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510(k) Data Aggregation
(202 days)
330psi Extension Y-Line with Dual Check Valve
The 330psi Extension Y-Line with Dual Check Valve is to be used as an interface between an Angiographic, CT, or MR Syringe and a needle catheter for the purpose of delivering diagnostic fluids (such as contrast media and saline) to the vascular system.
The 330psi Extension Y -Lines with Dual Check Valves will be offered in the following configurations:
i. 60" 330psi Extension Y-Line with Dual Check Valve (C405-1569)
ii. Short 330psi Extension Y-Line with Dual Check Valve (C405-2042)
iii. 60" 330psi Extension Y~Line with Dual Check Valve and Linden Adapters (C405-2155)
iv. 96" 330psi Extension Y-Line with Dual Check Valve (C405-2962)
The provided document is a 510(k) summary for a medical device called "330psi Extension Y-Line with Dual Check Valve". This document describes the device, its intended use, and the testing conducted to establish substantial equivalence to a predicate device. It specifically states that no clinical tests were submitted.
Therefore, it is not possible to provide a detailed response to most of the questions as they relate to performance studies, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance, which are typically associated with software as a medical device (SaMD) or AI/ML-driven devices. This document describes a physical medical device (an extension line) and its acceptance criteria are primarily based on non-clinical engineering and biocompatibility tests.
However, I can extract the acceptance criteria and summarize the study type to the best of what's available in the document.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on non-clinical laboratory testing. The document lists the tests conducted and their respective outcomes (Pass/Fail).
| Acceptance Criteria | Reported Device Performance | Study Proving Performance |
|---|---|---|
| Dimensional Evaluation | Verified dimensional acceptance. | Inspection of the product. |
| Crack Pressure and Flow Rate | Not explicitly stated, but implies meeting predefined functional requirements. | Functional Verification. |
| 330psi Pressure Test (Forward and Back) | Not explicitly stated, but implies meeting pressure resistance requirements. | Functional Verification. |
| Pressurize to Failure Test | Not explicitly stated, but implies meeting failure limits. | Functional Verification. |
| Pull Test (Bond) | Not explicitly stated, but implies meeting bond strength requirements. | Functional Verification. |
| Biocompatibility (ISO 10993 requirements for external communicating, indirect contact, less than 24-hour duration device) | Met requirements. | Biocompatibility testing (Cytotoxicity, Kligman Maximization, Intracutaneous Injection, Systemic Injection, Hemolysis, In Vitro Hemocompatibility, Rabbit Pyrogen, Unactivated Partial Thomboplastin, Complement Activation). |
| - Cytotoxicity | Pass | Biocompatibility Test |
| - Kligman Maximization Test | Pass | Biocompatibility Test |
| - Intracutaneous Injection Test | Pass | Biocompatibility Test |
| - Systemic Injection Test | Pass | Biocompatibility Test |
| - Hemolysis | Pass | Biocompatibility Test |
| - In Vitro Hemocompatibility Assay | Pass | Biocompatibility Test |
| - Rabbit Pyrogen Test | Pass | Biocompatibility Test |
| - Unactivated Partial Thomboplastin | Pass | Biocompatibility Test |
| - Complement Activation Assay | Pass | Biocompatibility Test |
Studies Proving Device Meets Acceptance Criteria:
The studies conducted were nonclinical laboratory tests to verify the physical and biological characteristics of the device.
- Sample size used for the test set and the data provenance: Not explicitly stated for each test, but standard engineering and biocompatibility testing typically uses a representative sample size of manufactured devices. The data provenance is from internal testing conducted by Coeur, Inc. (e.g., test dates provided for biocompatibility).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For engineering and biocompatibility tests, "ground truth" is typically defined by standardized test methods and established scientific principles, not expert consensus on individual cases.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Test results are typically objective (e.g., pressure readings, pass/fail for biological reactions) and do not require expert adjudication in the way clinical image interpretation might.
- 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, not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For dimensional and functional tests, the ground truth is against engineering specifications and industry standards. For biocompatibility, the ground truth is against ISO 10993 cytotoxicity, sensitization, irritation, systemic toxicity, and hemocompatibility standards.
- The sample size for the training set: Not applicable. This is a physical medical device; there is no "training set" in the context of an algorithm.
- How the ground truth for the training set was established: Not applicable.
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