(114 days)
Medline silicone Foley catheters are intended to be placed in the bladder, through the urethra, to drain urine into a collection device. Two-way catheters are intended for urological bladder drainage only. Three-way catheters are intended for urological bladder drainage and bladder irrigation.
Medline silicone Foley catheters are two-way Foley catheters which are placed in the bladder through the urethra. The urine drains out through the catheter into a collection device attached to the catheter. Threeway Foley catheters offer the option of irrigating the bladder through a 3rd lumen. These catheters have various balloon volumes, shaft sizes and irrigation features.
This document is a 510(k) Premarket Notification for a medical device: Medline Silicone Foley Catheters (K142635).
This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies to prove safety and effectiveness from scratch. Therefore, the information you're requesting regarding acceptance criteria and studies proving the device meets those criteria in the context of an AI/algorithm-driven device is largely not applicable to this document. This document describes a physical medical device, not an AI software.
Here's why and what can be extracted:
- No AI/Algorithm: The Medline Silicone Foley Catheter is a physical device used for urine drainage and irrigation. It does not incorporate any AI or advanced algorithms with performance metrics like sensitivity, specificity, or ROC curves that would require the typical "acceptance criteria" you're inquiring about for AI-based medical devices.
- Substantial Equivalence: The entire premise of a 510(k) is to demonstrate that the new device is "substantially equivalent" to an already legally marketed device (the predicate device) in terms of intended use, technological characteristics, and safety and effectiveness. This means it doesn't need to meet new acceptance criteria but rather demonstrate it performs similarly to an established device.
- Non-Clinical Testing: The document explicitly states "Summary of Non-Clinical Testing: Functional performance testing of the Medline silicone Foley catheter demonstrated device effectiveness in accordance with relevant ASTM F623 test methods." This indicates that the device was tested against an existing standard for physical catheters. The acceptance criteria would be defined within the ASTM F623 standard for properties like balloon integrity, flow rates, material compatibility, etc. The document does not report the specific results or acceptance criteria from these ASTM tests, but rather states that it met them.
- No Clinical Testing: The document explicitly states "Summary of Clinical Testing: Not applicable." This confirms that no clinical studies were performed to establish the device's efficacy or safety against new metrics.
Given this context, most of your requested information is not present or relevant to this 510(k) submission. However, I can fill in what is available from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance | Comments |
|---|---|---|
| Functional Performance | Demonstrated device effectiveness in accordance with relevant ASTM F623 test methods. | Specific criteria and numerical results are not detailed in this submission. Compliance with ASTM F623 implies meeting established engineering and material standards for Foley catheters. |
| Technological Characteristics | No significant differences in technological characteristics between Medline's silicone Foley catheters and the cited predicate device (Well Lead silicone and latex catheters, K082815). | This is the core of substantial equivalence. Details on specific characteristics compared are not provided in this summary. |
| Material Safety | Adequately supported by materials information and analysis data within this Premarket Notification. | Specific material tests and acceptance limits are not detailed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. Testing was non-clinical (functional performance tests according to ASTM F623).
- Data Provenance: Not specified, but generally, non-clinical tests are conducted in laboratories and are prospective for the testing of the specific device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical medical device, not an AI/algorithm. Ground truth as typically understood for AI models (e.g., expert consensus on image interpretation) is not relevant here. The "ground truth" for non-clinical performance would be defined by the ASTM F623 standard itself.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 3.
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. This is a physical medical device, not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a physical medical device. No algorithm is involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. For the non-clinical testing described, the "ground truth" would be defined by the established parameters and performance requirements outlined in the ASTM F623 standard.
8. The sample size for the training set
- Not Applicable. This is a physical medical device. No AI model was trained.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.