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Medline Catheter Specimen Collector is a tubular device that is inserted through the urethra and utilized for passage of fluids from the urinary tract.

The Medline Catheter Specimen Collector is a sterile, single-use device consisting of a straight polyvinyl chloride (PVC) tube that is inserted through the urethra and utilized for passage of fluids from the urinary tract directly into a collection container. It is intended to be used in urinary collection procedures as a way to obtain a urine sample through a catheter inserted through the urethra into the bladder. The sample is obtained by this method to avoid contamination from the urethra, or if urine cannot be obtained from the patient using the clean catch method. The Medline Catheter Specimen Collector includes a straight urethral catheter, a sheath to protect the catheter during shipping, a pre-attached collection container, and a cap. The catheter is made of polyvinyl chloride (PVC) and features a closed rounded tip with four (4) drainage eyelets. It is available in a combination of French sizes (5FR and 8FR) and lengths ranging from 6.5 to 14 inches.

Let's break down the information regarding the acceptance criteria and study for the Medline Catheter Specimen Collector (K172541), based on the provided text.

First, it's crucial to understand that this document describes a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a previously legally marketed device (predicate device). This is not a clinical study where a new treatment or diagnostic is being evaluated for efficacy in humans. Therefore, many of the typical acceptance criteria and study design elements you'd expect for a clinical effectiveness study (like MRMC studies, specific expert consensus for ground truth on patient data, human-in-the-loop performance, etc.) are not applicable or are addressed differently in a 510(k) for a device like a catheter.

The "acceptance criteria" here relate to demonstrating that the new device is as safe and effective as the predicate device by showing similar performance characteristics and meeting relevant standards.

Acceptance Criteria and Reported Device Performance

• Sensitization (Guinea Pig Maximization Test per ISO 10993-10)
• Irritation (Intracutaneous Reactivity per ISO 10993-10) | The device passed all biocompatibility tests.
  Implied: No adverse biological reactions observed that would differentiate it from equivalent devices. |
  | Functional Performance | - Catheter Surface Finish (per BS EN 1616:1997 §4.2)
• Catheter Dimensions (per BS EN 1616:1997 §4.3)
• Catheter Strength (per BS EN 1616:1997 §Annex A)
• Catheter Flow Rate (per BS EN 1616:1997 §Annex E) | The device met the specified standards for surface finish, dimensions, strength, and flow rate.
  Implied: Performs as expected for a urethral catheter. |
  | Sterility/Packaging | - Bioburden Testing
• Package Seal Integrity (per ASTM F1929)
• Stability (Shelf-Life) Testing
• Ethylene Oxide and Ethylene Chlorohydrin Residual Evaluation Studies | The device met the requirements for bioburden, package integrity, shelf-life, and acceptable residuals from sterilization.
  Implied: Maintains sterility and safety over time. |
  | Risk Management | - Internal Risk Analysis | An internal risk analysis was performed.
  Implied: Identified and mitigated potential risks to an acceptable level. |
  | Technological Equivalence| - Same Product Code (EZD)
• Same Intended Use
• Same Description of use
• Same Regulation Number (21 CFR 876.5130)
• Same Catheter Material (Clear PVC)
• Similar Catheter Sizes (5FR and 8FR)
• Similar Drainage Eyes (4 vs. 2 or 3 in predicate)
• Same Packaging
• Conforms to recognized standard for urethral catheters (as predicate)
• Same Prescription vs. OTC
• Same Contact Duration (≤ 24 h)
• Same Sterile vs. Non-Sterile
• Same Disposable vs. Non-Disposable
• Same Single Use vs. Reusable | The Medline Catheter Specimen Collector demonstrated substantial equivalence in technological characteristics and performance to the predicate device (Busse Hospital Disposable Urethral Catheter, K041464). |

Study Details:

This submission relies on non-clinical testing to demonstrate substantial equivalence to its predicate device, primarily focusing on physical and material properties, and safety.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: The document does not specify a "test set sample size" in terms of number of patients or images, as this is a non-clinical device submission. For the non-clinical tests (biocompatibility, functional, etc.), the sample sizes would be determined by the testing standards (e.g., number of catheters tested for flow rate, number of animals for biocompatibility). These specific quantities are not provided in this summary.
   • Data Provenance: The data comes from non-clinical evaluations (laboratory testing) as opposed to patient data. The country of origin of the data is not specified but would typically be from accredited testing facilities. The studies are prospective in the sense that they were conducted for the purpose of this submission following defined protocols.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not Applicable. For a 510(k) for a basic medical device like a catheter, "ground truth" in the clinical sense (e.g., expert consensus on medical images or pathology results) is not established. The "ground truth" for the non-clinical tests is adherence to recognized standards and objective measurements (e.g., a caliper measures "true" dimensions; a flow meter measures "true" flow rate).

3. Adjudication method for the test set:

   • Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review in clinical studies to resolve disagreements. Since this is non-clinical testing against objective standards, no such adjudication method is relevant.

4. 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. An MRMC study was not performed, nor is it applicable. This device is a physical medical device (catheter) used for fluid passage/specimen collection, not an AI-powered diagnostic or assistive tool for human readers.

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

   • Not Applicable. This is not an algorithm or AI device.

6. The type of ground truth used:

   • Standards and Objective Measurements. The "ground truth" for this device's performance is compliance with established engineering and biocompatibility standards (e.g., ISO 10993, BS EN 1616, ASTM F1929) and the objective measurements derived from these tests. These standards represent accepted benchmarks for safety and performance for this type of device.

7. The sample size for the training set:

   • Not Applicable. No "training set" is mentioned or implied for this device, as it is not an AI/machine learning product requiring data for model training.

8. How the ground truth for the training set was established:

   • Not Applicable. As no training set was used, this question is not relevant.

In summary: The Medline Catheter Specimen Collector achieved FDA clearance via a 510(k) pathway by demonstrating substantial equivalence to a predicate device (Busse Hospital Disposable Urethral Catheter, K041464) through comprehensive non-clinical testing. This testing confirmed the device's biocompatibility, functional performance (surface finish, dimensions, strength, flow rate), sterility, and package integrity, all in accordance with recognized industry standards. The submission did not involve clinical studies or human-in-the-loop evaluations, as its purpose was to show equivalence to an already approved physical medical device.

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