(263 days)
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
Smart Scope® CX is a handheld, reusable transvaginal digital examination camera designed for use in a hospital or clinical setting. It is intended for close examination and magnified visualization of the external genitalia, vagina, and cervix. The Smart Scope® CX camera probe is equipped with an integrated green and white LED light, which serves to illuminate the object under observation. Additionally, it features a 10X magnification camera, facilitating the capture of color images. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances by pressing respective buttons in the smart scope probe. By establishing a USB connection between the Smart Scope and a tablet, users can access live images and capture necessary stills using the Net4Medix® application, installed on the tablet. These captured images are then stored directly on the tablet. The Net4Medix® software further enables the creation and management of patient records, visit histories, and seamless integration with the Smart Scope® CX for functions such as image streaming, capture, storage, and assignment to the respective patient records. The Smart Scope® CX is designed and intended to be used only with speculum and it is not intended to come into direct contact with the body. Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test.
The provided text is a 510(k) summary for the Periwinkle Technologies Pvt. Ltd.'s Smart Scope® CX, a digital colposcope. It focuses on demonstrating substantial equivalence to a predicate device (Pocket Colposcope System K181034) by comparing technical specifications and performance data.
However, the document does not contain the detailed study information typically requested for evaluating "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML-driven device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (in the sense of clinical performance metrics like sensitivity, specificity, or reader agreement). The tables provided compare technical specifications of the device itself (e.g., illumination, magnification) rather than clinical performance outcomes or AI model performance metrics.
- Sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details. The document outlines the physical and software components of the device and its intended use for visual examination, but there is no mention of an AI algorithm making diagnostic interpretations or classifications that would require such rigorous validation studies.
Based on the provided text, the Smart Scope® CX is a digital colposcope that provides magnified visualization and image documentation. It is NOT an AI/ML-driven device that provides diagnostic interpretations or classifications. Therefore, the specific types of acceptance criteria and study designs typically used for AI/ML medical devices (e.g., sensitivity, specificity, MRMC studies, ground truth establishment by expert consensus) are not present or applicable in this 510(k) submission.
The performance data mentioned in the document refers to:
- Electrical Safety and EMC: Compliance with IEC 60601-1 and IEC 60601-1-2.
- Software: Compliance with FDA guidance and IEC 62304.
- Cybersecurity: Compliance with FDA guidance and IEC 81001-5-1.
- Risk Management: Compliance with ISO 14971.
- Reprocessing: Compliance with FDA guidance.
- Labels & IFU: Compliance with ISO 15223-1 and ISO 20417.
- Performance (Optical): Compliance with ISO 8600-3, ISO 8600-5, IEC 62471, and general optical performance evaluations. These relate to the physical device's imaging capabilities (e.g., field of view, resolution, photobiological safety), not an AI's diagnostic performance.
Therefore, I cannot fulfill the request as it relies on information typically found in submissions for AI/ML devices, which is not present in this document for the Smart Scope® CX. The "acceptance criteria" here are met through demonstrating technical comparability and compliance with relevant safety, software, and optical performance standards for a medical imaging device, rather than through a clinical performance study of an AI algorithm.
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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
June 14, 2024
Periwinkle Technologies Pvt. Ltd % Ankur Naik Managing Director IZiel Healthcare Pentagon P1, Office No. 601 and 604, Magarpatta City Pune. Mab 411028 INDIA
Re: K233043
Trade/Device Name: Smart Scope® (CX) Regulation Number: 21 CFR 884.1630 Regulation Name: Colposcope Regulatory Class: Class II Product Code: HEX Dated: May 9, 2024 Received: May 10, 2024
Dear Ankur Naik:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
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Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
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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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Reginald K. Avery -S
for Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K233043
Device Name Smart Scope® CX
Indications for Use (Describe)
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
510(k) summary of substantial equivalence for Smart Scope® CX is provided in accordance with 21 CFR 807.92.
