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The PuraCath™ Firefly™ Needleless Connector is a sterile single patient use connector for needleless access to the IV line and/or IV catheter during IV therapy and can be used for direct injection, intermittent infusion, continuous infusion or aspiration.

The PuraCath Firefly Needleless Connector, Model 9001, is a neutral displacement needleless connector intended for single patient use, including pediatrics and immunocompromised patients, for direct injection, intermittent infusion, continuous infusion or aspiration of drugs, blood and fluids when using a vascular access device. The PuraCath Firefly Needleless Connector is a closed, luer activated device that eliminates the risk of needlestick injuries. The PuraCath Firefly Needleless Connector does not require a specific clamping sequence or technique in order to be used safely. The clear housing and open, fluid filled design enhances flushing practice. The Firefly Needleless Connector may be used with power injector procedures to a maximum pressure of 325 psi at a flow rate of 10 mL per second. The Firefly Needleless Connector can be used for seven (7) days and 200 activations. The PuraCath Firefly Needleless Connector is designed to be disinfected using standard of care alcohol wipe down.

Here's a summary of the acceptance criteria and the study details for the Firefly Needleless Connector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document describes non-clinical bench testing as the study conducted to determine if the device is substantially equivalent to the predicate device. These tests covered biocompatibility testing and performance testing based on various international standards and FDA guidance documents.

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

The document does not specify the exact sample sizes (N-numbers) for each individual test conducted. It only states that "The following non-clinical data were provided in support of the substantial equivalence determination." and lists various test categories.

Regarding data provenance, the tests are non-clinical (bench testing), so there is no patient data involved from specific countries or retrospective/prospective collection. The provenance here refers to the standards and guidance followed (e.g., ISO, ASTM, USP, FDA Guidance).

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

This information is not applicable (N/A) as the tests are non-clinical bench tests (e.g., material compatibility, mechanical performance) and do not involve human interpretation or clinical ground truth established by experts in the typical sense of a diagnostic device. The "ground truth" for these tests are the defined pass/fail criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

This information is not applicable (N/A) for non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for human-in-the-loop studies or clinical trials where expert consensus is needed to establish ground truth for diagnostic decisions. In this case, the test results are objective measurements against predefined 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

There is no indication that an MRMC comparative effectiveness study was done. This device is a passive medical device (a needleless connector), not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable (N/A). The device is a physical medical device, not an algorithm, so standalone algorithm performance is not a relevant concept here.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests is established by objective measurements and observations performed according to recognized international standards (ISO, ASTM, USP) and FDA guidance documents. The acceptance criteria for each test are defined by these standards, and the device's performance is compared against these predetermined thresholds. For biocompatibility, this involves evaluating biological responses to materials. For performance, it involves mechanical, fluid dynamic, and durability assessments.

8. The Sample Size for the Training Set

This information is not applicable (N/A). This device is a physical medical device and does not involve AI/machine learning, and therefore does not have a "training set" in that context. The "design" and "testing" of the device are based on engineering principles and regulatory standards.

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

This information is not applicable (N/A), as it's not an AI/machine learning device requiring a training set.

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The PuraCath™ Firefly IM Peritoneal Dialysis Connector Disinfecting System is intended for use by PD (peritoneal dialysis) patients as a method of controlling air and touch contamination while performing a solution exchange dialysis patiens as a nethod of connector Disinfecting System is comprised of Firefly™ UV Purification Device, FireflyTM Transfer Catheter, FireflyTM Luer Cover, and FireflyTM 99% IPA bottle.

The effectiveness of the PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System was tested in viro against The enectivelless of the Funceoccus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Streptococus Staphylococcus autous, Staphylococcus aureus, and Candida albicans yielding ≥ 4log reduction in microorganisms.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System may be used in the home or a healthicare facility.

The PuraCath Firefly Peritoneal Dialysis Connector Disinfecting System provides a way for patients to ensure the cleanliness of the fluid connections associated with ambulatory peritoneal dialysis. The system accomplishes cleaning with a combination of alcohol, flushing with sterile dialysate, and ultraviolet (UV) light. The System consists of the components shown below.

