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510(k) Data Aggregation
(103 days)
PRO-PICC WITH VALVE TECHNOLOGY
The Pro-PICC catheter with valve technology is indicated for short and long peripheral access to the central venous system for intravenous therapy and power injection media, and allow for central venous pressure monitoring. For blood sampling, infusion, or therapies, use a 4F or larger catheter. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
The Pro-PICC®07 with Valve Technology is an open-ended lumen catheter designed for power injection. The catheters are an extension of the Medcomp® Pro-PICC®CT (K091953 and K092347). The Pro-PICC®67 with Valve Technology is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each luer is a Bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size, "Valved CT Catheter" or "Do Not Power Inject", and the maximum flow rates. The transition between lumen and extension is housed within a molded hub. The hub is marked with the catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter.
The Pro-PICC® with Valve Technology catheter is available in additional French sizes and either a single, double, or triple lumen. The catheter has a usable length of 50cm to 60cm depending on French size with depth markings in 5cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in a variety of trav configurations with the necessary accessories to facilitate catheter insertion.
The provided text appears to be a 510(k) summary for a medical device (Medcomp® Pro-PICC® with Valve Technology), rather than a study report detailing acceptance criteria and performance data for an AI/algorithm-based device.
Therefore, many of the requested categories for AI device studies (such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set details, and how ground truth was established for training and test sets) are not applicable or cannot be extracted from this document.
However, I can extract information related to the performance data (bench/performance data) as described in the document, which pertains to the physical device rather than an AI algorithm.
Here's the information that can be extracted, with notes on where the requested AI-specific information is not available:
Acceptance Criteria and Study for Medcomp® Pro-PICC® with Valve Technology
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit or Explicit in Document) | Reported Device Performance |
|---|---|---|
| Bench/Performance Data | Performance testing in accordance with applicable international standards and FDA guidance documents. | "The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices." |
| Performance standards for pressure injection (internal engineering testing methods). | Tested based on internal engineering methods. | |
| Biocompatibility | Meet requirements of ISO 10993. | All biocompatibility testing demonstrates materials meet ISO 10993 requirements. |
| Substantial Equivalence | Same intended use, operation, function as predicates. No new issues of safety and effectiveness. | "The proposed device is substantially equivalent to the legally marketed predicate device." |
Notes on AI-Specific Information (Not Applicable/Available from this document):
- This document describes a physical medical device (catheter), not an AI algorithm. Therefore, there are no specific AI-driven acceptance criteria for metrics like sensitivity, specificity, AUC, or F1-score that would be relevant for an AI system.
- The "performance" referred to in the document relates to the physical and functional characteristics of the catheter (e.g., pressure injection capabilities, material properties), not algorithmic performance.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. This document is for a physical medical device, not an AI algorithm. There is no mention of a "test set" in the context of an AI algorithm's performance evaluation. The "testing" mentioned refers to bench testing of the physical catheter.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This document is for a physical medical device. "Ground truth" in the context of expert consensus for image or data interpretation is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This document is for a physical medical device. Adjudication methods are relevant for expert review in AI studies, not for physical device testing.
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 document is for a physical medical device. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This document is for a physical medical device. There is no "algorithm only" performance reported, as there is no AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable. For the bench and biocompatibility testing, the "ground truth" would be established by validated measurement techniques, chemical analyses, and adherence to relevant ISO standards, rather than expert consensus on image interpretation or pathology.
8. The sample size for the training set
- Not Applicable. This document describes a physical medical device, not an AI algorithm. There is no concept of a "training set" for this type of device submission.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question does not apply.
Summary of Relevant Information from the Document:
The document is a 510(k) premarket notification for a physical medical device, the Medcomp® Pro-PICC® with Valve Technology, a catheter. The core of the submission is to demonstrate substantial equivalence to existing predicate devices.
- Study Objective: To demonstrate that the Medcomp® Pro-PICC® with Valve Technology is substantially equivalent to legally marketed predicate devices.
- Study Types:
- Bench/Performance Testing: Conducted in accordance with applicable international standards and FDA guidance documents, and internal engineering testing methods (specifically for pressure injection, where no FDA standard exists). The document states these tests "effectively demonstrate the proposed devices are equivalent to the predicate devices."
- Biocompatibility Testing: All materials used were tested on the complete, finished device, demonstrating they meet the requirements of ISO 10993.
- Conclusion: The device meets performance criteria of design verification as specified by ISO standards, guidance documents, and internal test protocols. It has the same intended use, operation, and function as the predicates, with no differences raising new safety or effectiveness issues, thus demonstrating substantial equivalence.
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