| Date Prepared: | 14 June 2024 |
|---|---|
| Submitter (Owner): | Veena MoktaliFounder & CEOPeriwinkle Technologies Pvt Ltd.B1, Samrat Ashok CHS,S. No. 88/2, Veerbhadra Nagar, Baner, Pune -411045, Maharashtra, India.P: +91 9021147173Email: vrmoktali@periwinkletech.com |
| 510(k) Contact Person: | Ankur NaikManaging DirectorIZiel Healthcare14, Hadapsar Industrial Estate,Hadapsar, Pune – 411013, India.P: +91 72762 2555 M: +91 7069553814Email: ankur.naik@izielhealthcare.com |
| Device Trade Name: | Smart Scope CX |
| Device Common Name | Colposcope |
| Classification Number: | 21 CFR 884.1630 |
| Classification Name: | Colposcope |
| Review Panel: | Obstetrics/Gynecology |
| Device Class: | Class II |
| Product Code: | HEX |
| Predicate Device: | Pocket Colposcope System (K181034) |
| The predicate device has not been subjected to adesign-related recall. |
Device Description
Smart Scope® CX is a handheld, reusable transvaginal digital examination camera designed for use in a hospital or clinical setting. It is intended for close examination and magnified visualization of the external genitalia, vagina, and cervix. The Smart
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Scope® CX was designed, developed, and manufactured at Periwinkle Technologies Pvt. Ltd. The model number is indicated below:
| ModelNumber | Model Name | Model Description |
|---|---|---|
| CX | Smart Scope® CX | Digital Cervical Examination (Trans-vaginal) |
The Smart Scope® CX packaging includes:
- Smart Scope® CX Probe ●
- . Lenovo Smart Tab M8 Tablet with Net4Medix® Software
- . Stand for tablet.
- . Tablet charger.
The Smart Scope® CX camera probe is equipped with an integrated green and white LED light, which serves to illuminate the object under observation. Additionally, it features a 10X magnification camera, facilitating the capture of color images. Users can switch between the white and green light illumination and zoom in or out to capture images at different working distances by pressing respective buttons in the smart scope probe. By establishing a USB connection between the Smart Scope and a tablet, users can access live images and capture necessary stills using the Net4Medix® application, installed on the tablet. These captured images are then stored directly on the tablet. The Net4Medix® software further enables the creation and management of patient records, visit histories, and seamless integration with the Smart Scope® CX for functions such as image streaming, capture, storage, and assignment to the respective patient records.
The Smart Scope® CX is designed and intended to be used only with speculum and it is not intended to come into direct contact with the body. Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test.
The Smart Scope® CX should be connected to the tablet via USB connections. The Smart Scope® camera probe is powered from the tablet through a connected USB interface. During the tablet's charging process, the device cannot be utilized. The Smart Scope® CX is intended to be used only with a Smart tablet that is customized and supplied with the device.
To enhance security and manageability, Periwinkle Technologies Pvt Ltd has preloaded the tablet with Enterprise-Device-Management (EDM) software. This software serves as a tool for the secure distribution of the Net4Medix® application and facilitates policy control for data security. This security framework restricts the usage of any software other than Net4Medix®, ensuring that the tablet is dedicated exclusively to this critical application. Consequently, users are unable to connect to external networks or access other internet facilities.
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Specification:
| Parameters | Specification |
|---|---|
| Operating System | Android 6+ operating system |
| Dimensions | 211 x 124 x 8.2 mm or a similar |
| Display Screen | Touchscreen with 7 to 8-inch display |
| Min. Resolution 1280X800, Gamut 60% NTSC,84.6% sRGB, Brightness 350+ Nits, Contrast 552+ | |
| Battery capacity | 4000+ mAh |
| Minimum storage capacity | 16 GB |
| Minimum RAM. | 2 GB |
Smart Scope Features:
The Smart scope device is used like other colposcopes, and has the following features:
- Camera & Lens: 0° lens, 5 Mega Pixel CMOS sensor ●
- Light Source: Four (4) white and four (4) green LEDs arranged in a circular at . the probe tip.
- Probe (Nozzle): 74 mm in length, 22.4 mm of Outer Diameter. .
- Probe (Handle): 134.3 mm in length. ●
- Zoom, light controls on the probe handle. ●
- Image capture and pdf report generated through the Net4Medix® application. ●
- USB 2.0 cable attached to scope handle to connect to a tablet. .
- Packaged non-sterile and designed for reuse after cleaning and Disinfection. ●
- . High-definition output.
