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The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is intended for sterile intermittent catherization for urine drainage from the bladder.

The Kendall FAST-CATH Pro-Lubricated Urethral Catheter is a sterile, single use system designed for the sterile intermittent cathererization for urine drainage from the bladder. The system is designed for use in both male and female patients. The system consists of a 1200cc plastic collection bag. A 14 Fr rubber or vinyl urological catheler is self contained within the collection bag. A pre-lubricated introducer up allows the catheter to be advanced through the top of the collection bag to perform wrinary cathelestization. A removable cover guards the introducer tip prior to use to maintain sterility.

The Kendall FAST-CATH Pre-Lubricated Urethral Catheter is a sterile, single-use system designed for intermittent catheterization for urine drainage. The provided documentation does not include explicit acceptance criteria with numerical targets. Instead, the testing focuses on demonstrating equivalence to predicate devices and adherence to general medical device standards.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for the biocompatibility or functional testing in terms of the number of individual devices or tests performed. The data provenance is not explicitly stated "country of origin" or "retrospective/prospective," but given the nature of the tests (biocompatibility and functional testing), they would typically be prospective laboratory studies conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This type of information is not applicable to this submission. The tests described (biocompatibility and functional performance) are objective laboratory measurements, not subjective evaluations requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert opinions on subjective data, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks involving human readers, which is not the function of a urinary catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. "Standalone" performance generally refers to AI algorithms performing a task without human intervention. The Kendall FAST-CATH is a medical device, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing was based on:

• Biocompatibility Standards: Compliance with ISO-10993, which defines acceptable biological responses of medical devices.
• Predicate Device Performance: Performance metrics (like flow rates, shaft stiffness) observed from commercially available predicate urinary catheterization systems. This implies that the 'ground truth' for functional performance was defined by the established performance of existing equivalent devices.

8. The Sample Size for the Training Set

This information is not applicable. The Kendall FAST-CATH is a physical medical device, not a machine learning model, and therefore does not have a "training set" in the computational sense. The design and manufacturing processes are informed by engineering principles and standards, not data training.

9. How the Ground Truth for the Training Set Was Established

This is not applicable, as there is no "training set" for this type of device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the (implicit) acceptance criteria is described under "7. Nonclinical Testing":

• Biocompatibility Testing: Performed on the catheter system following ISO-10993 Biological Evaluation of Medical Devices. The results "found the materials contained no toxic diffusible substances." This demonstrates compliance with established safety standards.
• Functional Testing: Performed to determine parameters such as "flow rates, shaft stiffness and other attributes." The results "demonstrated equivalence between the proposed catheter system and commercially available intermittent urological catheterization systems." This establishes that the device performs functionally comparably to legally marketed predicate devices.

The acceptance criteria are implicitly met by demonstrating compliance with international biocompatibility standards and functional equivalence to predicate devices, rather than through specific numerical thresholds. The submission relies on the concept of substantial equivalence under 510(k) regulations, where a new device is found to be as safe and effective as a legally marketed predicate device.

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