(173 days)
The 3F PRO-PICC® " catheter is indicated for short term or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media, and allows for central venous pressure monitoring. The maximum recommended infusion rate varies by catheter French size and is printed on the catheter.
The 3F PRO-PICC of catheter is an open-ended lumen catheter designed for power injection and pressure monitoring. The 3F PRO-PICC® " catheter is comprised of a soft radiopaque probate monitorial. The lumen has a reverse taper design and is connected to the extension via a soft pliable hub with suture wing for secure placement. The clamp on the extension tube prevents air/fluid communication. The female luer connector provides the connection for intravenous administration. The power injectable extension line is purple in color to differentiate it from non-power injectable catheters. The extension is also is printed with the words power injectable. The I.D. Ring within the clamp contains information regarding checking for blood return and flushing along with rate of infusion for power injection.
The 3F PRO-PICC® C catheter is available with a single lumen. The catheter has a usable length of 50cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion.
The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.
The 3F PRO-PICC® CT catheter is a medical device designed for short to long-term peripheral access to the central venous system for intravenous therapy, power injection of contrast media, and central venous pressure monitoring. The acceptance criteria and the study proving its performance are primarily outlined in the "Bench / Performance Data" section of the 510(k) summary (page 1).
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature/Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance Testing | Adherence to applicable international standards and FDA guidance documents. For pressure injection, internal engineering testing methods were used as no specific FDA standards exist under section 514 of the Federal Food, Drug and Cosmetic Act. | "The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices." |
| (Implies that the device met the criteria established by these standards/guidance and internal methods, confirming equivalence.) | ||
| Biocompatibility | Meet the requirements of ISO 10993. | "All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993." |
| Intended Use, Anatomical Location, Basic Design, Materials, Performance, Labeling, Manufacturing Process, Sterilization | Substantially equivalent to predicate devices (K091953 Medcomp, PRO-PICC® CT; K091586 Medcomp, Vascu-Picc & Midline; K102159 Bard Access Systems, Inc., PowerPICC SV Catheter). | "The 3F PRO-PICC® CT catheter is substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization." |
| Technological Characteristics | Remained the same compared to predicate devices. | "Technological similarities between the proposed device and predicate devices remain the same." |
| Safety and Effectiveness | No new issues of safety and effectiveness raised by any differences from predicate devices. | "There are no differences that raise new issues of safety and effectiveness." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The studies mentioned are referred to as "internal engineering testing methods" and "performance testing... in accordance with applicable international standards and FDA guidance documents."
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)
- The document does not mention the use of experts to establish ground truth for any test set. The evaluation relies on "internal engineering testing methods" and adherence to "international standards and FDA guidance documents," which typically involve engineering and quality control personnel, not clinical experts for ground truthing in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe any adjudication method. This type of method is typically used in clinical trials involving human readers assessing medical images or outcomes, which is not the nature of the "Bench / Performance Data" presented here for a catheter.
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
- No MRMC comparative effectiveness study was done. This is a physical medical device (catheter), not an AI-powered diagnostic tool, so such a study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No standalone algorithm performance was done. This is a physical medical device, not an algorithm. The performance evaluation focuses on its physical and material properties (e.g., pressure injection, biocompatibility, substantial equivalence to predicate devices).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the performance tests, the "ground truth" is established by the specified international standards, FDA guidance documents, and internal engineering testing methods. For biocompatibility, it's defined by the requirements of ISO 10993. For substantial equivalence, it's a direct comparison against the characteristics and performance of the identified predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used for ground truth.
8. The sample size for the training set
- The document does not mention a training set sample size. This is a physical device, and the testing methods described are typically verification and validation tests against established specifications rather than machine learning model training.
9. How the ground truth for the training set was established
- Not applicable, as there is no mention of a training set or machine learning components for this 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.”