(219 days)
Not Found
No
The document describes standard optical and digital imaging technology with image management software for viewing, comparing, recording, and printing images. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, diagnosis, or other functions beyond basic image handling.
No.
The device is intended for magnified viewing to assist in diagnosing abnormalities and selecting areas for biopsy, which are diagnostic purposes, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is used "to assist doctors in diagnosing abnormalities," which directly indicates its role as a diagnostic device. The "Device Description" also reinforces this, mentioning its use "to diagnose abnormalities and select areas for biopsy."
No
The device description clearly outlines hardware components including a CCD color camera, light source, stands, and optical imaging systems, in addition to the image management software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Colposcope System is used for direct visual examination of the vagina, cervix, and external genitalia in vivo (within the living body). It assists doctors in diagnosing abnormalities and selecting areas for biopsy, but it does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "magnified viewing of the vagina, cervix and external genitalia" to assist in diagnosis and biopsy selection. This is a direct visualization tool, not a laboratory test device.
Therefore, the Colposcope System falls under the category of a medical device used for direct examination, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
HEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
optical imaging, CCD imaging
Anatomical Site
vagina, cervix, external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained and qualified personnel in hospitals, clinics and private offices
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- 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:
- Illuminance Test
- Image Distortion Test
- System Resolution test
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right.
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.
1
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 (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,
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +86-516-87732208 Fax: +86-516-87732211 Email: wjkernel@126.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
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
-
- 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
- Identification of Predicate Devices
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.
-
- 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.
- Indications for Use
-
- Predicate Comparison
Table 1 Comparison of Technology Characteristics between the subject Video Colpscope System and predicate device 1
- Predicate Comparison
| Item | Colposcope System | Predicate Device 1 |
|---|---|---|
| Model | KN-2200/2200A/KN2200I/KN-2200I(H) | K021153 |
| 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 | |
| 200mm to 400mm | 2200Lx at working distance 200mm to | |
| 400mm | ||
| Illumination range | ≥φ60mm, at working distance | |
| 200mm | ≥φ60mm, at working distance 200mm | |
| Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours |
| ≤ 50, 000 h | ||
| MTBF | 59817 hours (KN-2200) | |
| 26985 hours (KN-2200A) | ||
| 19778 hours (KN-2200I) | ||
| 37301 hours (KN-2200I(H)) | ||
| System resolution | ≥ 700 TVL (KN-2200/2200A) | |
| ≥ 550 TVL (KN-2200I) | ||
| ≥ 1000 TVL (KN-2200I(H)) | ≥ 470 TVL | |
| Image geometric | ||
| distortion | 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.