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510(k) Data Aggregation
(214 days)
Firefly Needleless Connector
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
| Test | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Cytotoxicity | ISO 10993-5: 2009, Biological Evaluation of Medical Devices Part 5: Tests for in vitro Cytotoxicity | Pass - No reactivity |
| Intracutaneous reactivity / Irritation | ISO 10993-10: 2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass - Non-irritant |
| Sensitization | ISO 10993-10: 2013 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | Pass - Non-sensitizing |
| Acute Systemic Toxicity | ISO 10993-11: 2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity | Pass – Did not cause acute systemic toxicity |
| Hemolysis | ASTM F 756 – 17: Standard Practice for Assessment of Hemolytic Properties of Materials | Pass - Non-hemolytic |
| Pyrogenicity | USP Pyrogen Test Procedure, Section (USP40) | Pass - Non-pyrogenic |
| Particulate Matter | USP Particulate Matter in Injections | Pass |
| Sterility | ISO 11135:2014, Ethylene oxide — Requirements for development, v ISO 10993-7:2008 & ISO 10993-7:2008, Biological evaluation of medical devices — Part 7 - Ethylene oxide sterilization residuals validation and routine control | Pass |
| 6 Month Shelf Life | ASTM F1980-16: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices & ISO 11607-1 Second Edition 2019-02: Packaging for terminally sterilized medical devices - Part 1. Requirements for materials, sterile barrier systems, and packaging systems | Pass |
| MR Compatibility | FDA Guidance: Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment: 2014 | Pass |
| Microbial ingress (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Fluid displacement (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flow rate at gravity (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Power infusion flow (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flush volume (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Priming volume (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Size and weight (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve actuation force (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve recovery (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve cycle test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve back pressure test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Valve pressure test (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Tensile strength (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Flexural strength (FDA Guidance) | FDA Guidance: Intravascular Administration Sets Premarket Notification Submission [510(k)]: 2008 | Pass |
| Particulate contamination (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Leakage (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Tensile strength (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Male Conical fitting (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Reducing matter (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Metal ions (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Titration acidity or alkalinity (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Residue on evaporation (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| UV absorption (ISO 8536-4) | ISO 8536-4 Sixth edition 2019-09, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed | Pass |
| Dimensional requirements (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Positive pressure liquid leakage (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Sub-atmospheric pressure air leakage (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Stress cracking (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to separation from axial load (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to separation from unscrewing (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
| Resistance to overriding (ISO 80369-7) | ISO 80369-7 First edition 2016-10-15, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic application | Pass |
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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