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 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.
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.

AI/ML Overview

This document describes the Biop Digital Colposcope and its equivalence to a predicate device. However, it does not contain specific acceptance criteria for a device's performance in diagnosing abnormalities or selecting areas for biopsy using AI or advanced algorithms, nor does it provide a study proving such criteria are met. The document focuses on the physical and optical specifications of the colposcope itself, and its compliance with general medical device standards.

Therefore, for the specific questions requested, much of the information cannot be found in the provided text.

Here is what can be extracted or inferred:

1. A table of acceptance criteria and the reported device performance

The document lists various specifications and states that the device "met its predefined optical specifications" or "met predefined specifications" for those criteria. It does not provide specific acceptance values or thresholds for all listed specifications, nor does it present "device performance" in terms of diagnostic accuracy, sensitivity, or specificity, as the device itself is a viewing tool, not an AI diagnostic system.

Acceptance Criteria (from specifications/standards)	Reported Device Performance
Illumination (2200 Lux at 300mm WD, Diameter > 60mm at 200mm WD)	Met predefined specifications
On-axis spatial resolution (57 line-pairs/mm)	Met predefined specifications
On-axis angular resolution (0.005°)	Met predefined specifications
Geometric Distortion (<3%)	Met predefined specifications
Working Distance (200mm – 300mm)	Met predefined specifications
Field of View (e.g., At 200mm WD, min mag 28° or ≥φ99 mm; max mag 3.4° or ≥φ11.8 mm)	Met predefined specifications
Depth of Field (85mm (at 200mm) - 95mm (at 300mm))	Met predefined specifications
Focus mode (Manual)	Met predefined specifications (user has manual control)
Filter (Digital green, polarizing/glare reducing)	Met predefined specifications (performs function)
Magnification (Optical x3.7-x30 at 200mm WD)	Met predefined specifications
Freeze function	Yes
Video output (USB 3.0)	Yes
Compliance with ISO 8600-1:2005 (General requirements for medical endoscopes)	Met applicable requirements
Compliance with ISO 8600-3:1997/Amd 1:2003 (Field of view and direction of view)	Met predefined specifications
Compliance with ISO 8600-5:2005 (Optical resolution)	Met predefined specifications
Compliance with ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012 (Basic safety and essential performance)	Demonstrated to be basic safety compatible
Compliance with IEC 60601-1-2:2014 (Electromagnetic compatibility)	Demonstrated to be electromagnetically compatible
Compliance with IEC 62471 (Photobiological safety)	Demonstrated to be photo biologically safe
Shipping container performance (ASTM D4169-16, ASTM D4332-14)	Successfully passed environmental tests
Software requirements (FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices")	Met all Software Requirements Specifications, Moderate Level of Concern

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes bench testing and compliance with various standards related to the physical and software characteristics of the device, not clinical performance for diagnosis or biopsy selection. There is no mention of a human-in-the-loop diagnostic test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. As stated above, there is no mention of a diagnostic test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the document. The device description does not include AI or an algorithm for diagnostic assistance, beyond providing images for human interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided in the document. The device is a colposcope for human viewing, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document. The device does not appear to involve machine learning that would require a "training set" in the context of diagnostic performance. The "Software documentation reflected a Moderate Level of Concern," which refers to the documentation for the device's operational software, not an AI training set.

9. How the ground truth for the training set was established

This information is not provided in the document.

Summary

{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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sharon M. Andrews -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)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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 PRAStaff@fda.hhs.gov

