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.

Device Description

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

AI/ML Overview

This 510(k) submission is for a traditional medical device (colposcope), not an AI/ML powered device. As such, it does not contain information typically found in submissions for AI/ML devices regarding acceptance criteria, study designs, or performance metrics.

However, based on the provided text, I can infer the acceptance criteria and the study that proves the device meets the acceptance criteria from the perspective of demonstrating substantial equivalence to a predicate device.

Here's the breakdown, addressing the questions where information is available or inferable:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Comparison)

The acceptance criteria for the GC-3000E Digital Colposcope System are largely based on demonstrating that its performance characteristics are either equivalent to or better than the predicate device (SLC-2000A) and that any differences do not affect its effectiveness and safety.

Specification	Acceptance Criteria (Relative to Predicate SLC-2000A)	Reported GC-3000E Performance	Discussion / Rationale for Acceptance
Color Rendering	Equal to or better than predicate, without affecting effectiveness/safety.	85 or above (Predicate: 75 or below)	Met. Higher "color rendering" is considered better performance and does not affect effectiveness/safety.
Illuminance at 300mm	Sufficient light (≥ 2000 Lux) for visual tasks, not significantly worse than predicate, and without affecting effectiveness/safety.	2046 Lx (Predicate: 2200 Lx)	Met. Though slightly lower, it still provides sufficient light (≥ 2000 Lux) for visual tasks of low contrast and small size for prolonged periods. The difference does not affect effectiveness/safety.
Illuminance Range	Equal to predicate.	≥ φ60mm, at working distance 200mm (Predicate: ≥ φ60mm, at working distance 200mm)	Met. Identical.
Light Source Lifetime	Equal to predicate.	≥ 10,000 hours (Predicate: ≥ 10,000 hours)	Met. Identical.
MTBF (Mean Time Between Failures)	Sufficiently long for normal service life (≤ 10 years for a digital colposcope), even if lower than predicate, without affecting effectiveness/safety.	~38,000h (Predicate: ≤ 50,000h)	Met. While lower than the predicate, 38,000h translates to 25-26 years of operation (based on 1500 hours/year), which is significantly longer than a normal service life of ≤ 10 years. The difference does not affect effectiveness/safety.
System Resolution	Equal to or better than predicate, without affecting effectiveness/safety.	≥ 500 TVL (Predicate: ≥ 470 TVL)	Met. Higher resolution is considered better visual performance and does not affect effectiveness/safety.
Image Geometric Distortion	Equal to or better than predicate (i.e., lower distortion percentage), without affecting effectiveness/safety.	1.8% (Predicate: 2.6%)	Met. Lower distortion is considered a better visual result and does not affect effectiveness/safety.
Magnification	Equal to predicate.	Optical: 1~~36X, Digital: 1~~40X (Predicate: Optical: 1~~36X, Digital: 1~~40X)	Met. Identical.
Field of View	Equal to predicate.	52° or at minimum magnification ≥ 60mm & at maximum magnification ≥ 10mm (Predicate: 52° or at minimum magnification ≥ 60mm & at maximum magnification ≥ 10mm)	Met. Identical.
Depth of Field	Equal to predicate.	At min mag ≥ 120mm; At max mag ≥ 5mm (Predicate: At min mag ≥ 120mm; At max mag ≥ 5mm)	Met. Identical.
Focus Mode	Functionally equivalent to predicate, providing necessary control, without affecting effectiveness/safety.	Manual and auto focus (Predicate: Auto focus only)	Met. Provides more control capability. Does not affect visual quality, effectiveness, or safety.
Multi-spectral light imaging	Equal to predicate.	No (Predicate: No)	Met. Identical.
Electronic filter	Equal to predicate.	green filter (3 grade) (Predicate: green filter (3 grade))	Met. Identical.
Magnification and timing display	Equal to predicate.	Yes (Predicate: Yes)	Met. Identical.
Freeze function	Equal to predicate.	YES (Predicate: YES)	Met. Identical.
Stand type	Equal to predicate.	vertical (Predicate: vertical)	Met. Identical.
Video output	Equal to predicate.	S-Video, Video (Predicate: S-Video, Video)	Met. Identical.
External power source	Equal to predicate.	Voltage: 100~~240VAC, Frequency: 50/60Hz, Input power: Max 500VA, Fuse: Input:5A, Output: 2A (Predicate: Voltage: 100~~240VAC, Frequency: 50/60Hz, Input power: Max 500VA, Fuse: Input:5A, Output: 2A)	Met. Identical.
Conformance to Industrial Standards	Meet relevant safety and performance standards.	IEC 60601-1, IEC 60601-1-2:2007, ISO 8600-3, ISO 8600-5 (Predicate: IEC 60601-1)	Met. The GC-3000E conforms to more standards than the predicate (including newer versions and additional ISO standards), indicating robust compliance.

Study Proving Device Meets Acceptance Criteria

The study primarily consisted of nonclinical testing and comparison to the predicate device to demonstrate substantial equivalence.

Sample size used for the test set and the data provenance:
- This information is not provided in the context of specific "test sets" as would be typical for AI/ML device performance studies involving patient data. The nonclinical tests likely used engineering samples or manufactured units of the GC-3000E.
- Data Provenance: Not applicable in the sense of patient data. The tests would have been performed by the manufacturer.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. For a traditional colposcope, "ground truth" isn't established in the same way as for diagnostic AI where expert labels are needed. The "truth" for engineering specifications (e.g., illuminance, resolution) is determined by calibrated measurement equipment and established test protocols.
Adjudication method for the test set:
- Not applicable. No expert adjudication process is described or implied for these types of nonclinical engineering tests.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a traditional colposcope, not an AI-powered device. Therefore, no MRMC study comparing human readers with and without AI assistance was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a traditional colposcope, not an AI-powered device. Therefore, no standalone algorithm performance study was done. The device's performance is inherently "human-in-the-loop" as it is a viewing and imaging tool for clinicians.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical tests, the "ground truth" for specifications like illuminance, resolution, distortion, etc., is derived from objective physical measurements using calibrated instruments and adherence to established engineering standards (e.g., ISO and IEC standards). The effectiveness and safety are largely established through comparison to a legally marketed predicate device with similar technological characteristics and intended use.
The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As it's not an AI/ML device, there's no training set or ground truth for such a set.

