(246 days)
Not Found
No
The description focuses on the optical and mechanical aspects of a traditional colposcope, with no mention of AI, ML, image processing, or any features that would suggest algorithmic analysis of the images.
No.
The device is used for visual evaluation and selection of biopsy areas, which are diagnostic purposes, not therapeutic.
Yes
The device is used to evaluate tissues and select areas for biopsy, and a clinical study was conducted to evaluate agreement of diagnosis of cervical lesions using the device. These functions align with diagnostic purposes.
No
The device description clearly outlines a physical, hand-held colposcope with optical components (magnification, illumination), a battery, and a charging base. It is a hardware device for visualization.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Gynocular Function: The Gynocular is a colposcope. It is a medical device used for direct visual examination of the cervix, vagina, and external genitalia. It provides magnified visualization and illumination to help a medical professional evaluate these tissues and select areas for biopsy.
- No Sample Analysis: The Gynocular does not analyze any samples taken from the patient. It is a tool for direct observation in vivo (within the living body).
The Gynocular is a medical device used for visual examination and guidance for procedures, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
Product codes
HEX
Device Description
The Gynocular is a hand-held, colposcope, which provides a magnified visualization of the tissues of the cervix, vagina, vulva and anogential area. It is used to evaluate these tissues and select areas for biopsy, without contacting the patient. The user is a medical physician, or a trained colposcopist.
The Gynocular is a colposcope with similar specifications to traditional colposcopes. The Gynocular has a 300 mm focal distance, 3-magnifications: 5x, 8x, and 12x. It is a handheld device that comes with a tripod-mounting clip that screws into a standard tripod enabling the medical professional to also perform colposcopy hands-free mode for ease of biopsy. The Gynocular uses high intensity LEDs for illumination, has a green filter, and is powered by a rechargeable lithium-ion battery. We also provide a charging base for the Gynocular.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervix and external genitalia; cervix, vagina, vulva and anogential area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical physician, or a trained colposcopist
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
The following testing was conducted to support a substantial equivalence determination.
- Distortion testing:
- The analysis shows that the Gynocular exhibits a minimal Barrel type geometrical distortion: 0.47%, 0.75% and 0.81% for 5x, 8x and 12x magnification, respectively. This distortion is at levels of professional camera lenses considered and is considered negligible for a visual examination of tissue. The analysis shows that the Gynocular exhibits a negligible chromatic distortion: 3.3 um, 5.8 um and 3.3 um for 5x, 8x and 12x magnification, respectively. This chromatic distortion is equal and below the levels of visual acuity of the human eye (5-6 um at the retina).
- Magnification testing: 4.81x ±0.15,7.74x ±0.15,12.40x ±0.15
- Optical resolution: 5x = 28.6 cy/mm 8x = 40.5 cv/mm 12x = 56.8cy/mm
Design validation: . Firmware and mechanical tests were conducted to demonstrate that the mechanical functions and optical properties achieve the desired results.
-
Thermal safety:
After 1hr 55 min of continuous use, the Gynocular's outer heat sink reached 39.1 degrees C in an ambient temperature setting of 24 degrees C. The Gynocular has an automatic shut off mechanism if temperatures become unsafe. -
Battery Performance: .
The typical charging time from empty to full charge is 2.5 hours or less. The battery gives approximately 2hrs of illuminator on time (full intensity) from a full charge. The use of life for the battery is 500 full charging cycles.
Non-clinical tests: Appropriate risk analysis-driven product testing was conducted to evaluate product safety. The following standards were met:
- IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
- EN 60601-1 2006
Clinical tests: Gynius conducted a randomized, crossover, pilot clinical trial for evaluating agreement of diagnosis of cervical lesions by colposcopy using a standard colposcope and the Gynocular. The study population was 69 women that tested positive for visual inspection with acetic acid. Swede scores were given at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy. The Swede scores were compared across the two techniques and there was a 70% agreement overall. Conclusions: The study shows that in visual inspection with acetic acid positive women, a battery-driven, pocket-sized colposcope - the Gynocular, has a significant level of agreement with a stationary colposcope in assessing cervical lesions. The study was accepted and published by The Journal of Lower Genital Tract Disease in May 2013.
