(263 days)
Not Found
No
The description focuses on basic digital imaging, illumination, magnification, and image storage/management. There is no mention of any analytical or interpretive functions that would typically involve AI/ML.
No
The device is intended for diagnostic purposes (magnified visualization to aid in diagnosing abnormalities and selecting areas for biopsy) and documentation, not for treating any condition.
No
The text explicitly states: "Smart Scope® CX is not a substitute for histopathology and is not a diagnostic test."
No
The device description clearly states that the Smart Scope® CX includes a handheld camera probe with integrated LED lights and a 10X magnification camera, which are hardware components. While it utilizes software (Net4Medix® application) for image viewing and management, the core device includes physical hardware.
Based on the provided information, the Smart Scope® CX is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Smart Scope® CX is used for direct visualization of tissues within the body (vagina, cervix, external genitalia). It does not analyze samples like blood, urine, or tissue biopsies in a laboratory setting.
- The intended use is for magnified visualization to aid in diagnosing abnormalities and selecting areas for biopsy. This is a clinical examination tool, not a test performed on a sample outside the body.
- The device description explicitly states it is a "transvaginal digital examination camera" and is "not a substitute for histopathology and is not a diagnostic test." This further reinforces that it's a visualization tool, not a diagnostic test performed on a sample.
Therefore, the Smart Scope® CX falls under the category of a medical device used for clinical examination and visualization, not an In Vitro Diagnostic device.
N/A
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 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.
Product codes
HEX
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 Scope® CX was designed, developed, and manufactured at Periwinkle Technologies Pvt. Ltd. The model number is indicated below: 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (Digital Camera)
Anatomical Site
vagina, cervix, and external genitalia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical personnel in hospitals, clinics, and private offices, and is not intended for home use.
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)
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. Non-clinical studies included Electrical Safety and EMC (IEC 60601-1:2005+AMD1:2012+AMD2:2020, IEC 60601-1-2:2014+AMD1:2020), Software (Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, IEC 62304 Edition 1.1 2015-06), Cybersecurity (Guidance for Industry and Food and Drug Administration Staff: Content of Premarket Submissions for Management of Cybersecurity, IEC 81001-5-1 Edition 1.0 2021-12), Risk Management (ISO 14971:2019), Reprocessing (Guidance for Industry and Food and Drug Administration staff: Reprocessing Medical Devices in Health Care Settings: Validation Method and Labelling), Labels & IFU (ISO 15223-1, ISO 20417), and Performance (ISO 8600-3:2019, ISO 8600-5:2020, IEC 62471:2006, Optical performance evaluation).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pocket Colposcope System (K181034)
Reference Device(s)
Not Found
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 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).
2
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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4
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 |
| Founder & CEO | |
| Periwinkle Technologies Pvt Ltd. | |
| B1, Samrat Ashok CHS, | |
| S. No. 88/2, Veerbhadra Nagar, Baner, Pune - | |
| 411045, Maharashtra, India. | |
| P: +91 9021147173 | |
| Email: vrmoktali@periwinkletech.com | |
| 510(k) Contact Person: | Ankur Naik |
| Managing Director | |
| IZiel Healthcare | |
| 14, Hadapsar Industrial Estate, | |
| Hadapsar, Pune – 411013, India. | |
| P: +91 72762 2555 M: +91 7069553814 | |
| Email: 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 a | |
| 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
5
Scope® CX was designed, developed, and manufactured at Periwinkle Technologies Pvt. Ltd. The model number is indicated below:
| Model
| 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.
