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510(k) Data Aggregation
(127 days)
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafety IV Catheter is indicated to sample blood or administer fluids intravenously. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter may be used for any patient population with consideration given to adequacy for the vascular anatomy appropriateness for the solution being administered and duration of the therapy.
The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are safety medical devices used for inserting a catheter into a patient's body for purpose of delivery of fluids or drainage of fluids from the patient. The MedSource TrueSafe Safety IV Catheter and the MedSource TrueSafe Comfort Safety IV Catheter are comprised of the following components: protective needle cover, color-coded catheter hub, radiopaque catheter tube, catheter holder, needle guide, medical grade stainless steel needle hub, porous plug and gauge chamber. The components combine for an ergonomic design that incorporate a safety feature that when the device is withdrawn, the needle is completely enclosed within the chamber protecting healthcare and other personnel from exposure to patient body fluids after the device has been discarded post-use. The retraction mechanism is activated by the push of a button.
This document describes the safety and performance testing for the MedSource TrueSafe Safety IV Catheter and MedSource TrueSafe Comfort Safety IV Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Performed | Criteria | Result |
|---|---|---|
| Needle Point | Free from foreign parts with no blunt needles or dents | Pass |
| Flow Rate Through Catheter | Flow rate should be 55ml/min | Pass |
| Corrosion Resistance Test | There shall be no sign of corrosion | Pass |
| Method for Determining Tensile Force at Break | Minimum force at break shall be $\geq 5N$ | Pass |
| Catheter Collapse Through Aspiration Test | There shall be no ingress of air bubbles into the syringe | Pass |
| Gauging Test | NO-GO side of the steel gauge should not be inside the luer. | Pass |
| Liquid Leakage From Conical Fitting Assembly Under Pressure | No liquid leakage should be there, when the assembly is subjected to withstand a pressure of 3.0 to 3.2 bar for 30sec. | Pass |
| Air Leakage from the Conical Fitting Assembly During Aspiration | There should be no air bubble formation from the assembly up to 15sec. | Pass |
| Separation Force of Conical Fitting Assembly | There should be no detachment while applying a force of 10 newtons away from the fixture. | Pass |
| Stress Cracking | There should not be any sign of cracking in the device luer fitting | Pass |
| Unscrewing Torque of Fitting Assembly | There shall be no separation when the fitting is tested | Pass |
| Ease of Assembly | Male reference fitting should insert without any jerk and fit together securely. | Pass |
| Resistance to Overriding | There shall not be any unusual damage on either of the female part or to the reference fitting. | Pass |
| Radiopacity of Catheter | Visually compare the images of the test specimen to the background on the film. | Pass |
| Catheter Elongation Testing | Measure the gauge length and tensile strength at break | Pass |
| Catheter Stiffness Testing | As per manufacturer data, Shore: D-60 ± 4 | Pass |
| Resistance to Disinfection | No visual damage shall be present. As per ISO 527, the catheter shall show no degradation in tensile properties. Catheter tube elongation should be greater than 100% (as in control i.e., non-exposed samples) | Pass |
| Needle Hub Detachment Force | 20N when testing needles of nominal O.D $\geq$ 0.6 mm | Pass |
| Needle Safety Mechanism Activation Test | Check whether the activation Lever activated smoothly without any jerk and check the complete length of the needle enclose to the safety chamber. | Pass |
| Venipuncture Process: Needle Stick (Max Penetration Load) | 14G: 2.70N; 16G: 2.50N; 17G: 2.40N; 18G: 1.90N; 20G: 1.60N; 22G: 1.50N; 24G: 1.35N; 26G: 1.30N | Pass |
| Venipuncture Process: Needle Stick (Max Friction) | 14G: 0.70N; 16G: 0.60N; 17G: 0.60N; 18G: 0.50N; 20G: 0.40N; 22G: 0.35N; 24G: 0.34N; 26G: 0.45N | Pass |
| Venipuncture Process: Tightness Between Catheter Tube and Cannula Activation Testing | The distance should not exceed maximum value of 1.0mm and should be greater than 0.1mm. 97.5% confidence that the failure rate would be no higher than 0.7% and 99.5% confident that the failure rate is not higher than 1.1%. | Pass |
| Biocompatibility (Sensitization Testing) | Standard ISO 10993 Part 10 | Pass |
| Biocompatibility (Intracutaneous Reactivity Test) | Standard 10993 Part 5 | Pass |
| Biocompatibility (In-Vitro Cytotoxicity) | Standard ISO 10003 Part 5 | Pass |
| Biocompatibility (Systemic Toxicity) | Standard ISO 10993 Part 11 | Pass |
| Biocompatibility (Hemocompatibility Test) | Standard ISO 10993-1 | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions several types of testing:
- Nonclinical Bench Performance testing: The specific sample sizes for each of the listed bench tests (e.g., flow rate, corrosion, tensile strength) are not explicitly provided in the summary. However, these are generally performed on a sufficient number of units to demonstrate compliance with the referenced ISO standards.
- Simulated Clinical Use Testing: This test used a sample size of 500 units.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a 510(k) submission and the tests are bench and simulated clinical use, they are inherently prospective in nature, performed specifically for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
For the nonclinical bench tests and simulated clinical use testing described, there is no mention of "experts" in the sense of medical professionals establishing a ground truth. These tests rely on predefined engineering and scientific criteria (e.g., ISO standards, physical measurements). The "ground truth" for these tests is the objective measurement against the specified criteria.
4. Adjudication Method for the Test Set:
Not applicable. The tests described are objective, quantitative measurements or visual assessments against predefined criteria from standards (e.g., ISO standards). There is no "adjudication" necessary between multiple observers or experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not conducted or reported in this document. This submission focuses on the substantial equivalence of the device through bench and simulated use testing, not on comparative effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical device (an IV catheter), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
The ground truth for the performance tests is based on:
- Established engineering and performance standards: Primarily ISO 10555-1 and ISO 10555-5 for mechanical and functional aspects, and ISO 10993 series for biocompatibility.
- Objective physical measurements: For parameters like flow rate, tensile force, needle stick force, distance measurements, etc.
- Visual inspection criteria: For aspects like needle point defects, corrosion, and resistance to disinfection.
- Pre-defined pass/fail criteria: For all tests, specific thresholds or observations determine a "Pass" or "Fail."
8. The Sample Size for the Training Set:
Not applicable. This device is a physical product and not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this physical device.
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