(128 days)
The SeleneView® (model: HC29, HC29-G, HC35, HC35-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic procedures.
The SeleneView® (model: HO35, HO35-G, HO42, HO42-G) is used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and therapeutic procedures.
SeleneView® is intended for use in professional healthcare facility environments such as hospitals and clinics. SeleneView® is designed for use in adults.
SeleneView® Single-Use Digital Hysteroscope consists of a handle, insertion and endoscope cable. SeleneView® is provided sterile (sterilized by ethylene oxide [EO]) and intended to be single-use.
The built-in light emitting diode (LED) at the distal tip of SeleneView® Single-Use Digital Hysteroscope provides a light source, the lens module captures the light signal, then the complementary metal-oxide-semiconductor (CMOS) image module converts the light signal into an electrical signal; the endoscope cable connects SeleneView® Video Processor, which provides power and processes video signal from the endoscope.
The SeleneView® is intended to be used combined with ViewHub® Video Processor to perform its intended function and the ViewHub® has been 510(k) cleared in K233779.
SeleneView® Single-Use Digital Hysteroscope has the following physical and performance characteristics:
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Camera and LED light source at the distal tip
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Sterilized by Ethylene Oxide
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For single-use
This FDA 510(k) summary describes the "SeleneView® Single-Use Digital Hysteroscope" and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria in the context of an AI-powered diagnostic device.
The document focuses on non-clinical tests demonstrating the device's technical performance, sterility, biocompatibility, and electrical safety, comparing these aspects to a predicate hysteroscope. It explicitly states in section {6} related to non-clinical tests that "It is concluded form the nonclinical tests that the subject devices are as safe, as effective, and perform as well as the legally marketed predicate device identified above to support a substantial equivalence determination." This implies that the device is being cleared based on its equivalence in fundamental operating principles and safety features, not on the performance of a diagnostic algorithm meeting specific acceptance criteria for a clinical outcome.
Therefore, I cannot provide the requested table and information as it is not present in the provided text. The document does not describe an AI component or a study with clinical endpoints that would involve ground truth, expert adjudication, or sample sizes for AI model testing.
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.