(265 days)
The LiNA OperaScope is intended for use in visualization of the cervical canal and uterine cavity during diagnostic and therapeutic gynecological procedures.
The types of procedures where the OperaScope could offer visualization include:
· Assessment of abnormal bleeding, pelvic pain, amenorthea and abnormal findings from hysterosalpingogram;
- · Assessment of infertility and pregnancy wastage;
· Confirmation of the presence of intrauterine foreign body;
· Assist in locating submucosal fibroids and polyps targeted for removal;
· Provide visual guidance during directed biopsy, submucosal myomectomy, transection of intrauterine and septa.
The LiNA OperaScope is a handheld, battery-operated portable hysteroscope which allows direct viewing of the cervical canal and uterine cavity via the on-board LCD display. If the user wants to capture images and/or record video sequences utilizing a USB stick, a Recording Module is available, which connects to the device via the HDMI cable. The OperaScope can also be connected to an external monitor via the HDMI cable. External monitors are not provided by LiNA Medical ApS and therefore, monitors are not the subject of this 510(k) submission.
The OperaScope is supplied as a sterile, single use device and the Recording Module is supplied as a nonsterile reusable unit. The OperaScope contains a miniature Complimentary Medical Oxide Semi-conductor (CMOS) camera and a Light-Emitting Diode (LED) illumination at the tip, a channel for infusion of irrigating fluid and a channel for fluid outflow, a display unit (LCD display), microelectronics, firmware and single use batteries for powering the device. The Recording Module contains microelectronics, software, controls for recording pictures and video sequences, USB port for storage of pic/video, HDMI port for connection of the OperaScope, HDMI port for connecting an external monitor and an input port for external 9V DC power supply.
The provided text does not contain information about acceptance criteria for device performance, a study proving the device meets these criteria, or details regarding sample sizes, expert involvement, or adjudication methods for such a study.
The document is a 510(k) submission summary for the LiNA OperaScope, which focuses on demonstrating substantial equivalence to predicate devices based on:
- Indications for Use: The OperaScope's indications for use are compared to those of two predicate devices, affirming that its clinical use is not expanded.
- Technological Characteristics: A detailed comparison table (Table B) outlines features such as product code, regulation number, intended users, site of use, device features and components, optical image technology, image resolution, illumination source, inflow/outflow channel design, cannula tip design, image transmission, maximum insertion diameter, shaft/cannula length, LCD display size, energy source, sterilization methods, and tissue contact materials.
- Non-Clinical Performance Data: The submission lists a series of non-clinical performance tests conducted, including those for field of view, maximum width of insertion, biocompatibility, residual testing, electromagnetic compatibility, electrical safety, sterilization validation, mechanical testing, spatial resolution, a visualization and illumination study, in-flow and out-flow fluid delivery, functionality testing, shelf-life, battery lifetime, and software validation. These tests are stated to have been conducted in accordance with internal requirements, national, and international standards, and relevant FDA guidance.
The document asserts that the OperaScope "meets all the requirements for overall design, sterilization, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device," and that "The OperaScope passed all applicable testing." However, specific numerical acceptance criteria for these tests and their corresponding reported performance values are not provided in the text.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the specific study proving the device meets these criteria, as this information is not present in the provided document.
§ 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.