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ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs.

The antimicrobial treatment on the ClearGuard HD has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae.

The antimicrobial effectiveness was evaluated using in vitro methods and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. It is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter, and does not migrate to distal portions of the catheter.

The ClearGuard HD end cap is male lucr lock end cap that incorporates an antimicrobial treatment on its surfaces. It is designed to reduce microbial colonization within a hemodialysis catheter hub.

The ClearGuard HD end cap consists of 1) a copolyester polymer plug, which has a rod extending from the luer region that is coated with the antimicrobial agent chlorhexidine actate (CHA) and 2) a nylon lock ring with threads that are also coated with CHA. When a ClearGuard HD end cap is inserted into a liquid-filled catheter, CHA clutes into the catheter lock solution. This CHA solution is designed to reduce the number of microorganisms in the hemodialysis catheter hub.

The catheter extension line pinch clamps are used to maintain the lock solution within the catheter lumens and minimize the risk of air embolism. These clamps, which are closed when the catheter is not in use, mechanically confine the CHA and prevent diffusion of CHA toward the catheter tip and the patient's bloodstream.

This document describes the 510(k) summary for the Pursuit Vascular, Inc. ClearGuard HD.

The information provided within the input focuses on the submission for a medical device (ClearGuard HD End Cap) for 510(k) clearance based on substantial equivalence, primarily through non-clinical testing. Therefore, many of the typical acceptance criteria and study details for AI/software-based diagnostics (e.g., sample sizes for test sets, expert consensus, MRMC studies) are not applicable in this context.

Here's an analysis of the provided information, addressing what is present and what is not applicable:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" in a quantitative, pass/fail threshold manner for performance metrics like sensitivity or specificity, as one might find for a diagnostic algorithm. Instead, the "acceptance criteria" are implied by the requirements for demonstrating substantial equivalence to a predicate device.

The reported device performance primarily relates to its antimicrobial effectiveness and safety.

(Note: Not effective against Candida paratropicalis and Klebsiella pneumoniae). The antimicrobial agent (chlorhexidine acetate) is the same as on a reference device (Arrow Antimicrobial Pressure Injectable PICC). |
| Safety: Device is safe for use and introduces no new safety concerns. | Results of design verification and validation testing demonstrate that the ClearGuard HD end cap is safe for use with hemodialysis catheters and reliably seals catheter hubs. It introduces no new or increased safety concerns compared to the predicate and reference devices. The risk assessment results confirm this. |
| Reliable Seals: Ability to reliably seal catheter hubs. | Results of design verification and validation testing demonstrate that the ClearGuard HD end cap reliably seals catheter hubs. |
| Other: Hub compatibility, sterile, non-pyrogenic, single-use. | The device meets these characteristics, making it substantially equivalent to the predicate device in these aspects. |

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 for Clinical Data: The submission explicitly states: "Not applicable - no clinical data was needed to demonstrate substantial equivalence to its predicate device."
• For the non-clinical (in vitro) testing of antimicrobial effectiveness and safety, the specific "sample size" of individual tests (e.g., number of cultures, number of sealing integrity tests) is not detailed in this summary. The data provenance would be laboratory-based in vitro studies.

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: Given the absence of clinical data and the nature of the device (an end cap with antimicrobial properties), there was no "ground truth" to be established by clinical experts in the context of diagnostic accuracy. The effectiveness was assessed through in vitro microbiological methods.

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

• Not Applicable: There was no clinical imagery or diagnostic interpretation requiring an adjudication method.

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 is a physical medical device (an end cap), not an AI diagnostic algorithm. Therefore, MRMC studies and AI assistance are irrelevant to this submission.

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

• Not Applicable: This is a physical medical device.

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

• Not Applicable / In Vitro Results: For the antimicrobial effectiveness, the "ground truth" was established by in vitro microbiological culture results (i.e., quantifying microbial colonization reduction in laboratory settings). For safety and sealing, it was established by engineering and design verification/validation testing.

8. The sample size for the training set

• Not Applicable: As this is not an AI/machine learning device, there is no concept of a "training set."

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

• Not Applicable: There is no training set for this type of device.

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