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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the Gynescope™ System, a colposcope. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm's performance. The "Summary of Performance Testing" section details various engineering and safety tests (electrical safety, EMC, software, cybersecurity, imaging evaluation, biocompatibility, mechanical testing of the speculum) but does not present a clinical study with specific acceptance criteria related to a device's diagnostic performance against a ground truth, especially not involving AI.

Therefore, **I cannot extract the requested information based on the provided text, as it does not contain details about:

A table of acceptance criteria and reported device performance for a diagnostic task.
Sample sizes for a test set or its provenance for such a diagnostic study.
Number of experts or their qualifications for establishing ground truth for a diagnostic test set.
Adjudication methods for a diagnostic test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone algorithm performance without human-in-the-loop.
Type of ground truth (expert consensus, pathology, outcomes data) for a diagnostic task.
Sample size for a training set (indicating the absence of an AI component being evaluated here).
How ground truth for a training set was established.**

The document primarily focuses on the device's technical specifications, safety, and functional equivalence to a predicate colposcope, not on the performance of a diagnostic algorithm or AI system.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K190187

Device Name Gynescope™ System

Indications for Use (Describe)

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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510(k) Summary K190187 Gynescope™ System

Submitted by:	Lior GreensteinIllumigyn Ltd.Communications Center, Bldg BNeve Ilan 908500IsraelTel: +972-2-547-6319Email: lior.g@illumigyn.com
Correspondent:	Ahava SteinA. Stein Regulatory Affairs Consulting Ltd.20 Hata'as St., Beit Hapa'amon (Box 124)Kfar Saba 4442520IsraelTel: +972-9-7670002Email: 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 ColposcopeMedGyn 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) ●

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Gynescope™ System Console .
Gynescope™ Single Use Vaginal Speculum .

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™ System is intended for use in hospitals, clinics and doctors' offices.

TechnologicalCharacteristic	Gynescope™ SystemIllumigyn Ltd.K190187Subject Device	MedGyn Digital VideoColposcopeMedGyn Products Inc.K122973Predicate Device*	Comments
Indicationsfor Use	The Gynescope™System is intended forthe examination of the	Medgyn's digital videocolposcope is intendedfor magnified viewing of	Different - Although theindications statements arenot identical, the subject
	tissues of the vagina,cervix, and externalgenitalia, to investigate,by means ofmagnification,abnormalities such aslesions or cancer. TheGynescope™ System isintended to select areasfor biopsy, whenindicated.The GynescopетмSingle Use VaginalSpeculum component ofthe GynescopетмSystem is used to dilatethe vagina and exposethe interior of thevagina and exterior ofthe cervix during pelvicexaminations and othergynecologicalprocedures. TheGynescope™ SingleUse Vaginal Speculumcan be used only withthe Gynescope™System.The GynescopетмSystem is intended foruse in hospitals, clinicsand doctors' offices.	the tissues of the vagina,cervix and externalgenitalia in order toassist doctors indiagnosing abnormalitiessuch as lesions or cancer,and selecting areas forbiopsy. The images fromthe digital videocolposcope are to beviewed on a colormonitor. The digitalvideo colposcope isintended for use inhospitals, clinics, anddoctor's offices.	and predicate devices havethe same intended use –viewing the vagina, cervix,and external genitalia to aidin diagnosing abnormalitiessuch as lesions or cancerand selecting areas forbiopsy.
Components	The GynescoретмSystem consists of thefollowing components:• Colposcope (IAS)• Single use vaginalspeculum• System console withtouch screen	The MedGyn DigitalVideo Colposcopeconsists of the followingcomponents:• Colposcope• Stand	Different – The subject andpredicate device bothinclude colposcopecomponents and the abilityto display images on anexternal display. Thesubject device also includesa system console for datacollection, imageprocessing/display andstorage, and a speculum thatis required for subjectdevice use. The predicate.
			device includes a stand forthe colposcope, which is nota component of the subjectdevice. These differences donot raise different questionsof safety and effectiveness(S&E).
Workingdistance	50-160 mm	200-300 mm	Different – The subjectdevice has a shorterworking distance than thepredicate device. Thisdifference does not raisedifferent questions of S&E.
Focusingmechanism	Auto-focus	Auto-focus, manual	Different – The subjectdevice cannot be manuallyfocused. This differencedoes not raise differentquestions of S&E.
Magnification	3x-112x	1-40x	Different - The overallsubject devicemagnification is greaterthan the predicate device.This difference does notraise different questions ofS&E.
Depth of field	0.8-2 mm	5-120 mm	Different - The subjectdevice depth of field islower than the predicatedevice. This difference doesnot raise different questionsof S&E (e.g., opticalresolution, etc.).
Field of View	29mm - 70mm	At working distance 200mm):• 1x: 195 mm (52°)• 32x: 6.98 mm (2°)	Different - The subjectdevice field of view isdifferent than the predicatedevice. This differencedoes not raise differentquestions of S&E (e.g.,optical resolution, etc.).
On-axis SpatialResolution	16 line pairs/mm	11.37 line pairs/mm	Different – The subjectdevice resolution has moreline pairs/mm than thepredicate device. Thisdifference does not raisedifferent questions of S&E.
On-axisAngularResolution	0.016°	0.02354°	Different: The subjectdevice has a smaller on-axisangular resolution that the

Distortion	$≤$ 2%	$≤$ 2.49%	predicate device. Thisdifference does not raisedifferent questions of S&E.
Light source	White and greenLED light sources	White LED light source	SimilarDifferent – The subjectdevice includes a green lightsource in place of a greenfilter. This difference doesnot raise different questionsof S&E (e.g., light safety,etc.).
Illumination	~20000 lux at a 50 mmworking distance~1000 lux at a 160 mmworking distance	Not specified	Different - Predicatedevice illuminationinformation is not known;however, any differenceswould not raise differentquestions of S&E (e.g., lightsafety, software control oflight intensity, etc.). Inaddition, the illuminationintensity for the subjectdevice is within the range ofother cleared devices of thistype.
Green filter	No	Yes	Different – The subjectdevice uses greenillumination instead of agreen filter. This differencedoes not raise differentquestions of S&E (e.g., lightsafety, etc.).
Image Output	Output to view screenon the Gynescope™System Console and toan external monitor viaa DVI-D video output.	S-Video output tomonitor	Different – The subjectdevice includes a consolecomponent that is used toprocess, display and storedata collected from the IAS.Images from the subject canalso be displayed on aseparate external monitor.The predicate sends imageinformation to a connectedmonitor for viewing. Thisdifference does not raisedifferent questions of S&E.
Image FreezeFunction	Yes	Yes	Same
Speculum	Single-use speculumdesigned to connect to	Not a component of thepredicate device	Different – The subjectdevice requires the use of a

	the IAS required fordevice use		specialized speculum, whilethe predicate is used with amarketed speculum, whichis not provided. Thisdifference does not raisedifferent questions of S&E.
Sterility	Device components arenon-sterile.	The device is notintended to be sterile	Same

Comparison of Intended Use and Technological Characteristics of Subject and Predicate Devices

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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

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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.

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.