(478 days)
The PVC Hydrophilic Urethral Catheter is launched for clean intermittent catheterization -CIC treatment and indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.
The PVC Hydrophilic Urethral Catheter is a single use urinary catheter designed for clean intermittent catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer with/without water sachet (pure water). The catheters are coated with a coating containing polyvinyl pyrrolidone (PVP) - a kind of hydrophilic polymer, which binds the water molecules to the catheter to reduce the risk of friction while inserting the catheter into the urethra. Coating is activated by the water by squeezing the water sachet or purified water. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PVC Hydrophilic Urethral Catheter is supplied in French size ranging from 8 to 18. It is available for male and female.
This document describes a 510(k) premarket notification for a PVC Hydrophilic Urethral Catheter (K212567). However, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML medical device. The device described is a physical urological catheter, not an AI/ML algorithm.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as these concepts are not applicable to the type of medical device described in the provided text.
The document primarily focuses on demonstrating "substantial equivalence" of the new PVC Hydrophilic Urethral Catheter to a legally marketed predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) based on non-clinical performance testing and biocompatibility testing.
Here's a breakdown of the information that is present, but tailored to a physical medical device, not an AI/ML one:
Acceptance Criteria and Device Performance (for a physical catheter)
The document states that the "PVC Hydrophilic Urethral Catheter meets all the pre-determined testing and acceptance criteria." However, it does not explicitly list the specific numerical acceptance criteria. It mentions the types of tests conducted:
| Acceptance Criteria Category (Implied) | Reported Device Performance (Implied) |
|---|---|
| General Performance: | |
| - Flow rate | Met criteria |
| - Strength of the catheter | Met criteria |
| - Connector Security | Met criteria |
| - Coefficients of friction | Met criteria |
| Biocompatibility (ISO 10993-1:2009): | |
| - Cytotoxicity (ISO 10993-5:2009) | Biocompatible |
| - Irritation (ISO 10993-10:2010) | Biocompatible |
| - Sensitization (ISO 10993-10:2010) | Biocompatible |
| - Subacute toxicity (ISO 10993-11:2017) | Biocompatible |
Explanation of the Study and its intent:
The study conducted was a non-clinical performance testing and biocompatibility testing program. The purpose of these tests was to demonstrate that the new PVC Hydrophilic Urethral Catheter is substantially equivalent to a predicate device (K062444 - Hi-Slip Plus Hydrophilic Urethral Catheter) in terms of safety and effectiveness, as required for a 510(k) submission.
Regarding the specific questions asked for AI/ML devices, here's why they are not applicable and thus not available in the provided text:
- Sample sized used for the test set and the data provenance: Not applicable. This is a physical device, not an AI/ML model. Testing was likely performed on
physical catheter samples in a laboratory setting. - Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the AI/ML sense is established by human experts for a physical catheter's performance. Performance is measured against engineering specifications and biocompatibility standards.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This refers to expert consensus for AI/ML model output, not physical device testing.
- 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 is for AI-assisted image interpretation or similar.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML sense. The "truth" for this device's performance is derived from physical measurements (e.g., flow rate, strength, friction) and standardized biological responses from biocompatibility tests.
- The sample size for the training set: Not applicable. No AI/ML model, so no training set.
- How the ground truth for the training set was established: Not applicable. No AI/ML model, so no training set or ground truth establishment in that context.
§ 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.