(111 days)
The FlowPICC Catheter is indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 5F or larger catheter. The maximum recommended infusion rate is 5cc/sec.
The FlowPICC Catheter is indicated for use by itself or with the FlowPICC System (Stylet and Console) sold separately.
The FlowPICC Catheter is a double lumen open-ended PICC designed for power injection through one designated lumen. The FlowPICC Catheter is fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 cm with markings in 5 cm increments. The catheter is packaged with accessories necessary for implantation of a PICC catheter using a Seldinger or modified Seldinger technique. A stylet and adaptor sidenort are provided to assist in catheter insertion.
The provided text describes a medical device, the VasoNova FlowPICC Catheter, and its 510(k) submission. However, it does not contain detailed information about acceptance criteria for device performance or a specific study proving it meets those criteria in a quantitative manner.
The "Performance Data" section merely states: "In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria." It does not provide the acceptance criteria themselves, nor does it present the results of those tests.
Therefore, I cannot fulfill your request for the specific table, sample sizes, expert qualifications, or details about standalone or MRMC studies as these are not present in the provided document.
To answer your request, here's what can be extracted from the text, and where gaps exist:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | "In vitro and in vivo testing demonstrates that the VasoNova FlowPICC Catheter meets all acceptance criteria." (Specific results not provided.) |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not specified.
- Data provenance: "In vitro and in vivo testing." No country of origin or whether the data was retrospective or prospective is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document indicates performance data was generated through "in vitro and in vivo testing," but no mention of expert-established ground truth for a test set is made in the context of human evaluation.
4. Adjudication method for the test set
- Not applicable as no human-reviewed test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
- No, an MRMC comparative effectiveness study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a catheter, not an algorithm.
7. The type of ground truth used
- The document refers to "in vitro and in vivo testing." For a physical medical device like a catheter, "ground truth" would likely refer to established engineering standards, physiological measurements, or clinical outcomes from the in vivo studies. Specifics are not provided.
8. The sample size for the training set
- Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of available information:
The document is a 510(k) summary and an FDA clearance letter for a medical device (a catheter). It states that performance data exists from "in vitro and in vivo testing" and that this data meets "all acceptance criteria." However, it does not disclose the specifics of these criteria, the test results, sample sizes for studies, or any details related to human evaluation, ground truth establishment by experts, or AI-related performance metrics. The focus is on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation.
§ 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.”