(95 days)
Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Here's an analysis of the provided text regarding the asap endoscope's acceptance criteria and studies:
Assessment: The provided document is a 510(k) summary for a medical device (Hysteroscope and Gynecologic Laparoscope). For this type of submission, the primary focus is demonstrating substantial equivalence to existing predicate devices, rather than conducting new clinical trials to prove efficacy or performance against specific numerical acceptance criteria. Therefore, most of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test sets, expert-established ground truth, MRMC studies, or standalone algorithm performance, is not present in this document.
Summary of Device Acceptance and Study Information:
| Feature | Description from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is that the device is substantially equivalent to legally marketed predicate devices. This means that its specifications, intended use, and materials are equivalent, and there are no significant differences in design or conditions of intended use that would raise new questions of safety or effectiveness. |
Reported Performance: The document states that the asap endoscope's specifications and intended use are the same as the predicate devices. It is constructed of materials of the same specifications to ensure biocompatibility and conforms to applicable ISO standards. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol. |
| 2. Sample Size for Test Set & Data Provenance | Not applicable. This document does not describe a "test set" in the context of a clinical performance study with patient data. The evaluation is based on a comparison to predicate devices and adherence to standards. |
| 3. Number of Experts & Qualifications for Ground Truth | Not applicable. Ground truth for clinical performance was not established by experts for a new study, as the submission relies on equivalence to devices with established safety and effectiveness. |
| 4. Adjudication Method for Test Set | Not applicable. No test set requiring adjudication of findings is described. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. This is not an AI-assisted device, and no MRMC study is mentioned. |
| 6. Standalone Algorithm Performance Study | Not applicable. This is a physical medical device (endoscope), not a software algorithm. |
| 7. Type of Ground Truth Used | The "ground truth" implicitly used for this type of submission is the established safety and effectiveness of the legally marketed predicate devices, as determined by prior FDA approvals or marketing. The new device is deemed safe and effective if it can demonstrate substantial equivalence to these predicates. |
| 8. Sample Size for Training Set | Not applicable. This is a physical medical device, not an AI/ML system requiring a training set. |
| 9. How Ground Truth for Training Set was Established | Not applicable. |
Explanation of the 510(k) Process in this Context:
The 510(k) pathway is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed device (predicate device). This is called "substantial equivalence." The document's purpose is to show that the asap endoscope is substantially equivalent to the Baho and Galileo hysteroscopes and gynecologic laparoscopes.
The "study" described in the document is essentially a comparison study against predicate devices and adherence to recognized standards.
- Design Comparison: The "basic design of the asap endoscope is similar to those legally available for sale in the U.S.A."
- Materials Comparison: "constructed of materials of the same specifications as the predicate devices to ensure biocompatibility."
- Intended Use Comparison: The "indications for use" are explicitly stated to be "Like the predicate device" and "used to illuminate and visualize... for the purpose of performing diagnostic and surgical procedures."
- Compliance with Standards: The device "comply[s] with applicable portions of voluntary standards IEC 60601-2-18, DIN 58105, part 1 and 2, DIN 17442 (medical steel), as well as applicable portions of DIN 980." This demonstrates adherence to recognized safety and performance benchmarks.
- Sterilization Validation: "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." This is a crucial safety aspect for reusable devices.
This 510(k) summary does not involve a clinical trial with a "test set" of patients or data, nor does it involve AI algorithms with "training sets" or expert adjudications of performance. The acceptance is based on demonstrating that the new device is fundamentally the same as devices already on the market that have been deemed safe and effective.
§ 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.