(20 days)
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram.
The AQ Hydrophilic Urological Catheters are intended for drainage, irrigation and/or retrograde pyelogram. Materials that comprise these devices are polurethane, polyethylene, vinyl and hydrophilic coating. The hydrophilic coating will allow the catheters to become lubricious which will reduce friction.
This 510(k) premarket notification for the "AQ Hydrophilic Urological Catheters" is a very early regulatory submission (from 1996) and does not contain the kind of detailed performance study information typically found in more recent submissions, especially those involving AI/ML devices. The document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and intended use, rather than presenting a performance study with acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the given document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any quantitative acceptance criteria or report performance metrics (e.g., success rates, friction reduction values, specific drainage efficiency) for the AQ Hydrophilic Urological Catheters. The focus is on design and material equivalence to predicates, implying that if the design and materials are equivalent, the performance will also be considered equivalent for this type of device at that time.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or related study data is 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)
- Cannot be provided. No test set or ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is mentioned.
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
- Cannot be provided. This document is for a physical medical device (catheter), not an AI/ML device, and therefore, an MRMC study with AI assistance is entirely irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. As above, this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth is established as no performance study is detailed.
8. The sample size for the training set
- Cannot be provided. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Cannot be provided. No training set or ground truth is mentioned.
Summary of what is present:
- Device: AQ Hydrophilic Urological Catheters
- Intended Use: Drainage, irrigation, and/or retrograde pyelogram.
- Materials: Polyurethane, polyethylene, vinyl, and hydrophilic coating.
- Key Feature: Hydrophilic coating makes the catheters lubricious to reduce friction.
- Predicate Devices: Slip-Coat™ Catheters (Cook Incorporated) and uncoated urological catheters (Cook Urological).
- Basis for Substantial Equivalence: Indications for use, design, and materials of construction are substantially equivalent to predicate devices. The document also mentions manufacturing according to specified process controls, a Quality Assurance Program, and similar packaging and sterilization procedures to currently marketed devices.
This submission relies entirely on demonstrating substantial equivalence to already legally marketed devices, rather than providing new performance data from a specific study against predefined acceptance criteria. For devices like this in 1996, the FDA often accepted equivalence based on material composition, design, manufacturing processes, and intended use without requiring explicit clinical performance trials or new performance data, especially if the changes were incremental (like adding a coating to an existing catheter design).
§ 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.