EVA (Enhanced Visual Assessment) System

K161871 · Mobileodt , Ltd. · HEX · Dec 19, 2016 · Obstetrics/Gynecology

Device Facts

• Record ID: K161871
• Device Name: EVA (Enhanced Visual Assessment) System
• Applicant: Mobileodt , Ltd.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Dec 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.

Device Story

Handheld colposcope; utilizes smartphone (Motorola G2/G3) as imaging/display unit. Device comprises colposcope body, lens, smartphone brackets, LED electronics. Operator captures images via CervDx app; images transferred to online portal for remote viewing. Used in hospitals, clinics, rural settings. Provides magnified view (up to 16x digital) of vagina/cervix; aids clinician in identifying abnormalities and biopsy site selection. Features include acetic acid timer, LED illumination, image annotation, and cloud-based storage. Benefits include portability, ease of use, and remote access to clinical images for decision-making.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via electrical safety (AAMI/ANSI 60601-1), EMC (IEC 60601-1-2), and optical standards (ISO 8600-3, ISO 8600-5). Additional bench testing included power consumption, battery life, image distortion, cervical model image quality, and illuminance. Software validated per IEC 62304; usability validated per IEC 62366-1.

Technological Characteristics

Handheld colposcope; materials: PU (Biresin RG53 FR), 6061/5052 Aluminum, Stainless Steel. Optical magnification up to 4.0x (16x digital). Light source: 3W 6500k star LED. Working distance: 22.5-42.5 cm. Connectivity: Smartphone-based (Motorola G2/G3) with cloud portal. Power: Battery-operated (10-hour life). Software: CervDx app for image capture/annotation. Standards: AAMI/ANSI 60601-1, IEC 60601-1-2, ISO 8600-3, ISO 8600-5, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for magnified viewing of vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting biopsy sites. Intended for use in hospitals, doctor's offices, and remote/rural clinics.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• MedGyn Digital Video Colposcope (K122973)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 19, 2016

MobileODT Ltd. Jen Acobas RA/QA Manager Ben Avigdor 8, 3rd Floor Tel Aviv, 6721832 Israel

Re: K161871

> Trade/Device Name: EVA (Enhanced Visual Assessment) System Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: Class II Product Code: HEX Dated: November 29, 2016 Received: November 29, 2016

Dear Jen Acobas,

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

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Benjamin R. Fisher -S

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) K161871

Device Name

EVA (Enhanced Visual Assessment) System

Indications for Use (Describe)

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.

Type of Use (Select one or both, as applicable)

| <span style="font-size:12px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

# K161871

#### Submitter Information 1.

Manufacturer Name and Address MobileODT Ltd. Ben Avigdor 8, 3rd Floor Tel Aviv 6721832 Israel Phone: [phone]

### Official Correspondent

Jennifer Acobas, VP Regulatory MobileODT Ltd. Ben Avigdor 8, 3rd Floor Tel Aviv 6721832 Israel Phone: [phone]

#### 2. Date Prepared: December 14, 2016

#### 3. Device Information

| Proprietary Name: | EVA (Enhanced Visual Assessment) System |
|--------------------------|-----------------------------------------|
| Common Name: | Colposcope |
| FDA Classification Name: | 21 CFR 884.1630; Colposcope |
| FDA Classification: | Class II, Product Code: HEX |

#### 4. Predicate Device

The EVA System is substantially equivalent to the following device:

| Manufacturer | Device | 510(k) | Date Cleared |
|-----------------------|------------------------------------|---------|---------------|
| MedGyn Products, Inc. | MedGyn Digital<br>Video Colposcope | K122973 | June 12, 2013 |

#### ട. Device Description

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and

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selecting areas for biopsy. The EVA System is a handheld device in which a smartphone is fitted and consists of a colposcope body, lens, smartphone upper and lower brackets, LED electronics, CervDx app for image capture, and online portal for image transfer and remote viewing. The device also includes the strap, carrier case, and instruction manual. During colposcopy, the operator may mount the EVA System on a tripod for hands free imaging, turn on the LED light for improved viewing, see a magnified view of the vagina and cervix on a smartphone screen resting at the back of the device, annotate and save images on the CervDx app, and upload images to the portal. The EVA System is compatible with Motorola G2 and Motorola G3 smartphones.

The EVA System is capable of working for ten hours before recharging. The EVA System weighs about 0.5 kg and is light enough that the device can be operated for 10 minutes at a time without any fatiguing.

The device operates at a working distance of 22.5 - 42.5 cm with an optical magnification up to 4.0x and ultimately up to 16x, with digital zoom.

