GC-3000E DIGITAL COLPOSCOPE

{0}------------------------------------------------ ### 510(k) SUMMARY #### 1. Submitter Information 2. 3. 4. : | Name: | Shenzhen GoldCare Meditech Co., Ltd. | | | | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------|--|--------|-----------------| | Address: | 10/F, Zonghe Bldg., Zhongxing Industry Block, Chuangye<br>Road, Nanshan District,<br>Shenzhen, Guangdong, 518054, P.R.CHINA | | | | | Phone: | 86-755-86161828 | | Fax: | 86-755-86161838 | | Date Submitted: | 9/6/2013 | | | | | Contact Information | | | | | | Name: | Jimmy Wu | | | | | Phone: | 626-799-0998 | | Email: | jwu@leexiao.com | | Device Information | | | | | | Common Name: | Colposcope (HEX) | | | | | CFR Section: | 21 CFR 884.1630 | | | | | Product Classification: | Class II | | | | | Classification Panel: | Obstetrics/Gynecology | | | | | Product Code: | HEX | | | | | Trade Name: | GC-3000E Digital Colposcope System | | | | | Predicate Device | | | | | | Manufacturer: | Goldway | | | | | Trade name: | SLC-2000 Digital Video Colposcope Imaging System | | | | | 510(k) Number: | K021153 | | | | - 5. Device Description: {1}------------------------------------------------ GC-3000E is a digital colposcope intended to provide magnified viewing of the vagina, cervix and external genitalia. GC-3000E is used to diagnose abnormalities and select areas for biopsy. GC-3000E acquires and displays high-resolution still and sequentially captured images and videos. GC-3000E offers non-patient contact, fully digital and high-resolution imaging of the cervix. The field of view is illuminated by circular LED group light source; a high-resolution color CCD camera provides crisp magnified color images. The images can be viewed on a commercially available color monitor. Components: Digital Camera, Vertical Stand #### 6. Intended Use The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics. | Specification | SLC-2000A (GW) | GC-3000E | Discussion | |---------------------------------------------|-----------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Standard<br>Configuration | Digital Camera, Stand | Digital Camera, Stand | | | Minimum monitor<br>resolution specification | 1024 * 768 | 1024 * 768 | | | Light module | Loop group LED light | Loop group LED light | | | Light source | main: white light | main: white light | | | White light color<br>rendering | 75 or below | 85 or above | High "color rendering" allows an<br>object's color to appear more natural<br>GC-3000E has higher "color<br>rendering" performance than SLC-<br>2000A, and it provides better<br>performance. The difference does<br>not affect GC-3000E's effectiveness<br>and safety. | #### 7. Comparison to Predicate Device {2}------------------------------------------------ | Illuminance | 2200 Lx at working<br>distance 300 mm | 2046 Lx at working<br>distance 300 mm | GC-3000E's illuminance at working<br>distance of 300mm is slightly lower<br>than SLC-2000A's illuminance.<br>Both devices, at working distance of<br>300mm, provide sufficient light, ≥<br>2000Lux, for performance of visual<br>tasks of low contrast and small size<br>for prolonged periods of time. The<br>difference does not affect GC-<br>3000E's effectiveness and safety. | |-------------------------------|-------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Illuminance range | ≥ φ60mm, at working<br>distance 200mm | ≥ φ60mm, at working<br>distance 200mm | | | Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours | | | MTBF | ≤50,000h | ~38,000h | GC-3000E will be turned on 6 hours<br>per day, 250 days per year, totally<br>1,500 hours per year. Therefore, GC<br>3000E's MTBF in years is between<br>25 & 26 years. Although GC-<br>3000E's MTBF may be less than<br>Predicate device's MTBF (≤ 50,000<br>hours), it will not affect GC-3000E's<br>safety & effectiveness because both<br>MTBFs are longer than digital<br>colposcope's normal service lives, ≤<br>10 years. | | System resolution | ≥ 470 TVL | ≥ 500 TVL | GC-3000E's system resolution is<br>higher than SLC-2000A's system<br>resolution, and it performs better<br>visually.