The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use or to touch the patient.

Device Description

The Edan video colposcope, including models C3A and C6A, consists of the camera module (CCD color camera), stand (vertical or swing arm stand), video capture box, foot switch, and video colposcope software. The Edan video colposcope is a non-patient contacting medical device. The C3A, C6A video colposcope is a digital imaging equipment that works as follows: The loop group LED light illumines the target, and the CCD camera takes images of the target. The images are converted into video signals, which are then captured and transmitted to a commercially available computer or monitor. The video colposcope software implements the functions of displaying images, capturing images or taking videos, storing and managing images and providing reports.

AI/ML Overview

The provided text is a 510(k) summary for the Edan Instruments, Inc. Video Colposcope, models C3A and C6A. It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical context.

Here's an attempt to extract and infer information based on the request, acknowledging that a direct "study proving acceptance criteria" as might be found in a clinical trial report is not present in this regulatory document.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format for direct comparison with performance results for clinical outcomes. Instead, it lists technical specifications and compares them to a predicate device. The performance data section refers to bench testing and compliance with standards.

Acceptance Criteria (Implied from Predicate Comparison & Standards)	Reported Device Performance (Edan C3A, C6A)
Power Supply
Voltage: 100 V-240 V~	100 V-240 V~
Frequency: 50 Hz/60 Hz	50 Hz/60 Hz
Input power (Maximum): Comparable to predicate	C3A, C6A: 48 VA (Predicate: 500 VA) - Different, but deemed acceptable for substantial equivalence.
Specifications
Standard Configuration: Digital CCD camera, Stand	Digital CCD camera, Stand
Light module: Comparable to predicate	C3A: Single loop group LED light; C6A: Double loop group LED light (Predicate: Double loop group LED light) - Different, but deemed acceptable.
Light source: White LED light	White LED light
Illumination: Comparable to predicate	C3A: 1600 lux at 300 mm; C6A: 3000 lux at 300 mm (Predicate: 2200 lux at 300 mm) - Different, C6A better, C3A lower but still acceptable.
Illumination range: ≥φ60 mm at 200 mm	≥φ60 mm at 200 mm
Light source lifetime: ≥10,000 hours	≥10,000 hours
System resolution: Comparable to predicate	≥500 TVL (Predicate: ≥470 TVL) - Better.
Space resolution: Comparable or sufficient (Predicate: N/A)	≥10 lpm - Specific value provided.
Image geometric distortion: Comparable to predicate	<3% (Predicate: <2.6%) - Slightly higher distortion, but deemed acceptable.
Magnification: Comparable to predicate	C3A: 1 ~ 28X; C6A: 1 ~ 36X (Predicate: 1 ~ 40X) - Different, but within a functional range.
Operation Distance: 200 mm-300 mm	200 mm-300 mm
Field of view: Comparable to predicate	3X: ≥φ80 mm OR ≥16.5°; 18X: ≥φ12 mm OR ≥2.5° (Predicate: At min mag 52° or ≥φ60 mm; At max mag ≥φ10 mm) - Different measurements, implied as functionally similar.
Depth of field: Comparable to predicate	6X: ≥120 mm; 18X: ≥6 mm (Predicate: 1X: ≥ 120 mm; 40X: ≥ 5 mm) - Different measurements, implied as functionally similar.
Focus mode: Electronic control	Electronic control: Manual and auto focus (Predicate: Auto focus only) - Improved functionality.
Electronic Filter: Green filter (3 grades)	Green filter (3 grades)
Magnification and timing display: YES	YES
Freeze function: YES	YES
Stand type: Vertical	Vertical, swing arm (optional) - More options.
Video Output: S-Video, Video	S-Video - Different, but common and compatible.
MBTE: Comparable to predicate	< 48,956h (Predicate: < 50,000h) - Slightly lower, but still meeting reliability expectations.
Standards Compliance
IEC 60601-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5	IEC 60601-1:2005/A1:2012, IEC 60601-1-2:2007 (Specific compliance listed for electrical safety & EMC). Bench testing in line with ISO 8600-3 and ISO 8600-5.
Software Level of Concern	"Moderate"
Image Geometric Distortion	Performed, results not explicitly detailed percentage-wise but deemed acceptable.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not applicable in the context of this 510(k) summary. The document describes engineering and performance bench testing rather than clinical study data with test sets of patient cases.
Data Provenance: The 'data' in this context refers to engineering test results, not patient data. It's generated from testing the physical device in a lab setting, presumably by Edan Instruments, Inc. in P.R. China, where the company is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not applicable. This is not a study involving expert-established ground truth for a test set of images or cases. It's a technical specification and bench testing summary.

4. Adjudication Method for the Test Set

Not applicable. There is no test set of cases requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The document does not describe human reader performance or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a video colposcope, which is a physical imaging tool used by a human clinician. It does not involve a standalone algorithm for diagnosis.

7. The Type of Ground Truth Used

For the technical performance aspects, the "ground truth" is established by direct physical measurements and functional testing against recognized standards (e.g., IEC, ISO) and comparison to the predicate device's specifications. For instance, illumination is measured in lux, resolution in TVL, and lifetime in hours.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require a training set of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an algorithm.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three profiles merging into a single form, overlaid with a symbol resembling a stylized caduceus or a flowing ribbon.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 1, 2015

Edan Instruments, Inc. % Doug Worth Sr. Director, US Regulatory and Quality Affairs Edan Medical USA, Inc. 1200 Crossman Ave, Suite 200 Sunnyvale, CA 94086

Re: K151878

Trade/Device Name: Video Colposcope, Models C3A, C6A Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: October 21, 2015 Received: October 26, 2015

