(60 days)
No
The description focuses on standard digital imaging and control features, with no mention of AI, ML, or advanced image analysis beyond basic viewing and filtering.
No
The device is used for magnified viewing and image acquisition to assist in diagnosis, not for treating or rehabilitating a condition.
Yes
The device's intended use explicitly states, "in order to assist doctors in diagnosing abnormalities such as lesions or cancer." This directly indicates its role in the diagnostic process.
No
The device description explicitly lists hardware components: a Control unit, a Colposcope unit, and a dedicated PC with a touch screen. Performance studies also include testing of hardware standards (ISO, IEC, ASTM).
Based on the provided information, the Biop Digital Colposcope is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Biop Digital Colposcope Function: The Biop Digital Colposcope is used for in vivo (inside the body) magnified viewing of the vagina, cervix, and external genitalia. It assists doctors in visually identifying abnormalities and selecting areas for biopsy. It does not analyze samples taken from the body.
The device is an optical imaging device used for direct visualization within the body, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for 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.
Product codes
HEX
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vagina, cervix and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospitals, clinics, and doctor's offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was performed per the following voluntary performance standards or FDA guidance:
- ISO 8600-1:2005 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements. Results: This testing demonstratedthat the Biop Digital Colposcope met its predefined optical specifications.
- ISO 8600-3: 1997/Amd 1:2003 Optics and optical instruments - Medical endoscopes and endoscopic accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics. Results: This testing demonstrated that the field of view and direction of view of the Biop Digital Colposcope met predefined specifications.
- ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics. Results: This testing demonstrated the optical resolution of the Biop Digital Colposcope met predefined specifications.
- ANSI/AAMI ES60601- 1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. Results: The Biop Digital Colposcope was demonstrated to be basic safety compatible in its intended environment.
- IEC 60601-1- 2:2014 (Edition 4) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - requirements and tests. Results: The Biop Digital Colposcope was demonstrated to be electromagnetically compatible in its intended environment.
- IEC 62471 Photobiological safety of lamps and lamp systems. Results: The Biop Digital Colposcope was demonstrated to be photo biologically safe in its intended environment and classification.
- ASTM D4169-16 Standard practice for performance testing of shipping containers and systems. Results: The Biop Digital Colposcope, inside its package, successfully passed the environmental tests to ensure that it can withstand the expected distribution environment.
- ASTM D4332-14 Standard practice for conditioning containers, packages, or packaging components for testing. Results: The Biop Digital Colposcope, inside its package, successfully passed the environmental conditioning tests to ensure that it can withstand the expected distribution environment.
- FDA guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," issued May 11, 2005. Results: The Biop Digital Colposcope software has been demonstrated to meet all Software Requirements Specifications. Software documentation reflected a Moderate Level of Concern.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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
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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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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| Specification | Subject Device:
Biop Digital Colposcope | Primary Predicate
Device:
AL-106 | Discussion of Substantial
Equivalence |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer / K# | Biop Medical / K182764 | MedGyn / K122973 | N/A |
| Intended
Environment | Hospitals, clinics, and
doctor's office | Hospitals, clinics, and
doctor's office | Same |
| Standard
configuration | CMOS digital camera,
stand, PC and touch
screen | Digital HAD CCD
camera, Stand | Different; Biop digital colposcope has
additional components: PC and touch
screen. These additional components
do not affect device output, which is
similar to the predicate device. This
difference does not raise different
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
and/or delivered | White LED light | White LED light | Same |
| Illumination | 2200 Lux at WD of 300
mm
Diameter > 60 mm at WD
of 200 mm | Not specified | Different; images provided are similar
to the predicate device. The difference
does not raise different questions of
safety and effectiveness. |
| On - axis spatial
resolution | 57 line-pairs/mm | 11.37 line-pairs/mm | Different; images are similar to the
predicate device. The difference does
not raise different questions of safety
and effectiveness. |
| On - axis angular
resolution | 0.005° | 0.02534° | Different; images are similar to the
predicate device. The difference does
not raise different questions of safety
and effectiveness. |
| Geometric
Distortion |