(203 days)
The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.
The provided FDA 510(k) clearance letter and summary describe a medical device (FLEX XC ureteroscope), not an AI or software-based medical device. Therefore, the information requested about acceptance criteria and studies that apply to AI/Software as a Medical Device (SaMD) are not present in this document.
The clearance is based on the substantial equivalence of the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) to a previously cleared predicate device (K141250 KARL STORZ Flexible Video-Uretero-Renoscope).
Here's an analysis of the provided information concerning the device's performance, but it does not include any of the AI/SaMD specific criteria you requested as the device is a physical endoscope.
Device: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Product Code: FGB
Regulatory Class: Class II
Acceptance Criteria and Reported Device Performance (Non-AI/SaMD)
Since this is a physical medical device (endoscope), the "acceptance criteria" primarily relate to its physical and functional specifications, and its compliance with relevant performance and safety standards.
| Acceptance Criteria Category (Derived from document) | Assumed Acceptance Criteria for Substantial Equivalence (General) | Reported Device Performance (Subject Device FLEX XC) | Predicate Device Performance (K141250) |
|---|---|---|---|
| Endoscope Type | Flexible CMOS video endoscope | Flexible CMOS video endoscope | Same as subject |
| Camera Control Unit | Image 1 S CCU (Connect and Link modules required) | Image 1 S CCU (Connect and Link modules required) | Same as subject |
| Deflection | Adequate deflection for urinary tract access (e.g., comparable to predicate) | 285° up/down, 270° with instruments in the working channel | 270° up/down |
| Working Length | Suitable for urological procedures | 675mm | Same as subject |
| Working Channel Diameter | Adequate for instrumentation | 1.2mm | Same as subject |
| Outer Diameter | Maximally small for patient comfort/safety, but sufficient for function | 2.9mm | Same as subject |
| Light Source | Internal LED for illumination | Internal LED | Same as subject |
| Direction of View | Standard direct view | 0° | Same as subject |
| Field of View | Adequate for visualization | 80-110° | 80-95° |
| Biocompatibility | Compliance with ISO 10993 series | Complies with ISO 10993-1, -2, -5, -10, -11, -12, -18, -23 | (Assumed compliant, as it's the predicate) |
| Reprocessing Validation | Compliance with relevant sterilization/cleaning standards | Complies with ISO 14937, ISO 17665-1, ANSI/AAMI ST98, ASTM F3208-20, ISO 17664-1, ANSI/AAMI ST77, ISO 22441:2022 | (Assumed compliant, as it's the predicate) |
| Bench Performance | Compliance with endoscope-specific performance standards | Complies with ISO 8600-1, ISO 8600-3, IEC 62471 | (Assumed compliant, as it's the predicate) |
Note on Differences: The subject device (FLEX XC) shows an improved deflection range (285° up/down vs. 270°) and a potentially wider field of view range (80-110° vs. 80-95°) compared to the predicate. The submission argues these differences do not raise new questions of safety and effectiveness, supported by non-clinical bench testing.
Study Details (Based on provided document)
The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications."
Therefore, the following information, which is typically relevant for AI/SaMD clinical validation studies, is not applicable or not provided in this document:
- Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/SaMD performance was used. The reported "performance" comes from bench testing of the physical device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/SaMD performance was not established.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a physical device, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device is its compliance with recognized performance standards and its physical and functional characteristics being comparable (or superior, without raising new concerns) to a cleared predicate.
- The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion: The provided FDA 510(k) clearance documentation for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) pertains to a traditional physical medical device, not a software-as-a-medical-device (SaMD) or AI-enabled device. The clearance is based on a demonstration of substantial equivalence to a predicate device through non-clinical bench testing, not through clinical studies involving human readers or AI algorithm performance analysis. Therefore, the specific criteria and study details related to AI/SaMD validation are absent from this document.
§ 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.