<br>The difference does not affect GC-<br>3000E's effectiveness and safety. | | Image geometric<br>distortion | 2.6% | 1.8% | GC-3000E's has lower image<br>distortion, and provides better visual<br>result.<br>The difference does not affect GC-<br>3000E's effectiveness and safety. | | Magnification | Optical: 1~36X<br>Digital<br>Magnification: 1~<br>40X | Optical: 1~36X<br>Digital Magnification:<br>1~40X | | {3}------------------------------------------------ | Field of View | 52° or at minimum<br>magnification $\ge$ 60mm<br>& at maximum<br>magnification<br>$\ge$ 10mm. | 52° or at minimum<br>magnification $\ge$ 60mm &<br>at maximum<br>magnification<br>$\ge$ 10mm. | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Depth of field | At minimum<br>magnification<br>$\ge$ 120mm;<br>At maximum<br>magnification $\ge$ 5mm | At minimum<br>magnification $\ge$ 120mm;<br>At maximum<br>magnification $\ge$ 5mm | | | Focus mode | Electronic control:<br>Auto focus only | Electronic control:<br>Manual and auto focus | GC-3000E's focus control mode<br>provides more control capability. It<br>does not affect GC-3000E's visual<br>quality.<br>The difference does not affect GC-<br>3000E's effectiveness and safety. | | Multi-spectral light<br>imaging | No | No | | | Electronic filter | green filter<br>(3 grade) | green filter<br>(3 grade) | | | Magnification and<br>timing display | Yes | Yes | | | Freeze function | YES | YES | | | Stand type | vertical | vertical | | | Video output | S-Video, Video | S-Video, Video | | | External power source | Voltage: 100~<br>240VAC<br>Frequency: 50/60Hz<br>Input power:<br>Maximum 500VA<br>Fuse: Input:5A,<br>Output: 2A | Voltage: 100~240VAC<br>Frequency: 50/60Hz<br>Input power: Maximum<br>500VA<br>Fuse: Input:5A,<br>Output: 2A | | | Conformance to<br>industrial standards | IEC 60601-1 | IEC 60601-1, IEC 60601-<br>1-2:2007, ISO 8600-3,<br>ISO 8600-5 | | {4}------------------------------------------------ #### 8. Nonclinical Tests GC-3000E colposcope meets following performance standards: - ISO 8600-3, 1st edition 1997 . - ISO 8600-5, 1st edition 2005 ● - IEC 60601-1, 2nd edition 1988 (A1:1991 + A2:1995) . - IEC 60601-1-2, 3rd edition 2007 . Other nonclinical tests on thermal safety, image quality and device reliability were met: - Thermal Safety Test . - Image Distortion Test ● - Reliability Prediction of Electronic Equipment Standard, 1991 . #### 9. Conclusion The GC-3000E colposcope has the same intended use and substantially equivalent technological characteristics as the predicate devices. The non-clinical testing which included the use of recognized performance standards demonstrates that the GC-3000E colposcope is substantially equivalent to the predicate device. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure or a caduceus, which is a symbol often associated with healthcare. The symbol is composed of three curved lines that converge at the bottom. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 24, 2013 Shenzhen GoldCare Meditech Co., Ltd. % Jimmy Wu Associate Lee & Xiao Attorneys 2600 Mission Street, Suite 100 San Marino, CA 91108 Re: K122311 Trade/Device Name: GC-3000E Digital Colposcope System Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated (Date on orig SE ltr): September 6, 2013 Received (Date on orig SE Itr): September 10, 2013 Dear Jimmy Wu, This letter corrects our substantially equivalent letter of September 18, 2013. 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. {6}------------------------------------------------ Page 2 - Jimmy Wu 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 of medical device-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 Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 {7}------------------------------------------------ ### Statement of Indications for Use 510(k) Number (if known): K122311 Device Name: GC-3000E Digital Colposcope System Indications for Use: The GC-3000E Digital Colposcope is intended for the magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and select areas for biopsy. The image can be viewed on a color screen or computer monitor and printed on a color printer. The device is intended to be used in hospitals and clinics. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) # Herbert P. Lerner -S Page 1 of 1