(96 days)
Not Found
No
The description focuses on standard imaging and data processing, with no mention of AI/ML terms or functionalities like automated analysis, lesion detection algorithms, or learning from data.
No
The device is intended for examination and investigation to identify abnormalities, not for treatment or therapy.
Yes
The Gynescope™ System is intended for "the examination...to investigate, by means of magnification, abnormalities such as lesions or cancer," and "to select areas for biopsy," which are all diagnostic activities.
No
The device description clearly outlines multiple hardware components: the Gynescope™ Image Acquisition System (IAS) with optics, sensors, and keypad; the Gynescope™ Single Use Vaginal Speculum; and the Gynescope™ System Console with a touchscreen and video output. While the console performs data processing (software function), the system is fundamentally a hardware-based colposcope with integrated software.
Based on the provided information, the Gynescope™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
- Gynescope™ System's Function: The Gynescope™ System is used for the direct examination of the vagina, cervix, and external genitalia in vivo (within the living body) using optical imaging (colposcopy). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "examination of the vagina, cervix, and external genitalia" and to "select areas for biopsy." This is a direct visualization and procedural aid, not an analysis of a biological specimen.
Therefore, the Gynescope™ System falls under the category of a medical device used for direct visualization and examination, not an IVD.
N/A
Intended Use / Indications for Use
The Gynescope™ System is intended for the examination of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated.
The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.
The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.
Product codes
HEX, HIB
Device Description
The Gynescope™ System is a colposcope platform for physicians to perform examinations of the vagina, cervix and external genitalia. The Gynescope™ System consists of the following components:
- Gynescope™ Image Acquisition System (IAS)
- Gynescope™ System Console
- Gynescope™ Single Use Vaginal Speculum
The IAS is a handheld colposcope that includes imaging optics and provides white and green illumination using both centered and side illumination techniques. The IAS also includes color and monochrome sensors. The color sensor is used for standard examinations under white or green illumination, while the monochrome sensor is only used for imaging target tissues under green illumination. Key functions of the device (e.g., magnification, illumination, light source, image capture, etc.) can be operated using a built-in keypad on the IAS. A cable connects the IAS to the Gynescope™ System Console.
During use, the IAS is attached to the Gynescope™ Single Use Vaginal Speculum to form a single body. When combined, the Gynescope™ Single Use Vaginal Speculum provides access to the vaginal cavity and prevents direct contact of the IAS with the patient. This component also includes a separate opening for instruments if needed during an examination. The Gynescope™ Single Use Vaginal Speculum is non-sterile, made of polycarbonate, and is provided in four sizes.
The Gynescope™ System Console is responsible for data processing, storage and display of information to the user. In addition, the Gynescope™ System Console can be used to control functions of the IAS (e.g., magnification, illumination, light source, image capture, etc.). User's interact with the Gynescope™ System Console via a 12.2-inch touchscreen interface. This component also includes a video output connection that allows connection to a peripheral video device (e.g., monitor). A cradle is also mounted on the Gynescope™ System Console that is used to hold and protect the IAS between uses.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical imaging with white and green illumination.
Anatomical Site
vagina, cervix, and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, and doctors' 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance tests were conducted in support of the substantial equivalence determination. All test results met pre-determined acceptance criteria:
Electrical Safety - The Gynescope™ System was tested and shown to comply with the following electrical safety standards:
- IEC 60601-1:2005, + A1:2012
- IEC 60601-1-11 Edition 2.0 2015-01
- IEC 60601-2-57 Edition 1.0 2011-01
Electromagnetic Compatibility (EMC) - The Gynescope™ System was tested and shown to comply with the IEC 60601-1-2:2014.
Software Testing – Software for the Gynescope™ System was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for this device was considered as minor.
Cybersecurity - Cybersecurity information for the Gynescope™ System was provided in accordance with FDA's guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Imaging Evaluation - The performance of the imaging features of the Gynescope™ System was assessed as follows:
- Field and depth of view per ISO 8600-3:1997
- Optical resolution per ISO 8600-5:2005
- Image distortion
- Color performance testing
- Illumination intensity at different working distances
- Photobiological safety per IEC 62471: 2006
Gynescope™ Single Use Vaginal Speculum Testing:
- Biocompatibility testing - the following tests were conducted on the patient-contacting materials of the speculum:
- Cytotoxicity per ISO 10993-5:2009
- Vaginal irritation per ISO 10993-10:2010
- Guinea pig maximization sensitization testing per ISO 10993-10:2010
Testing showed the Gynescope™ Single Use Vaginal Speculum materials to be non-cytotoxic, non-irritating, and non-sensitizing.
