CO-1000 COLPOSCOPE, MULTIPLE

K061306 · Gynex Corp. · HEX · Aug 7, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K061306
• Device Name: CO-1000 COLPOSCOPE, MULTIPLE
• Applicant: Gynex Corp.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The Gynex brand Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix.

Device Story

The CO-1000 Colposcope is a stereoscopic optical instrument for gynecologic examinations. It provides direct visualization of vaginal and cervical tissues via a telescopic system positioned outside the body. Key features include 12.5X eyepiece magnification, 9X overall magnification, 320mm focal length, and adjustable brightness via a built-in rheostat. The device incorporates a green filter for enhanced tissue contrast and a universal Teflon ball joint for 360° positioning. It is operated by clinicians in a clinical setting to identify abnormalities and select biopsy sites. The device is a standalone optical system requiring no digital processing or software.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Stereoscopic optical colposcope; 12.5X eyepiece magnification; 9X overall magnification; 320mm focal length; halogen light source with rheostat; green filter; Teflon ball joint for positioning; standalone mechanical/optical device; no software or electronic processing.

Indications for Use

Indicated for patients requiring examination of vaginal and cervical tissues for the diagnosis of abnormalities. For use by clinicians in a gynecological setting.

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

• DFV CPG Colposcope (K021854)

Submission Summary (Full Text)

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K061306 p.1/2

| Summary of 510(k) Information | CO-1000 Colposcope |
|----------------------------------------|-----------------------------------|
| Premarket Notification, Section 510(k) | GYNEX Corporation, April 26, 2006 |

Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:

- CO-1000 Colposcope 1. Device Name: Common Name: Colposcope Classification Name: Colposcope & Accessories
AUG - 7 2006

- 2. Establishment Name & Registration Number: Name: Gynex Corporation Number: 3032109
Subpart B -- Obstetrical and Gynecological Diagnostic Devices

Sec. 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 (performance standards).

| Device Class: | Class II |
|-----------------------|----------------------|
| Classification Panel: | Ob/Gyn Devices Panel |
| Product Code: | 85 HEX |

## 4. Equivalent Legally Marketed Device(s):

The GYNEX CO-1000 Colposcope is substantially equivalent in terms of intended use, basic design, materials, method of manufacture, physical dimensions, and clinical utility as the following legally marketed device:

- . DFV CPG Colposcope, K021854, DF Vasconcellos, SA
## 5. Device Description:

The CO-1000 Colposcope is a precise optical instrument designed specially for the gynecologic examination. The Gynex brand colposcope can be used to view vaginal and cervical tissues using stereoscopic optics.

The Gynex CO-1000 Colposcope has detailed features that include wide field of view, long focal length, uniform illumination, adjustable brightness, ease of operation, and exceptional optics. It is an essential instrument for any gynecologic examination. The general features of the device are as follows:

- Eyepiece magnification: 12.5X .
- ◆ Overall Magnification: 9X
- Focal length: 320mm ●
- . Individually adjustable evepieces
- . Smooth adjustable controls for fine focus
- . Universal Teflon ball joint gives you 360° easy motion for gross focus
- Built-in green filter for enhanced contrast .
- . Built-in rheostat
- Easy replacement of halogen light bulb
- Unit is completely assembled and ready for use once power is on .

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Indications for Use: The Gynex **CO-1000 Colposcope** is a device designed to permit viewing of the tissues
of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to
diagnose and examine abnormalities of the vagina and cervix.

- 6. Applicant Name & Address: GYNEX Corporation 2789 -- 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115
- 7. Company Contact: Mr. Stephen J. Sullivan, President GYNEX Corporation 2799 - 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115 [e-mail]

8. Submission Correspondent: Karen Cardiff GYNEX Corporation 2799 - 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115 [e-mail]

p.Z/2

K061306

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three wavy lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

Ms. Karen Cardiff Official Correspondent Gynex Corporation 2789-152nd Avenue, N.E. REDMOND WA 98052

Re: K061306

Trade/Device Name: CO-1000 Colposcope Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: April 26, 2006 Received: May 10, 2006

## Dear Ms. Cardiff:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo contains the letters "FDA" in a bold, stylized font. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed in a cursive font. Three stars are printed below the word "Centennial". The logo is surrounded by a circular border with text printed along the border.

Protecting and Promoting Public Health

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Page 2 -

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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrlvindustry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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Kob 12,06 510(k) Number (if known):

Devicc Name(s): CO-1000 Colposcope

## Intended Use:

The Gynex brand Colposcope is a device designed to permit viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina. A Colposcope is used to diagnose and examine abnormalities of the vagina and cervix.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X ============================================================================================================================================================================ OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

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