Biop Digital Colposcope

K182764 · Biop Medical , Ltd. · HEX · Nov 27, 2018 · Obstetrics/Gynecology

Device Facts

• Record ID: K182764
• Device Name: Biop Digital Colposcope
• Applicant: Biop Medical , Ltd.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Nov 27, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

Intended Use

The Biop Digital Colposcope is intended for magnified viewing 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 Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.

Device Story

Digital colposcope system for magnified visualization of cervical/vaginal/genital tissues; assists clinicians in identifying abnormalities and biopsy sites. System includes control unit, colposcope unit, and dedicated touch-screen PC. Operates at 200-300mm working distance; utilizes LED illumination; features digital green filter and polarizing/glare-reducing filter. Clinician operates via keypad or touch-screen GUI to adjust zoom, pan, and illumination; captures real-time video and snapshots for display on monitor. Facilitates clinical decision-making by providing high-resolution magnified imagery for visual assessment. Used in hospitals, clinics, and doctor's offices.

Clinical Evidence

Bench testing only. Performance verified against ISO 8600-1, ISO 8600-3, ISO 8600-5, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62471, and ASTM shipping standards. Software documentation provided for Moderate Level of Concern.

Technological Characteristics

CMOS digital camera; LED illumination (2200 Lux at 300mm); manual focus; digital green filter; polarizing filter; USB 3.0 output. PC-based touch-screen interface. Complies with ISO 8600 series for optical performance, IEC 60601-1 for electrical safety, and IEC 62471 for photobiological safety.

Indications for Use

Indicated for magnified viewing of vagina, cervix, and external genitalia to assist physicians in diagnosing abnormalities (e.g., lesions, cancer) and selecting biopsy sites.

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 AL-106 Digital Video Colposcope (K122973)

Reference Devices

• Mobile ODT, The Eva (Enhanced Visual Assessment) System (K161871)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains 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.

November 27, 2018

Biop Medical Ltd. % Janice M. Hogan Partner Hogan Lovells US LLP 1735 Market Street Philadelphia, PA 19103

Re: K182764 Trade/Device Name: Biop Digital Colposcope Regulation Number: 21 CFR§ 884.1630 Regulation Name: Colposcope Regulatory Class: II Product Code: HEX Dated: September 28, 2018 Received: September 28, 2018

Dear Janice M. Hogan:

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 mav, 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 avare 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.

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.

{1}------------------------------------------------

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.html; 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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Sharon M. Andrews -S

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K182764

Device Name Biop Digital Colposcope

Indications for Use (Describe)

The Biop Digital Colposcope is intended for magnified viewing 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 Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="white-space: nowrap;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY - K182764

Biop Medical's Biop Digital Colposcope

#### 1. Submitter's identification

Biop Medical Ltd. 10 O'haliav Street Ramat-Gan, 5252263, Israel Phone: [phone] Contact Person: Ilan Landesman Date Prepared: November 20, 2018

#### 2. Name of Device

Name of Device: Biop Digital Colposcope Common or Usual Name: Digital Colposcope Classification: 21 CFR 884.1630 Classification Name: Colposcope Regulatory Class: II Product Code: HEX Product Code Name: Colposcope (and colpomicroscope)

#### 3. Predicate and Reference Device information

Predicate: K122973, MedGyn Products Inc., MedGyn AL-106 Digital Video Colposcope Reference: K161871, Mobile ODT, The Eva (Enhanced Visual Assessment) System

The predicate device has not been subject to a design-related recall.

## 4. Device Description

The Biop Digital Colposcope comprises 3 components:

- . Biop Digital Colposcope Control unit;
- . Biop Digital Colposcope unit;
- Dedicated PC (touch screen) containing software and vertical stand.

The Biop Digital Colposcope is designed to be utilized at a working distance (WD) of 8" (200mm) -12" (300mm) from the cervix and acquires magnified images according to the doctor's requirements. The colposcope includes LED illumination and digital green filter capabilities as well.

The user can operate the Biop Digital Colposcope unit using the keypad on the Biop Digital Colposcope Control unit and/or via the touch screen of the PC. Via the operation screen on the monitor, the user can visualize the cervix, take snapshots, take video, and use the green filter and additional illumination functionalities. Each of these functions can be controlled and adjusted by designated menus.

