The CooperSurgical Digital Colposcopy System combines a standard colposcope with a computer-based Digital Documentation System. The colposcope is intended to permit direct magnified viewing of the tissues of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Digital Documentation System is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color monitor, printed on a color printer, or archived for storage and subsequent retrieval.

Device Description

The colposcope portion of the CooperSurgical Digital Colposcopy System consists of a stereo microscope with a halogen light source and optional green filter, and is mounted on a mobile base. The Digital Documentation System consists of a CCD camera, an embedded computer, an LCD monitor, a "palm-mouse" pointing device, an optional keyboard, and an optional printer. The functional requirements of the Digital Documentation System include:

Storing digital images for viewing during the colposcopy exam, and for printing and/or later review
Storing textual information about a patient's medical history related to colposcopy
Storing textual information about observations seen during a colposcopy examination
Printing a colposcopy report that integrates images and textual information.
Implementation of the software green filter.
A patent-pending procedure to reduce the amount of distracting glare which is often present in pictures of the cervix and other wet tissue.

AI/ML Overview

The provided document (K972636, P192, and K972630) does not contain information regarding traditional acceptance criteria, performance studies, or clinical validation data often associated with modern medical device submissions, especially for AI/ML-driven devices. This is likely due to the nature and vintage of the submission, which pre-dates many requirements for sophisticated performance evaluations.

The CooperSurgical Digital Colposcopy System, described in a 510(k) submission from 1997, is essentially a colposcope with an integrated digital documentation system. It is not an AI/ML-driven diagnostic or assistive device that would have quantifiable performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.

Instead, its "acceptance criteria" and "study" are focused on demonstrating substantial equivalence to predicate devices. The performance of the device is implicitly tied to its ability to perform its stated functions, such as image acquisition, storage, and display, comparable to existing devices, rather than achieving specific diagnostic thresholds.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is absent for a device of this type and era:

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

No explicit acceptance criteria with numerical targets (e.g., sensitivity > X%, specificity > Y%) are stated in the document, nor are there reported device performance metrics in that context. The "performance" is described in terms of functional capabilities and comparison to predicate devices.

Acceptance Criteria (Implied/Functional)	Reported Device Performance (as described)
Permit direct magnified viewing of tissues of the vagina, cervix, and external genitalia.	The colposcope portion consists of a stereo microscope with a halogen light source and optional green filter, mounted on a mobile base, enabling direct magnified viewing for diagnosis and biopsy selection.
Provide documentation of the image in the field of view of the colposcope.	The Digital Documentation System provides this function.
Allow image viewing on a color monitor.	The system includes an LCD monitor for image viewing.
Allow image printing on a color printer.	The system allows for printing images on an optional color printer.
Allow archiving for storage and subsequent retrieval.	The system is intended to archive images for storage and retrieval.
Store digital images for viewing during exam, printing, and later review.	The Digital Documentation System fulfills this requirement.
Store textual information about patient medical history related to colposcopy.	The Digital Documentation System fulfills this requirement.
Store textual information about observations seen during colposcopy examination.	The Digital Documentation System fulfills this requirement.
Print a colposcopy report integrating images and textual information.	The Digital Documentation System fulfills this requirement.
Implement a software green filter.	The Digital Documentation System includes implementation of a software green filter.
Reduce distracting glare in images of the cervix and other wet tissue.	The Digital Documentation System includes "A patent-pending procedure to reduce the amount of distracting glare which is often present in pictures of the cervix and other wet tissue."
Substantially equivalent to predicate colposcopes and video colposcopes in intended use and technology.	The device is described as substantially equivalent to the Leisegang Model 1D Colposcope (K940094) and Welch Allyn Model 88000 and 89000 Video Colposcopes (K955635), sharing the same intended purpose of direct viewing and imaging of tissues to diagnose abnormalities.

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

The document does not describe a "test set" in the context of a clinical performance study with human subjects or retrospective data. The evaluation for substantial equivalence would have been based on technical specifications, functional testing, and comparison to predicate devices, not, for example, a dataset of patient images.

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

Not applicable. No "ground truth" establishment by experts for a test set is described, as it's not an AI/ML diagnostic device requiring such validation. The primary diagnostic function (viewing tissues to diagnose abnormalities) remains with the physician using the colposcope.