Intended Use / Indications for Use
Smart Scope® CX is intended for gynecological examination. It provides a portable means of magnified visualization of the tissues of the vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting areas for biopsy. The Net4Medix® application is intended to provide documentation of the image in the field of view of the scope. The Smart Scope® CX camera probe is intended to be inserted into the vagina via a speculum by trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
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Substantial Equivalence Discussion
The Pocket Colposcope (K181034) has been selected as the primary predicate device for the substantial equivalence discussion regarding the Smart Scope® CX. The details regarding the substantial equivalence between the subject device and the predicate devices are explained below:
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Comparison to predicate devices:
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
|---|---|---|---|---|---|
| Product Name | Smart Scope® CX | Pocket Colposcope | Not Applicable | ||
| Manufacturer | Periwinkle Technologies Pvt Ltd | Hadleigh Health Technologies,LLC | Not Applicable | ||
| RegulationNumber | 21 CFR 884.1630 | 21 CFR 884.1630 | Identical | ||
| Product Code | HEX | HEX | Identical | ||
| Product Class | Class II | Class II | Identical | ||
| Indication for Use | Smart Scope® CX is intended forgynecological examination. Itprovides a portable means ofmagnified visualization of thetissues of the vagina, cervix, andexternal genitalia to aid indiagnosing abnormalities andselecting areas for biopsy. TheNet4Medix® application is intendedto provide documentation of theimage in the field of view of thescope. The Smart Scope® CXcamera probe is intended to beinserted into the vagina via aspeculum by trained medicalpersonnel in hospitals, clinics, andprivate offices, and is not intendedfor home use. | The Pocket Colposcope is a digitalvideo colposcope intended forqynecological examination. Itprovides a portable means ofmagnified visualization of thetissues of the vagina, cervix, andexternal genitalia in order to aid indiagnosing abnormalities andselecting areas for biopsy. Theimage system is intended toprovide documentation of theimage in the field of view of thecolposcope. The PocketColposcope System is intended tobe inserted into the vagina via aspeculum by trained medicalpersonnel in hospitals, clinics, andprivate offices, and is not intendedfor home use. | Similar | ||
| Multiple Use | Yes | Yes | Identical | ||
| Prescription (Rxonly) | Yes | Yes | Identical | ||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| Anatomical Site | External genitalia, vagina, andcervix | Cervix, vagina, and externalgenitalia | Identical | ||
| Intended User | Trained medical professionals | Trained medical professionals | Identical | ||
| UseEnvironment | Hospitals, clinics, and privateoffices | Hospitals, clinics, and privateoffices | Identical | ||
| Device Design | Image: Subject Device | Image: Predicate Device | Not Applicable | ||
| StandardConfiguration | Digital Camera connected to Tabletvia USB cable and used withoutstand. | Digital CMOS camera used withoutstand. | Identical | ||
| External PowerSource | Voltage: 5VFrequency: DCInput power: USB 5V from a tabletdevice | Voltage: 5VFrequency: DCInput power: USB 5V | Identical | ||
| Materials | Housing: Acrylonitrile-butadiene-styrene (ABS) PlasticButtons: ThermoplasticpolyurethaneCamera protector: Glass | Housing: ABS PlasticLens: PMMA | DifferentThe housing of thesubject andpredicate device ismade up of ABSplastic. The othersubject devicecomponents aremade of otherplastics or glassthat differ from thepredicate device. | ||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| FundamentalScientificTechnology | The camera has optics that relayoptical information (live streamingof images) to a smart tablet(visualization/ annotation module). | The camera has optics that relayoptical video information to a PC orlaptop (visualization/ annotationmodule). | However, thedifferences do notraise differentquestions of safetyand effectiveness.DifferentThe Net4Medixapplication isinstalled on theSmart Tablet andaids in visualizationand annotation.The predicatedevice required aPC or laptop torelay and visualizethe opticalinformation. Thisdifference does notraise differentquestions of safety | ||
| Device Specification: Light | and effectiveness. | ||||
| Light Module | LEDs in circular form. | Single loop group LED light | Identical | ||
| Light Source | White and green LED light | White and green LED light | Identical | ||
| Light SourceLifetime | ≥ 10,000 hrs | ≥ 10,000 hrs | Identical | ||
| MaximumIllumination | White-450 lux at working distanceof 35-40mm | 20,000 lux at a working distance of5mm. | Different | ||
| Green-550 lux at working distanceof 35-40mm | 462 lux at a working distance of50mm. | The illumination ofthe subject devicedoes not exceed | |||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| IlluminationRange/BeamDiameter | 75 mm at a working distance of 40mm | 74.5 mm at working distance of 50mm | the illumination forthe predicatedevice. Thesedifferences do notraise differentquestions of safetyand effectiveness.DifferentThe subject andpredicate devicehave a similarillumination rangeat different workingdistances. Thesedifferences do notraise differentquestions of safetyand effectiveness. | ||
| Device Specification: Camera | |||||
