acceptance criteria, or most of the requested information about sample sizes, ground truth establishment, or expert involvement for the current device.

However, the document does state that the safety and effectiveness are based on:

Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal.
The long history of use of lasers for the treatment of genital condylomas and general warts.
Two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.

Without the actual study reports for these "two recent clinical studies," it's impossible to extract the specific acceptance criteria and detailed study information as requested. The available document only provides a high-level summary of the basis for substantial equivalence.

Therefore, most of the requested information cannot be filled from the provided text.

Here's an attempt to answer what can be inferred from the document, with caveats:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., a specific percentage of lesion clearance, a recurrence rate threshold, or a specific safety metric) for the CooperSurgical Infrared Coagulator or its performance in the context of acceptance criteria.
It states that "two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts" were performed.
Inference: The "acceptance criteria" for the CooperSurgical IRC was likely demonstrating equivalence (non-inferiority) to the established safety and efficacy profiles of the predicate devices for the new indicated uses (genital condylomas and general warts), rather than meeting predefined numerical thresholds reported in this summary. The performance would then be interpreted as "equivalent to predicate devices."

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Equivalence in safety and effectiveness to predicate devices	Demonstrated equivalence to predicate devices
for treatment of genital condylomas and general warts.	for the treatment of genital condylomas and
	general warts, based on two clinical studies.

2. Sample size used for the test set and the data provenance

The document mentions "two recent clinical studies," but does not provide any details on the sample size used for the test set (patients/cases) or the data provenance (e.g., country of origin, retrospective or prospective nature) for these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not specify the number or qualifications of experts used to establish ground truth in the clinical studies. Given the context (treatment of condylomas and warts), it is highly probable that clinicians (e.g., dermatologists, gynecologists, urologists) would have been involved in diagnosing and assessing treatment outcomes, but no details are provided.

4. Adjudication method for the test set

The document does not describe any adjudication method used in the clinical studies.

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

This device is an infrared coagulator, not an AI-powered diagnostic or treatment assistance tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and was not performed.

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

This device is a hardware medical device for tissue coagulation, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not performed.

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

For the "two recent clinical studies," the ground truth for efficacy would likely be based on clinical assessment of lesion clearance/resolution and possibly recurrence rates as determined by treating physicians (outcomes data). For safety, it would involve monitoring adverse events. The document does not explicitly state the type of ground truth beyond "demonstrating that the IRC is equivalent."

8. The sample size for the training set

As this is a hardware device cleared based on substantial equivalence and clinical studies, rather than an AI/ML algorithm requiring a training set, the concept of a "training set" in the AI sense is not applicable here. The design and parameters of the device were developed through engineering and pre-clinical testing, not a "training set" of data.

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

Again, as this is not an AI/ML device, the concept of establishing ground truth for a training set is not applicable. Device design is typically based on engineering principles, material science, and pre-clinical/bench testing, as well as prior knowledge from predicate devices.

Summary

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K974168

JAN 2 3 1998

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

Contact:	John Grasso
	President, CooperSurgical, Inc.
Phone:	(203) 925-6621
Facsimile:	(203) 925-0135

Name of the Device

CooperSurgical Infrared Coagulator

Common or Usual Name

Infrared Coagulator

Predicate Devices

Redfield Corporation's Redfield Infrared Coagulator for the (1) treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648).
Laserscope's KTP/YAG Surgical Laser Systems (K913758) (2)
Sharplan Lasers, Inc.'s Model 3100 Nd:YAG Surgical Laser (3) (K951165)
Xanar Surgical Laser Systems' Xanar CO2 Surgical Laser System (4) Model XAP-15 (K861688).

Intended Use

The CooperSurgical Infrared Coagulator ("IRC") is intended for coagulative necrosis of tissue. It is indicated for the treatment of genital condylomas (condyloma accuminata) and general warts.

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Principles of Operation

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

The CooperSurgical IRC consists of the following main components: (1) a control unit; (2) a hand piece; (3) a removable light guide; and (4) a disposable contact tip. With the exception of two features, 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 (K842810/A) and chronic rhinitis (K950836), and for tattoo removal (K911648).

Summary of the Basis for the Finding of Substantial Equivalence

The safety and effectiveness of the CooperSurgical IRC is based on: (1) Redfield IRC's premarket clearances for the treatment of hemorrhoids and chronic rhinitis, and for tattoo removal; (2) the long history of use of lasers for the treatment of genital condylomas and general warts; and (3) two recent clinical studies demonstrating that the IRC is equivalent to its predicate devices for the treatment of genital condylomas and general warts.

With the exception of two features, the CooperSurgical IRC is practically the same device as the Redfield IRC, which has already received premarket clearance for the treatment of hemorrhoids (K842810/A) and chronic rhinitis (K950836) and for tattoo removal (K911648). The primary differences between the devices are (1) the indications for use; (2) the inclusion of single use/sterile (as opposed to reusable) contact tips with an integral sheath to protect the light guide from tissue contact; and (3) the use of a different 15 volt halogen bulb.

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In addition, the CooperSurgical IRC is substantially equivalent to several lasers that have received premarket clearance for genital condylomas (condyloma accuminata) and general warts: Laserscope's KTP/YAG Surgical Laser Systems (K913758), Sharplan Lasers, Inc.'s Model 3100 Nd:YAG Surgical Laser (K951165) and Xanar Surgical Laser Systems' Xanar CO2 Surgical Laser System Model XAP-15 (K861688).

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Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 3 1998

CooperSurgical. Incorporated C/O Mr. Jonathan S. Kahan Hogan & Hartson 555 13th Street. N.W. Washington, DC 20004-1109

K974168 Re:

Trade Name: CooperSurgical Infrared Coagulator Regulatory Class: II Product Code: KNS Dated: November 4, 1997 Received: November 5, 1997

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 eompliance with the … current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) 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

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Page 2 - Mr. Kahan

devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing vour 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 vours.

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): K 97 4/6 P

Device Name: Cooper Surgical Infrared Coagulator

Indications For Use:

For the treatment of genital condylomas (condyloma accuminata) and general warts.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
		(Division Sign-Off)
		Division of General Restorative Devices
		510(k) Number	K974168
Prescription UsePer 21 CFR 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).