MEDISCOPE

K031436 · Sometech Corporation · HEX · Dec 19, 2003 · Obstetrics/Gynecology

Device Facts

• Record ID: K031436
• Device Name: MEDISCOPE
• Applicant: Sometech Corporation
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

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

Device Story

Mediscope is a colposcope consisting of a main power unit and a probe; used to magnify and view cervical tissues to diagnose abnormalities and select biopsy sites. Device facilitates communication and education between clinicians and patients. Input is visual tissue data captured by the camera probe; output is a magnified video signal displayed on external monitors (TV, CCTV) or captured via color video printer. Operated by clinicians in clinical settings. Benefits include enhanced visualization of cervical tissue for improved diagnostic accuracy.

Clinical Evidence

Bench testing only. Device underwent electrical safety and electromagnetic compatibility testing per IEC 60601-1 and EN 60601-1-2 standards.

Technological Characteristics

Colposcope system comprising a main power unit and camera probe. Connectivity via video output to external displays (TV, CCTV) or printers. Complies with IEC 60601-1 (general safety) and EN 60601-1-2 (electromagnetic compatibility).

Indications for Use

Indicated for magnified viewing of cervical tissues for diagnostic purposes in gynecological and obstetrical settings.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Welch Allyn Colposcope/Vertical Rolling Base/Swing Arm (K955635)

Submission Summary (Full Text)

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K03/436
1 of 2

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

TEL: [phone]

FAX: [phone]

# 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)

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, 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.

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.
- 2. 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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)