{4}------------------------------------------------

The touch-screen graphical user interface (GUI) consists of three menu options: Menu 1, 2, or 3, which allow control over the Biop Digital Colposcope, including the illumination system, zoom functions and Pan options. Each Operation Screen can be used during the colposcopy exam and shows the video taken by the Biop Digital Colposcope camera in real time. Images acquired during colposcopy are shown on the right of the screen. The user can toggle through all images obtained via the Biop Digital Colposcope unit and, if indicated, can acquire the biopsies in a standard manner. In addition, the system also enables full screen presentation of the images.

#### 5. Indications for Use

The Biop Digital Colposcope is intended for magnified viewing of 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 Colposcope are to be viewed on a color display. The Biop Digital Colposcope is intended for use in hospitals, clinics, and doctor's offices.

The predicate MedGyn's AL-106 Digital Video Colposcope (K122973) is intended for magnified viewing of 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 predicate device are to be viewed on a color monitor. The predicate device is intended for use in hospitals, clinics, and doctor's offices.

The Biop Digital Colposcope and the predicate device have the same intended use - to permit direct viewing and imaging of the tissues of the vaqina, cervix and external genitalia to assist doctors in diagnosing abnormalities and select areas for biopsy.

## 6. Summary of Technological Characteristics and Comparison

The Biop Digital Colposcope has similar technological characteristics as the predicate device, i.e., both devices incorporate illumination, power and video into stand-alone units. They provide image capture function at the same working distance and resolution and record images of the examined area. They also have focusing, magnification and green filter capabilities. The technological characteristics of the subject and predicate devices are summarized in the table below.

{5}------------------------------------------------

| Specification | Subject Device:<br>Biop Digital Colposcope | Primary Predicate<br>Device:<br>AL-106 | Discussion of Substantial<br>Equivalence |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer / K# | Biop Medical / K182764 | MedGyn / K122973 | N/A |
| Intended<br>Environment | Hospitals, clinics, and<br>doctor's office | Hospitals, clinics, and<br>doctor's office | Same |
| Standard<br>configuration | CMOS digital camera,<br>stand, PC and touch<br>screen | Digital HAD CCD<br>camera, Stand | Different; Biop digital colposcope has<br>additional components: PC and touch<br>screen. These additional components<br>do not affect device output, which is<br>similar to the predicate device. This<br>difference does not raise different<br>questions of safety and effectiveness. |
| Voltage | 100 V - 240 V~ | 100 V - 240 V~ | Same |
| Frequency | 50 Hz / 60 Hz | 50 Hz / 60 Hz | Same |
| Energy Used<br>and/or delivered | White LED light | White LED light | Same |
| Illumination | 2200 Lux at WD of 300<br>mm<br>Diameter > 60 mm at WD<br>of 200 mm | Not specified | Different; images provided are similar<br>to the predicate device. The difference<br>does not raise different questions of<br>safety and effectiveness. |
| On - axis spatial<br>resolution | 57 line-pairs/mm | 11.37 line-pairs/mm | Different; images are similar to the<br>predicate device. The difference does<br>not raise different questions of safety<br>and effectiveness. |
| On - axis angular<br>resolution | 0.005° | 0.02534° | Different; images are similar to the<br>predicate device. The difference does<br>not raise different questions of safety<br>and effectiveness. |
| Geometric<br>Distortion | <3% | ≤3% | Same |
| Working Distance | 200 mm – 300 mm | 200 mm – 300 mm | Same |
| Specification | Subject Device:<br>Biop Digital Colposcope | Primary Predicate<br>Device:<br>AL-106 | Discussion of Substantial<br>Equivalence |
| Field of View | At working distance of 8"<br>(200 mm):<br>At minimum magnification<br>28° or ≥φ99 mm.<br>At maximum magnification<br>3.4° or ≥φ11.8 mm<br><br>At working distance of 12"<br>(300 mm):<br>At minimum magnification<br>30° or ≥φ160 mm.<br>At maximum magnification<br>3.8° or ≥φ20mm | At working distance of<br>200mm:<br>At 1X magnification<br>52° or ≥φ195 mm.<br>At 32X magnification<br>2° or ≥φ6.978 mm | Different; Biop digital colposcope has a<br>larger FOV than the predicate at<br>maximum magnification; however, its<br>resolution is equivalent to the predicate.<br>This difference does not raise different<br>questions of safety and effectiveness. |
| Depth of Field | 85mm (at 200mm) -95mm<br>(at 300mm) | 5mm-120mm | Different; Depth of field is within range<br>of predicate. This difference does not<br>raise different questions of safety or<br>effectiveness. |
| Focus mode | Manual | Automatic / Manual | Different; User has manual control over<br>focus like the predicate. Colposcopes<br>with manual focus only have been<br>previously cleared (K161871, EVA<br>System). This difference does not raise<br>different questions of safety or<br>effectiveness. |
| Filter | Digital green filter,<br>polarizing/glare reducing<br>filter | 3 grades of green filter | Different; The additional polarizing filter<br>reduces glare in images and does not<br>impair image quality or alter the<br>imaging modality. The digital green<br>filter performs the same function as the<br>predicate's green filter. A digital green<br>filter is used in the previously cleared<br>EVA System. The differences in filters<br>does not raise different questions of<br>safety and effectiveness. |
| Magnification | Optical magnification: x3.7-<br>x30 at 8" (200mm) working<br>distance | Optical magnification:<br>x1-x36<br>Digital magnification: 1-<br>40x | Different; minimum optical<br>magnification is higher (x3.7) than the<br>predicate (x1) and maximum<br>magnification is slightly lower (x30)<br>than the predicate (x36). However,<br>clinical functionality is substantially<br>equivalent. The difference does not<br>raise different questions of safety and<br>effectiveness. |
| Specification | Subject Device:<br>Biop Digital Colposcope | Primary Predicate<br>Device:<br>AL-106 | Discussion of Substantial<br>Equivalence |
| Freeze function | Yes | Yes | Same |
| Video output | USB 3.0 | S-Video | Different; Biop digital colposcope has a<br>digital signal output, while predicate<br>device has an analog signal output.<br>This difference does not change device<br>output and does not raise different<br>questions of safety or effectivness. |

