(267 days)
The Schoelly Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with intracorporeal pneumatic, ultrasound, electrohydraulic or laser lithotripters.
The Schoelly Ultra-Mini Nephroscope Set is used for the disintegration and removal / extraction of kidney stones. The stones are removed, under endoscopic control, through percutaneous passages, in conjunction with laser lithotripters.
The proposed Schoelly Nephroscope Family comprises two different application sets: One set for Percutaneous Nephrolithotomy (PCNL) with the trade name "Schoelly Nephroscope Set'' and one set for Mini PCNL with the trade name "Ultra-Mini Nephroscope Set".
Both sets include a rigid, reusable endoscope (nephroscope) that is used in conjunction with a commercially available and approved light guide, light source. video camera, monitor, and printer. Light guide, light source, video camera, monitor, and printer are not included in the scope of delivery and are further not within the scope of this application.
In case of both sets, the nephroscope is accompanied by corresponding accessories to allow for access and passage of the nephroscope and retrieval instruments and for irrigation. Those include compatible endoscopic sheaths, obturators, and bridges.
The Schoelly Nephroscope Set and the Schoelly Ultra-Mini Nephroscope set are delivered in non-sterile conditions and have already obtained CE mark.
The provided document describes the Schoelly Nephroscope Set and Schoelly Ultra-Mini Nephroscope Set and claims substantial equivalence to predicate devices. It does not present a study proving the device meets specific performance acceptance criteria in terms of clinical outcomes or diagnostic accuracy in humans.
Instead, the performance data section focuses on engineering and biocompatibility testing to demonstrate the device's safety and functionality in a technical sense, aligning with established medical device standards.
Here's an analysis based on the information provided:
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Table of acceptance criteria and reported device performance:
Performance Metric (Acceptance Criteria Implicitly Met) Reported Device Performance (as per testing) Temperature (specified in IEC 60601-2-18) Measured surface temperatures at various locations using different light sources reached steady state and met requirements specified in IEC 60601-2-18. Optical Parameters (specified in ISO 8600) Tested for all relevant optical parameters (e.g., field of view and direction of view accuracy) and met requirements specified in ISO 8600. Biocompatibility (according to ISO 10993) A series of biocompatibility tests (cytotoxicity, sensitization, acute systemic toxicity) demonstrated that patient-contacting components are biocompatible. Reprocessing - Cleaning (AAMI TIR12:2010, AAMI Reprocessing validations completed, including manual and automated cleaning. These studies were performed in accordance with AAMI TIR12:2010, AAMI TIR30:2011, and ANSI/AAMI ST15883-1:2009. Reprocessing - Sterilization (ISO 14937:2009, Reprocessing validations completed, including steam sterilization. These studies were performed in accordance with ISO 14937:2009, ANSI/AAMI ST81:2004, ISO 17664:2004, and ANSI/AAMI/ISO 17665-1:2006. Electrical Safety (IEC 60601-2-18) The device is stated to be IEC 60601-2-18 compliant, indicating it meets electrical safety standards. -
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of clinical studies. The document describes device testing (temperature, optical, biocompatibility, reprocessing) which involves physical samples of the device components, not a patient test set. No patient data is involved in these reported performance tests.
- Data Provenance: The tests conducted are laboratory-based engineering and biological compatibility tests. They are not derived from patient data or clinical settings. The document implies these tests were conducted by the manufacturer (Schoelly Fiberoptic, GmbH) as part of their submission to the FDA.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are engineering and safety tests against predefined standards (e.g., IEC, ISO, AAMI TIR), not clinical studies requiring expert ground truth for diagnostic accuracy.
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Adjudication method for the test set:
- Not applicable. This concept applies to clinical studies where expert consensus might be needed for diagnosis or outcome measurement. The reported tests are objective measurements against specified technical standards.
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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:
- No MRMC or AI-related study was done or is mentioned. The device is a traditional endoscope (nephroscope) and its accessories, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a surgical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the reported performance evaluations is defined by international and national standards for medical device safety, performance, and reprocessing (e.g., IEC 60601-2-18, ISO 8600, ISO 10993, AAMI TIR, ISO 17664). The device's performance is compared against the technical specifications and requirements outlined in these standards.
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The sample size for the training set:
- Not applicable. The device is a physical instrument, not an AI algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set mentioned or implied for this type of device submission.
§ 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.