(122 days)
INTENDED USE:
The AMSure® Hydrophilic Intermittent Catheter is inserted into the patient's bladder and indicated for intermittent use for the purpose of drainage of urine from the bladder. The catheter does not contain a balloon on its tip. An optional Water sachet is included to activate the hydrophilic-coated surface prior to use. The target populations for the subject device are Adults and Pediatrics.
The AMSure® Hydrophilic Intermittent Catheter is a urethral catheter intended to be passed through the urethra during urinary catheterization and into the bladder to drain urine. It is hydrophilic and lubricous coated flexible tube owns a hydrophilic polymer in the surface which makes the catheter highly lubricious and good adhesion upon contact with water, saline solution, body fluids. The catheter and gripper is manufactured with medical grade PVC, the surface is coated with a hydrophilic lowfriction coating (polyvinyl pyrrolidone, or PVP), the water sachet is with USP grade sterile water. Each catheter is provided in sterile, single-use packages, intended to be used by adults and pediatrics.
The provided document is a 510(k) summary for the AMSure® Hydrophilic Intermittent Catheter. This document details the regulatory pathway for a medical device and typically does not include the specifics of a standalone algorithm study, MRMC comparative effectiveness study, or details like the number and qualifications of experts for ground truth establishment, which are more common for AI/ML-based device submissions.
Based on the provided text, here's a summary of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Test items" under "Performance Testing" which serve as the acceptance criteria for the device. The reported performance is that these tests were conducted and demonstrate the device's substantial equivalence. Specific quantitative performance metrics (e.g., specific friction values, flow rates, or strength measurements) that would constitute "acceptance criteria" are not reported in this summary, only the tests performed.
| SN | Test items (Acceptance Criteria) | Reported Device Performance (Summary) |
|---|---|---|
| 1 | Packaging inspection | Conducted |
| 2 | Appearance inspection | Conducted |
| 3 | Leakage | Conducted |
| 4 | Kink resistance | Conducted |
| 5 | Strength test | Conducted |
| 6 | Connector security | Conducted |
| 7 | Flow test | Conducted |
| 8 | Friction value | Conducted |
| 9 | Chemical performance: Reducing matter | Conducted |
| 10 | Chemical performance: pH value | Conducted |
| 11 | Chemical performance: Metal ions | Conducted |
| 12 | Chemical performance: EO residue | Conducted |
| 13 | Biological performance: Sterility | Conducted |
| 14 | Physical performance: Water sachet | Conducted |
| 15 | Chemical performance: sterile water | Conducted |
| 16 | Aging (shelf life/stability testing) | Conducted |
| 17 | Human factor testing | Conducted |
| Biocompatibility | Cytotoxicity, Sensitization, and Irritation | Demonstrated biological safety per ISO 10993-5 and ISO 10993-10 for direct contact with patients. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for performance testing (test set) for any of the listed items (e.g., number of catheters tested for leakage, kink resistance, etc.). The data provenance (country of origin, retrospective/prospective) is also not mentioned.
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)
This information is not applicable and is not provided in the document. The device is a physical urological catheter, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and is not provided in the document, as it relates to expert review for diagnostic devices, not performance testing of a physical medical device.
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 MRMC comparative effectiveness study was performed or mentioned. This type of study is relevant for AI-powered diagnostic devices, which this catheter is not.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone algorithm performance study was not performed. The device is a physical medical device (catheter) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance tests would be based on the established standards for each physical and chemical test (e.g., passing a specific leakage pressure, meeting a defined friction value, demonstrating sterility). For biocompatibility, the ground truth is generally adherence to ISO 10993 standards and the absence of adverse biological reactions. It's not a diagnostic "ground truth" in the AI/ML sense.
8. The sample size for the training set
This information is not applicable. The device is a physical catheter, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. The device is a physical catheter and does not involve a training set.
§ 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.