"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: +972-3-9444670 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:Biop Digital Colposcope	Primary PredicateDevice:AL-106	Discussion of SubstantialEquivalence
Manufacturer / K#	Biop Medical / K182764	MedGyn / K122973	N/A
IntendedEnvironment	Hospitals, clinics, anddoctor's office	Hospitals, clinics, anddoctor's office	Same
Standardconfiguration	CMOS digital camera,stand, PC and touchscreen	Digital HAD CCDcamera, Stand	Different; Biop digital colposcope hasadditional components: PC and touchscreen. These additional componentsdo not affect device output, which issimilar to the predicate device. Thisdifference does not raise differentquestions 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 Usedand/or delivered	White LED light	White LED light	Same
Illumination	2200 Lux at WD of 300mmDiameter > 60 mm at WDof 200 mm	Not specified	Different; images provided are similarto the predicate device. The differencedoes not raise different questions ofsafety and effectiveness.
On - axis spatialresolution	57 line-pairs/mm	11.37 line-pairs/mm	Different; images are similar to thepredicate device. The difference doesnot raise different questions of safetyand effectiveness.
On - axis angularresolution	0.005°	0.02534°	Different; images are similar to thepredicate device. The difference doesnot raise different questions of safetyand effectiveness.
GeometricDistortion	<3%	≤3%	Same
Working Distance	200 mm – 300 mm	200 mm – 300 mm	Same
Specification	Subject Device:Biop Digital Colposcope	Primary PredicateDevice:AL-106	Discussion of SubstantialEquivalence
Field of View	At working distance of 8"(200 mm):At minimum magnification28° or ≥φ99 mm.At maximum magnification3.4° or ≥φ11.8 mmAt working distance of 12"(300 mm):At minimum magnification30° or ≥φ160 mm.At maximum magnification3.8° or ≥φ20mm	At working distance of200mm:At 1X magnification52° or ≥φ195 mm.At 32X magnification2° or ≥φ6.978 mm	Different; Biop digital colposcope has alarger FOV than the predicate atmaximum magnification; however, itsresolution is equivalent to the predicate.This difference does not raise differentquestions of safety and effectiveness.
Depth of Field	85mm (at 200mm) -95mm(at 300mm)	5mm-120mm	Different; Depth of field is within rangeof predicate. This difference does notraise different questions of safety oreffectiveness.
Focus mode	Manual	Automatic / Manual	Different; User has manual control overfocus like the predicate. Colposcopeswith manual focus only have beenpreviously cleared (K161871, EVASystem). This difference does not raisedifferent questions of safety oreffectiveness.
Filter	Digital green filter,polarizing/glare reducingfilter	3 grades of green filter	Different; The additional polarizing filterreduces glare in images and does notimpair image quality or alter theimaging modality. The digital greenfilter performs the same function as thepredicate's green filter. A digital greenfilter is used in the previously clearedEVA System. The differences in filtersdoes not raise different questions ofsafety and effectiveness.
Magnification	Optical magnification: x3.7-x30 at 8" (200mm) workingdistance	Optical magnification:x1-x36Digital magnification: 1-40x	Different; minimum opticalmagnification is higher (x3.7) than thepredicate (x1) and maximummagnification is slightly lower (x30)than the predicate (x36). However,clinical functionality is substantiallyequivalent. The difference does notraise different questions of safety andeffectiveness.
Specification	Subject Device:Biop Digital Colposcope	Primary PredicateDevice:AL-106	Discussion of SubstantialEquivalence
Freeze function	Yes	Yes	Same
Video output	USB 3.0	S-Video	Different; Biop digital colposcope has adigital signal output, while predicatedevice has an analog signal output.This difference does not change deviceoutput and does not raise differentquestions 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. orGuidance	Standard or Guidance Title	Results
ISO 8600-1:2005	Endoscopes - Medical endoscopes andendotherapy devices - Part 1: Generalrequirements	This testing demonstratedthat the BiopDigital Colposcope met its predefined opticalspecifications.
ISO 8600-3:1997/Amd 1:2003	Optics and optical instruments - Medicalendoscopes and endoscopic accessories -Part 3: Determination of field of view anddirection of view of endoscopes with optics	This testing demonstrated that the field ofview and direction of view of the Biop DigitalColposcope met predefined specifications.
ISO 8600-5:2005	Optics and photonics - Medical endoscopesand endotherapy devices - Part 5:Determination of optical resolution of rigidendoscopes with optics	This testing demonstrated the opticalresolution of the Biop Digital Colposcopemet predefined specifications.
ANSI/AAMIES60601-1:2005/(R)2012and A1:2012	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance	The Biop Digital Colposcope wasdemonstrated to be basic safety compatiblein its intended environment.
IEC 60601-1-2:2014 (Edition 4)	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral standard:Electromagnetic compatibility -requirements and tests	The Biop Digital Colposcope wasdemonstrated to be electromagneticallycompatible in its intended environment.
IEC 62471	Photobiological safety of lamps and lampsystems	The Biop Digital Colposcope wasdemonstrated to be photo biologically safe inits intended environment and classification.

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

Standards No. orGuidance	Standard or Guidance Title	Results
ASTM D4169-16	Standard practice for performance testingof shipping containers and systems	The Biop Digital Colposcope, inside itspackage, successfully passed theenvironmental tests to ensure that it canwithstand the expected distributionenvironment.
ASTM D4332-14	Standard practice for conditioningcontainers, packages, or packagingcomponents for testing	The Biop Digital Colposcope, inside itspackage, successfully passed theenvironmental conditioning tests to ensurethat it can withstand the expecteddistribution environment.
FDA guidance	"Guidance for the Content of PremarketSubmissions for Software Contained inMedical Devices," issued May 11, 2005	The Biop Digital Colposcope software hasbeen demonstrated to meet all SoftwareRequirements Specifications. Softwaredocumentation reflected a Moderate Level ofConcern.

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.

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.