(120 days)
The Flexible HD Cysto-Urethroscope System is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
The components subject of this submission are: the Flexible HD Cysto-Urethroscope (Part Number: 11272VH(U)), the LUER ports (Part Number: 11014L(U)), the Suction Valve (Part Number: 11301CE1/20), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).
The provided information is a 510(k) summary for the KARL STORZ Flexible HD Cysto-Urethroscope System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria based on AI performance or clinical efficacy. The changes submitted in this 510(k) are related to adding new sterilization methods (Sterilization V PRO-60 and High Level Disinfection).
Therefore, the document does not contain the kind of information requested regarding acceptance criteria and performance studies for an AI/ML driven device, specifically:
- A table of acceptance criteria and the reported device performance: This document does not describe performance metrics for a diagnostic or AI-driven device, but rather refers to reprocessing validation and biocompatibility.
- Sample size used for the test set and the data provenance: Not applicable as there's no mention of a test set for AI performance. The studies mentioned are non-clinical (biocompatibility and reprocessing validation).
- Number of experts used to establish the ground truth...: Not applicable as there's no AI component or ground truth establishment for diagnostic performance.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: The document explicitly states "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This means no MRMC study was performed.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI/ML device.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of Device Performance and Acceptance Criteria from the Provided Document:
The acceptance criteria and performance data in this 510(k) summary are related to the safety and functionality of the endoscope itself, particularly regarding its reprocessing and biocompatibility, as opposed to diagnostic performance of an AI component.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-5:2009/(R) 2014 Cytotoxicity | Performed according to ISO 10993-1 and FDA Guidance. |
| ISO 10993-10:2010 Sensitization & Irritation | Performed according to ISO 10993-1 and FDA Guidance. | |
| ISO 10993-11:2006/(R) 2010 Systemic Toxicity | Performed according to ISO 10993-1 and FDA Guidance. | |
| Overall Conclusion | The biocompatibility evaluation for patient-contacting components was performed and deemed acceptable. | |
| Reprocessing Validation | Cleaning Validation | Validation activities performed according to FDA Guidance. The device maintained functionality after reprocessing cycles. |
| Sterilization Validation (V-PRO 60 and HLD) | Validation activities performed according to FDA Guidance and relevant standards (AAMI TIR 12, ISO 15883-5, AAMI TIR 30, AAMI/ANSI/ISO 11737-1, ASTM E1837-96). Confirmed effective sterilization for specified methods. | |
| Overall Conclusion | The reprocessing data submitted is in compliance with relevant standards, demonstrating the device can be effectively cleaned, sterilized, and high-level disinfected. | |
| Functional Equivalence | Comparison to Predicate Device (K182723) | The nonclinical tests demonstrate that the subject device performs as well as or better than the legally marketed predicate device (KARL STORZ Flexible HD Cysto-Urethroscope K182723). |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the biocompatibility or reprocessing validation tests. These tests are typically performed on a limited number of device samples or representative materials.
- Data provenance is not specified beyond being "non-clinical bench testing." There's no mention of country of origin or retrospective/prospective nature as this applies to clinical study data, which was explicitly not required.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts pertains to diagnostic or clinical performance evaluations, which were not part of this 510(k) submission.
4. Adjudication method 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:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This device is an endoscope system, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI-driven device.
7. The type of ground truth used:
- Not applicable in the context of diagnostic performance. For biocompatibility and reprocessing, the "ground truth" is adherence to established international standards and FDA guidance for these types of non-clinical tests.
8. The sample size for the training set:
- Not applicable. No training set is mentioned as this is not an AI/ML device.
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.