MEDISCOPE, colposcope ( Obstetrical and Gynecological Diagnostic Device ) is a medical camera unit and accessories to be used to magnify and view tissues of the cervix and diagnose abnormalities and select areas for biopsy. Mediscope consists of a main unit ( power source ) and probe. MEDISCOPE is designed for effective communication and education between doctors and patients. MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.

AI/ML Overview

This document is a 510(k) premarket notification for a colposcope, which is a medical device. As such, the information provided focuses on demonstrating substantial equivalence to a predicate device and adherence to safety standards, rather than the kind of clinical study data typically associated with novel AI-driven diagnostic devices. Therefore, many of the requested fields regarding acceptance criteria and performance against a gold standard derived from clinical studies will not be found in this type of document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to Predicate Device	"SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALLY EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM (510(K) NUMBER K955635)."
Design Specifications	"MEDISCOPE MEETS ALL DESIGN SPECS"
Electrical Safety Standards	Met IEC 60601-1 (Medical electrical equipment Part 1: General requirements for safety.)
Electromagnetic Compatibility (EMC) Standards	Met En 60601-1-2 (Standard for Electromagnetic Compatibility.)
General Safety Requirements for Medical Devices	"MEDISCOPE meets or exceeds all safety requirements for a medical device in its class."

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

This document does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The device is a colposcope, a visual magnification tool for examination. The evaluation focuses on safety and technical equivalence to a predicate device, not on diagnostic output.

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

Not applicable. As noted above, this submission is for a medical device (colposcope) that is a tool for visual examination, not a diagnostic AI algorithm. Therefore, no "ground truth" establishment by experts in the context of a diagnostic performance study is described.

4. Adjudication method for the test set

Not applicable. No diagnostic performance test set 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

Not applicable. This is not an AI-driven device, and no MRMC study is mentioned.

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

Not applicable. This is not an AI algorithm.

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

Not applicable. The "ground truth" used for this submission is adherence to established medical device standards for design, safety, and equivalence to a legally marketed predicate device.

8. The sample size for the training set

Not applicable. No machine learning model or training set is described.

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

Not applicable. No machine learning model or training set is described.

Summary

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K03/436
1 of 2

SOMETECH CORPORATION 6669 PEACHTREE INDUSTRIAL BOULEVARD, SUITE J NORCROSS, GEORGIA 30092

TEL: 770-825-0100

FAX: 770-849-9733

SUMMARY OF SAFETY AND EFFECTIVENESS

APPLICANT'S NAME/ADDRESS

SOMETECH INC. JUNGIL B/D 6F 142-2 NONHYUN-DONG KANGNAM-GU SEOUL 135-010 SOUTH KOREA

CONTACT PERSON:

TRADE NAME:

COMMON/USUAL NAME:

CLASSIFICATION NAME:

OWNER OPERATOR #:

CLASSIFICATION:

PERFORMANCE STANDARD:

Mr. Ki Cheol Han

MEDISCOPE

COLPOSCOPE (AND COLPOMICROSCOPE)

9057673

CLASS II UNDER 21 CODE OF FEDERAL REGULATION 884.1630

MEDISCOPE MEETS ALL DESIGN SPECS AND IS EQUIVALENT TO THE PREDICATE DEVICE.

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703.436

2082

SUBSTANTIAL EQUIVALENCE:

SOMETECH INC. BELIEVES THE MEDISCOPE IS SUBSTANTIALL Y EQUIVALENT TO THE WELCH ALLYN COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM ( 510 (K) NUMBER K955635 ).

MEDISCOPE is designed for effective communication and education between doctors and patients.

MEDISCOPE can be connected to a TV, CCTV, or Color Video Printer.

MEDISCOPE has undergone various electrical safety tests and has met the following standards.

1. IEC 60601-1, Medical electrical equipment Part 1 : General requirements for safety.
1. En 60601-1-2, Standard for Electromagnetic Compatiblity.

In summary, MEDISCOPE meets or exceeds all safety requirements for a medical device in its class. Our dedication to safety is evidenced in the many steps we have taken to insure a safe product.

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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 consists of a stylized caduceus symbol, which features three wavy lines that resemble a stylized human figure. The caduceus is enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the upper portion of the circular border.

DEC 1 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Ki Cheol Han President Sometech Corporation 6669 Peachtree Industrial Blvd. Suite J NORCROSS GA 30092

Re: K031436

Trade/Device Name: MEDISCOPE Regulation Number: 21 CFR §884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: 85 HEX Dated: September 16, 2003 Received: September 22, 2003

Dear Mr. Han:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

PMN 510(k) Number: KO3/436

MEDISCOPE Device Name:

(Colposcope (And colpomicroscope))

Indication for Use:

Gynecological and (Obstetrical colposcope MEDISCOPE, Diagnostic Device), is intended for magnified viewing of the tissues of cervix.

David C. Leyshon
(Division Sign-Off)

Division of Reproductive, Abdomin and Radiological De

510(k) Number

Prescription Use . ﺪ (Per 21 CFR 801.109)

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.