Video Colposcope

K151878 · Edan Instruments, Inc. · HEX · Dec 1, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K151878
• Device Name: Video Colposcope
• Applicant: Edan Instruments, Inc.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Dec 1, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

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 not intended for home use or to touch the patient.

Device Story

Video colposcope (models C3A, C6A) provides magnified visualization of gynecological anatomy. System comprises CCD color camera, stand (vertical or swing arm), video capture box, foot switch, and software. LED light illuminates target; CCD camera captures images; converted to video signals; transmitted to external computer/monitor. Software displays, captures, stores, manages images, and generates reports. Used by trained clinicians in hospitals/clinics for diagnostic support and biopsy site selection. Non-patient contacting device. Benefits include enhanced visualization of cervical/vaginal tissue to aid clinical diagnosis.

Clinical Evidence

Bench testing only. No clinical data provided. Performance validated via electrical safety (IEC 60601-1:2005/A1:2012), EMC (IEC 60601-1-2:2007), and optical performance standards (ISO 8600-3:2003, ISO 8600-5:2005). Additional testing included thermal and image geometric distortion analysis.

Technological Characteristics

Digital CCD camera; LED illumination (single or double loop); manual/auto focus; S-Video output. Power: 100-240V, 50/60Hz. Compliance: IEC 60601-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5. Software-based image management. Non-patient contacting.

Indications for Use

Indicated for gynecological examination in hospitals, clinics, and private offices by trained personnel. Provides magnified visualization of vagina, cervix, and external genitalia to assist in diagnosing abnormalities and selecting biopsy sites. Not for home use; non-patient contacting.

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

• SLC-2000 Digital Video Colposcope Imaging System (K021153)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# Indications for Use

510(k) Number (if known) K151878

Device Name Video Colposcope, models C3A, C6A

#### Indications for Use (Describe)

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 not intended for home use or to touch the patient.

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

| <div> <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|

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# 510 (K) Summary

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

| Submitted by: | Edan Instruments, Inc.<br>3/F - B, Nanshan Medical<br>Equipments Park, Nanhai Rd 1019#,<br>Shekou, Nanshan Shenzhen,<br>518067 P.R. China |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date prepared: | November 30, 2015 |
| Device Identification: | Trade name: Video Colposcope, models C3A, C6A<br>Common name: Colposcope<br>Regulation No: 21 CFR 884.1630, Colposcope<br>Regulatory Class: II<br>Product Code: HEX – Colposcope |
| Predicate Device: | Shenzhen Goldway Medical Electronics Co., Ltd,<br>SLC-2000 Digital Video Colposcope Imaging System<br>(K021153)<br>Cleared - February 10, 2003 |
| Device Description: | The Edan video colposcope, including models C3A and<br>C6A, consists of the camera module (CCD color camera),<br>stand (vertical or swing arm stand), video capture box, foot<br>switch, and video colposcope software. The Edan video<br>colposcope is a non-patient contacting medical device.<br>The C3A, C6A video colposcope is a digital imaging<br>equipment that works as follows: The loop group LED<br>light illumines the target, and the CCD camera takes<br>images of the target. The images are converted into video<br>signals, which are then captured and transmitted to a<br>commercially available computer or monitor. The video<br>colposcope software implements the functions of |

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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:

| Comparison<br>Items | SLC-2000A(GW) | C3A&C6A | Comparison<br>of C3A, C6A<br>with<br>SLC-2000A |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Manufacturer/K# | Goldway/K021153 | EDAN | N/A |
| Indications for<br>Use | The Goldway Digital Video<br>Colposcope Imaging System is<br>intended for magnified<br>viewing of the vagina, cervix<br>and external genitalia in order<br>to diagnose abnormalities and<br>select areas for biopsy. The<br>image system is intended to<br>provide documentation of the<br>image in the field of view of<br>the colposcope. The image can<br>be viewed on a color screen,<br>printed on a color printer or<br>archived for storage and<br>subsequent retrieval. The<br>device is intended to be used<br>in Hospitals and clinics. | The C3A, C6A video<br>colposcope is intended<br>for gynecological<br>examination. It provides<br>magnified visualization<br>of the vagina, cervix and<br>external genitalia, which<br>can help diagnose<br>abnormalities and select<br>areas for biopsy. It is<br>intended to be used only<br>by trained and qualified<br>personnel in hospitals,<br>clinics and private<br>offices, and not intended<br>for home use or to touch<br>the patient. | Different |
| Power Supply | | | |
| Voltage | 100 V-240 V~ | 100 V-240 V~ | Same |
| Frequency | 50 Hz/60 Hz | 50 Hz/60 Hz | Same |

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| Input power | 500 VA | 48 VA | Different |
|----------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-----------|
| (Maximum) | | | |
| Specifications | | | |
| Standard<br>Configuration | Digital CCD camera, Stand | Digital CCD camera,<br>Stand | Same |
| Light module | Double loop group LED light | Single loop group LED<br>light (C3A)<br>Double loop group LED<br>light (C6A) | Different |
| Light source | White LED light | White LED light | Same |
| Illumination | 2200 lux at working distance<br>300 mm | 1600 lux at working<br>distance 300 mm (C3A)<br>3000 lux at working<br>distance 300 mm (C6A) | Different |
| Illumination<br>range | ≥φ60 mm at working distance<br>200 mm | ≥φ60 mm at working<br>distance 200 mm | Same |
| Light source<br>lifetime | ≥10,000 hours | ≥10,000 hours | Same |
| System resolution | ≥470 TVL | ≥500 TVL | Different |
| Space resolution | Not available | ≥10 lpm | Different |
| Image geometric<br>distortion | <2.6% | <3% | Different |
| Magnification | 1 ~ 40X | 1 ~ 28X (C3A)<br>1 ~ 36X (C6A) | Different |
| Operation<br>Distance: | 200 mm-300 mm | 200 mm-300 mm | Same |
| Field of view | At minimum magnification<br>52°or ≥φ60 mm<br>At maximum magnification<br>≥φ10 mm | 3X: ≥φ80 mm OR ≥16.5°<br>18X:≥φ12 mm OR ≥2.5° | Different |
| Depth of field: | 1X: ≥ 120 mm<br>40X: ≥ 5 mm | 6X: ≥120 mm<br>18X: ≥6 mm | Different |
| Focus mode | Electronic control:<br>Auto focus only | Electronic control:<br>Manual and auto focus | Different |
| Electronic Filter | Green filter (3 grades) | Green filter (3 grades) | Same |
| Magnification<br>and timing<br>display | YES | YES | Same |
| Freeze function | YES | YES | Same |
| Stand type | Vertical | Vertical, swing arm<br>(optional) | Different |
| Video Output | S-Video, Video | S-Video | Different |
| MBTE | < 50,000h | < 48,956h | Different |

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| Standards Compliance | | |
|----------------------|-------------------------------------------------------------------------|-----------|
| IEC60601-1 | IEC 60601-1: 2005,<br>IEC 60601-1-2: 2007,<br>ISO 8600-3,<br>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.