(263 days)
The Silicone Urethral Catheter is passed through the urethra during urinary catheterization and into the bladder to drain urine, or for routine post-operative drainage and bladder irrigation. It is intended for use by male, female and pediatric patients (2 years old to less than 12 years old).
The Silicone Urethral Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of shaft, drainage funnel, inflation funnel, irrigation funnel (if present), balloon and valve. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid.
The device is made of silicone and available in different types (e.g., male, female, Tiemann, 2-way, 3-way etc.) and sizes for adult and pediatric use.
The device is for single use and provided with sterile. The indwelling time is no more than 30 days.
This document is a 510(k) clearance letter for a Silicone Urethral Catheter, a physical medical device. The request asks for details about acceptance criteria and a study proving the device meets those criteria, typically found in submissions for AI/ML-enabled medical devices.
Therefore, the provided document does not contain the information requested for an AI/ML-enabled medical device. It thoroughly details the non-clinical performance testing for a traditional, physical medical device, but there is no mention of an algorithm, AI, machine learning, or any form of data-driven performance metrics, ground truth establishment, or human-in-the-loop studies.
Here's a breakdown of why the requested information cannot be extracted from this document:
- No AI/ML Component: The device is a Silicone Urethral Catheter, which is a physical product for urine drainage. The 510(k) summary focuses on its material, dimensions, performance (e.g., flow rate, balloon integrity), biocompatibility, sterilization, and shelf-life. There's no indication of any software, algorithm, or AI component.
- Non-Clinical Testing Only: The "Summary of Non-Clinical Performance Testing" explicitly states the types of bench tests conducted (e.g., Balloon Size and Shaft Size, Flow Rate, Balloon Integrity, etc.) and biocompatibility tests.
- No Clinical/Animal Testing: Section 9, "Clinical Testing and animal testing," explicitly states: "Clinical and animal testing were not performed for Silicone Urethral Catheter as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Silicone Urethral Catheter, did not require clinical and animal studies to support substantial equivalence." This further confirms the absence of any studies involving human data or interpretations by experts for diagnostic purposes that would be relevant to AI/ML.
To answer your specific questions based on the absence of this information in the provided document:
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Table of acceptance criteria and the reported device performance: Applicable to physical performance characteristics (e.g., flow rate, balloon volume), but not "AI performance" criteria like sensitivity, specificity, AUC.
- Acceptance Criteria Examples (from document):
- Meets all requirements of biocompatibility (tested per ISO 10993-1)
- Meets pre-determined testing and acceptance criteria for bench tests (ASTM F623-19, ISO 20696:2018, FDA guidance 'Conventional Foley Catheters')
- Sterilized in accordance with ISO 11135:2014
- Maintains product and package integrity and device sterility throughout shelf-life.
- Reported Device Performance: The document states that the testing "demonstrated that the Silicone Urethral Catheter meets all the pre-determined testing and acceptance criteria" and that "All evaluation acceptance criteria were met" for biocompatibility. Specific quantitative results are not provided in this summary but would be in the full submission.
- Acceptance Criteria Examples (from document):
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Sample size used for the test set and the data provenance: Not applicable to an AI test set. This would refer to the number of units tested for physical properties (e.g., how many catheters were tested for flow rate). The document doesn't specify these sample sizes, nor does it mention data provenance as it's not a data-driven device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" as understood in AI/ML (e.g., expert labels for images) was established, as there's no diagnostic or analytical function.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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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. No AI component, no human readers involved in a diagnostic workflow related to the device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic ground truth. The "ground truth" for this device would be its physical specifications and performance against established standards (e.g., a catheter's flow rate must meet X ml/min, balloon must hold Y volume without rupture).
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The sample size for the training set: Not applicable. No AI model to train.
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How the ground truth for the training set was established: Not applicable.
In conclusion, the provided FDA 510(k) clearance letter for the Silicone Urethral Catheter pertains to a conventional medical device and does not contain any information related to AI/ML device performance, acceptance criteria, or study methodologies.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.