Summary of Nonclinical Tests Conducted (from Section 8):

The device meets acceptance criteria by conforming to the following standards and internal tests:

ISO 8600-3, 1st edition 1997: Endoscopes – medical endoscopes and endoscope accessories – Part 3: Determination of essential technical characteristics.
ISO 8600-5, 1st edition 2005: Endoscopes – medical endoscopes and endoscope accessories – Part 5: Test methods for safety requirements.
IEC 60601-1, 2nd edition 1988 (A1:1991 + A2:1995): Medical electrical equipment – Part 1: General requirements for safety.
IEC 60601-1-2, 3rd edition 2007: Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility – Requirements and tests.
Thermal Safety Test: Likely an internal test to ensure the device operates within safe temperature limits.
Image Distortion Test: An internal test to quantify and verify image geometric distortion, as reported in the comparison table.
Reliability Prediction of Electronic Equipment Standard, 1991: An internal test/methodology used to predict the Mean Time Between Failures (MTBF), as reported in the comparison table.

Conclusion stated in the 510(k): "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."

Summary

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510(k) SUMMARY

1. Submitter Information

Name:	Shenzhen GoldCare Meditech Co., Ltd.
Address:	10/F, Zonghe Bldg., Zhongxing Industry Block, ChuangyeRoad, Nanshan District,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

1. Device Description:

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Components: Digital Camera, Vertical Stand

6. Intended Use

Specification	SLC-2000A (GW)	GC-3000E	Discussion
StandardConfiguration	Digital Camera, Stand	Digital Camera, Stand
Minimum monitorresolution 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 colorrendering	75 or below	85 or above	High "color rendering" allows anobject's color to appear more naturalGC-3000E has higher "colorrendering" performance than SLC-2000A, and it provides betterperformance. The difference doesnot affect GC-3000E's effectivenessand safety.

7. Comparison to Predicate Device

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Illuminance	2200 Lx at workingdistance 300 mm	2046 Lx at workingdistance 300 mm	GC-3000E's illuminance at workingdistance of 300mm is slightly lowerthan SLC-2000A's illuminance.Both devices, at working distance of300mm, provide sufficient light, ≥2000Lux, for performance of visualtasks of low contrast and small sizefor prolonged periods of time. Thedifference does not affect GC-3000E's effectiveness and safety.
Illuminance range	≥ φ60mm, at workingdistance 200mm	≥ φ60mm, at workingdistance 200mm
Light source lifetime	≥ 10,000 hours	≥ 10,000 hours
MTBF	≤50,000h	~38,000h	GC-3000E will be turned on 6 hoursper day, 250 days per year, totally1,500 hours per year. Therefore, GC3000E's MTBF in years is between25 & 26 years. Although GC-3000E's MTBF may be less thanPredicate device's MTBF (≤ 50,000hours), it will not affect GC-3000E'ssafety & effectiveness because bothMTBFs are longer than digitalcolposcope's normal service lives, ≤10 years.
System resolution	≥ 470 TVL	≥ 500 TVL	GC-3000E's system resolution ishigher than SLC-2000A's systemresolution, and it performs bettervisually.The difference does not affect GC-3000E's effectiveness and safety.
Image geometricdistortion	2.6%	1.8%	GC-3000E's has lower imagedistortion, and provides better visualresult.The difference does not affect GC-3000E's effectiveness and safety.
Magnification	Optical: 1~~36XDigitalMagnification: 1~~40X	Optical: 1~~36XDigital Magnification:1~~40X

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Field of View	52° or at minimummagnification $\ge$ 60mm& at maximummagnification$\ge$ 10mm.	52° or at minimummagnification $\ge$ 60mm &at maximummagnification$\ge$ 10mm.
Depth of field	At minimummagnification$\ge$ 120mm;At maximummagnification $\ge$ 5mm	At minimummagnification $\ge$ 120mm;At maximummagnification $\ge$ 5mm
Focus mode	Electronic control:Auto focus only	Electronic control:Manual and auto focus	GC-3000E's focus control modeprovides more control capability. Itdoes not affect GC-3000E's visualquality.The difference does not affect GC-3000E's effectiveness and safety.
Multi-spectral lightimaging	No	No
Electronic filter	green filter(3 grade)	green filter(3 grade)
Magnification andtiming display	Yes	Yes
Freeze function	YES	YES
Stand type	vertical	vertical
Video output	S-Video, Video	S-Video, Video
External power source	Voltage: 100~240VACFrequency: 50/60HzInput power:Maximum 500VAFuse: Input:5A,Output: 2A	Voltage: 100~240VACFrequency: 50/60HzInput power: Maximum500VAFuse: Input:5A,Output: 2A
Conformance toindustrial standards	IEC 60601-1	IEC 60601-1, IEC 60601-1-2:2007, ISO 8600-3,ISO 8600-5

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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.

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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.

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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

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Statement of Indications for Use

510(k) Number (if known): K122311

Device Name: GC-3000E Digital Colposcope System

Indications for Use:

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

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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.