Smart Scope® CX

K233043 · Periwinkle Technologies Pvt., Ltd. · HEX · Jun 14, 2024 · Obstetrics/Gynecology

Device Facts

• Record ID: K233043
• Device Name: Smart Scope® CX
• Applicant: Periwinkle Technologies Pvt., Ltd.
• Product Code: HEX · Obstetrics/Gynecology
• Decision Date: Jun 14, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1630
• Device Class: Class 2

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 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.

Device Story

Handheld, reusable transvaginal digital camera probe; connects via USB to dedicated tablet running Net4Medix® software. Probe features 5MP CMOS sensor, 10X magnification, and integrated white/green LEDs for illumination. Operator (physician/clinician) inserts probe into speculum; captures live/still images via tablet interface. Software manages patient records, visit history, and image storage. Device provides magnified visualization to assist in identifying abnormalities and biopsy site selection. Benefits include portable, high-definition visualization for gynecological exams. Security managed via Enterprise-Device-Management (EDM) software, restricting tablet to Net4Medix® application only.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 8600-3 (field of view), ISO 8600-5 (optical resolution), IEC 62471 (photobiological safety), and electrical safety/EMC standards (IEC 60601-1, IEC 60601-1-2). No clinical data provided.

Technological Characteristics

Handheld digital colposcope; ABS plastic housing, glass camera protector, thermoplastic polyurethane buttons. 5MP CMOS sensor; 4 white/4 green LEDs. USB 2.0 connectivity to tablet. Powered via USB from tablet. Non-sterile, reusable. Software: Net4Medix® application on Android 6+ tablet. Cybersecurity: EDM software restricts tablet to dedicated application.

Indications for Use

Indicated for gynecological examination in hospitals, clinics, and private offices by trained medical personnel. Used for magnified visualization of vagina, cervix, and external genitalia to aid in diagnosing abnormalities and selecting biopsy sites. Not for home use.

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

• Pocket Colposcope System (K181034)

Submission Summary (Full Text)

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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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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 ([e-mail]) or phone [phone] 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 Moktali<br>Founder & CEO<br>Periwinkle Technologies Pvt Ltd.<br>B1, Samrat Ashok CHS,<br>S. No. 88/2, Veerbhadra Nagar, Baner, Pune -<br>411045, Maharashtra, India.<br>P: [phone]<br>Email: [e-mail] |
| 510(k) Contact Person: | Ankur Naik<br>Managing Director<br>IZiel Healthcare<br>14, Hadapsar Industrial Estate,<br>Hadapsar, Pune – 411013, India.<br>P: [phone] M: [phone]<br>Email: [e-mail] |
| 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 a<br>design-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:

| Model<br>Number | 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,<br>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:

