(116 days)
The Flexible Ureterorenoscope is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
The Flexible Ureterorenoscope (Model: US27F-12-EU; US27F-12-US) is intended to be used with the Video Processor (cleared via K211169). The Flexible Ureterorenoscope is inserted through the natural orifice urethra and when used with the compatible Video Processor and monitor, the endoscope system can be operated as intended and indicated. The Flexible Ureterorenoscope is a single-use endoscope, which consists of a Handle, an Insertion Section, and an Endoscope Connector. The handle includes a deflection lever, a lever lock, a push button for picture taking/video recording, a Luer port for insertion of accessory devices and irrigation to the working channel and a LED for illumination. The insertion section contains one working channel, wiring to transmit the image signals to the Video Processor, and two optical fibers to transmit illumination from the handle to the distal tip. The distal bending section of the insertion section is controlled by the user via the deflection lever on the handle. The distal end of the insertion section contains a CMOS sensor for capturing image and transmitting it to the Video Processor, optical fibers for transmitting illumination from the LED inside the Handle, and the distal opening of the working channel. The Endoscope Connector connects the endoscope handle to the video processor, which provides power and processes video signals from the endoscope.
Mechanism of action:
The light emitted from the distal tip of the Flexible Ureterorenoscope is irradiated into the body cavity, and the light reflected from the cavity enters the optical system and is captured by the CMOS image sensor. The CMOS acquisition image is controlled by the CMOS drive circuit, and the RGB video signal is output to the Video Processor via the VI circuit. The Video Processor receives video signals from the endoscope, processes the video signals, and outputs the processed video signal to the attached monitor. The video processor also controls the brightness of the LED on the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Maneuverable tip controlled by the user
- Flexible insertion cord
- Camera at the distal tip
- LED in the handle and transmitted to the distal tip by optical fibers
- Sterilized by Ethylene Oxide
- For single use
The provided FDA 510(k) clearance letter and summary for the Flexible Ureterorenoscope (K243857) does not contain details about a study evaluating AI performance directly or outlining acceptance criteria for such a study.
This document primarily focuses on the substantial equivalence of a medical device (endoscope) based on its physical properties, performance characteristics (mechanical, optical), electrical safety, biocompatibility, sterilization, and packaging. The "non-clinical tests summary & conclusions" explicitly state "Clinical Testing: Not Applicable."
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI performance, human reader improvement with AI, or standalone AI performance, as this information is not present in the provided text.
The closest relevant information is about the device's optical performance and image quality, which are foundational for any imaging device, and would implicitly establish a baseline for an AI to process.
Here's what I can provide based on the given information, primarily highlighting the device's tested performance attributes, which serve as foundational acceptance criteria for the hardware itself, not an AI component:
Acceptance Criteria and Device Performance (Flexible Ureterorenoscope - K243857)
Since the provided document is for a medical imaging device (uroscope) and not an AI/software as a medical device (SaMD), the "acceptance criteria" discussed are for the physical and functional performance of the endoscope itself, rather than for an AI algorithm built upon imagery from such a device. There is no mention of AI in this clearance.
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document lists "applicable parts" of standards and general categories of testing rather than specific numerical acceptance thresholds or quantitative performance metrics. The reported performance is adherence to these standards and the successful execution of these tests.
| Criteria Category | Acceptance Standard/Test | Reported Device Performance |
|---|---|---|
| Electrical Safety | ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | In compliance with the standard |
| Electromagnetic Compatibility | ANSI AAMI IEC 60601-1-2:2014 [Including AMD 1:2021] | In compliance with the standard |
| Particular Requirements for Endoscopic Equipment | IEC 60601-2-18 Edition 3.0 2009-08 | In compliance with the standard |
| Electromagnetic Phenomena - Guidance on Basic EMC Aspects | IEC/TR 60601-4-2 Edition 1.0 2016-05 | In compliance with the standard |
| Photobiological Safety | IEC 62471:2006 (Medical electrical equipment, Photobiological safety of lamps and lamp systems) | Tested according to the standard and found compliant |
| Mechanical Performance | Applicable parts of ISO 8600 | Leakage tightness, bending, deflection endurance, and tensile strength testing performed and met requirements |
| Optical Performance | Applicable parts of ISO 8600 | Optical measurements performed and met requirements |
| Image Quality Parameters (Comparative to Predicate) | Direction of view, field of view, MTF/DOF, color performance, SNR/Dynamic Range, Resolution, and Image intensity uniformity compared favorably to the predicate to support substantial equivalence. | |
| Biocompatibility | ISO 10993-1 and FDA Guidance | Cytotoxicity, Sensitization, Irritation, Material-mediated pyrogenicity, Acute systemic toxicity tests conducted and met requirements |
| Sterilization Validation | ISO 11135:2014 | Validated, determined routine control and monitoring parameters |
| EO/ECH Residuals | ISO 10993-7:2008 | Test performed and met requirements |
| Shelf Life (Accelerated Aging) | ASTM F1980-21 | Determined based on stability study (aging test) |
| Package Validation | ISO 11607-1:2019 and ISO 11607-2:2019 | Conducted according to standards |
| Package Integrity (Seal Strength) | ASTM F88/F88M-21 | Conducted according to standard |
| Package Integrity (Dye Penetration) | ASTM F1929-15 | Conducted according to standard |
| Transport & Shipping | ASTM D4169-22 | Testing performed and met requirements |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated for specific tests (e.g., how many units were tested for mechanical performance). The testing is primarily bench/lab-based.
- Data Provenance: The tests are non-clinical, hardware-focused performance evaluations. Data is generated during these laboratory tests performed by the manufacturer, Shanghai AnQing Medical Instrument Co., Ltd. (China). This is implied to be prospective testing for regulatory submission.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The document explicitly states "Clinical Testing: Not Applicable." Ground truth, in this context, would relate to clinical outcomes or expert review of images for diagnostic purposes, which are not part of this 510(k) submission for the device itself. Performance is evaluated against engineering standards and specifications.
4. Adjudication Method for Test Set
- Not applicable. No clinical test set or expert review requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document explicitly states "Clinical Testing: Not Applicable." No MRMC study or AI assistance evaluation is mentioned.
6. Standalone Performance (Algorithm Only)
- Not applicable. This submission is for the endoscope hardware, not a standalone AI algorithm. No algorithm performance is described.
7. Type of Ground Truth Used
- Engineering/Technical Standards: The "ground truth" for this device's performance is adherence to established international and national standards (e.g., IEC, ISO, ASTM, ANSI AAMI) for medical device safety, electrical performance, optical quality, biocompatibility, sterilization, and mechanical integrity. Performance is measured against these technical specifications.
8. Sample Size for Training Set
- Not applicable. There is no mention of an AI component requiring a training set.
9. How Ground Truth for Training Set Was Established
- Not applicable. There is no mention of an AI component or a training set.
§ 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.