(191 days)
Medline Poly-Cath Red Polymer Urethral Catheter is intended for use in the drainage of urine from the bladder, and it is indicated for the intermittent catheterization of male adults who are not capable of voluntary urination. This product is not designed for use as an indwelling catheter.
Medline Poly-Cath™ Red Polymer Urethral Catheter is a single use, flexible, straight urinary catheter that is inserted through the urethra into the bladder allowing urine to drain. The proposed device is comprised of a polyvinyl chloride (PVC) compound that does not contain bis (2-ethylhexyl) phthalate (DEHP). The catheter has a rounded closed tip with two oval drainage eyes at one end, and a funnel bonded to the opposite end. Medline Poly-Cath™ Red Polymer Urethral Catheter is provided sterile.
This document describes the regulatory submission for the Medline Poly-Cath™ Red Polymer Urethral Catheter, seeking substantial equivalence to a predicate device. It primarily focuses on the device's characteristics and performance relative to existing standards, rather than proving the performance of an AI/ML-based device against specific acceptance criteria using a clinical study.
Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and acceptance criteria based on AI/ML metrics, cannot be found in this document.
The document describes non-clinical testing to demonstrate performance and safety, primarily through bench testing and biocompatibility testing against established standards for urological catheters.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria for an AI/ML device. Instead, it refers to industry standards for traditional medical devices.
- Device Type: Medline Poly-Cath™ Red Polymer Urethral Catheter (a physical medical device, not an AI/ML diagnostic tool).
- Acceptance Criteria (as implied by testing, not explicit thresholds): Conformance to relevant industry standards.
- Reported Device Performance (from "Summary of Non-Clinical Testing" and "Performance Testing (Bench)" table):
| Test Objective | Testing Standards | Performance Results |
|---|---|---|
| Catheter Surface Finish | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.2 Requirements |
| Catheter Dimensional Analysis | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.3 Requirements |
| Catheter Strength | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.4 Requirements |
| Catheter Flow Rate | BS EN 1616:1997, BS EN 1618:1997 | Meet BS EN 1616:1997 § 4.8 Requirements and BS EN 1618:1997 § Annex E |
| Connector Security | BS EN 1616:1997 | Meet BS EN 1616:1997 § 4.5 Requirements |
- Biocompatibility Testing (Pass/Fail implied):
- Cytotoxicity: Per ISO 10993-5:2009
- Sensitization: Per ISO 10993-10:2010
- Irritation: Per ISO 10993-10:2010
- Acute Systemic Toxicity: Per ISO 10993-11:2006
- Results are implicitly "passed" or "met requirements" as the overall conclusion states "results of these tests have demonstrated the overall safety of the proposed device and ultimately support a substantial equivalence determination."
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: Not specified for any test. The tests are bench tests of physical properties, not clinical data sets.
- Data Provenance: Not applicable in the context of clinical data. The tests were likely conducted in a lab setting by or for Medline Industries, Inc. (Northfield, IL, USA).
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. This is not a study requiring expert ground truth for image or clinical data interpretation. The ground truth is established by the specifications in the referenced standards (e.g., BS EN 1616:1997).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring clinical or image data adjudication.
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. This document is for a physical medical device (catheter), not an AI/ML diagnostic or assistance tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This document is for a physical medical device (catheter).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance testing, the "ground truth" (or "reference standard") is the specifications and methodology defined within the cited ISO and BS EN standards (e.g., BS EN 1616:1997). For biocompatibility, it's the pass/fail criteria outlined in the ISO 10993 series.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device being "trained."
9. How the ground truth for the training set was established
- Not applicable.
§ 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.