(63 days)
The Gyrus ACMI Invisio Digital Hysteroscope is intended to be used to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.
The Gyrus ACMI Invisio Digital Hysteroscope System includes the Invisio Digital Hysteroscope and IDC Invision™ Controller. The IDC Controller is intended to be used to process the video signal from the Invisio Digital Hysteroscope and ensure brightness, image clarity and color.
Diagnostic Hysteroscopy:
- Abnormal uterine bleeding
- Infertility & pregnancy wastage
- Evaluation of abnormal hysterosalpingogram
- Intrauterine foreign body
- Amenorrhea
- Pelvic pain
Operative Hysteroscopy:
- Directed biopsy
- Removal of fibroids and polyps
- Transection of intrauterine adhesions
- Transection intrauterine septa
The Gyrus ACMI® Invisio® Digital Hysteroscope System is comprised of the Invisio Digital Hysteroscope and Invisio Digital Controller (IDC-1500). The Gyrus ACMI Invisio Digital Hysteroscope is a semi-rigid (rigi-flex) hysteroscope that incorporates CMOS (complimentary medical oxide semi-conductor) sensor technology to generate an image. There is a miniature CMOS sensor located in the distal tip, wiring running through the endoscope shaft, a printed circuit board (PCB), a light-emitting diode (LED) light source located in the handle, and an electrical cord that connects the endoscope to the Camera Control Unit (CCU).. The Invisio Digital Hysteroscope connects to a CCU, (the Invisio Digital Controller (IDC-1500)), that contains printed circuits boards (PCBs), software, power supply and power cables to process and display the images transmitted by the camera.
The provided 510(k) summary for the Gyrus ACMI® Invisio® Digital Hysteroscope System (K092278) does not contain information regarding acceptance criteria, performance studies, or clinical trial data to support the device's efficacy or safety.
This 510(k) notification focuses on establishing substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document primarily describes the device, its intended use, and argues for its substantial equivalence to other hysteroscopes and similar digital endoscopes already on the market.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria because it is not present in the provided text.
Here's a breakdown of why the information is absent from the provided document:
- 510(k) Pathway: The 510(k) premarket notification pathway is typically used for devices that are "substantially equivalent" to already legally marketed devices (predicates). This pathway often relies on demonstrating that the new device has similar technological characteristics and the same intended use as a predicate, rather than requiring extensive new clinical efficacy studies or establishing novel acceptance criteria.
- Focus on Substantial Equivalence: The summary extensively details the "Technological Characteristics and Substantial Equivalence" section, comparing the Invisio Digital Hysteroscope System to existing predicate devices like other Gyrus ACMI endoscopes and hysteroscopes from Karl Storz and Olympus. The argument is that because it shares similar technology, design, and patient-contacting materials with already cleared devices, it presents no new questions of safety or efficacy.
- Lack of Performance Data: There are no sections describing performance metrics, study designs (e.g., sample sizes, ground truth establishment), or results of any clinical or non-clinical trials demonstrating specific performance against predefined acceptance criteria. This type of data is more common in a Premarket Approval (PMA) application or a 510(k) for a novel device that cannot demonstrate substantial equivalence based on technological characteristics alone.
In summary, none of the requested information (acceptance criteria table, study sample sizes, ground truth details, adjudication methods, MRMC studies, standalone performance, training set details) can be extracted from the provided 510(k) notification.
§ 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.