(49 days)
These endoscopes are intended to be used for endoscopic surgery within the thoracic and perioneal cavities including the female reproductive organs. The device is also indication of transanal and transvaginal applications.
The "ULTRA" Telescopes are rigid endoscopes. An image relay system of rod lenses transmits the endoscopic image. A bundle of optical fibers transmits light from an external light source to illuminate the endoscopic image. The "ULTRA" Telescopes are delivered non-sterile. They are reusable and fully autoclavable. Before first and each subsequent use the device must be inspected and reprocessed according to defined reprocessing methods in the Instructions for Use. The "ULTRA" Telescopes will be marketed as individual telescopes. The "ULTRA" Telescopes are available in two different diameters (5.4 mm and 10 mm) with three different directions of view (0°, 30°, 45°) each to allow use for various applications in accordance with the intended use as submitted with this 510(k).
This document is a 510(k) premarket notification for the "ULTRA" Telescopes, a type of rigid endoscope. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain a specific study demonstrating device performance against quantitative acceptance criteria for a diagnostic AI/ML device.
Here's why the requested information cannot be fully provided based on this document:
- Device Type: The "ULTRA" Telescopes are physical medical devices (endoscopes) used for visualization and endoscopic surgery, not a diagnostic AI/ML tool. The performance data presented focuses on physical safety and functional standards rather than diagnostic accuracy or AI performance.
- Nature of "Acceptance Criteria" and "Device Performance": For a physical device like an endoscope, acceptance criteria relate to compliance with established engineering and safety standards (e.g., biocompatibility, electrical safety, thermal safety, optical performance, mechanical integrity). "Device performance" in this context refers to successfully passing these tests. This is distinct from the statistical metrics (e.g., sensitivity, specificity, AUC) and clinical study designs typically used to evaluate AI/ML diagnostic tools.
Therefore, the sections requested about sample sizes, ground truth, experts, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this document as it does not describe an AI/ML device or a study evaluating its diagnostic accuracy.
The document does describe the performance data for the "ULTRA" Telescopes in terms of meeting various standards, which could be considered their "acceptance criteria" and "device performance" for a physical device.
Here's an attempt to structure the available information regarding "acceptance criteria" and "device performance" relevant to this physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance (for the physical endoscope):
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | FDA Blue Book Memo #G95-1, ISO-10993 (Parts 1, 5, 12) | Successful completion of Cytotoxicity and Chemical Analysis testing. |
| Electrical Safety | AAMI/ANSI ES 60601-1:2005 and C1:2009 and A2:2010 | Electrical Safety tested successfully. (EMC stated as not applicable). |
| Thermal Safety | IEC 60601-2-18:2009, "Hysteroscopes and Gynecology Laparoscopes - Submission Guidance for a 510(k)" | Thermal Safety tested successfully. |
| Performance (Bench) | Internal design specifications, relevant ISO standards (e.g., ISO 8600 series) | Successfully passed optical and mechanical performance testing, shipping tests, service life tests, and illumination system tests. Design validation/usability tests conducted. |
| Risk Management | ISO-14971:2007 | Risk analysis carried out in accordance with established in-house acceptance criteria. |
| Sterilization | ISO 17665-1:2006 (for reprocessing procedures) | (Mentioned as "fully autoclavable" and reprocessing procedures defined in IFU; implicit compliance with sterilization standards for reusable devices.) |
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 for this type of device and performance testing. The "test set" here refers to the actual devices undergoing physical tests, not a dataset for an algorithm.
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. Ground truth, in the context of diagnostic performance, is not relevant to the engineering and safety tests performed on an endoscope.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. For this device, "ground truth" relates to objective measures against engineering standards, not diagnostic outcomes.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.