(80 days)
UltraSightHD™ C31 with ImageSense™ and Remote Viewer Telemedicine is a digital colposcope designed to image the cervix and lower genital tract under illumination and magnification. Colposcopy is indicated for women with an abnormal Pap smear in order to affirm normality or detect abnormal appearances consistent with neoplasia, often with directed biopsy.
OpacityViewer™ is an ImageSense™ digital filter for displaying areas of acetowhitening. It is a tool that should NOT be used as a substitute for a thorough colposcopic evaluation. The Remote Viewer Telemedicine Technology is a software feature that enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station.
The UltraSightHD™ C31 Digital Colposcopy System with ImageSense™ and Remote Viewer Telemedicine Technologies represents a modification to the UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology. It is a digital colposcope designed to acquire images of the vagina, cervix and external genitalia. It is used to diagnose abnormalities and select areas for biopsy. The illumination and optical design of the device enable the user to capture high resolution digital images. The optical subsystem is augmented by integrated image quality assessment algorithms, ensuring that focused, centered, and balanced-contrast images are acquired. Two liquid crystal displays (LCDs) provide video display and user interface information. The software includes functionality for annotating, filtering and storing the images on external PACS servers via the DICOM protocol. The ImageSense™ filters highlight certain characteristics of the captured images. The Remote Viewer Telemedicine feature enables medical personnel to view live video of an ongoing medical exam from a remote viewing station.
Here's an analysis of the provided text regarding the UltraSightHD™ C31 Digital Colposcopy System:
Based on the provided 510(k) summary, the device is a modification of an existing predicate device (UltraSightHD (C30) Digital Colposcopy System with ImageSense Technology, K090324). The main modification is the addition of "Remote Viewer Telemedicine Technology."
The document states that the device is not patient contacting and therefore no biocompatibility testing was required. This indicates the acceptance criteria and study focus are not on direct patient interaction safety or efficacy in clinical diagnosis but rather on the overall system's electrical safety, electromagnetic compatibility (EMC), and the functionality of the new telemedicine feature.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria with numerical performance metrics for clinical efficacy. The acceptance criteria appear to be compliance with relevant safety and EMC standards, and functional equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Safety | Compliance with IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) | "Successful compliance testing in accordance with IEC 60601-1... was conducted." |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests) | "Successful compliance testing in accordance with... 60601-1-2 (Safety and EMC) was conducted." |
| Biocompatibility | Not applicable for patient contact (no direct patient contact) | "The device is not patient contacting and therefore no biocompatibility testing was required." |
| Functional Equivalence | Equivalence in indications for use, safety, efficacy, overall design, function, product performance, and materials to the predicate device (K090324) | "The UltraSightHD™ C31 Digital Colposcopy System... is equivalent to the UltraSightHD™ (C30) Digital Colposcopy System... The indications for use, safety and efficacy, basic overall design and function, product performance, and materials used are equivalent. The addition of the remote viewer does not affect the safety and effectiveness of the device." |
| Remote Viewer Functionality | Enables medical personnel to view live video from the UltrasightHD during an ongoing medical exam from a remote viewing station. | "The addition of the remote viewing capability allows a computer at a different location to securely connect with the device to view the same imagery visible on the colposcope." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not report any clinical study with a test set involving patient data for the purpose of demonstrating diagnostic accuracy or clinical efficacy. The testing mentioned refers to engineering and regulatory compliance testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set requiring expert ground truth was reported for this 510(k). The evaluation focuses on technical equivalence and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was reported for this 510(k).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence to a predicate device and technical compliance rather than clinical comparative effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The device includes "integrated image quality assessment algorithms" (ImageSense™) and "OpacityViewer™ digital filter for displaying areas of acetowhitening." However, the document does not describe a standalone performance study for these algorithms. The algorithms are described as augmenting the optical subsystem and providing a tool for displaying characteristics, but not as a standalone diagnostic tool. The OpacityViewer™ is explicitly stated as "a tool that should NOT be used as a substitute for a thorough colposcopic evaluation."
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical studies requiring ground truth were reported for this 510(k).
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance. The existing ImageSense™ algorithms are mentioned as integrated, but their development or training details are not part of this submission summary.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no machine learning algorithm training data or studies were reported in this 510(k) for the purpose of demonstrating diagnostic performance.
§ 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.