Key Metrics
Not Found
Predicate Device(s)
K122973, K031629, K880195, K853389
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.
0
GYNIUS AB 510(k) submission Gynoculan Colposcope
APR 0 8 2014
5. 510(k) Summary
April 4th, 2014
(1) Submitter Information Name: Gynius AB Address: Gynius AB Dobelnsgatan 23 11140, Stockholm, Sweden Telephone #: +46 700237670 Email: info@gynocular.com
Contact Person: Matthew Volsky CEO - Gynius AB
(2) Name of Device
Trade Name: Gynocular Common Name: Colposcope Classification: Colposcope, 21 CFR 884.1630, Class II Product Code: HEX
(3) Predicate devices
| Applicant | Medgyn
Products,
Inc. | Intermed
Group Inc. | Medgyn
Products,
Inc. | Wallach
Surgical
Devices, Inc. |
|-------------|----------------------------------------------------|------------------------------------|-----------------------------|--------------------------------------|
| Device Name | Digital Colposcope &
Image Management
System | The Intermed
Zoom
Colposcope | Gynescope | Wallach Zoom
Colopscope |
| Model | AL-106 | IZM-310 | AL 103 | ColpoStar IH |
| K-Number | K122973 | K031629 | K880195 | K853389 |
(4) Device Description
The Gynocular is a hand-held, colposcope, which provides a magnified visualization of the tissues of the cervix, vagina, vulva and anogential area. It is used to evaluate these tissues and select areas for biopsy, without contacting the patient. The user is a medical physician, or a trained colposcopist.
The Gynocular is a colposcope with similar specifications to traditional colposcopes. The Gynocular has a 300 mm focal distance, 3-magnifications: 5x, 8x, and 12x. It is a handheld device that comes with a tripod-mounting clip that screws into a standard tripod enabling the
510(k) Submission Gynius AB P.O. Box 55503 10204, Stockholm Sweden info@gynocular.com T: 011 46 700237670
1
1
medical professional to also perform colposcopy hands-free mode for ease of biopsy. The Gynocular uses high intensity LEDs for illumination, has a green filter, and is powered by a rechargeable lithium-ion battery. We also provide a charging base for the Gynocular.
(5) Indications for use (colposcopy):
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
(6) Comparison to Predicate Devices
| Applicant | Medgyn
Products, Inc. | Intermed
Group Inc. | Medgyn
Products,
Inc. | Wallach
Surgical
Devices, Inc. | Gynius AB |
|---------------------|---------------------------------------------------|---------------------------------------|--------------------------------|--------------------------------------|-------------------------------------|
| Device Name | Digital
Colposcope
&
Image
Management | The
Intermed
Zoom
Colposcope | Gynescope | WALLACH
ZOOM
COLPOSCO
PE | The
Gynocular |
| Model | AL-106 | IZM-310 | AL 103 | ColpoStar IH | VI |
| K-Number | K122973 | K031629 | K880195 | K853389 | n/a |
| Magnification | Optical
Display
;
36x | Standard 10x | 4.3x/7x/11.
3x | 12x | 5x/8x/12x |
| Working
distance | 200-300 mm | 310 mm | 300 mm | 300 mm | 300 mm |
| Lamp | LEDs | Halogen | Halogen | Halogen | LEDs |
| Filter | Green filter | Green filter | Green filter | Green filter | Green filter |
| Ocular type | Monocular | Binocular | Binocular | Binocular | Monocular |
| Stand | Stationary | Stationary | Stationary | Stationary | Portable/stationary on a
tripod. |
| Energy
source | Standard AC
Power Supply | Standard AC
Power
Supply | Standard AC
Power
Supply | Standard AC
Power
Supply | Lithium-ion
Battery |
The Gynocular's performance specifications are substantially equivalent to the listed predicate devices.
