(28 days)
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
The Poly Per-Q-Cath PICC Catheters are open-ended radiopaque polyurethanc catheters. Catheter sizes are3, 4, 5 Fr SL and 5, 6 Fr DL with 60 cm usable length. The catheter has a reverse taper design. The catheter extension legs are polyurethane extrusions. Extension legs are 2.2 in. in length and cach leg has a thumb clamp. Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for the catheter insertion point. Catheters are provided sterile in basic, intermediate and RadPICC kit configurations.
The provided text is a 510(k) summary for the Poly Per-Q-Cath PICC, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for clinical efficacy claims based on detailed studies with acceptance criteria, human readers, or an AI component. Therefore, much of the requested information is not present in this document.
Here's an analysis of the available information:
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Table of Acceptance Criteria and Reported Device Performance:
The document states: "The modified device met the acceptance criteria for the tests performed." and "The modified Poly Per-Q-Cath PICC met predetermined performance acceptance criteria of testing performed and is substantially equivalent to the predicate Poly Per-Q-Cath PICC catheter, cleared under K031129."
However, the specific acceptance criteria and the detailed reported device performance are not provided in this 510(k) summary. The summary only generally states that criteria were met.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the 510(k) summary. The document mentions "Verification testing was performed according to protocols based on the above-referenced guidance document recommendations and standards, as well as in accordance with in-house protocols," but does not detail the sample sizes or data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the 510(k) summary. The testing described is likely bench testing or engineering verification, not a clinical study requiring expert ground truth for imaging interpretation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the 510(k) summary. Adjudication methods are typically relevant for clinical studies with subjective assessments, which is not the nature of the testing described here.
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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:
This information is not provided and is not applicable. This submission predates widespread AI in medical devices (2004) and is for a physical catheter, not an imaging or diagnostic AI tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided and is not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The document refers to "predetermined performance acceptance criteria" and "Verification testing." The "ground truth" for this device would be defined by the physical, mechanical, and biocompatibility standards it was tested against (e.g., tensile strength, flow rates, material compatibility). This is inherent in the design and testing of a physical medical device, not a diagnostic tool requiring expert consensus or pathology for ground truth.
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The sample size for the training set:
This information is not provided and is not applicable. There is no mention of a "training set" as this is not an AI or machine learning device.
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How the ground truth for the training set was established:
This information is not provided and is not applicable.
In summary, the provided 510(k) summary (K034019) focuses on demonstrating substantial equivalence of a physical medical device (PICC catheter) to a predicate device through verification testing against industry standards and internal protocols. It does not contain the detailed clinical study information, AI performance metrics, or ground truth establishment methods requested in the prompt, as those are not typically part of a 510(k) submission for this type of device.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”