- Mechanical testing on the speculum to assess breakage forces. All devices passed the predefined acceptance criterion.
- Compatibility of the speculum with gynecologic tools and instruments. Testing showed that common instruments used during colposcopy examinations (e.g., biopsy punch and PAP smear collection device) were compatible with the working channel of the Gynescope™ Single Use Vaginal Speculum.
The results of the performance testing described above demonstrates that the subject devices are as safe and effective as the predicate devices and supports a determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 8, 2019
Illumigyn Ltd. % Ahava Stein Regulatory Consultant A. Stein Regulatory Affairs Consulting Ltd. 20 Hataas St., Suite 102 Kfar Saba, 4442520 Israel
K190187 Re: Trade/Device Name: Gynescope™ System Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX, HIB Dated: January 29, 2019 Received: February 7, 2019
Dear Ahava Stein:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon M. Andrews Assistant Division Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190187
Device Name Gynescope™ System
Indications for Use (Describe)
The Gynescope™ System is intended for the examination of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™ System is intended to select areas for biopsy, when indicated.
The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.
The Gynescope™ System is intended for use in hospitals, clinics, and doctors' offices.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K190187 Gynescope™ System
| Submitted by: | Lior Greenstein
Illumigyn Ltd.
Communications Center, Bldg B
Neve Ilan 908500
Israel
Tel: +972-2-547-6319
Email: lior.g@illumigyn.com |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Correspondent: | Ahava Stein
A. Stein Regulatory Affairs Consulting Ltd.
20 Hata'as St., Beit Hapa'amon (Box 124)
Kfar Saba 4442520
Israel
Tel: +972-9-7670002
Email: ahava@asteinrac.com |
| Date Prepared: | April 29, 2019 |
| Trade Name: | Gynescope™ System |
| Common Name: | Colposcope |
| Regulation Number: | 21 CFR 884.1630 |
| Regulation Name: | Colposcope |
| Product Code: | HEX (Colposcope [and Colpomicroscope]), HIB (Speculum, Vaginal,
Nonmetal) |
| Regulatory Class: | Class II |
| Predicate Device: | MedGyn Digital Video Colposcope
MedGyn Products, Inc.
510(k) Number – K122973 |
The predicate device has not been subject to a design-related recall.
Device Description:
The Gynescope™ System is a colposcope platform for physicians to perform examinations of the vagina, cervix and external genitalia. The Gynescope™ System consists of the following components:
- Gynescope™ Image Acquisition System (IAS) ●
4
- Gynescope™ System Console .
- Gynescope™ Single Use Vaginal Speculum .
The IAS is a handheld colposcope that includes imaging optics and provides white and green illumination using both centered and side illumination techniques. The IAS also includes color and monochrome sensors. The color sensor is used for standard examinations under white or green illumination, while the monochrome sensor is only used for imaging target tissues under green illumination. Key functions of the device (e.g., magnification, illumination, light source, image capture, etc.) can be operated using a built-in keypad on the IAS. A cable connects the IAS to the Gynescope™ System Console.
During use, the IAS is attached to the Gynescope™ Single Use Vaginal Speculum to form a single body. When combined, the Gynescope™ Single Use Vaginal Speculum provides access to the vaginal cavity and prevents direct contact of the IAS with the patient. This component also includes a separate opening for instruments if needed during an examination. The Gynescope™ Single Use Vaginal Speculum is non-sterile, made of polycarbonate, and is provided in four sizes.
The Gynescope™ System Console is responsible for data processing, storage and display of information to the user. In addition, the Gynescope™ System Console can be used to control functions of the IAS (e.g., magnification, illumination, light source, image capture, etc.). User's interact with the Gynescope™ System Console via a 12.2-inch touchscreen interface. This component also includes a video output connection that allows connection to a peripheral video device (e.g., monitor). A cradle is also mounted on the Gynescope™ System Console that is used to hold and protect the IAS between uses.
