(28 days)
The KARL STORZ Flexible Video-Uretero-Renoscope System 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 Flexible Video-Uretero-Renoscope System is used for visualization purposes during diagnostic and therapeutic procedures. The system components are the Flexible Video-Uretero-Renoscope and the Image 1 SPIES Camera Control Unit (CCU). The Flexible Video-Uretero-Renoscope uses an LED light integrated in the handle and fiber light guides to illuminate the cavity under examination. The video image is produced by a complementary metal-oxide-semiconductor (CMOS) imaging sensor is located at the tip of the insertion shaft. The imaging sensor transfers the video signal to the Image1 SPIES CCU via electronics in the handle. The Image1 HD CCU processes the sensor images and displays them on a standard HD display monitor. The modifications made to the Flexible Video-Uretero-Renoscope System (K131369) are the conversion to the Image 1 SPIES CCU (K135319), material changes for STERRAD compatibility, a reduction in the insertion portion from 700mm to 675mm, and revision of the reprocessing instructions.
This document is a 510(k) summary for the KARL STORZ Flexible Video-Uretero-Renoscope System. It describes modifications to a previously cleared device (K131369) and asserts substantial equivalence to that predicate device.
Here's an analysis of the provided information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present a formal table of acceptance criteria with corresponding performance results. Instead, it describes general compliance with standards and successful testing.
| Acceptance Criteria Category | Device Performance (as reported) |
|---|---|
| Risk Management | Evaluated according to ISO 14971 risk management process. |
| Functional and Performance Testing | System was successfully tested for its functions and performance. |
| Optical Characteristics | Verification of optical characteristics per ISO 8600 (image quality, illumination). |
| Electrical Safety | Performed electrical safety testing per IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Performed EMC testing per IEC 60601-1-2. |
| Biocompatibility | Performed biocompatibility testing of patient contacting materials per ISO 10993. |
| Reprocessing (Cleaning/Sterilization) | Validations conducted for the manual cleaning method and sterilization process. |
| Substantial Equivalence | Modified system is substantially equivalent to its predicate devices (K131369), with similar indications for use, methods of operation, design, and materials (or substantially equivalent materials). |
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not specify a sample size for any test set (e.g., number of devices tested, number of simulated uses, etc.).
- The data provenance is non-clinical testing performed by the manufacturer, Karl Storz Endoscopy-America, Inc. There is no mention of country of origin of the data beyond implied internal testing by the applicant. The testing described is prospective in nature, as it's for a modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable as the document explicitly states: "Clinical testing was not required to demonstrate substantial equivalence to the predicate device." Therefore, there was no clinical test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
- Not applicable for the reasons stated above; no clinical test set was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document states "Clinical testing was not required."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- This device is a physical medical instrument (Flexible Video-Uretero-Renoscope System) with an imaging sensor, not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The testing described is for the device's physical and functional performance, optical characteristics, and safety.
7. The Type of Ground Truth Used:
- For the non-clinical performance and safety testing, the "ground truth" was established by compliance with recognized international standards (e.g., ISO 14971, ISO 8600, IEC 60601-1, IEC 60601-1-2, ISO 10993) and the validated functional specifications of the device.
8. The Sample Size for the Training Set:
- This device is a physical medical instrument, not an AI/ML algorithm. Therefore, the concept of a "training set" in the context of machine learning is not applicable.
9. How the Ground Truth for the Training Set Was Established:
- As above, the concept of a "training set" is not applicable for this device.
§ 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.