(211 days)
Intermittent urinary catheterization by inserting through the urethra to pass urine from the bladder.
Intermittent nelaton catheter for single use is a disposable sterile catheter intended to be inserted through the urethra to the bladder for urine drainage. The target users are children (greater than 2 years of age), women and men. The catheter body is made of polyvinyl chloride (PVC) coated with gel lubricating substance. The distal end is either a smooth closed straight or coude tip and has two eyelets for efficient drainage. The funnel shaped color-coded connector at the proximal end can be connected to a urine collection container. There is a contact free device, which is for an easy grip, allowing for touchless insertion. The product is packaged in sealed plastic bags and sterilized with ethylene oxide.
The provided document is a 510(k) summary for a medical device (Intermittent nelaton catheter for single use), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance of an AI-powered device. Therefore, much of the requested information regarding AI study design (like sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance, and effect size) is not applicable or present in this document.
However, I can extract the relevant information concerning the non-clinical performance data for the Intermittent nelaton catheter for single use, which serves as the "study" demonstrating the device meets certain performance characteristics.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various non-clinical performance tests conducted, referencing relevant standards where applicable, and reports a "Pass" result for all of them. This implies that the device met the acceptance criteria defined by these standards or internal benchmarks.
| Test Performed | Reference to Standard | Acceptance Criterion (Implied by "Pass" result) | Reported Device Performance |
|---|---|---|---|
| Product length | ISO 20696:2018 | Conforms to ISO 20696:2018 | Pass |
| ID/OD (Inner Diameter/Outer Diameter) | ASTM F623-19, EN 1616:1997 | Conforms to ASTM F623-19, EN 1616:1997 | Pass |
| Eyelets dimensions | N/A (likely internal specification) | Conforms to internal specification | Pass |
| Drainage Funnel Connector separation force | ISO 20696:2018 | Conforms to ISO 20696:2018 | Pass |
| Peak tensile force | ISO 20696:2018 | Conforms to ISO 20696:2018 | Pass |
| Flow Rate | ASTM F623-19, EN 1616:1997, ISO 20696:2018 | Conforms to specified standards | Pass |
| Bending resistance | YY-0325:2016 | Conforms to YY-0325:2016 | Pass |
| Kink stability | ISO 20696:2018 | Conforms to ISO 20696:2018 | Pass |
| Lubricity of coating | N/A (likely internal specification) | Conforms to internal specification | Pass |
| Gel appearance | N/A (likely internal specification) | Conforms to internal specification | Pass |
| Biocompatibility Testing | ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-23:2021, ISO 10993-7:2008 | Conforms to specified ISO standards | Pass |
| Sterilization | ISO 11135: 2014 | Conforms to ISO 11135: 2014 | Pass |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of units tested) for each non-clinical test. It states that "bench testing performed verifies that the performance of the subject device is substantially equivalent." The data provenance would be from internal laboratory testing conducted by the manufacturer, Hangzhou Jimushi Meditech Co., Ltd., which is based in P.R. China. These are retrospective tests performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. These are physical/chemical performance tests on a medical device, not diagnostic interpretations requiring human expert consensus. The "ground truth" is established by adherence to specified international or national standards (e.g., ISO, ASTM, EN, YY).
4. Adjudication method for the test set
Not applicable. Testing against defined physical/chemical standards does not involve expert adjudication in the same way as clinical interpretation. The "adjudication" is inherent in whether the measured performance meets the limits set by the referenced standards.
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 describes a physical medical device, not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used
For most tests, the ground truth is established by adherence to well-defined international or national standards (e.g., ISO 20696:2018 for product length, flow rate, peak tensile force; ISO 10993 series for biocompatibility; ISO 11135: 2014 for sterilization). For tests where "N/A" is listed for the standard (e.g., Eyelets dimensions, Lubricity of coating, Gel appearance), the ground truth is based on internal specifications and quality control parameters established by the manufacturer.
8. The sample size for the training set
Not applicable. This is not an AI-powered device that requires a training set.
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.