(304 days)
The ureteroscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The RenaNav Ureteroscope System is comprised of a single-use ureteroscope and a multi-use video processing unit (VPU). The RenaNav Single-Use Digital Flexible Ureteroscope is a sterile, single use device and is compatible with the multi-use System Video Processing Unit. The Ureteroscope is used by physicians to access, visualize, and perform procedures in the urinary tract. The flexible shaft of the ureteroscope includes one working channel which enables the delivery of therapeutic accessories and irrigation/ contrast solutions to the distal tip and desired anatomical location.
The provided text describes a 510(k) submission for the RenaNav Ureteroscope System, asserting its substantial equivalence to a predicate device (LithoVue System, K153049). It lists various performance tests conducted to assure this equivalence and functionality, but it does not include specific acceptance criteria values or the quantitative results of those tests. It also does not detail any comparative effectiveness studies (MRMC) with human readers or standalone algorithm performance, as the device is a medical instrument (ureteroscope) for visualization and procedures, not an AI/imaging analysis software.
Therefore, many of the requested details cannot be extracted from the given text. Below is an attempt to address the points based on the provided information, noting where information is absent.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance tests, but it does not provide specific numerical acceptance criteria or the reported device performance for each metric. It generally states that "All test results met the requirements" or "The device passed the following tests."
| Test Category | Specific Test / Metric | Acceptance Criteria (Not provided in detail) | Reported Device Performance (Not provided in detail) |
|---|---|---|---|
| Biocompatibility | Per ISO 10993-1 | Met requirements | No adverse biocompatibility risks |
| Sterilization | Per ANSI/AAMI/ISO 11135 | Validated | Passed |
| Packaging | Per ANSI/AAMI/ISO 11607-1 | Validated | Passed |
| Electrical Safety & EMC | Per IEC 60601-1, -1-2, -2-18 | Complies with applicable clauses | Passed |
| Simulated Use Testing | Use with ancillary devices | Performed | Passed |
| Dimensional Verification | Proximal/distal OD, working length & ID, channel length, curl diameter, umbilical cable length | Verified | Passed |
| Deflection | Up/Down Deflection (270 degrees, both directions) | Verified | Passed |
| Image Testing | Illumination verification | Verified | Passed |
| Field of View and direction measurement | Measured | Passed | |
| Camera function | Verified | Passed | |
| Camera light ingress and glare | Verified | Passed | |
| HDMI Compatibility | N/A | Verified | Passed |
| Image Functionality | Gain function | Verified | Passed |
| Sheath Compatibility | N/A | Verified | Passed |
| Leak Test | N/A | Verified | Passed |
| Tensile Tests | N/A | Verified | Passed |
| Optics Testing | Resolution, Depth of Field, Field of View, Geometric distortion, Signal-to-Noise Ratio, Dynamic Range, Image intensity uniformity, color performance | Evaluated | Passed |
2. Sample Size Used for the Test Set and the Data Provenance
The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test (e.g., number of ureteroscopes tested). There is no mention of data provenance in terms of country of origin or whether testing was retrospective or prospective, as the tests relate to device performance rather than patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. The device is a ureteroscope for direct visualization and procedures, not an AI or imaging analysis system that generates diagnostic interpretations requiring expert ground truth for a test set. The "ground truth" for the device's performance would be established through engineering specifications and objective measurements (e.g., measuring dimensions, image quality metrics, deflection angles), not expert consensus on medical images.
4. Adjudication Method for the Test Set
This information is not applicable. As explained above, the tests are primarily engineering and functional assessments of the physical device, not an AI diagnostic system requiring adjudicated interpretations.
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 such study was done or mentioned. This type of study is relevant for AI-powered diagnostic aids, not for a direct visualization medical device like a ureteroscope. The document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a ureteroscope, a physical instrument for visualizing and performing procedures. It does not operate as a standalone algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the RenaNav Ureteroscope System's performance is established through engineering specifications, physical measurements, and industry standards (e.g., ISO, IEC). For example:
- Dimensional Verification: Measured against design specifications.
- Image Testing: Objectively measured against predefined optical and image quality parameters.
- Biocompatibility: Demonstrated through lab tests against ISO 10993-1.
- Electrical Safety & EMC: Verified against IEC 60601 series standards.
There is no "expert consensus, pathology, or outcomes data" as ground truth in the context of this device's performance testing for 510(k) clearance.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical instrument, not an AI model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI model or training set, this question is not relevant.
§ 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.