#### 6. Indications for Use

The EVA (Enhanced Visual Assessment) System is intended to provide magnified viewing of the vagina, cervix and external genitalia in order to aid in diagnosing abnormalities and selecting areas for biopsy. The device is intended for use in hospitals, doctor's offices, and remote and rural clinics.

#### Predicate Comparison 7.

The following table compares the EVA System to the predicate device with respect to indications for use, technological characteristics, and materials:

| Device & Predicate Device(s): | Subject Device: | Predicate Device: |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | EVA System | MedGyn Digital Video Colposcope |
| | K161871 | K122973 |
| Indications for Use | The EVA (Enhanced Visual<br>Assessment) System is intended to<br>provide magnified viewing of the<br>vagina, cervix and external genitalia in<br>order to aid in diagnosing abnormalities | Medgyn's digital video colposcope<br>is intended for magnified viewing<br>of the tissues of the vagina, cervix<br>and external genitalia in order to<br>assist doctors in diagnosing |
| | and selecting areas for biopsy. The<br>device is intended for use in hospitals,<br>doctor's offices, and remote and rural<br>clinics. | abnormalities such as lesions or<br>cancer, and selecting areas for<br>biopsy. The images from the digital<br>video colposcope are to be viewed<br>on a color monitor. The digital<br>video colposcope is intended for |
| | | use in hospitals, clinics, and<br>doctor's offices. |
| Device Characteristics | | |
| Working Distance | 225-425mm | 200-300mm |
| Focusing Mechanism | Manual | Autofocus, manual |
| Magnification | 225:16x<br>425: 15x | 1-40x |
| Digital Magnification | 1x-4x | 1-32x (model 106A: 1-40x) |
| Optical magnification | 225: 4.0x<br>425: 3.8x | 1-18x (model 106A: 1-36x) |
| Depth of Field | 17mm (at 225mm) - 34mm (at 425mm) | 5-120mm |
| Field of View | 45mm (at 225mm) – 100mm (at<br>425mm) | 1x: ≥60mm<br>32x: ≥6mm<br>At working distance 200mm<br>1x: 195mm (52°)<br>32x: 6.98mm (2°) |
| On-axis Spatial Resolution | 11.78 line-pairs/mm | 11.31 line-pairs/mm |
| On-axis Angular Resolution | 0.022° | 0.02534° |
| Distortion | ≤2.5% | 2.49% |
| Light Source | 3W 6500k star LED | Double circular LED group |
| Color | Digital green filter, polarizing/glare<br>reducing filter | 3 Grade filter function |
| Image Output | Image capture, cloud patient recording<br>and image exporting | S-Video |
| Image Freeze | Full image capturing support | Image Freeze Control |
| Illuminance | ≥1000lux at working distance 425mm | When working distance is 300mm,<br>≥ 1600 lx<br>When working distance is 200mm |
| | | $\ge$ 2000 1x |
| Controls | Interactive GUI mobile application<br>Timers – Acetic Acid Timer | "Multi-function" button control<br>Timers- Magnification & Acetic<br>Acid Timer |
| Materials | PU – Biresin RG53 FR<br>6061 Aluminum<br>5052 Aluminum<br>Stainless Steel | Not Available |

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The EVA System has the same intended use but different technological characteristics compared to the predicate device. The differences in technological characteristics do not raise different questions of safety and effectiveness.

#### 8. Non-Clinical Performance Testing

Non-clinical tests were conducted to verify that the EVA System met all design specifications and is substantially equivalent to the predicate. The test results demonstrated that the proposed device complies with the following standards:

- AAMI/ANSI 60601-1 (2012), Medical Electrical Equipment Part 1: General ● Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, Mod).
- IEC 60601-1-2 (Edition 3.0, 2007), Medical Electrical Equipment Part 1-2: General . Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests.
- ISO 8600-3:1997 Optics and Optical instruments - Medical endoscopes and endoscopic accessories - 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.
- The EVA System was further tested for the following:
- Power Consumption O
- Battery Lifetime O
- Image Distortion o
- Cervical Model Image Quality O
- Image Pairs Evaluation O
- Working Distance о

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- o Illuminance
- Validation of the device software was performed according to the clause 14 of IEC . 60601-1 (third edition) Software requirements, IEC 62304:2004 to IEC 62304-2006/AC 2008, Medical device, and Software life-cycle processes standards.
- Usability testing was conducted according to the IEC 62366-1:2015 standard and FDA ● guidelines for Applying Human Factors and Usability Engineering to Medical Devices.

#### Clinical Performance Data 9.

Not Applicable

#### 10. Conclusion

Based on the comparison and analysis above, the EVA System is substantially equivalent to the predicate device.