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.

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.

AI/ML Overview

Acceptance Criteria and Device Performance for Gynocular Colposcope

The Gynocular colposcope's acceptance criteria and reported performance are detailed below, based on the provided 510(k) submission.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Optical Properties:
Distortion	Minimal Barrel type geometrical distortion: 0.47% (5x), 0.75% (8x), 0.81% (12x). Negligible chromatic distortion: 3.3 um (5x), 5.8 um (8x), 3.3 um (12x).
Magnification	4.81x ± 0.15 (at 5x setting), 7.74x ± 0.15 (at 8x setting), 12.40x ± 0.15 (at 12x setting)
Optical Resolution	28.6 cy/mm (5x), 40.5 cy/mm (8x), 56.8 cy/mm (12x)
Thermal Safety
Device Surface Temperature (after 1hr 55 min continuous use)	39.1 degrees C (in 24 degrees C ambient)
Battery Performance
Charging Time (empty to full)	2.5 hours or less
Illumination Time (full intensity, from full charge)	Approximately 2 hours
Battery Life Cycle	500 full charging cycles
Clinical Agreement with Standard Colposcope
Agreement of diagnosis of cervical lesions (Swede scores vs. histological diagnosis)	70% overall agreement

Note: The document states that the observed distortion and chromatic distortion levels are considered "negligible" for visual examination and "equal and below the levels of visual acuity of the human eye," implying these values met the internal acceptance limits. The thermal safety performance is also implicitly accepted as the device has an automatic shut-off mechanism for unsafe temperatures, and the reported temperature is within a safe range. The specific acceptance criteria for magnification and optical resolution are not explicitly stated as numerical thresholds, but the reported values are presented as performance achievements.

2. Sample Size and Data Provenance for the Test Set

Sample Size for the test set: 69 women.
Data Provenance: The study was a "randomized, crossover, pilot clinical trial" but the country of origin is not explicitly stated. However, Gynius AB is based in Stockholm, Sweden, and the study was published in "The Journal of Lower Genital Tract Disease in May 2013," suggesting a prospective clinical trial, likely conducted in Sweden or a similarly regulated environment.

3. Number of Experts and their Qualifications for Ground Truth

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. It mentions that "Swede scores were given at the time of colposcopy and compared with the final histological diagnosis after directed cervical biopsy." This implies that the initial "Swede scores" were given by the medical professionals conducting the colposcopy, and the histological diagnosis (pathology) served as the primary ground truth.

4. Adjudication Method for the Test Set

The document does not specify an adjudication method for disagreements. It directly compares "Swede scores" from both the Gynocular and a standard colposcope with the "final histological diagnosis after directed cervical biopsy."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. The study described is a comparison of two colposcopes (Gynocular vs. standard colposcope) used by human medical professionals, not evaluating AI assistance.

6. Standalone (Algorithm Only) Performance

No, a standalone (algorithm only without human-in-the-loop performance) was not done. The Gynocular is a medical device (colposcope) that is used by a human operator (medical physician or trained colposcopist) for visual examination. It does not employ an AI algorithm for diagnosis.

7. Type of Ground Truth Used

The primary ground truth used for the clinical trial was pathology ("final histological diagnosis after directed cervical biopsy"). The "Swede scores" obtained during colposcopy were compared against this histological diagnosis.

8. Sample Size for the Training Set

The document does not mention any training set. This is because the Gynocular is a visual diagnostic tool (colposcope) operated by a human, and not an AI/machine learning algorithm requiring a training set in the conventional sense. The "clinical tests" described represent a validation study, not a training phase for an algorithm.

9. How Ground Truth for the Training Set Was Established

As there was no AI/machine learning component to the Gynocular described in the submission, there was no "training set" and therefore no ground truth established for a training set.

Summary

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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	MedgynProducts,Inc.	IntermedGroup Inc.	MedgynProducts,Inc.	WallachSurgicalDevices, Inc.
Device Name	Digital Colposcope &Image ManagementSystem	The IntermedZoomColposcope	Gynescope	Wallach ZoomColopscope
Model	AL-106	IZM-310	AL 103	ColpoStar IH
K-Number	K122973	K031629	K880195	K853389

(4) Device Description

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

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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	MedgynProducts, Inc.	IntermedGroup Inc.	MedgynProducts,Inc.	WallachSurgicalDevices, Inc.	Gynius AB
Device Name	DigitalColposcope&ImageManagement	TheIntermedZoomColposcope	Gynescope	WALLACHZOOMCOLPOSCOPE	TheGynocular
Model	AL-106	IZM-310	AL 103	ColpoStar IH	VI
K-Number	K122973	K031629	K880195	K853389	n/a
Magnification	OpticalDisplay;36x	Standard 10x	4.3x/7x/11.3x	12x	5x/8x/12x
Workingdistance	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 atripod.
Energysource	Standard ACPower Supply	Standard ACPowerSupply	Standard ACPowerSupply	Standard ACPowerSupply	Lithium-ionBattery

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

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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

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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.

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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

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. 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

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.