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510(k) Data Aggregation
(533 days)
MagiCath II is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for general patient with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
MagiCath II, safety IV catheter is inserted into the patient's blood vessel for short-term use to collect blood, monitor blood pressure, or inject drugs. It consists of an over-the-needle, catheter made of radiopaque polyurethane with a passive safety shielding mechanism that will engage upon needle removal from the patient in order to prevent accidental needlestick injuries. The device is available in 18, 20, 22 and 24-gauge catheter.
MagiCath II is designed to allow users handling the device with single-hand, using the MagiGrip. In the MagiGrip, a vent fitting to regulate blood flow is placed. The needle hub is equipped with a vent filter which suppresses blood leakage, so the flashback can be more visible.
The provided document is a 510(k) Summary for the MagiCath II, a safety IV catheter. It discusses the device's substantial equivalence to a predicate device but does not contain specific acceptance criteria, reported device performance metrics in a defined table, or detailed information about a clinical study involving a test set, expert adjudication, or human reader performance with or without AI assistance.
The document primarily focuses on:
- Comparison of technological characteristics with the predicate device (BD Insyte™ Autoguard™ Intravascular Catheter).
- Bench testing against various ISO standards to demonstrate performance and safety, particularly for sharps injury prevention and material compatibility.
- Biocompatibility testing in accordance with ISO 10993 series.
- Sterilization validation per ISO 11135:2014.
Therefore, many of the requested details cannot be extracted from this document as no clinical study with a test set, ground truth experts, or MRMC study is reported.
However, I can provide the acceptance criteria based on the standards cited for performance as these standards implicitly define performance requirements. The "reported device performance" would then be that the device conformed to these standards.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria/Standard | Reported Device Performance |
|---|---|
| Performance (Mechanical/Physical Characteristics): | |
| - Conical fittings with 6% (Luer) taper for syringe, needles, and certain other medical equipment (ISO 594-1:1986, ISO 594-2:1998) | Device conforms to the requirements of ISO 594-1 and ISO 594-2. This implies acceptance of proper fitting, leak-tightness, and disconnection force. |
| - Intravascular catheter, general requirements (ISO 10555-1:2013) | Device conforms to the general requirements for intravascular catheters, covering aspects like sterility, freedom from defects, material compatibility, and certain physical attributes. |
| - Over-needle peripheral catheters (ISO 10555-5:2013) | Device conforms to specific requirements for over-needle peripheral catheters, addressing features like catheter tip design, flow rates, and insertion characteristics. |
| - Stainless steel needle tubing for the manufacture of medical devices (ISO 9626:2016) | Device conforms to requirements for needle tubing, ensuring attributes like tensile strength, rigidity, and surface finish. |
| - Sterile hypodermic needles for single use (ISO 7864:2016) | Device conforms to requirements for hypodermic needles, including needle point geometry, resistance to corrosion, and freedom from manufacturing defects. |
| - Sharps injury protection features (ISO 23908:2011, FDA Guidance for Medical Devices with Sharps Injury Prevention Features) | Device conforms to sharps injury protection requirements, demonstrating that the passive safety mechanism performs as intended to prevent accidental needlestick injuries (as noted in "Note 2" of the submission summary, "Performance testing per ISO 23908:2011 demonstrated that the safety mechanism feature performs as intended."). |
| - Particulate Matter in Injections (USP ) | Device conforms to limits for particulate matter, ensuring safety when administered intravenously. |
| Biocompatibility (ISO 10993 Series): | |
| - Cytotoxicity (ISO 10993-5) | Device materials are non-cytotoxic. |
| - Sensitization (ISO 10993-10) | Device materials do not cause sensitization. |
| - Intracutaneous (Intradermal) Reactivity (ISO 10993-10) | Device materials do not cause significant intracutaneous reactions. |
| - Acute, Subacute/Subchronic, and Material-Mediated Pyrogenicity (ISO 10993-11) | Device materials are not acutely toxic, do not cause subacute/subchronic toxicity, and are non-pyrogenic. |
| - Genotoxicity (ISO 10993-3/ISO 10993-33) | Device materials are not genotoxic (did not induce bacterial reverse mutation or mammalian chromosomal aberration). |
| - Hemocompatibility (ISO 10993-4/ASTM F756-17, F2382-18, F2888-19) | Device materials do not cause significant hemolysis, do not adversely affect partial thromboplastin time, do not cause significant changes in platelet/leukocyte counts or adherence, and do not cause undesired complement activation. |
| - Implantation (ISO 10993-6) | Device materials demonstrate appropriate tissue response upon implantation. |
| Sterilization (ISO 11135:2014): | |
| - Sterilization process validation (Ethylene Oxide) | The Ethylene Oxide sterilization method is validated in accordance with ISO 11135:2014, ensuring sterility of the device. |
Missing Information (Not found in the provided text):
- Sample size used for the test set and the data provenance: Not applicable as no clinical study or specific test set for AI/human performance is detailed. The performance evaluations are bench tests against standards.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth established by experts for a clinical test set is mentioned.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication process for a test set is described.
- 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 device is a physical medical device (catheter), not an AI-powered diagnostic tool, so an MRMC study comparing human readers with/without AI assistance is not relevant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/clinical study. For the device's performance, the "ground truth" is defined by adherence to the cited international consensus standards (ISO, ASTM, USP).
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning device.
Summary of the Study Proving Device Meets Criteria:
The "study" proving the device meets the acceptance criteria is a comprehensive set of bench tests, biocompatibility tests, and sterilization validation performed according to recognized international and national standards (ISO, ASTM, USP, FDA guidance). The document asserts that these tests "demonstrate substantial equivalence to the predicate device" and that "no new safety and effectiveness questions are raised." The performance testing per ISO 23908:2011 specifically confirmed the sharps injury prevention feature performs as intended. The biocompatibility assessment was conducted per ISO 10993-1, and sterilization was validated per ISO 11135:2014.
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