Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard digital colposcope for image acquisition and display, with no mention of AI/ML for image analysis, diagnosis, or other functions.

Therapeutic

No
The device is used for magnified viewing and diagnosing abnormalities, not for treatment or therapy.

Diagnostic

Yes

The device, a digital colposcope, is used to "aid in diagnosing abnormalities" and "diagnose abnormalities and select areas for biopsy," which explicitly states its role in diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components (Digital Camera, Vertical Stand) and describes physical characteristics like an LED light source and CCD camera, indicating it is a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the GC-3000E Digital Colposcope is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD devices are used to examine specimens derived from the human body. The GC-3000E is used for direct, non-contact viewing of the vagina, cervix, and external genitalia in situ (on the patient). It does not analyze samples like blood, urine, tissue biopsies, etc.
The intended use and device description clearly state it's for magnified viewing and aiding in diagnosis by selecting areas for biopsy. This is a visual examination tool, not a laboratory test.
The performance studies listed are related to electrical safety, optical standards, and reliability, not the analytical or clinical performance typically associated with IVD tests.

Therefore, the GC-3000E Digital Colposcope falls under the category of a medical device used for direct patient examination, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

HEX

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

vagina, cervix and external genitalia

Indicated Patient Age Range

Not Found

Intended User / Care Setting

hospitals and clinics.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K021153

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

510(k) SUMMARY

1. Submitter Information

:

Name:	Shenzhen GoldCare Meditech Co., Ltd.
Address:	10/F, Zonghe Bldg., Zhongxing Industry Block, Chuangye
Road, 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:

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
Configuration	Digital Camera, Stand	Digital Camera, Stand
Minimum monitor
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
rendering	75 or below	85 or above	High "color rendering" allows an
object's color to appear more natural
GC-3000E has higher "color
rendering" performance than SLC-
2000A, and it provides better
performance. The difference does
not affect GC-3000E's effectiveness
and safety.

7. Comparison to Predicate Device

2

| Illuminance | 2200 Lx at working
distance 300 mm | 2046 Lx at working
distance 300 mm | GC-3000E's illuminance at working
distance of 300mm is slightly lower
than SLC-2000A's illuminance.
Both devices, at working distance of
300mm, provide sufficient light, ≥
2000Lux, for performance of visual
tasks of low contrast and small size
for prolonged periods of time. The
difference does not affect GC-
3000E's effectiveness and safety. |
|-------------------------------|-------------------------------------------------------|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Illuminance range | ≥ φ60mm, at working
distance 200mm | ≥ φ60mm, at working
distance 200mm | |
| Light source lifetime | ≥ 10,000 hours | ≥ 10,000 hours | |
| MTBF | ≤50,000h | 38,000h | GC-3000E will be turned on 6 hours
per day, 250 days per year, totally
1,500 hours per year. Therefore, GC
3000E's MTBF in years is between
25 & 26 years. Although GC-
3000E's MTBF may be less than
Predicate device's MTBF (≤ 50,000
hours), it will not affect GC-3000E's
safety & effectiveness because both
MTBFs are longer than digital
colposcope's normal service lives, ≤
10 years. |
| System resolution | ≥ 470 TVL | ≥ 500 TVL | GC-3000E's system resolution is
higher than SLC-2000A's system
resolution, and it performs better
visually.
The difference does not affect GC-
3000E's effectiveness and safety. |
| Image geometric
distortion | 2.6% | 1.8% | GC-3000E's has lower image
distortion, and provides better visual
result.
The difference does not affect GC-
3000E's effectiveness and safety. |
| Magnification | Optical: 136X
Digital
Magnification: 1~
40X | Optical: 136X
Digital Magnification:
140X | |

3

| Field of View | 52° or at minimum
magnification $\ge$ 60mm
& at maximum
magnification
$\ge$ 10mm. | 52° or at minimum
magnification $\ge$ 60mm &
at maximum
magnification
$\ge$ 10mm. | |
|----------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Depth of field | At minimum
magnification
$\ge$ 120mm;
At maximum
magnification $\ge$ 5mm | At minimum
magnification $\ge$ 120mm;
At maximum
magnification $\ge$ 5mm | |
| Focus mode | Electronic control:
Auto focus only | Electronic control:
Manual and auto focus | GC-3000E's focus control mode
provides more control capability. It
does not affect GC-3000E's visual
quality.
The difference does not affect GC-
3000E's effectiveness and safety. |
| Multi-spectral light
imaging | No | No | |
| Electronic filter | green filter
(3 grade) | green filter
(3 grade) | |
| Magnification and
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~
240VAC
Frequency: 50/60Hz
Input power:
Maximum 500VA
Fuse: Input:5A,
Output: 2A | Voltage: 100~240VAC
Frequency: 50/60Hz
Input power: Maximum
500VA
Fuse: Input:5A,
Output: 2A | |
| Conformance to
industrial standards | IEC 60601-1 | IEC 60601-1, IEC 60601-
1-2:2007, ISO 8600-3,
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

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