(167 days)
The MicroSpan Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptic hysteroscope without through lumens. The device consists of an outer stainless steel shaft, inner illumination fibers, and an imaging fiber bundle. At one end of the imaging bundle is the distal lens and at the other is the rotatable eyepiece. An endoscopic light source is connected to the light post of the hysteroscope through compatible light cables. If desired, the eyepiece can be connected through a focusing optical coupler to a camera head which carries the image by cable to the camera.
The provided 510(k) summary for the MicroSpan Hysteroscope does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/algorithm-driven medical device.
The document describes a physical medical device (a hysteroscope) and its performance is evaluated based on optical, mechanical, thermal, and biocompatibility characteristics, along with the effect of simulated reuses. It is a traditional medical device, not an AI or algorithm-based device.
Therefore, I cannot extract the following information that would be relevant to an AI/algorithm study:
- A table of acceptance criteria and the reported device performance (in terms of AI metrics like sensitivity, specificity, accuracy)
- Sample sizes for test or training sets
- Data provenance
- Number/qualifications of experts for ground truth
- Adjudication methods
- MRMC comparative effectiveness study results
- Standalone algorithm performance
- Type of ground truth used (pathology, outcomes data, etc.)
- How ground truth was established for training or test sets
Instead, the document details non-clinical tests for a physical device:
- Performance Summary: "Non-clinical tests were performed to demonstrate that the device performed according to its description. Testing included evaluation of optical and mechanical characteristics of the device and the effect of simulated reuses on these characteristics. The device was also evaluated for its thermal characteristics and biocompatibility."
This summary indicates that the "acceptance criteria" would be standards for these physical and functional characteristics, and the "study" would be the non-clinical tests described. However, specific numerical targets for these characteristics are not provided in this summary.
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| OCT 1 5 1996 | 510(k) Summary | K9616 88 |
|---|---|---|
| Submitter: | Imagyn Medical, Inc.27651 La Paz RoadLaguna Niguel, CA 92656-3917(714) 362-2500Contact: Debra A. Rinderer | |
| Summary Preparation: | April 30, 1996 | |
| Device: | MicroSpan Hysteroscope | |
| Predicate Devices: | Imagyn HysteroscopeImagyn MicroLap LaparoscopeKarl Storz Miniscope Straight Forward TelescopeOptimed Technologies Rigid Fiber Optic Hysteroscope | |
| Device Description: | The MicroSpan Hysteroscope is a small diameter, rigid, fiberoptichysteroscope without through lumens. The device consists of an outerstainless steel shaft, inner illumination fibers, and an imaging fiber bundle. Atone end of the imaging bundle is the distal lens and at the other is the rotatableeyepiece. An endoscopic light source is connected to the light post of thehysteroscope through compatible light cables. If desired, the eyepiece can beconnected through a focusing optical coupler to a camera head which carriesthe image by cable to the camera. | |
| Intended Use of Device: | The MicroSpan Hysteroscope is used to permit viewing of the cervical canaland the uterine cavity for the purpose of performing diagnostic and surgicalprocedures. | |
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted throughillumination fibers to the distal end of the hysteroscope in order to illuminatethe target object. The distal lens system focuses the image of the object ontoimage fibers, which then transmits the image to the proximal lens system. Theproximal lens system magnifies and focuses the image onto an eyepiece at theproximal end of the hysteroscope for viewing and/or directly to standardvideo cameras, monitors and recording equipment. The MicroSpanHysteroscope and the predicate devices all have equivalent technologicalcharacteristics. | |
| Performance Summary | Non-clinical tests were performed to demonstrate that the device performedaccording to its description. Testing included evaluation of optical andmechanical characteristics of the device and the effect of simulated reuses onthese characteristics. The device was also evaluated for its thermalcharacteristics and biocompatibility. |
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Imagyn Medical, Inc.
27651 La Paz Road
Laguna Niguel, CA 92677
Laguna Niguel, CA 92677
Tel: (714) 362-2500 Fax:(714) 362-2520
§ 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.