(127 days)
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.
Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.
The 510(k) summary explicitly states:
Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.
Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope
As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.
Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.
| Acceptance Criterion (Implied by Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, chemical characterization, animal welfare) | Complies with FDA 2023 biocompatibility guidance and ISO 10993 series standards (ISO 10993-1, -2, -5, -10, -11, -12, -18, -23). |
| Reprocessing Validation (Cleaning and Sterilization) | Complies with ANSI/AAMI/ISO 14937, ANSI/AAMI ST98, ASTM F3208-20, ISO 17664-1, ISO 22441, AAMI TIR12:2020/(R)2023, and FDA Guidance Document: Reprocessing Medical Devices in Health Care Settings. (Details on specific cleaning/sterilization efficacy were not provided in the summary, but successful validation is stated.) |
| Mechanical Performance (e.g., shaft length, diameter, deflection, working channel) | Meets design specifications; functionally similar to predicate device (e.g., Working shaft length: 370 mm, Deflection: 210˚ Up, 140˚ Down). Successful completion of "Bench testing – Mechanical Performance Verification" is reported. |
| Optical Performance (e.g., field of view, direction of view, image quality through eyepiece) | Field of view: 116˚, Direction of view: 0˚. Successful completion of "Bench testing – Optical Performance Verification" is reported. |
| Photobiological Safety | Successful completion of "Bench testing – Photobiological Safety" in compliance with IEC 62471:2006. |
| Thermal Safety | Successful completion of "Bench testing – Thermal Safety" in compliance with IEC 60601-2-18:2009. |
| General Electrical Safety | Compliance with IEC 60601-2-18:2009. |
| Optical Instrument Standards | Compliance with ISO 8600-3:2019 and ISO 8600-5:2020. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
- Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study was not conducted as no clinical performance study was performed or required.
6. If a Standalone Performance Study (Algorithm Only) Was Done
Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.
8. The Sample Size for the Training Set
Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No clinical training set was used.
§ 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.