(57 days)
The Medline Latex Foley Catheter is intended to be used as a urological catheter inserted through the urethra for the purpose of draining urine and other fluids from the urinary tract.
The Medline Latex Foley Catheter is a flexible tubular device manufactured from natural high grade latex. It is sterile as packaged and intended for single patient use. The Medline Latex Foley Catheter consists of two types (2-way & 3-way) of devices. These catheters constitute a double or triple lumen drainage tube with two opposing eyelets on the proximal tip. On the other end of the catheter shaft, the urine drains out into an appropriate collection device. The 3-way catheter has an additional set of eyelets for irrigation purposes. A silicon elastomer coating is applied to the catheter through a dipping process. The catheters are supplied in individually packaged, sealed single use poaches.
The provided document is a 510(k) premarket notification for the Medline Latex Foley Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new performance studies against specific acceptance criteria for the proposed device. Therefore, the information requested below regarding acceptance criteria and performance studies of the proposed device is largely not present in this document.
The document asserts substantial equivalence based on the predicate device's established performance and the identical nature of the materials, manufacturing, and intended use.
Here's an attempt to answer the questions based on the available information:
Acceptance Criteria and Device Performance
This document does not define specific acceptance criteria or report performance data for the proposed Medline Latex Foley Catheter. Instead, it relies on demonstrating that the proposed device is substantially equivalent to a predicate device (Foleycath NR Latex Balloon Catheter, K903777).
The "performance" demonstrated is that the proposed device is identical to the predicate in key characteristics, implying it will perform equivalently.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Proposed Device) |
|---|---|
| Intended Use matches predicate | Matches predicate |
| Patient Populations match predicate | Matches predicate |
| Types (2-way, 3-way) match predicate | Matches predicate |
| Size Range (Fr) matches predicate | Matches predicate |
| Balloon Capacity matches predicate | Matches predicate |
| Material (Natural rubber latex) matches predicate | Matches predicate |
| Coating (Silicone) matches predicate | Matches predicate |
| Manufacturing Method (including sterilization) matches predicate | Matches predicate |
| Biocompatibility status equivalent to predicate | Equivalent to predicate (well-established) |
Study Details
Given the nature of a 510(k) submission based on substantial equivalence, a traditional "study" demonstrating the proposed device's performance against specific acceptance criteria was not conducted or reported here. The "study" is implicitly the comparison to the predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. No new test set data was generated for the proposed device in this submission. The performance of the predicate device (K903777), referenced for its established performance and function, is not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. No new ground truth for a test set was established for the proposed device in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. No test set requiring expert adjudication was performed for the proposed 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. This device is a urological catheter, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This device is a urological catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided for the proposed device. The "ground truth" for this submission is the established safety, effectiveness, and performance of the predicate device (K903777) based on its historical marketing approval and adherence to relevant standards.
8. The sample size for the training set
- Not applicable / Not provided. This is a medical device, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is a medical device, not a machine learning algorithm.
§ 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.