(145 days)
Not Found
No
The description focuses on standard digital imaging and image capture/management software, with no mention of AI/ML terms or functionalities.
No.
The device is used for diagnosis and visualization, not for treating any medical condition.
Yes
Explanation: The device is intended to "help diagnose abnormalities" by providing "magnified visualization" of anatomical sites. This falls under the definition of a diagnostic device.
No
The device description explicitly states that the device consists of hardware components including a camera module, stand, video capture box, and foot switch, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "gynecological examination" and provides "magnified visualization of the vagina, cervix and external genitalia." It helps "diagnose abnormalities and select areas for biopsy." This describes a device used for direct visualization and examination of the patient's body, not for testing samples taken from the body.
- Device Description: The description details a "digital imaging equipment" that uses light and a camera to capture images of the target. It explicitly states it is a "non-patient contacting medical device." This aligns with an imaging device used externally or internally for visualization, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used for direct visual examination of the patient.
N/A
Intended Use / Indications for Use
The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and not intended for home use or to touch the patient.
Product codes
HEX
Device Description
The Edan video colposcope, including models C3A and C6A, consists of the camera module (CCD color camera), stand (vertical or swing arm stand), video capture box, foot switch, and video colposcope software. The Edan video colposcope is a non-patient contacting medical device. The C3A, C6A video colposcope is a digital imaging equipment that works as follows: The loop group LED light illumines the target, and the CCD camera takes images of the target. The images are converted into video signals, which are then captured and transmitted to a commercially available computer or monitor. The video colposcope software implements the functions of displaying images, capturing images or taking videos, storing and managing images and providing reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (CCD color camera, LED light)
Anatomical Site
vagina, cervix and 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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the C3A, C6A video colposcope. The system complies with the IEC 60601-1:2005/A1: 2012 and standards for safety and the IEC 60601-1-2: 2007 standard for EMC.
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Bench Testing was conducted to show the effectiveness of the subject device, including:
- ISO 8600-3: 2003 Optics and photonics -Medical endoscopes and endotherapy devices — 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.
- Thermal Testing
- Image Geometric Distortion Testing
Key Metrics
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 seal of the Department of Health & Human Services - USA. The seal features the department's name in a circular arrangement around an emblem. The emblem is a stylized representation of a human figure, with three profiles merging into a single form, overlaid with a symbol resembling a stylized caduceus or a flowing ribbon.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 1, 2015
Edan Instruments, Inc. % Doug Worth Sr. Director, US Regulatory and Quality Affairs Edan Medical USA, Inc. 1200 Crossman Ave, Suite 200 Sunnyvale, CA 94086
Re: K151878
Trade/Device Name: Video Colposcope, Models C3A, C6A Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: October 21, 2015 Received: October 26, 2015
Dear Doug Worth,
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.
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 device
1
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 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,
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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Indications for Use
510(k) Number (if known) K151878
Device Name Video Colposcope, models C3A, C6A
Indications for Use (Describe)
The C3A, C6A video colposcope is intended for gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose abnormalities and select areas for biopsy. It is intended to be used only by trained and qualified personnel in hospitals, clinics and not intended for home use or to touch the patient.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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510 (K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| Submitted by: | Edan Instruments, Inc.
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
Shekou, Nanshan Shenzhen,
518067 P.R. China |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Queena Chen
Tel: +86(0755) 26858736
Fax: +1 (408) 418-4059
Email: chenqin@edan.com.cn |
| Date prepared: | November 30, 2015 |
| Device Identification: | Trade name: Video Colposcope, models C3A, C6A
Common name: Colposcope
Regulation No: 21 CFR 884.1630, Colposcope
Regulatory Class: II
Product Code: HEX – Colposcope |
| Predicate Device: | Shenzhen Goldway Medical Electronics Co., Ltd,
SLC-2000 Digital Video Colposcope Imaging System
(K021153)
Cleared - February 10, 2003 |
| Device Description: | The Edan video colposcope, including models C3A and
C6A, consists of the camera module (CCD color camera),
stand (vertical or swing arm stand), video capture box, foot
switch, and video colposcope software. The Edan video
colposcope is a non-patient contacting medical device.
The C3A, C6A video colposcope is a digital imaging
equipment that works as follows: The loop group LED
light illumines the target, and the CCD camera takes
images of the target. The images are converted into video
signals, which are then captured and transmitted to a
commercially available computer or monitor. The video
colposcope software implements the functions of |
4
displaying images, capturing images or taking videos, storing and managing images and providing reports.
- The C3A, C6A video colposcope is intended for Indications for Use: gynecological examination. It provides magnified visualization of the vagina, cervix and external genitalia, which can help diagnose 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 or to touch the patient.
Predicate Device Comparison
The subject device and the predicate device (K021153) have the same fundamental technology and similar technological characteristics, detailed in the table below:
| Comparison
Items | SLC-2000A(GW) | C3A&C6A | Comparison
of C3A, C6A
with
SLC-2000A |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Manufacturer/K# | Goldway/K021153 | EDAN | N/A |
| Indications for
Use | The Goldway Digital Video
Colposcope Imaging 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 to be used
in Hospitals and clinics. | The C3A, C6A video
colposcope is intended
for gynecological
examination. It provides
magnified visualization
of the vagina, cervix and
external genitalia, which
can help diagnose
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 or to touch
the patient. | Different |
| Power Supply | | | |
| Voltage | 100 V-240 V~ | 100 V-240 V~ | Same |
| Frequency | 50 Hz/60 Hz | 50 Hz/60 Hz | Same |
5
| Input power | 500 VA | 48 VA | Different |
|---|---|---|---|
| (Maximum) | |||
| Specifications | |||
| Standard | |||
| Configuration | Digital CCD camera, Stand | Digital CCD camera, | |
| Stand | Same | ||
| Light module | Double loop group LED light | Single loop group LED | |
| light (C3A) | |||
| Double loop group LED | |||
| light (C6A) | Different | ||
| Light source | White LED light | White LED light | Same |
| Illumination | 2200 lux at working distance | ||
| 300 mm | 1600 lux at working | ||
| distance 300 mm (C3A) | |||
| 3000 lux at working | |||
| distance 300 mm (C6A) | Different | ||
| Illumination | |||
| range | ≥φ60 mm at working distance | ||
| 200 mm | ≥φ60 mm at working | ||
| distance 200 mm | Same | ||
| Light source | |||
| lifetime | ≥10,000 hours | ≥10,000 hours | Same |
| System resolution | ≥470 TVL | ≥500 TVL | Different |
| Space resolution | Not available | ≥10 lpm | Different |
| Image geometric | |||
| distortion |