Dear Doug Worth,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device

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

related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K151878

Device Name Video Colposcope, models C3A, C6A

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
----------------------------------------------------------------------------------------------------	---------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510 (K) Summary

Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92

Submitted by:	Edan Instruments, Inc.3/F - B, Nanshan MedicalEquipments Park, Nanhai Rd 1019#,Shekou, Nanshan Shenzhen,518067 P.R. China
Contact person:	Queena ChenTel: +86(0755) 26858736Fax: +1 (408) 418-4059Email: chenqin@edan.com.cn
Date prepared:	November 30, 2015
Device Identification:	Trade name: Video Colposcope, models C3A, C6ACommon name: ColposcopeRegulation No: 21 CFR 884.1630, ColposcopeRegulatory Class: IIProduct Code: HEX – Colposcope
Predicate Device:	Shenzhen Goldway Medical Electronics Co., Ltd,SLC-2000 Digital Video Colposcope Imaging System(K021153)Cleared - February 10, 2003
Device Description:	The Edan video colposcope, including models C3A andC6A, consists of the camera module (CCD color camera),stand (vertical or swing arm stand), video capture box, footswitch, and video colposcope software. The Edan videocolposcope is a non-patient contacting medical device.The C3A, C6A video colposcope is a digital imagingequipment that works as follows: The loop group LEDlight illumines the target, and the CCD camera takesimages of the target. The images are converted into videosignals, which are then captured and transmitted to acommercially available computer or monitor. The videocolposcope software implements the functions of

{4}------------------------------------------------

displaying images, capturing images or taking videos, storing and managing images and providing reports.

The C3A, C6A video colposcope is intended for Indications for Use: gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and private offices, and not intended for home use or to touch the patient.

Predicate Device Comparison

The subject device and the predicate device (K021153) have the same fundamental technology and similar technological characteristics, detailed in the table below:

ComparisonItems	SLC-2000A(GW)	C3A&C6A	Comparisonof C3A, C6AwithSLC-2000A
Manufacturer/K#	Goldway/K021153	EDAN	N/A
Indications forUse	The Goldway Digital VideoColposcope Imaging System isintended for magnifiedviewing of the vagina, cervixand external genitalia in orderto diagnose abnormalities andselect areas for biopsy. Theimage system is intended toprovide documentation of theimage in the field of view ofthe colposcope. The image canbe viewed on a color screen,printed on a color printer orarchived for storage andsubsequent retrieval. Thedevice is intended to be usedin Hospitals and clinics.	The C3A, C6A videocolposcope is intendedfor gynecologicalexamination. It providesmagnified visualizationof the vagina, cervix andexternal genitalia, whichcan help diagnoseabnormalities and selectareas for biopsy. It isintended to be used onlyby trained and qualifiedpersonnel in hospitals,clinics and privateoffices, and not intendedfor home use or to touchthe patient.	Different
Power Supply
Voltage	100 V-240 V~	100 V-240 V~	Same
Frequency	50 Hz/60 Hz	50 Hz/60 Hz	Same

{5}------------------------------------------------

Input power	500 VA	48 VA	Different
(Maximum)
Specifications
StandardConfiguration	Digital CCD camera, Stand	Digital CCD camera,Stand	Same
Light module	Double loop group LED light	Single loop group LEDlight (C3A)Double loop group LEDlight (C6A)	Different
Light source	White LED light	White LED light	Same
Illumination	2200 lux at working distance300 mm	1600 lux at workingdistance 300 mm (C3A)3000 lux at workingdistance 300 mm (C6A)	Different
Illuminationrange	≥φ60 mm at working distance200 mm	≥φ60 mm at workingdistance 200 mm	Same
Light sourcelifetime	≥10,000 hours	≥10,000 hours	Same
System resolution	≥470 TVL	≥500 TVL	Different
Space resolution	Not available	≥10 lpm	Different
Image geometricdistortion	<2.6%	<3%	Different
Magnification	1 ~ 40X	1 ~ 28X (C3A)1 ~ 36X (C6A)	Different
OperationDistance:	200 mm-300 mm	200 mm-300 mm	Same
Field of view	At minimum magnification52°or ≥φ60 mmAt maximum magnification≥φ10 mm	3X: ≥φ80 mm OR ≥16.5°18X:≥φ12 mm OR ≥2.5°	Different
Depth of field:	1X: ≥ 120 mm40X: ≥ 5 mm	6X: ≥120 mm18X: ≥6 mm	Different
Focus mode	Electronic control:Auto focus only	Electronic control:Manual and auto focus	Different
Electronic Filter	Green filter (3 grades)	Green filter (3 grades)	Same
Magnificationand timingdisplay	YES	YES	Same
Freeze function	YES	YES	Same
Stand type	Vertical	Vertical, swing arm(optional)	Different
Video Output	S-Video, Video	S-Video	Different
MBTE	< 50,000h	< 48,956h	Different

{6}------------------------------------------------

Standards Compliance
IEC60601-1	IEC 60601-1: 2005,IEC 60601-1-2: 2007,ISO 8600-3,ISO 8600-5	Different

The technological characteristics of the C3A, C6A video colposcope are comparable to the predicate device.

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the C3A, C6A video colposcope. The system complies with the IEC 60601-1:2005/A1: 2012 and standards for safety and the IEC 60601-1-2: 2007 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

Bench Testing

The most important performance specification is about the features associated with imaging, testing conducted to show the effectiveness of the subject device include:

· ISO 8600-3: 2003 Optics and photonics -Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics.
· ISO 8600-5: 2005 Optics and photonics -Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics.
· Thermal Testing
· Image Geometric Distortion Testing

Conclusion

The results of the testing demonstrate that the C3A, C6A video colposcope is as safe and effective as the predicate device and supports a determination of substantial equivalence.

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.