4. Adjudication method for the test set

Not applicable, as no test set requiring ground truth adjudication is mentioned.

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 such study was conducted or mentioned. The device is a "Digital Colposcopy System," which implies an enhancement in documentation and viewing capabilities, not an AI-assisted diagnostic tool that would demonstrate improvement in human reader performance.

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

Not applicable. The device is not an algorithm-only diagnostic. It is a system intended to be used by a healthcare professional (human-in-the-loop) for visual examination and documentation.

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

Not applicable. Ground truth, in the context of diagnostic accuracy, is not mentioned because this device's validation focuses on functional equivalence and safety, not on its own diagnostic accuracy. The physician's diagnosis (potentially confirmed by pathology from biopsies) constitutes the ground truth for patient management, but the device itself is a tool for the physician.

8. The sample size for the training set

Not applicable. There is no mention of a training set, as the device does not employ machine learning or AI models that require data for training.

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

Not applicable, as no training set is mentioned.

Summary

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K 972636

P192

510(k) Summary CooperSurgical Digital Colposcopy System

Sponsor

FEB - 2 1998

CooperSurgical, Inc. 15 Forest Parkway Shelton, CT 06484 (203) 929-6321 Telephone: Facsimile: (203) 925-0135

John Grasso Contact Person: Vice President, Operations

July 11, 1997 Date Prepared:

Device Name 2.

Classification Name: Colposcope, 21 CFR 884.1630, Class II CooperSurgical Digital Colposcopy System Proprietary Name:

Intended Use 3.

Device Description 4.

{1}------------------------------------------------

K972630
PLOL

device, an optional keyboard, and an optional printer. The functional requirements of the Digital Documentation System include:

Storing digital images for viewing during the colposcopy exam, and for . printing and/or later review
Storing textual information about a patient's medical history related to . colposcopy
Storing textual information about observations seen during a colposcopy . examination
Printing a colposcopy report that integrates images and textual information. .
Implementation of the software green filter. . .
A patent-pending procedure to reduce the amount of distracting glare which . is often present in pictures of the cervix and other wet tissue.

Basis For Substantial Equivalence 5.

The CooperSurgical Digital Colposcopy System is substantially equivalent to the Leisegang Model 1D Colposcope, manufactured by Leisegang Medical, Inc., and the Model 88000 and 89000 Video Colposcopes, manufactured by Welch Allyn, Inc. The Leisegang device received 510(k) premarket notification clearance under K940094 while the Welch Allyn devices were cleared under K955635.

The CooperSurgical, Leisegang and Welch Allyn colposcopes are all intended to permit direct viewing and imaging of the tissues of the vagina and cervix to diagnose abnormalities and select areas for biopsy. While the Leisegang device is video adaptable, the CooperSurgical and Welch Allyn devices contain integrated imaging systems. These imaging systems provide the physician with a means to record pictures of the tissues for review over time.

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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health. The logo features a stylized eagle with three wavy lines representing its body and wings. The words "DEPARTMENT OF HEALTH" are written vertically along the left side of the logo.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 1998

CooperSurgical, Inc. c/o Ms. Mary McNamara-Cullinane Staff Consultant Medical Device Consultants. Inc. 49 Plain Street North Attleboro, MA 02760

Re: K972630

CooperSurgical Digital Colposcopy System Dated: December 24, 1997 Received: December 29, 1997 Regulatory Class: II 21 CFR 884.1630/Procode: 85 HEX

Dear Ms McNamara-Cullinane:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 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 Resultations. 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 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 marked 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) 594-4613. 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,

W. Liao Yu

Lillian Yin, Ph.D. 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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K912630 510(k) Number (if known):

CooperSurgical Digital Colposcopy System Device Name:

Indications For Use:

The image contains a black line.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Doler R. Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1972630 510(k) Number.

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

CooperSurgical Digital Colposcopy System 510(k)

7/11/97

Page vi

Regulation Number and Section

§ 884.1630 Colposcope.

(a)
Identification. A colposcope is a device designed to permit direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. It is used to diagnose abnormalities and select areas for biopsy. This generic type of device may include a light source, cables, and component parts.(b)
Classification. Class II (special controls). The device, when it is a standard colposcope (or colpomicroscope) that uses only a white light source, does not use filters other than a green filter, does not include image analysis software, and is not smartphone-based, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.