Colposcope System

K160341 · Xuzhou Kernel Medical Equipment Co., Ltd. · HEX · Sep 14, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K160341
• Device Name: Colposcope System
• Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Sep 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing 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.

Device Story

Colposcope System (video and binocular models) provides magnified visualization of vaginal, cervical, and external genital tissues. Video models use CCD color cameras with digital magnification (up to x16) and LED illumination; binocular models combine optical telescopic viewing with CCD image capture. Devices are mounted on stands or trolleys. Systems include image management software on CD-ROM for viewing, recording, comparing, and printing images via connected computer/monitor. Used by physicians/trained personnel in clinical settings to identify abnormalities and guide biopsy site selection. Benefits include enhanced visualization for diagnostic accuracy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and optical performance standards (ISO 8600-3, ISO 8600-5). Performance specifications verified via illuminance, image distortion, and system resolution testing.

Technological Characteristics

Video and binocular configurations. Video models: CCD camera, LED light, electronic focus (manual/auto). Binocular models: optical telescope, CCD camera, LED light, manual focus. Connectivity: PC-based image management software via CD-ROM. Standards: IEC 60601-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5. Non-patient contacting materials.

Indications for Use

Indicated for magnified viewing of the vagina, cervix, and external genitalia to assist clinicians in diagnosing abnormalities and selecting biopsy sites. Intended for use by trained personnel in hospitals, clinics, and private offices; not for home use.

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

• Goldway SLC-2000 Digital Video Colposcope Imaging System (K021153)
• Colposcope COLPO-99/99 Plus (K070845)
• Leisegang Colposcope Systems (K140754)

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

September 14, 2016

Xuzhou Kernel Medical Equipment Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K160341

> Trade/Device Name: Colposcope System Models: KN-2200/ KN-2200A/ KN-2200I/ KN-2200I(H)/ KN-2200B/ KN-2200BI Regulation Number: 21 CFR& 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: August 8. 2016 Received: August 18, 2016

Dear Diana Hong:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

For Division

# Douglas Silverstein -S 2016.09.14 16:35:35 -04'00'

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) K160341

Device Name Colposcope System

Models: KN-2200/ KN-2200A/ KN-2200I/ KN-2200I(H)/ KN-2200B/ KN-2200BI

Indications for Use (Describe)

The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing 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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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## 510(k) Summary K160341

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

- Date of Preparation: 09/02/2016 1.
- Sponsor Identification 2.

Xuzhou Kernel Medical Equipment Co., LTD Kernel Mansion, Economic Development District, Xuzhou, Jiangsu, 221004, China

Establishment Registration Number: 3008393409

Contact Person: Jing Wang Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

#### 4. Identification of Proposed Device

Trade Name: Colposcope System Common Name: Video Colposcope and Binocular Colposcope Models: KN-2200/ KN-2200A/ KN-2200I/ KN-2200I(H)/ KN-2200B/ KN-2200BI

Regulatory Information Classification Name: Colposcope Regulatory Classification: Class II Product Code: HEX, colposcope (and colpomicroscope) Regulation Number: 21CFR 884.1630 Review Panel: Obstetrics/Gynecology

- 5. Identification of Predicate Devices
Predicate Device 1 510(k) Number: K021153 Product Name: Goldway SLC-2000 Digital Video Colposcope Imaging System Model Name: SLC-2000A

Predicate Device 2 510(k) Number: K070845 Product Name: Colposcope COLPO-99/99 Plus Model Name: COLPO-99 Plus

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Predicate Device 3 510(k) Number: K140754 Product Name: Leisegang Colposcope Systems Model Name: 3ML

#### 6. Device Description

The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The Colposcope System has two kinds of colposcopes, a video colposcope and a binocular colposcope.

The video colposcope system is a non-patient contacting image capture device (CCD color camera) with a digital magnification of up to x16, working distance supporting 200mm, and a green filtered light source mounted on a vertical stand, swing arm stand or trolley. Tissue is magnified and viewed directly via the LCD screen attached to the capture device or on the commercially available color monitor. The video colposcope system has four models, including KN-2200A, KN-22001 and KN-2200I(H).

The binocular colposcope system is designed based on an optical colposcope. Its imaging system consists of optical imaging and CCD imaging. It permits viewing of the vagina, cervix and external genitalia by a telescopic system and the CCD camera captures digital images. The binocular colposcope system has two models, including KN-2200B and KN-2200BI. The two models have the same binoculars, CCD camera, cables except for the light source size and the stand type.

Both video colposcope system and binocular colposcope come with image management software, which is provided on a CD-ROM. The image management software allows the viewer to view, compare, record and print the image by series peripheral units, such as computer, monitor and printer.

- 7. Indications for Use
The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing 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.

