(332 days)
The Hysteroscope System is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Note: Hysteroscopes are used as tools to access the uterine cavity and are not, in and of themselves, a method of surgery.
Generally recognized indications for diagnostic hysteroscopy include:
- Abnormal bleeding
- Infertility and pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain
Generally recognized indications for operative hysteroscopy include:
- Directed endometrial biopsy
- Polypectomy
- Submucous myomectomy
- Transection of intrauterine adhesions
- Transection of intrauterine septa
- Endometrial ablation
The Hysteroscope System consists of a sterile single-use disposable Rigid Hysteroscope and video processor for clinical image processing. The Rigid Hysteroscope (available in models GSA01-B, GSB04-B and GSB14-B) are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. Model GSA01-B is intended for diagnostic hysteroscopy only, and has a rigid shaft without operative channel (injection channel only). Models GSB04-B and GSB14-B are intended for both diagnostic and operative hysteroscopy, and have an operative (insertion) channel. GSB04-B has a rigid shaft, and GSB14-B has a curved tip. The video processor provides power and processes the images from the Rigid Hysteroscopes. Anatomical images are collected via a CMOS chip at the distal end of the hysteroscope and are transmitted through the video processor to a monitor.
The provided text is a 510(k) Summary for a Hysteroscope System. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. However, it does not include information about acceptance criteria and a study proving that the device meets those criteria in the way typically expected for a clinical performance study involving AI or human readers.
The performance data included in this document focuses on non-clinical testing performed to ensure the device's safety and effectiveness in relation to its physical and functional attributes. This is standard for medical devices like hysteroscopes, which are tools for visualization and surgical procedures, rather than AI-driven diagnostic or interpretative devices.
Therefore, the requested information elements related to AI, human readers, effect size, and specific ground truth establishment (like expert consensus, pathology, or outcomes data for complex diagnostic tasks) are not applicable to the content provided.
Here's the information that can be extracted or inferred from the document regarding acceptance criteria and performance data:
Acceptance Criteria and Device Performance for Shanghai AnQing Medical Instrument CO., Ltd. Hysteroscope System (K181545)
The acceptance criteria for the Hysteroscope System are based on engineering and performance standards relevant to a medical device of its type (a hysteroscope). The "study" proving acceptance criteria is a series of non-clinical tests.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Evaluated per ISO 10993-1:2009 for "Surface – Mucosal Membrane" with "Limited ( |
§ 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.