(81 days)
Like the predicate devices, the asap endoscope is used to visualize the body cavities, hollow organs and canals during diagnostic and, in conjunction with additional instruments, therapeutic procedures.
The 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.
This 510(k) submission for the Asap Endoscope describes a substantial equivalence determination rather than a study with specific acceptance criteria and performance metrics for a novel device. Therefore, a table of acceptance criteria and reported device performance, information regarding sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, and details on training sets for AI models are not applicable to this document. These would be relevant for devices that utilize AI or have new performance claims requiring specific clinical studies.
The provided document primarily focuses on establishing substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.
Here's an analysis of the information that is available in the document, framed by the spirit of your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implied by Substantial Equivalence): The primary "acceptance criterion" for this submission is that the asap endoscope must be "substantially equivalent" to its predicate devices in terms of safety and effectiveness. This is demonstrated by showing that its specifications, intended use, materials, and sterilization properties are comparable to those of the predicate devices.
- Reported Device Performance: The document states that "The specifications and intended use of the asap endoscope are the same to those of the claimed predicate devices." It also confirms that "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." These statements imply that the device performs equivalently to the predicates for its intended use and meets sterilization requirements.
An adapted table based on the document's content would look like this:
| Feature/Criterion | Acceptance / Predicate Device Standard | Reported asap Endoscope Performance |
|---|---|---|
| Intended Use | Visualization of body cavities, hollow organs, and canals during diagnostic/therapeutic procedures (like predicates) | "The specifications and intended use of the asap endoscope are the same to those of the claimed predicate devices." |
| Design | Rigid endoscope with eyepiece, body, light guide, and rod-lens system (like predicates) | "The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A." "new generation of compact objectives and a newly developed rod-lens system." (Implied to be functionally equivalent to predicates) |
| Materials | Surgical steel with known biocompatibility (like predicates) | "constructed of materials of the same specifications as the predicate devices to ensure biocompatibility." "conforms to applicable ISO standards." |
| Sterilization | Capable of repeated, adequate sterilization | "The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol." |
| Safety | Established safety profile of predicate devices | "There are no significant differences between the asap endoscope and the claimed predicates in design or conditions of intended use." "asap endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA." |
| Effectiveness | Established effectiveness of predicate devices for visualization | "There are no significant differences between the asap endoscope and the claimed predicates in design or conditions of intended use." "asap endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA." |
| Voluntary Standards Compliance | IEC 60601-2-18, DIN 58105, DIN 17442 (medical steel), DIN 980 | "The asap endoscope complies 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" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This submission relies on a comparison to predicate devices, not on a clinical test set with human or synthetic data to evaluate new performance claims. The "test" in this context is primarily a comparison against existing device specifications and relevant standards. The sterilization validation would have involved a sample size of devices, but the specific numbers and provenance for that internal validation are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No expert review of a test set, as would be required for AI/imaging devices, is conducted or reported here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No adjudication process for a test set is conducted or reported here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a passive optical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Implied: The "ground truth" for this type of submission is the established safety and effectiveness of the predicate devices based on their prior clearances and regulatory compliance. The "truth" is that the asap endoscope's fundamental characteristics (design, materials, intended use) are equivalent to those already accepted by regulatory bodies.
8. The sample size for the training set
- Not applicable. No AI/machine learning training set is involved.
9. How the ground truth for the training set was established
- Not applicable. No AI/machine learning training set is involved.
In summary: The provided 510(k) summary is for a traditional medical device demonstrating substantial equivalence to predicates, not a device with complex performance claims typically associated with AI or advanced diagnostic capabilities that would require the extensive study details requested. The "study" done here is a detailed comparison of the new device to existing, cleared devices and adherence to relevant standards.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.