{6}------------------------------------------------

{7}------------------------------------------------

## 7. Summary of Performance Data

Bench testing was performed per the following voluntary performance standards or FDA guidance:

| Standards No. or<br>Guidance | Standard or Guidance Title | Results |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 8600-1:2005 | Endoscopes - Medical endoscopes and<br>endotherapy devices - Part 1: General<br>requirements | This testing demonstratedthat the Biop<br>Digital Colposcope met its predefined optical<br>specifications. |
| ISO 8600-3:<br>1997/Amd 1:2003 | Optics and optical instruments - Medical<br>endoscopes and endoscopic accessories -<br>Part 3: Determination of field of view and<br>direction of view of endoscopes with optics | This testing demonstrated that the field of<br>view and direction of view of the Biop Digital<br>Colposcope met predefined specifications. |
| ISO 8600-5:2005 | Optics and photonics - Medical endoscopes<br>and endotherapy devices - Part 5:<br>Determination of optical resolution of rigid<br>endoscopes with optics | This testing demonstrated the optical<br>resolution of the Biop Digital Colposcope<br>met predefined specifications. |
| ANSI/AAMI<br>ES60601-<br>1:2005/(R)2012<br>and A1:2012 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance | The Biop Digital Colposcope was<br>demonstrated to be basic safety compatible<br>in its intended environment. |
| IEC 60601-1-<br>2:2014 (Edition 4) | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral standard:<br>Electromagnetic compatibility -<br>requirements and tests | The Biop Digital Colposcope was<br>demonstrated to be electromagnetically<br>compatible in its intended environment. |
| IEC 62471 | Photobiological safety of lamps and lamp<br>systems | The Biop Digital Colposcope was<br>demonstrated to be photo biologically safe in<br>its intended environment and classification. |

{8}------------------------------------------------

| Standards No. or<br>Guidance | Standard or Guidance Title | Results |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ASTM D4169-16 | Standard practice for performance testing<br>of shipping containers and systems | The Biop Digital Colposcope, inside its<br>package, successfully passed the<br>environmental tests to ensure that it can<br>withstand the expected distribution<br>environment. |
| ASTM D4332-14 | Standard practice for conditioning<br>containers, packages, or packaging<br>components for testing | The Biop Digital Colposcope, inside its<br>package, successfully passed the<br>environmental conditioning tests to ensure<br>that it can withstand the expected<br>distribution environment. |
| FDA guidance | "Guidance for the Content of Premarket<br>Submissions for Software Contained in<br>Medical Devices," issued May 11, 2005 | The Biop Digital Colposcope software has<br>been demonstrated to meet all Software<br>Requirements Specifications. Software<br>documentation reflected a Moderate Level of<br>Concern. |

#### 8. Conclusions

The Biop Digital Colposcope is as safe and effective as the MedGyn AL-106 Digital Video Colposcope. Performance data demonstrate that the Biop Digital Colposcope is as safe and effective as the MedGyn AL-106 Digital Video Colposcope. Thus, the Biop Digital Colposcope is substantially equivalent to the predicate.