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510(k) Data Aggregation
(319 days)
The device has been developed to be used with endoscopic accessories such as a biopsy forceps and Endoscopic Video Image Processor for endoscopy and endoscopic surgery within urinary tract and interior of the ureter and kidney.
The Single-Use Video Flexible Ureterorenoscope System consists of a sterile Single-Use Video Flexible Ureterorenoscope (consists of handle and insertion portion) and an Endoscopic Video Image Processor (the video system, touch PC ) with its accessories power adapter, footswitch.The Ureterorenoscope is provided sterile (sterilized by EO) and intended to be single-use.The video system is powered by the main line.
The handle includes a deflection lever, a lever lock, and a Luer port for insertion of accessory devices and irrigation to the working channel. The insertion portion contains one working channel and wiring to transmit the image signals to the Video Image Processor. The distal bending section of the insertion portion controlled by the user via the deflection lever on the handle. The distal end of the insertion portion contains a CMOS sensor for capturing image and transmitting it to the Video Image Processor, LEDs for illumination, and the distal opening of the working channel. The video cable connects the endoscope handle to the Video Image Processor, which provides power and processes video signals from the endoscope.
Flexible Ureterorenoscope has the following physical and performance characteristics:
- Flexible insertion portion
- Camera and LED light source at the distal tip
The provided text describes a submission for a Single-Use Video Flexible Ureterorenoscope System seeking 510(k) clearance.
However, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does NOT present acceptance criteria or a study proving the device meets specific performance criteria through a clinical or performance study in the way typically seen for AI/ML devices or novel diagnostic tools.
Instead, the submission details a comparison of the subject device's technological characteristics to a legally marketed predicate device and summarizes various engineering and bench tests, along with biocompatibility and sterilization validations, to show that the new device performs similarly and is safe and effective for its intended use.
Therefore, many of the requested sections regarding acceptance criteria, device performance, sample sizes, ground truth, expert opinions, and MRMC studies are not applicable to the information provided in the given text.
Based on the provided text, here is what can be inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) with numerical targets. Instead, it indicates that the device's characteristics and performance were evaluated against established specifications and recognized standards, and compared to a predicate device.
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Predicate Comparison | Be similar to or better than the predicate device in technological characteristics (indications for use, anatomical site, target population, environment, flexible scope, CMOS imager, LED light source, deflection (at least 270°), 0° direction of view, 120° field of view, 3-50mm depth of field, system composition, patient-contacting materials, single-use, EO sterilized) to not raise new questions of safety and effectiveness. | Matches or is similar to the predicate device in all listed characteristics. Differences in deflection, insertion width, working length, and channel width are noted as either better or not raising new safety/effectiveness questions, confirmed by performance testing. For example, deflection is 275° (better), working length 670mm (longer). |
| Electrical Safety | Compliance with IEC 60601-1:2012, AAMI/ANSI ES60601-1:2005/(R)2012, IEC 60601-2-18:2009, and IEC 60601-1-2:2014 and A1:2020. | In compliance with the listed FDA recognized standards. |
| Photobiological Safety | Compliance with IEC 62471:2006. | Tested according to IEC 62471:2006. |
| Mechanical & Optical Performance | Compliance with ISO 8600-1:2015 (applicable parts), ISO 12233:2017, ISO 15739:2017, and internal specifications for water delivery, fatigue, stress of bending, tensile strength, insertion width, channel width, deflection, field of view, direction of view, resolution, depth of field, distortion, SNR, illumination, dynamic range, color performance. | The device was designed to comply, and performance measurements were performed according to, the listed standards. Bench test results claim "same or similar image quality, optical performance and mechanical performance" compared to the predicate. Specific numerical performance values are not provided. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, -11 for "Surface – Mucosal Membrane" with "Limited (< 24 hours)" contact. | Evaluation conducted according to FDA guidance and specific ISO 10993 parts. Tests for Cytotoxicity, Sensitization, Intracutaneous reactivity/irritation, Material-mediated pyrogenicity, and Acute systemic toxicity were performed. (Results not detailed, but implied compliance). |
| Sterilization & Shelf Life | Compliance with ISO 11607:2006, ISO 11135:2014, ISO 10993-7:2008, ASTM F1980-16, ASTM F 1980 07. Maintain sterility and functionality after aging. | Sterile barrier systems evaluated per ISO 11607. Sterilization validated per ISO 11135. EO/ECH residual test per ISO 10993-7. Shelf life determined by stability studies including accelerated aging (ASTM F1980). |
| Package Validation | Compliance with ISO 11607-1:2019, ISO 11607-2:2019, F88/F88M-15, ASTM F 1929-15, and ISTA 2A:2011. | Conducted according to the listed standards for package validation and transport/shipping testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable. The document discusses non-clinical bench testing, not a clinical "test set" in the context of patient data for a diagnostic algorithm. The tests involve physical samples of the device and its components.
- Data Provenance: Not applicable, as it concerns non-clinical tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. There is no mention of "ground truth" established by human experts for a data set, as this is a device clearance based on engineering and performance characteristics, not a diagnostic AI/ML algorithm.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no human adjudication of a clinical test set is described.
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
Not applicable. The document explicitly states: "No clinical study is included in this submission." Therefore, no MRMC study was performed or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (ureterorenoscope), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The concept of "ground truth" as it applies to clinical diagnostics or AI/ML performance evaluation is not relevant to this submission. The "ground truth" for the device's performance is compliance with international standards and direct measurement of physical and optical properties during bench testing.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a medical device, not an AI/ML algorithm requiring a training set and ground truth establishment.
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