(82 days)
The PRO-PICC m C 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. 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 m C catheter is a triple lumen open-ended picc designed for power injection through one designated lumen. The catheter is an extension of the Medcomp® Pro-Line™ CT Power Injectable CVC (K053345) and Power Injectable Implantable Port (K070003) catheter line. The PRO-PICC m C catheter 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. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated power injectable extension line and clamp material are purple in color to differentiate it from the non-power injectable extensions and the purple lumen identifies it as a power injectable catheter. The center extension also is printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection. Injectable CVC. The PRO-PICC m ™ catheter is available in 6F triple lumen. The catheter has a usable length of 60 cm with depth markings in 5 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion. The catheter is packaged sterile in two radiology versions and two nursing configurations with the necessary accessories to facilitate catheter insertion.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: Medcomp® PRO-PICC ™ CT Peripherally Inserted Central Catheter
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from ISO 10555-1, 10555-3, and internal engineering protocols) | Reported Device Performance |
|---|---|
| Air/Liquid Leakage | Within acceptable limits based on in vitro testing. |
| Force at Break | Within acceptable limits based on in vitro testing. |
| Elongation | Within acceptable limits based on in vitro testing. |
| Gravity Flow | Within acceptable limits based on in vitro testing. |
| Static Burst Pressure | Within acceptable limits based on in vitro testing. |
| High Pressure Injection Flow Rate | Within acceptable limits based on in vitro testing. |
| Chemical Testing | Within acceptable limits based on in vitro testing. |
| Biocompatibility (for permanent external communicating blood contact device) | Materials met requirements of ISO 10993 (based on predicate device testing). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "in vitro testing was performed" without specifying the number of units tested.
- Data Provenance: In vitro testing was performed. The country of origin for the testing is not specified, but the submitter is based in Harleysville, PA, USA. The testing is not retrospective or prospective in the clinical sense, as it was lab-based in vitro testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- No human experts were used to establish ground truth for this in vitro test set. The acceptance criteria are based on engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols, which are objective, measurable performance parameters.
4. Adjudication Method for the Test Set
- Not applicable. As the ground truth was established by objective engineering standards and measurements, no human adjudication was required.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. Clinical studies were explicitly not deemed necessary. The device's safety and effectiveness were demonstrated through in vitro testing and comparison to legally marketed predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone (algorithm only)" performance is not a relevant concept for this product.
7. The Type of Ground Truth Used
- Objective Engineering Standards and Measurements: The ground truth for the device's performance was established using objective measurements against established international engineering standards (ISO 10555-1, 10555-3) and internal engineering protocols. These standards define the acceptable range for physical and chemical properties (e.g., burst pressure, flow rate, leakage).
- Biocompatibility Standard: For biocompatibility, the ground truth was meeting the requirements of ISO 10993.
8. The Sample Size for the Training Set
- Not applicable. This refers to a physical medical device, not a machine learning algorithm. Therefore, there is no "training set." The design and materials are based on existing, cleared predicate devices and engineering principles.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" in the context of this device, this question is not relevant. The device's design is informed by established engineering principles and prior validated devices.
§ 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.”