| Magnification | 29 or 46X on tablet displaydepending on orientation | 3X-52X | DifferentThe magnificationof the subjectdevice is within therange specified bypredicate device.This does not raiseany differentquestions of safetyand effectiveness. | ||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| System Resolution | ≥ 1944 TVL | ≥ 1944 TVL | Identical | ||
| Optical Resolution | MTF50=0.182 cy/px (or 0.182 line-pairs per pixel) or 130 lp/mm giventhe 1.4 x 1.4 µm size of the pixel | Lowest: 13.51 lp/mmHighest: 121.02 lp/mm | DifferentThe opticalresolution of thesubject device ishigher than thepredicate device.This does not raiseany differentquestions of safetyand effectiveness. | ||
| Focus Mode | Manual Control: Auto Focus only | Manual Control: Auto focus only | Identical | ||
| Video Output | USB | USB | Identical | ||
| Image GeometricDistortion | <1% (±1) | 0.3% to -3.24% | DifferentThe geometricdistortion in theimage falls withinthe predicatedevice limits. Thisdoes not raise anydifferent questionsof safety andeffectiveness. | ||
| Working Distance | 30- 40 mm | 5-50 mm | DifferentTo observe thestandard cervix sizeof 25 to 30 mm, thefield of viewprovided within the35 to 40 mm | ||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| Field of View(FoV) | At 35mm working distance ≥ 44mmFoV(D): 63°DoV: 0° | At min. magnification ≥ 54.2 mmAt max. magnification ≥ 5.87 mm | working distance isadequatelysufficient.This does not raiseany differentquestions of safetyand effectiveness.DifferentTo observe thestandard cervix sizeof 25 to 30 mm, thefield of viewprovided within the35 mm workingdistance isadequatelysufficient. The fieldof view offered bythe subject deviceencompasses alarger area than thestandard cervixsize. This does notraise any differentquestions of safetyand effectiveness. | ||
| Depth of Field | At 35mm working distance 15.1mm | At min. magnification 11.71 mmAt max. magnification ≥ 1.86 mm | DifferentThis subject devicehas a greater depthof field than thepredicate device | ||
| ComparableProperties | Subject Device | Predicate Device (K181034) | ComparisonResults | ||
| This does not raiseany differentquestions of safetyand effectiveness. | |||||
| Freeze Function | Yes | Yes | Identical | ||
| VascularVisualization | Green LED light | Green LED light | Identical | ||
| Cleaning | Handle, Cable, and Tablet:Surfaces disinfected with adisinfectant wipe.Nozzle: Cleaned and Disinfected | Handle and Cord: Surfacesdisinfected with disinfectant wipe.Probe: High Level Disinfection | Identical | ||
| Radiation Safety | Does not emit any ionizingradiation | Does not emit any ionizingradiation | Identical |
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Discussion of similarities and differences:
The Smart Scope® CX and the Pocket Colposcope are intended for gynecological examinations, providing a portable means of magnified visualization to assist in detecting and monitoring abnormalities and infections of the external genitalia, vagina, and cervix. The Smart Scope® CX utilizes Net4Medix® software installed on a Smart tablet for visualization and annotation, while the Pocket Colposcope employs a laptop for this purpose. Both devices utilize both Green and white LED illumination.
The subject device operates within a recommended and fixed range of working distance (30 to 40 mm). The camera autofocuses at this minimum distance, leading to variations in calculation parameters compared to the predicate device working distance range (5-50 mm). All other parameters adjust according to the working distance. There are also differences in the illumination level, optical specification (e.g., depth of field, field of view), and magnification. These specifications are adequate for viewing the entire cervix, and the differences do not raise any different questions of safety and effectiveness.
Performance data
The following standards, guidance, and testing were used to evaluate performance of the Smart Scope® CX:
Electrical Safety and EMC:
-
- IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV Consolidated version Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
-
- IEC 60601-1-2:2014+AMD1:2020 CSV Consolidated version Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromaqnetic disturbances - Requirements and tests.
Software:
-
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Issued June 14, 2023.
-
- IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION Medical device software - Software life cycle processes.
Cybersecurity:
-
- Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity. Issued September 27, 2023.
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-
- IEC 81001-5-1 Edition 1.0 2021-12 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
Risk Management:
-
- ISO 14971:2019 Medical devices Application of risk management to medical devices.
Reprocessing:
- Guidance for Industry and Food and Drug Administration staff: Reprocessing Medical Devices in Health Care Settings: Validation Method and Labelling. Issued March 17, 2015.
Labels & IFU:
-
- ISO 15223-1 Fourth edition 2021-07 Medical devices Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements.
-
- ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices -Information to be supplied by the manufacturer.
Performance:
-
- ISO 8600-3:2019 Endoscopes Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics.
-
- ISO 8600-5:2020 Optics and photonics Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics.
-
- IEC 62471:2006 Photobiological safety of lamps and lamp systems
-
- Optical performance evaluation
Conclusion
The results of non-clinical testing demonstrate that the subject device is safe and effective as the predicate device to support a substantial equivalence determination.
§ 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.