The Firefly UV Purification Device is a multi-year reusable device which helps to clean the connection between the Firefly Transfer Catheter and the dialysate Y-set (Y-set). The UV Purification Device is powered by off-the-shelf, replaceable AA batteries. The UV Purification Device directs ultraviolet (UV) light through the Transfer Catheter connector. UV Purification Device uses lights and an audible alert to indicate device status.

The Firefly Transfer Catheter is a sterile, 6 month use, disposable device providing communication between the indwelling patient catheter and the Y-set. A proprietary, UV transparent control valve on the end of the Transfer Catheter allows for draining and filling the peritoneum. The control valve is actuated manually, adjustable between fully open and fully closed. The Transfer Catheter also has a flush feature. The flush feature allows for flushing of air and potential contaminants from the Y-set prior to fluid exchange.

The Firefly Luer Cover is a 6 month use, disposable, UV transparent component designed to protect the Transfer Catheter connector between uses and to aid in keeping the control valve closed.

The Firefly IPA Dropper Bottle provides a convenient way to apply 99% IPA solution to the inside of the Y-set and Transfer Catheter connectors.

Acceptance Criteria and Study for the Firefly™ Peritoneal Dialysis Connector Disinfecting System

This document describes the acceptance criteria and the study conducted to prove that the Firefly™ Peritoneal Dialysis Connector Disinfecting System meets those criteria, as detailed in the provided FDA 510(k) summary (K151620).

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document primarily details in vitro studies for microbiological efficacy and various bench tests for physical and electrical performance.

• Microbiological Testing: The sample size for the microbiological efficacy testing is not explicitly stated. It is described as "in vitro antimicrobial efficacy studies," suggesting laboratory-based experiments using cultured microorganisms.
• Other Performance Tests (Biocompatibility, Sterilization, Electrical Safety, Life Cycle, Light Leak, Transit, Water Ingress, Human Factors): The sample sizes for these tests are not explicitly stated in the summary. These would typically involve testing a representative number of devices or components.
• Data Provenance: All described studies are pre-market, laboratory-based in vitro and bench testing. No clinical data from human subjects is mentioned for performance evaluation. The data provenance is implied to be from the manufacturer's testing facilities or accredited laboratories. There is no indication of country of origin of the data beyond the manufacturer being US-based, and the submission being to the US FDA.

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

This information is not provided in the given 510(k) summary. For in vitro and bench testing, "ground truth" is typically established by the reference standards and protocols of the tests themselves, conducted by qualified scientists and engineers in a laboratory setting, rather than through expert consensus on observational data.

4. Adjudication Method for the Test Set

This concept is not applicable to the type of studies presented (in vitro microbiological tests and various bench performance tests). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image review settings where human interpretation introduces variability requiring a consensus process.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or described. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant for this device as it is a physical disinfecting system, not an AI-assisted diagnostic tool.

6. Standalone Performance (Algorithm Only without Human-in-the Loop Performance)

Yes, a form of standalone performance was assessed. The "Microbiological testing" section describes the device's ability to achieve a "≥ 4 log reduction in micro-organisms" in vitro. This demonstrates the device's inherent capability to disinfect independently of human factors (beyond proper operation of the system). Similarly, other bench tests (e.g., electrical safety, life cycle) evaluate the device's inherent performance characteristics as a standalone product. The device itself is not an "algorithm" in the sense of software for interpretation, but rather a physical system.

7. Type of Ground Truth Used

The ground truth for the performance evaluations described in this document is primarily based on:

• In Vitro Microbiological Reference Standards: For the microbiological testing, the ground truth is the known concentration of specified microorganisms and the quantitative measurement of their reduction after exposure to the device. This is a highly controlled, objective, and quantifiable measure.
• Engineering Specifications and Standardized Testing Protocols: For other performance tests (e.g., electrical safety, life cycle, light leak), the ground truth is established by meeting predefined engineering specifications and adhering to recognized industry standards (e.g., ISO, IEC, AAMI/ANSI). These are objective, measurable criteria.
• Physical Measurements and Observations: For tests like transit or water ingress, the ground truth is the observable outcome or measured performance against defined pass/fail criteria.

8. Sample Size for the Training Set

This is not applicable. The Firefly™ Peritoneal Dialysis Connector Disinfecting System is a physical medical device, not a machine learning or AI algorithm that requires a "training set" of data.

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

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

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