Indications for Use:
The Gynescope™ System is intended for the examination of the tissues of the vagina, cervix, and external genitalia, to investigate, by means of magnification, abnormalities such as lesions or cancer. The Gynescope™M System is intended to select areas for biopsy, when indicated.
The Gynescope™ Single Use Vaginal Speculum component of the Gynescope™ System is used to dilate the vagina and expose the interior of the vagina and exterior of the cervix during pelvic examinations and other gynecological procedures. The Gynescope™ Single Use Vaginal Speculum can be used only with the Gynescope™ System.
The Gynescope™ System is intended for use in hospitals, clinics and doctors' offices.
| Technological
Characteristic | Gynescope™ System
Illumigyn Ltd.
K190187
Subject Device | MedGyn Digital Video
Colposcope
MedGyn Products Inc.
K122973
Predicate Device* | Comments |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Gynescope™
System is intended for
the examination of the | Medgyn's digital video
colposcope is intended
for magnified viewing of | Different - Although the
indications statements are
not identical, the subject |
| | tissues of the vagina,
cervix, and external
genitalia, to investigate,
by means of
magnification,
abnormalities such as
lesions or cancer. The
Gynescope™ System is
intended to select areas
for biopsy, when
indicated.
The Gynescopетм
Single Use Vaginal
Speculum component of
the Gynescopетм
System is used to dilate
the vagina and expose
the interior of the
vagina and exterior of
the cervix during pelvic
examinations and other
gynecological
procedures. The
Gynescope™ Single
Use Vaginal Speculum
can be used only with
the Gynescope™
System.
The Gynescopетм
System is intended for
use in hospitals, clinics
and doctors' offices. | the tissues of the vagina,
cervix and external
genitalia in order to
assist doctors in
diagnosing abnormalities
such as lesions or cancer,
and selecting areas for
biopsy. The images from
the digital video
colposcope are to be
viewed on a color
monitor. The digital
video colposcope is
intended for use in
hospitals, clinics, and
doctor's offices. | and predicate devices have
the same intended use –
viewing the vagina, cervix,
and external genitalia to aid
in diagnosing abnormalities
such as lesions or cancer
and selecting areas for
biopsy. |
| Components | The Gynescoретм
System consists of the
following components:
• Colposcope (IAS)
• Single use vaginal
speculum
• System console with
touch screen | The MedGyn Digital
Video Colposcope
consists of the following
components:
• Colposcope
• Stand | Different – The subject and
predicate device both
include colposcope
components and the ability
to display images on an
external display. The
subject device also includes
a system console for data
collection, image
processing/display and
storage, and a speculum that
is required for subject
device use. The predicate. |
| | | | device includes a stand for
the colposcope, which is not
a component of the subject
device. These differences do
not raise different questions
of safety and effectiveness
(S&E). |
| Working
distance | 50-160 mm | 200-300 mm | Different – The subject
device has a shorter
working distance than the
predicate device. This
difference does not raise
different questions of S&E. |
| Focusing
mechanism | Auto-focus | Auto-focus, manual | Different – The subject
device cannot be manually
focused. This difference
does not raise different
questions of S&E. |
| Magnification | 3x-112x | 1-40x | Different - The overall
subject device
magnification is greater
than the predicate device.
This difference does not
raise different questions of
S&E. |
| Depth of field | 0.8-2 mm | 5-120 mm | Different - The subject
device depth of field is
lower than the predicate
device. This difference does
not raise different questions
of S&E (e.g., optical
resolution, etc.). |
| Field of View | 29mm - 70mm | At working distance 200
mm):
• 1x: 195 mm (52°)
• 32x: 6.98 mm (2°) | Different - The subject
device field of view is
different than the predicate
device. This difference
does not raise different
questions of S&E (e.g.,
optical resolution, etc.). |
| On-axis Spatial
Resolution | 16 line pairs/mm | 11.37 line pairs/mm | Different – The subject
device resolution has more
line pairs/mm than the
predicate device. This
difference does not raise
different questions of S&E. |
| On-axis
Angular
Resolution | 0.016° | 0.02354° | Different: The subject
device has a smaller on-axis
angular resolution that the |
| | | | |
| Distortion | $≤$ 2% | $≤$ 2.49% | predicate device. This
difference does not raise
different questions of S&E. |
| Light source | White and green
LED light sources | White LED light source | Similar
Different – The subject
device includes a green light
source in place of a green
filter. This difference does
not raise different questions
of S&E (e.g., light safety,
etc.). |
| Illumination | ~20000 lux at a 50 mm
working distance
~1000 lux at a 160 mm
working distance | Not specified | Different - Predicate
device illumination
information is not known;
however, any differences
would not raise different
questions of S&E (e.g., light
safety, software control of
light intensity, etc.). In
addition, the illumination
intensity for the subject
device is within the range of
other cleared devices of this
type. |
| Green filter | No | Yes | Different – The subject
device uses green
illumination instead of a
green filter. This difference
does not raise different
questions of S&E (e.g., light
safety, etc.). |
| Image Output | Output to view screen
on the Gynescope™
System Console and to
an external monitor via
a DVI-D video output. | S-Video output to
monitor | Different – The subject
device includes a console
component that is used to
process, display and store
data collected from the IAS.
