(78 days)
The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.
- transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
- tumor diagnostics and / or biopsy
- removal of foreign bodies .
The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.
Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.
The uretero-renoscope may be inserted with the introduction sheath, 8706.042 to view the renal pelvis. The introduction sheath remains stationary while the ureterorenoscope may be removed and replaced by a flexible uretero-renoscope when reaching the upper calyx group.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Compact Operating Uretero-Renoscope with Insertion Sleeve":
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, the device did not have explicit, quantifiable acceptance criteria or associated performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance benchmarks.
| Acceptance Criteria (Stated/Implied) | Reported Device Performance |
|---|---|
| Safe and Effective when used according to instructions manual | "These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual." (Conclusion Drawn) |
| Technological characteristics: |
- Atraumatic tip
- Sharp, brilliant image quality
- Autoclavable/steam sterilizable (134°C / 273°F) | "atraumatic tip for problem free introduction into the uteri ostium."
"sharp, brilliant quality over the entire image."
". autoclavable / steam sterilization 134°C / 273°C" |
| Substantially equivalent to predicate device (K963855) | "The submitted devices are substantially equivalent to existing devices sold by Richard Wolf." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No clinical or performance tests were conducted on a 'test set' as defined for typical device performance studies (e.g., diagnostic accuracy, efficacy).
- Data Provenance: Not applicable. No data from a test set was generated from specific countries or in a retrospective/prospective manner.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth was established for a test set, as no clinical performance studies were performed. The submission relies on design and testing to assure safety and effectiveness, and claims substantial equivalence.
4. Adjudication Method for the Test Set:
- Not applicable. No clinical performance studies were performed that would require an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical tests performed were not performed." Therefore, there is no effect size reported for human readers with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
- No standalone performance study was done. This device is a physical medical instrument (uretero-renoscope), not an algorithm or AI-powered system, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
- Not applicable in the context of clinical performance or diagnostic accuracy. The "ground truth" for the device's claims of safety and effectiveness, and substantial equivalence, appears to be based on:
- Engineering design and testing ("These devices are designed and tested to assure their safety and effectiveness...")
- Comparison to a predicate device already on the market (K963855).
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI/ML algorithm that would require a training set of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As this is not an AI/ML device, there is no training set or ground truth for it.
§ 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.