(26 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 RadPICC 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 polyurethane catheters. Catheter sizes are 3, 4, 5 Fr SL and 4, 5, 6 Fr DL. All are 60 cm usable length. The catheter has a reverse taper design. The catheter extension legs provide for improved durability and resistance to alcohol and have 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 configurations.
The provided text is a 510(k) summary for the Poly Per-Q-Cath PICC catheters, detailing modifications to a predicate device. This document focuses on demonstrating substantial equivalence to a previously cleared device (K012902) rather than presenting a de novo clinical study with specific acceptance criteria and detailed device performance metrics in the way a new device might.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not explicitly present in the provided text. The document refers to "predetermined acceptance criteria" and "performance data demonstrating equivalence" but does not detail these criteria or the test results themselves.
Here's an analysis of the provided information in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not contain a table of acceptance criteria and reported device performance. It states generally:
- "The modified devices met the acceptance criteria for the tests performed."
- "The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate Poly Per-Q-Cath PICC catheters."
The specific performance data and the exact acceptance criteria are not presented in this summary document. The focus is on the equivalence of the modified device to the predicate for "design, material, etc." where "the durometer of the extension leg material was changed for improved durability and resistance to alcohol." The performance data would pertain to these changes, but details are not included.
2. Sample sized 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 and validation testing was performed according to protocols," but does not specify the sample sizes, data provenance (e.g., country of origin), or whether it was retrospective or prospective. Given the nature of a 510(k) for modifications to an existing device, the testing would likely be bench testing rather than clinical studies on human subjects.
3. 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 applicable and not provided. The device is an intravascular catheter, and the evidence presented in this 510(k) summary is based on engineering and biocompatibility testing (bench testing), not on expert-adjudicated clinical data requiring ground truth establishment by medical professionals.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies where expert consensus is needed to establish ground truth for diagnostic or prognostic endpoints. The testing performed for this device was verification and validation testing against engineering 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
This information is not applicable and not provided. An MRMC study is relevant for AI-powered diagnostic devices involving human readers. This device is a medical catheter and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable and not provided. As mentioned above, this device is a medical catheter, not an algorithm, so standalone algorithm performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established standards and guidance documents for medical device testing. The document states:
- "Design validation was performed to meet the recommendations of the FDA guidance document, Design Control Guidance for Medical Device Manufacturers, dated March 11, 1997."
- "The FDA's Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, dated 3/16/95, and relevant ISO 10555 Standards were used to determine the appropriate methods for evaluating the modified device's performance."
- "Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing, and the FDA-Modified ISO 10993 Test Profile for externally communicating, blood-contacting, long-term devices, were met."
So, the "ground truth" for demonstrating performance was compliance with these established regulatory and international standards for medical device testing and biocompatibility.
8. The sample size for the training set
This information is not applicable and not provided. The device is a physical medical catheter, not a software algorithm that requires a training set. The testing performed would be lab-based verification and validation.
9. How the ground truth for the training set was established
This information is not applicable and not provided. As explained above, there is no "training set" for this type of medical device's assessment.
§ 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.”