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The proposed device is intended for use in the drainage of urine from the urinary bladder. The proposed as intended for intermittent catheterization on patients who are not capable of rne product is intonetion. This product is not designed for use as an indwelling catheter.

Device Description

The Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter is a sterile, single use, intermittent urinary drainage catheter made from latex using dipping technology.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and supporting studies:

This 510(k) submission for the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter does not contain the kind of detailed information typically found in acceptance criteria and efficacy studies for more complex medical devices. This is a pre-amendment device, meaning it was legally marketed before May 28, 1976. This typically implies a different, less stringent review pathway focusing primarily on substantial equivalence to a predicate device rather than novel performance claims and extensive clinical studies.

Therefore, many of the requested categories will be "Not Applicable" or "Not Provided" based on the nature of this submission.

Acceptance Criteria and Device Performance

Based on the provided document, the "acceptance criteria" for this device are primarily tied to its substantial equivalence to an existing, legally marketed predicate device, and biocompatibility. There are no explicit performance metrics (e.g., success rate of urine drainage, specific flow rates, or duration of function) outlined as acceptance criteria with corresponding performance results.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Substantial Equivalence	Same intended use, function, and mode of operation as predicate device.	"The proposed DOVER® RED RUBBER ROBINSON Catheter is substantially equivalent to the predicate device in that each product has the same intended use and same physical, functional and performance characteristics. The proposed and predicate devices are made from the same materials and have the same design."
Biocompatibility	Meets requirements of ISO 10993-1 (with G95-1 modifications).	"Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
Sterility	Sterile (implied by "sterile, single use").	Stated as "sterile, single use". Specific sterility assurance levels or tests are not detailed in this summary.
Materials	Made from latex using dipping technology (same as predicate).	Stated as "made from latex using dipping technology" and "made from the same materials [as predicate]".
Design	Same design as predicate device.	"have the same design [as predicate device]".

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not provided/Applicable. The submission focuses on substantial equivalence and non-clinical biocompatibility testing. There is no mention of a "test set" from a human factors or clinical performance perspective for this type of device. Biocompatibility testing involves material samples, not a patient test set.

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)

Not Applicable. No clinical "ground truth" or expert review of device performance on patients is described in this 510(k) summary for establishing a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As no clinical test set for performance is described, no adjudication method is relevant.

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 device is a urological catheter, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Substantial Equivalence: The "ground truth" is the predicate device itself, meaning its established characteristics, materials, and intended use as a legally marketed product.
For Biocompatibility: The "ground truth" is adherence to the ISO 10993-1 standard and FDA modifications, demonstrated through laboratory testing on materials.

8. The sample size for the training set

Not Applicable. No "training set" in the context of machine learning or clinical validation is described.

9. How the ground truth for the training set was established

Not Applicable. As no training set is described, this question is not relevant.

Summary of Approach in the 510(k):

This 510(k) submission relies on demonstrating substantial equivalence to a previously legally marketed predicate device (the Tyco Healthcare/Kendall DOVER® RED RUBBER ROBINSON Catheter, which was marketed pre-1976). This means the core "study" is a comparison:

Intended Use: Identical.
Technological Characteristics: Identical (materials, design, function, mode of operation).

The only specific "testing" mentioned is biocompatibility testing to confirm the safety of the materials in contact with the body, aligning with recognized international standards (ISO 10993-1) as modified by FDA guidance (G95-1).

There are no performance studies against specific clinical endpoints or comparison against human performance because the device is a simple, well-understood urological catheter and the regulatory pathway allows for reliance on substantial equivalence to a pre-amendment device.

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