| Comparable<br>Properties | Subject Device | Predicate Device (K181034) | Comparison<br>Results | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Name | Smart Scope® CX | Pocket Colposcope | Not Applicable | | |
| Manufacturer | Periwinkle Technologies Pvt Ltd | Hadleigh Health Technologies,<br>LLC | Not Applicable | | |
| Regulation<br>Number | 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 for<br>gynecological examination. It<br>provides a portable means of<br>magnified visualization of the<br>tissues of the vagina, cervix, and<br>external genitalia to aid in<br>diagnosing abnormalities and<br>selecting areas for biopsy. The<br>Net4Medix® application is intended<br>to provide documentation of the<br>image in the field of view of the<br>scope. The Smart Scope® CX<br>camera probe is intended to be<br>inserted into the vagina via a<br>speculum by trained medical<br>personnel in hospitals, clinics, and<br>private offices, and is not intended<br>for home use. | The Pocket Colposcope is a digital<br>video colposcope intended for<br>qynecological examination. It<br>provides a portable means of<br>magnified visualization of the<br>tissues of the vagina, cervix, and<br>external genitalia in order to aid in<br>diagnosing abnormalities and<br>selecting areas for biopsy. The<br>image system is intended to<br>provide documentation of the<br>image in the field of view of the<br>colposcope. The Pocket<br>Colposcope System is intended to<br>be inserted into the vagina via a<br>speculum by trained medical<br>personnel in hospitals, clinics, and<br>private offices, and is not intended<br>for home use. | Similar | | |
| Multiple Use | Yes | Yes | Identical | | |
| Prescription (Rx<br>only) | Yes | Yes | Identical | | |
| Comparable<br>Properties | Subject Device | Predicate Device (K181034) | Comparison<br>Results | | |
| Anatomical Site | External genitalia, vagina, and<br>cervix | Cervix, vagina, and external<br>genitalia | Identical | | |
| Intended User | Trained medical professionals | Trained medical professionals | Identical | | |
| Use<br>Environment | Hospitals, clinics, and private<br>offices | Hospitals, clinics, and private<br>offices | Identical | | |
| Device Design | Image: Subject Device | Image: Predicate Device | Not Applicable | | |
| Standard<br>Configuration | Digital Camera connected to Tablet<br>via USB cable and used without<br>stand. | Digital CMOS camera used without<br>stand. | Identical | | |
| External Power<br>Source | Voltage: 5V<br>Frequency: DC<br>Input power: USB 5V from a tablet<br>device | Voltage: 5V<br>Frequency: DC<br>Input power: USB 5V | Identical | | |
| Materials | Housing: Acrylonitrile-butadiene-<br>styrene (ABS) Plastic<br>Buttons: Thermoplastic<br>polyurethane<br>Camera protector: Glass | Housing: ABS Plastic<br>Lens: PMMA | Different<br>The housing of the<br>subject and<br>predicate device is<br>made up of ABS<br>plastic. The other<br>subject device<br>components are<br>made of other<br>plastics or glass<br>that differ from the<br>predicate device. | | |
| Comparable<br>Properties | Subject Device | Predicate Device (K181034) | Comparison<br>Results | | |
| Fundamental<br>Scientific<br>Technology | The camera has optics that relay<br>optical information (live streaming<br>of images) to a smart tablet<br>(visualization/ annotation module). | The camera has optics that relay<br>optical video information to a PC or<br>laptop (visualization/ annotation<br>module). | However, the<br>differences do not<br>raise different<br>questions of safety<br>and effectiveness.<br>Different<br>The Net4Medix<br>application is<br>installed on the<br>Smart Tablet and<br>aids in visualization<br>and annotation.<br>The predicate<br>device required a<br>PC or laptop to<br>relay and visualize<br>the optical<br>information. This<br>difference does not<br>raise different<br>questions 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 Source<br>Lifetime | ≥ 10,000 hrs | ≥ 10,000 hrs | Identical | | |
| Maximum<br>Illumination | White-450 lux at working distance<br>of 35-40mm | 20,000 lux at a working distance of<br>5mm. | Different | | |
| | Green-550 lux at working distance<br>of 35-40mm | 462 lux at a working distance of<br>50mm. | The illumination of<br>the subject device<br>does not exceed | | |
| Comparable<br>Properties | Subject Device | Predicate Device (K181034) | Comparison<br>Results | | |
| Illumination<br>Range/Beam<br>Diameter | 75 mm at a working distance of 40<br>mm | 74.5 mm at working distance of 50<br>mm | the illumination for<br>the predicate<br>device. These<br>differences do not<br>raise different<br>questions of safety<br>and effectiveness.<br>Different<br>The subject and<br>predicate device<br>have a similar<br>illumination range<br>at different working<br>distances. These<br>differences do not<br>raise different<br>questions of safety<br>and effectiveness. | | |
| | Device Specification: Camera | | | | |
| Magnification | 29 or 46X on tablet display<br>depending on orientation | 3X-52X | Different<br>The magnification<br>of the subject<br>device is within the<br>range specified by<br>predicate device.<br>This does not raise<br>any different<br>questions of safety<br>and effectiveness. | | |
| Comparable<br>Properties | Subject Device | Predicate Device (K181034) | Comparison<br>Results | | |
| System Resolution | ≥ 1944 TVL…