CO-1000 COLPOSCOPE, MULTIPLE by GYNEX CORP.

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 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.

AI/ML Overview

The provided text describes a 510(k) Premarket Notification for the CO-1000 Colposcope. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical studies and acceptance criteria. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets said criteria in the way one might expect for a novel device or a Premarket Approval (PMA) application.

Instead, the submission asserts that the CO-1000 Colposcope is substantially equivalent to the DFV CPG Colposcope (K021854). Substantial equivalence is established by comparing the device's intended use, basic design, materials, method of manufacture, physical dimensions, and clinical utility to the predicate device.

Given this, I cannot extract the specific information requested in your prompt regarding acceptance criteria and studies demonstrating their fulfillment, as this information is not part of this 510(k) summary.

However, I can provide available information based on the document's content:

Summary of Device Information based on 510(k) Submission:

The GYNEX CO-1000 Colposcope is a Class II device intended for direct viewing of the tissues of the vagina and cervix by a telescopic system located outside the vagina, used to diagnose abnormalities and select areas for biopsy.

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

This document does not define specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy) for diagnosis or examination.
The "performance" described relates to the device's functional features (e.g., magnification, focal length, illumination) and its claim of substantial equivalence to a predicate device.

Criterion Type (Implied for Colposcopes based on description)	Reported Device Performance / Feature
Optical System
Eyepiece Magnification	12.5X
Overall Magnification	9X
Focal Length	320mm
Field of View	Wide
Optics Quality	Exceptional
	Individually adjustable eyepieces
Illumination	Uniform Illumination
	Adjustable Brightness
	Built-in rheostat
Ergonomics / Functionality	Ease of Operation
	Smooth adjustable controls for fine focus
	Universal Teflon ball joint for 360° easy motion (gross focus)
Enhancement Features	Built-in green filter for enhanced contrast
Maintenance	Easy replacement of halogen light bulb
Assembly	Completely assembled and ready for use once power is on

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. This 510(k) submission does not describe a clinical study with a test set. The substantial equivalence argument relies on comparing the CO-1000 Colposcope's specifications and design to a legally marketed predicate device, not on new clinical data demonstrating its performance against a specific test set.

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

Not applicable / Not provided. No test set or ground truth establishment is described in this regulatory submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. No test set or adjudication 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:

No. This device is a colposcope, an optical instrument, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.

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

No. This device is a physical optical instrument, not an algorithm. Standalone algorithm performance is not applicable.

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

Not applicable / Not provided. No new clinical study requiring ground truth is described. The basis for clearance is substantial equivalence to a predicate device, which inherently means the predicate device's existing regulatory clearance and presumed safety and effectiveness serve as the "ground" for the new device's clearance.

8. The sample size for the training set:

Not applicable / Not provided. No training set is mentioned as this device is a physical instrument, not a learned algorithm.

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

Not applicable / Not provided. No training set or ground truth establishment is described.

In summary, the provided document is a 510(k) premarket notification for a Class II medical device, a colposcope. The regulatory pathway for this device is based on demonstrating substantial equivalence to a predicate device, not on presenting new clinical data from studies designed to meet specific performance acceptance criteria. Therefore, most of the detailed questions regarding study design, sample sizes, and ground truth establishment are not addressed in this type of submission.

Summary

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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
1. 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 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.

1. Applicant Name & Address: GYNEX Corporation 2789 -- 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115
1. Company Contact: Mr. Stephen J. Sullivan, President GYNEX Corporation 2799 - 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115 ssullivan@gynex.com

Submission Correspondent: Karen Cardiff GYNEX Corporation 2799 - 152nd Avenue, N.E. Redmond, Washington 98052 425.882.1179 - 425.895.0115 kcardiff@gynex.com

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 (800) 638-2041 or (240) 276-3150

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:

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

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.