(306 days)
The Goldway Digital Video Colposcope Imaging System is intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy. The image system is intended to provide documentation of the image in the field of view of the colposcope. The image can be viewed on a color screen, printed on a color printer or archived for storage and subsequent retrieval. The device is intended for use in Hospitals and clinics.
The Goldway Digital Video Colposcope Imaging Systems, SLC-2000A and SLC-2000B are intended for magnified viewing of the vagina, cervix and external genitalia in order to diagnose abnormalities and select areas for biopsy.
The SLC-2000A consists of a ¼' Super HAD CCD color camera and image management workstation. Tissue is magnified and viewed directly either via a 5.6" LCD screen attached to the capture device or on the 14'' color monitor attached to the image workstation. The SLC-2000B contains the same capture device but does not include the image workstation. Images can only be viewed via the 5.6'' LCD screen with this model. The images provide recorded documentation for the physician or nurse practitioner to review for diagnostic purposes. The Goldway Colposcopes have a non-patient contact of up to 350mm. Both colposcopes have the option of being equipped with a Dermatology and Venereal Disease application kit and Dynamic White Polarization kit.
The Goldway Colposcopes, SLC-2000A and SLC-2000B are a non-patient contacting CCD color camera with a magnification of x1 ~ x28, working distances supporting 150-350mm, and a green filtered light source mounted on a floor stand. The SLC-2000B also comes with an image workstation which consists of a CCD camera, computer, LCD monitor, a mouse, a keyboard and color printer. The functions of the image management workstation include:
- Storing digital images for viewing during the colposcopy exam, and for printing and/or later review
- Storing textual information about a patient's medical history related to colposcopy
- Storing textual information about observations seen during a colposcopy examination
- Printing a colposcopy report that integrates images and textual information
The provided 510(k) summary for the Goldway SLC-2000 Digital Video Colposcope Imaging System states that no clinical tests were performed for the determination of substantial equivalence.
Therefore, the following information cannot be extracted from the document:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document explicitly states under section "8. Discussion of Clinical Tests Performed:" that it is "Not Applicable." The submission relies on non-clinical tests (meeting standards like IEC60601-1, ISO9001, EN46001) and comparison to predicate devices to demonstrate substantial equivalence, arguing that "any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
§ 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.