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To replace: Cracked or broken female luer lock connectors or repair damaged extension where there is a minimum of 4.5 cm of viable extension tubing on the following catheters: Soft-Cell* Long-Term Dual Lumen Catheter, Opti-Flow* Long-Term Dual Lumen Catheter, Slim-Cath* Short-Term Dual Lumen Catheter, Vaccess* Short-Term Single Lumen Catheter, HemoStar* Long-Term Dual Lumen Catheter, Flexxicon* Short-Term Dual Lumen Catheter, Niagara* Short-Term Dual Lumen Catheter, Flexxicon* II Short-Term Dual Lumen Catheter, HemoGlide* Long-Term Dual Lumen Catheter, and HemoSplit* Long-Term Hemodialysis Catheter.

The Catheter Repair Kit with Replacement Connector is exactly the same as the predicate device.

Here's an analysis of the provided text regarding the Catheter Repair Kit with Replacement Connector:

The provided document is a 510(k) summary for a medical device called the "Catheter Repair Kit with Replacement Connector." This type of submission aims to demonstrate that a new device is substantially equivalent to a previously cleared device (predicate device), rather than proving stand-alone safety and effectiveness through extensive clinical trials. Therefore, the information typically found in studies designed to "prove the device meets acceptance criteria" in the way one might expect for novel, high-risk devices or AI algorithms is not present here.

Instead, the "study" demonstrating that the device meets acceptance criteria primarily consists of non-clinical performance testing to show equivalence to the predicate device, especially in light of a minor material formulation change.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly present a table of "acceptance criteria" and "reported device performance" in the typical format of sensitivities, specificities, or other statistical measures for a decision-making algorithm. Instead, the acceptance criteria implicitly relate to the device functioning in a manner equivalent to the predicate device after a material change. The "performance" is demonstrated through non-clinical testing.

   Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
   Safety and Effectiveness not adversely affected by minor material change.	FMEA conducted, no new safety/effectiveness questions raised. Performance data demonstrate equivalence.
   Maintain intended use and functional characteristics of predicate device.	Testing based on FDA guidance and standards to evaluate performance. Performance data demonstrate equivalence.
   Compatibility with listed catheters for repair (cracked/broken luer lock, damaged extension).	Assumed to be met through equivalence to predicate device and non-clinical testing.

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

   • Sample Size for Test Set: Not specified. The document refers to "testing" and "performance data" without detailing the number of units or test iterations.
   • Data Provenance: Not applicable in the context of human data. The testing would be laboratory-based (in-vitro) on device components.

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

   • This is not applicable as the study described is for a physical medical device (catheter repair kit) and not an AI/diagnostic algorithm where expert ground truth is typically established. The "ground truth" would be the engineering specifications and intended function of the device.

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

   • Not applicable as this is not a study involving human readers or diagnostic interpretation. The "adjudication" of test results would be based on engineering and quality control standards.

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 is not an AI device.

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

   • No. This is not an AI device.

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

   • For this type of device, the "ground truth" for performance testing (e.g., tensile strength, leak resistance, biocompatibility) would be defined by engineering specifications, recognized industry standards (e.g., ISO), and FDA guidance documents. The device must meet these predetermined physical and functional criteria.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, there is no training set for this type of device.

Summary of the "Study" from the document:

The "study" referenced in the 510(k) process for the Catheter Repair Kit with Replacement Connector is a non-clinical performance testing program. This program was undertaken because of a minor material formulation change in the new device compared to its predicate.

• Objective: To determine if the material change affects the safety or effectiveness of the device and to demonstrate substantial equivalence to the predicate device (K030442).
• Methodology:
  • A Failure Modes and Effects Analysis (FMEA) was conducted in accordance with ISO 14971:2000 to identify potential risks.
  • Performance testing was conducted based on FDA guidance documents and standards.
• Results/Conclusion:
  • The FMEA did not raise any new types of safety or effectiveness questions.
  • The performance data generated from the testing demonstrated equivalence to the predicate device.

This approach is standard for 510(k) submissions where changes to an existing device are minor and do not introduce new scientific or technological challenges. The "acceptance criteria" are intrinsically linked to demonstrating that the new device performs identically (or equivalently) to the already cleared predicate device, ensuring no new risks or diminished effectiveness due to the material change.

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