(46 days)
The Galileo Disposable Hysteroscopes are endoscopes intended for visualization of the cervical canal and uterine cavity for diagnostic and surgical procedures during gynecological procedures. The Hysteroscope diagnostic indications include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain. The Hysteroscope is indicated for surgical procedures such as directed biopsy, removal of submucous fibroids and large polyps, submucous myomectomy, transection of intrauterine adhesions and septa and endometrial ablation.
The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in several sizes and lengths. The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor. The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.
Galileo Disposable Hysteroscopes (K981828) - Acceptance Criteria and Study Findings
The provided document describes the acceptance criteria and study findings for the Galileo Disposable Hysteroscopes, primarily focusing on optical performance and thermal safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Acceptance Criteria (after deflection tests): | Passed. "The results of this testing showed that both the stainless steel and the polyimide sheathed sample scopes showed no change in any tested optical performance criteria. These results demonstrate that both samples maintained structural integrity of the optics assembly when subjected to the test protocol." This includes: |
- Field of view
- Angle of view
- Resolution on axis
- Uniformity of illumination |
| Thermal Safety (per IEC 601-2-18) | Passed. "The Disposable Hysteroscopes passed the Thermal Safety Testing." |
Note: Electrical safety testing was planned but not detailed in this submission as being completed prior to commercial distribution.
2. Sample Size and Data Provenance
- Test Set Sample Size: "Samples of each type of hysteroscope containing the lens, image fiber, and illumination fiber were used for this testing." The exact number of samples is not specified beyond "samples of each type."
- Data Provenance: The study was conducted by Galileo Corporation, a U.S. company. The data is based on laboratory testing of their manufactured devices. This is a prospective study in the sense that the testing was performed specifically to evaluate the performance of the new disposable hysteroscopes against their internal acceptance criteria.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. The ground truth for this study was established through objective engineering and optical measurements, not expert human assessment.
4. Adjudication Method
Not applicable. The study involved objective measurements and comparisons against predefined optical and safety standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This study focuses on the intrinsic performance of the device's optical and thermal properties, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was performed. The testing described (optical performance after deflection, thermal safety) evaluated the device itself without human interaction or interpretation as part of the primary outcome. The optical properties (field of view, angle of view, resolution, uniformity of illumination) were objective measurements of the device's capabilities.
7. Type of Ground Truth Used
The ground truth used was based on objective engineering measurements and predefined technical standards/specifications. Specifically:
- Optical Performance: Established prior to and after mechanical stress (deflection) by measuring field of view, angle of view, resolution on axis, and uniformity of illumination. The "ground truth" was that these pre- and post-stress measurements should meet the optical acceptance criteria and show no significant change.
- Thermal Safety: Established by compliance with the IEC 601-2-18 standard.
8. Sample Size for the Training Set
Not applicable. This device is a mechanical/optical medical device, not an AI or algorithm-driven system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.