6
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:
8
Comparison to predicate devices:
| Comparable
Properties | Subject Device | Predicate Device (K181034) | Comparison
Results | | |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Product Name | Smart Scope® CX | Pocket Colposcope | Not Applicable | | |
| Manufacturer | Periwinkle Technologies Pvt Ltd | Hadleigh Health Technologies,
LLC | Not Applicable | | |
| Regulation
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
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. | The Pocket Colposcope is a digital
video colposcope intended for
qynecological examination. It
provides a portable means of
magnified visualization of the
tissues of the vagina, cervix, and
external genitalia in order to aid in
diagnosing abnormalities and
selecting areas for biopsy. The
image system is intended to
provide documentation of the
image in the field of view of the
colposcope. The Pocket
Colposcope System 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. | Similar | | |
| Multiple Use | Yes | Yes | Identical | | |
| Prescription (Rx
only) | Yes | Yes | Identical | | |
| Comparable
Properties | Subject Device | Predicate Device (K181034) | Comparison
Results | | |
| Anatomical Site | External genitalia, vagina, and
cervix | Cervix, vagina, and external
genitalia | Identical | | |
| Intended User | Trained medical professionals | Trained medical professionals | Identical | | |
| Use
Environment | Hospitals, clinics, and private
offices | Hospitals, clinics, and private
offices | Identical | | |
| Device Design | Image: Subject Device | Image: Predicate Device | Not Applicable | | |
| Standard
Configuration | Digital Camera connected to Tablet
via USB cable and used without
stand. | Digital CMOS camera used without
stand. | Identical | | |
| External Power
Source | Voltage: 5V
Frequency: DC
Input power: USB 5V from a tablet
device | Voltage: 5V
Frequency: DC
Input power: USB 5V | Identical | | |
| Materials | Housing: Acrylonitrile-butadiene-
styrene (ABS) Plastic
Buttons: Thermoplastic
polyurethane
Camera protector: Glass | Housing: ABS Plastic
Lens: PMMA | Different
The housing of the
subject and
predicate device is
made up of ABS
plastic. The other
subject device
components are
made of other
plastics or glass
that differ from the
predicate device. | | |
| Comparable
Properties | Subject Device | Predicate Device (K181034) | Comparison
Results | | |
| Fundamental
Scientific
Technology | The camera has optics that relay
optical information (live streaming
of images) to a smart tablet
(visualization/ annotation module). | The camera has optics that relay
optical video information to a PC or
laptop (visualization/ annotation
module). | However, the
differences do not
raise different
questions of safety
and effectiveness.
Different
The Net4Medix
application is
installed on the
Smart Tablet and
aids in visualization
and annotation.
The predicate
device required a
PC or laptop to
relay and visualize
the optical
information. This
difference does not
raise different
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
Lifetime | ≥ 10,000 hrs | ≥ 10,000 hrs | Identical | | |
| Maximum
Illumination | White-450 lux at working distance
of 35-40mm | 20,000 lux at a working distance of
5mm. | Different | | |
| | Green-550 lux at working distance
of 35-40mm | 462 lux at a working distance of
50mm. | The illumination of
the subject device
does not exceed | | |
| Comparable
Properties | Subject Device | Predicate Device (K181034) | Comparison
Results | | |
| Illumination
Range/Beam
Diameter | 75 mm at a working distance of 40
mm | 74.5 mm at working distance of 50
mm | the illumination for
the predicate
device. These
differences do not
raise different
questions of safety
and effectiveness.
Different
The subject and
predicate device
have a similar
illumination range
at different working
distances. These
differences do not
raise different
questions of safety
and effectiveness. | | |
| | Device Specification: Camera | | | | |
| Magnification | 29 or 46X on tablet display
depending on orientation | 3X-52X | Different
The magnification
of the subject
device is within the
range specified by
predicate device.
This does not raise
any different
questions of safety
and effectiveness. | | |
| Comparable
Properties | Subject Device | Predicate Device (K181034) | Comparison
Results | | |
| 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 given
the 1.4 x 1.4 µm size of the pixel | Lowest: 13.51 lp/mm
Highest: 121.02 lp/mm | Different
The optical
resolution of the
subject device is
higher than the
predicate device.
This does not raise
any different
questions of safety
and effectiveness. | | |
| Focus Mode | Manual Control: Auto Focus only | Manual Control: Auto focus only | Identical | | |
| Video Output | USB | USB | Identical | | |
| Image Geometric
Distortion |