Images from the subject can
also be displayed on a
separate external monitor.
The predicate sends image
information to a connected
monitor for viewing. This
difference does not raise
different questions of S&E. |
| Image Freeze
Function | Yes | Yes | Same |
| Speculum | Single-use speculum
designed to connect to | Not a component of the
predicate device | Different – The subject
device requires the use of a |
| | | | |
| | the IAS required for
device use | | specialized speculum, while
the predicate is used with a
marketed speculum, which
is not provided. This
difference does not raise
different questions of S&E. |
| Sterility | Device components are
non-sterile. | The device is not
intended to be sterile | Same |
Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices
5
6
7
8
As shown above, the indications for use of the subject Gynescope™ System is not identical to the predicate device; however, the differences do not represent a new intended use as both devices are used for viewing the vagina, cervix, and external genitalia to aid in diagnosing abnormalities such as lesions or cancer and selecting areas for biopsy.
Regarding technological characteristics, the subject and predicate devices have some similarities in their designs. However, many differences exist as described in the table above (e.g., optical parameters, components, etc.). The differences identified do not raise different questions of safety and effectiveness as compared to the predicate device as stated in the table.
Summary of Performance Testing:
The following performance tests were conducted in support of the substantial equivalence determination. All test results met pre-determined acceptance criteria:
Electrical Safety - The Gynescope™ System was tested and shown to comply with the following electrical safety standards:
- IEC 60601-1:2005, + A1:2012 ●
- IEC 60601-1-11 Edition 2.0 2015-01 ●
- IEC 60601-2-57 Edition 1.0 2011-01 ●
Electromagnetic Compatibility (EMC) - The Gynescope™ System was tested and shown to comply with the IEC 60601-1-2:2014.
Software Testing – Software for the Gynescope™ System was provided in accordance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software level of concern for this device was considered as minor.
Cybersecurity - Cybersecurity information for the Gynescope™ System was provided in accordance with FDA's guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices."
Imaging Evaluation - The performance of the imaging features of the Gynescope™ System was assessed as follows:
- Field and depth of view per ISO 8600-3:1997
- Optical resolution per ISO 8600-5:2005
- Image distortion
- Color performance testing
9
- Illumination intensity at different working distances ●
- Photobiological safety per IEC 62471: 2006 ●
Gynescope™ Single Use Vaginal Speculum Testing:
- Biocompatibility testing - the following tests were conducted on the patient-contacting materials of the speculum:
- Cytotoxicity per ISO 10993-5:2009 O
- Vaginal irritation per ISO 10993-10:2010 O
- Guinea pig maximization sensitization testing per ISO 10993-10:2010 O
Testing showed the Gynescope™ Single Use Vaginal Speculum materials to be non-cytotoxic, non-irritating, and non-sensitizing.
- Mechanical testing on the speculum to assess breakage forces. All devices passed the predefined acceptance criterion.
- Compatibility of the speculum with gynecologic tools and instruments. Testing showed that common instruments used during colposcopy examinations (e.g., biopsy punch and PAP smear collection device) were compatible with the working channel of the Gynescope™ Single Use Vaginal Speculum.
Conclusion
The results of the performance testing described above demonstrates that the subject devices are as safe and effective as the predicate devices and supports a determination of substantial equivalence.