(7) Performance Data
.
The following testing was conducted to support a substantial equivalence determination.
- . Distortion testing:
- The analysis shows that the Gynocular exhibits a minimal Barrel type geometrical
distortion: 0.47%, 0.75% and 0.81% for 5x, 8x and 12x magnification, respectively. This distortion is at levels of professional camera lenses considered and is considered negligible for a visual examination of tissue. The analysis shows that the Gynocular exhibits a
510(k) Submission Gynius AB P.O. Box 55503 10204, Stockholm Sweden info@gynocular.com T: 011 46 700237670
2
2
negligible chromatic distortion: 3.3 um, 5.8 um and 3.3 um for 5x, 8x and 12x magnification, respectively. This chromatic distortion is equal and below the levels of visual acuity of the human eye (5-6 um at the retina).
- . Magnification testing: 4.81x ±0.15,7.74x ±0.15,12.40x ±0.15
- � Optical resolution: 5x = 28.6 cy/mm 8x = 40.5 cv/mm 12x = 56.8cy/mm
Design validation: . Firmware and mechanical tests were conducted to demonstrate that the mechanical functions and optical properties achieve the desired results.
-
. Thermal safety:
After 1hr 55 min of continuous use, the Gynocular's outer heat sink reached 39.1 degrees C in an ambient temperature setting of 24 degrees C. The Gynocular has an automatic shut off mechanism if temperatures become unsafe. -
Battery Performance: .
The typical charging time from empty to full charge is 2.5 hours or less. The battery gives approximately 2hrs of illuminator on time (full intensity) from a full charge. The use of life for the battery is 500 full charging cycles.
Non-clinical tests
Appropriate risk analysis-driven product testing was conducted to evaluate product safety. The following standards were met:
- · IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
- · EN 60601-1 2006
Clinical tests
Gynius conducted a randomized, crossover, pilot clinical trial for evaluating agreement of diagnosis of cervical lesions by colposcopy using a standard colposcope and the Gynocular. The study population was 69 women that tested positive for visual inspection with acetic acid. Swede scores were given at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy. The Swede scores were compared across the two techniques and there was a 70% agreement overall. Conclusions: The study shows that in visual inspection with acetic acid positive women, a battery-driven, pocket-sized colposcope - the Gynocular, has a significant level of agreement with a stationary colposcope in assessing cervical lesions. The study was accepted and published by The Journal of Lower Genital Tract Disease in May 2013.
(8) Conclusions
The Gynocular is equivalent in safety and efficacy to the legally marketed predicate devices.
510(k) Submission Gynius AB P.O. Box 55503 10204, Stockholm Sweden info@gynocular.com T: 011 46 700237670
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged in a circular fashion around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with healthcare, with a double-stranded snake winding around a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002
April 8, 2014
Gynius AB Matthew Volsky CEO Dobelnsgatan 23 Stockholm 11140 Sweden
Re: K132423
Trade/Device Name: The Gynocular Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: March 6, 2014 Received: March 10, 2014
Dear Matthew Volsky,
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 mislcading.
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.
4
Page 2 - Matthew Volsky
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-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 go to http://www.fda.gov/AboutFDA/CentersOfTices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/Safety/ReportalProblem/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/Resources/orYou/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
5
. GYNIUS AB
510(k) submission Gynocular™ Colposcope
4. Indications for Use
510(k) Number: K132423
Device Name: The Gynocular
Indications for Usc:
The Gynocular is intended to provide magnified visualization of the tissues of the vagina, cervix and external genitalia. It is used to evaluate these tissues and select areas for biopsy.
Prescription for Use: X
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P 2014.04.08 13:36:
510(k) Submission
Gynius AB P.O. Box 55503 1 0204, Stockholm Sweden info@gynocular.com T: 011 46 700237670