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The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children.

The Medcomp 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique. The purpose of the device is to facilitate the insertion of a peripheral, mid-line, or central venous catheter. The introducer is inserted over a .010 inch diameter guidewire that has been placed into the target vessel using a needle or IV catheter. Upon placement of the introducer, the guidewire is removed. When the catheter is ready for insertion, the dilator of the introducer is withdrawn from the sheath and the catheter is threaded into the vein through the sheath. When the catheter has been placed, the sheath is simultaneously split and withdrawn leaving the catheter in place. The Vascu-Sheath Tearaway Introducer is packaged sterile in either a pouch or a variety of tray configurations with additional accessories to facilitate catheter insertion.

The Medcomp Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children. The study demonstrates that this device is substantially equivalent to legally marketed predicate devices through performance testing.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

The document does not specify the exact sample sizes used for each individual performance test (Freedom from Liquid Leakage, Force at Break, Simulated Use, Guidewire Passage, Accelerated Aging). It simply states that "Performance testing of the proposed devices was conducted." The provenance of the data is from internal engineering protocols and testing conducted by Medcomp. No specific country of origin is mentioned beyond Medcomp's location in Harleysville, PA, USA. The testing appears to be retrospective in the sense that it was performed on finished products, but the studies themselves are not characterized as retrospective or prospective clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is not an AI/CADe device that requires expert review for ground truth establishment. The performance criteria are objective engineering and material science tests.

4. Adjudication method for the test set

Not applicable. As noted above, this device is not an AI/CADe device. The acceptance criteria are based on objective, quantifiable engineering and biocompatibility 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

Not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI-assisted device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance tests consists of predefined engineering specifications, thresholds for physical properties (e.g., force at break), and established international standards for biocompatibility (ISO 10993) and risk management (ISO 14971:2000).

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning product and therefore does not have a training set in that context.

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/machine learning product.

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