- 8. Predicate Comparison
Table 1 Comparison of Technology Characteristics between the subject Video Colpscope System and predicate device 1

| Item | Colposcope System | Predicate Device 1 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | KN-2200/2200A/KN2200I/KN-2200I(H) | K021153<br>SLC-22000A |
| Intended environment | Hospitals, clinics and doctor's office | Hospitals, clinics and doctor's office |
| Intended Use | The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing 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. | The Goldway Digital Video Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in hospitals and clinics. |

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| Configuration | Digital camera, stand | Digital camera, stand |
|---------------------------------|--------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Light module | Loop group LED light | Loop group LED light |
| Working distance | 200mm~400mm | 150mm~350mm |
| Illumination | ≥1200Lx at working distance<br>200mm to 400mm | 2200Lx at working distance 200mm to<br>400mm |
| Illumination range | ≥φ60mm, at working distance<br>200mm | ≥φ60mm, at working distance 200mm |
| Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours |
| | | ≤ 50, 000 h |
| MTBF | 59817 hours (KN-2200)<br>26985 hours (KN-2200A)<br>19778 hours (KN-2200I)<br>37301 hours (KN-2200I(H)) | |
| System resolution | ≥ 700 TVL (KN-2200/2200A)<br>≥ 550 TVL (KN-2200I)<br>≥ 1000 TVL (KN-2200I(H)) | ≥ 470 TVL |
| Image geometric<br>distortion | <2.5% | 2.6% |
| Focus mode | Electronic control:<br>Manual and auto focus | Electronic control:<br>Auto focus only |
| Multi-spectral light<br>imaging | No | No |
| Electronic filter | Green filter | Green filter |
| Freeze function | Yes | Yes |
| Biocompatibility | No patient contacting material | No patient contacting material |

The proposed video colposcope system has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

| Table 2 Comparison of Technology Characteristics between subject Binocular Colpscope System and | |
|-------------------------------------------------------------------------------------------------|--|
| predicate devices 2 and 3 | |

| Item | Colposcope System | Predicate Device 2 | Predicate device 3 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | KN-2200B/2200BI | Colpo-99 Plus | 3ML |
| Product Code | HEX | HEX | HEX |
| Regulation Number | CFR 884.1630 | CFR 884.1630 | CFR 884.1630 |
| Intended enviroment | Hospitals, clinics and doctor's office | Hospitals, clinics and doctor's office | Hospitals, clinics and doctor's office |
| Intended Use | The Colposcope System is intended for magnified viewing of the vagina, cervix and external genitalia in order to assist doctors in diagnosing 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. | The Sounmed Colposcope COLPO-99 is intended 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 area for biopsy. | The Cooper Surgical Leisegang Colposcope Systems are intended for the magnified viewing of the tissues of the vagina, cervix, and external genitalia in order to assist doctors in diagnosing abnormalities such as lesions or cancer, and selecting areas for biopsy. The |

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| | | | images from Cooper<br>Surgical Leisegang<br>Colposcopes may be<br>viewed directly and/or on<br>a color monitor (if so<br>equipped). Cooper<br>Surgical Leisegang<br>Colposcopes are intended<br>for use in hospitals,<br>clinics, and doctor's<br>offices. |
|-------------------------------|---------------------------------------|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Configuration | Binoculars, Digital Camera;<br>Stand; | Binoculars, Stand; | Binoculars, Digital Camera; Stand; |
| Light source | LED light | Halogen lamp | LED light |
| Binoculars | Inclined, f'=160mm | Straight, f'=160mm | Straight or inclined |
| Objective | f'=300mm | f'=300mm | Unknown |
| Eyepiece<br>magnification | 12.5x with diopter adjustment | 12.5x with diopter<br>adjustment | Unknown |
| Diopter adjustment | -5D to +5 D | -5D to +5 D | -7D to +7 D |
| 5 step magnification | 0.4x, 0.6x, 1x, 1.6x, 2.5x | 0.4x, 0.6x, 1x, 1.6x, 2.5x | Unknown |
| MTBF | 41445 hours | Unknown | Unknown |
| Illumination | ≥30,000 lx | 80,000lx | 23,000~35,000lx |
| Image geometric<br>distortion | ≤2.5% | Unknown | Less than 7% |
| Focus mode | Manual | Manual | Manual |
| Electronic filter | Green filter | Green filter | Green filter |
| Biocompatibility | No patient contacting material | No patient contacting<br>material | No patient contacting<br>material |

The proposed binocular colposcope system has the same intended use but different technological characteristics compared to the predicate devices. The differences in technological characteristics do not raise different questions of safety and effectiveness.

- 9. Summary of Non-Clinical Tests
Non-clinical tests were conducted to verify that the proposed device met all design specifications and is substantially equivalent to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1-2005+CORR.1:2006+CORR.2:2007, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance, including the US National Differences
- > IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
- A ISO 8600-3:1997 Optics and optical instruments--Medical endoscopes and endoscopic accessories 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

Other non-clinical tests were conducted to show that the device met its performance specifications. The following tests were conducted:

- A Illuminance Test
- A Image Distortion Test
- A System Resolution test

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### 10. Conclusions

Based on the comparison and analysis above, the proposed device is substantially equivalent to the predicate devices.