(80 days)
The PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, and blood sampling.
The CT rated PICC is also indicated for the power injection of contrast media.
The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec.
The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
The PICC (CT Rated and Non-Rated) is a family of peripherally inserted central venous catheters designed to perform infusion. intravenous therapy, and blood sampling. The catheters, made of radiopaque polyurethane tubing, are inserted peripherally. Each PICC has a kink resistant, reverse tapered catheter design. The PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations.
The PICC (CT Rated and Non-Rated) is indicated for dwell times shorter or greater than 30 days.
The PICC (CT Rated and Non-Rated) product line has catheters in 4 Fr and 5 Fr single lumen and 5 Fr and 6 Fr dual lumen. The catheters are attached to an injection-molded polyurethane hub that has extension legs with Luer lock fittings for access attachment.
The CT rated PICC is also indicated for the power injection of contrast media studies. The CT rated PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec with a maximum power injector pressure of 300 psi. All PICC products have a maximum recommended infusion rating of 5 ml/sec. The maximum pressure or pounds per square inch (psi) of the power injector utilized should not exceed 300 psi.
Here's an analysis of the provided text regarding the acceptance criteria and study for the PFM Medical PICC (CT Rated and Non-Rated) device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Intended Use & Performance Data) | Reported Device Performance |
|---|---|
| General PICC Performance: | |
| - Reliable design and performance for infusion, IV therapy, blood sampling. | Demonstrated through "in vitro testing... to assure reliable design and performance in accordance with established standards and specifications." Specifically, testing included: tensile strength, dynamic flow, dynamic failure, static burst. |
| - Biocompatibility for permanent contact device (based on ISO 10993). | "Biocompatibility testing on the PICC (CT Rated and Non-Rated) demonstrates that the materials used meet the requirements of ISO 10993 for a permanent contact device." |
| CT Rated PICC Specific Performance: | |
| - Withstand power injection of worst-case viscosity injection media at 5 ml/sec. | "The CT rated PICC catheter assemblies have been tested to withstand power injection of worst-case viscosity injection media at 5 ml/sec." This is corroborated by the "power injection performance" testing mentioned. |
| - Withstand maximum power injector pressure of 300 psi. | "The CT rated PICC catheter assemblies have been tested to withstand... a maximum power injector pressure of 300 psi." This is corroborated by the "power injection performance" testing mentioned. |
| - Maximum recommended infusion rating of 5 ml/sec (for all PICC products, including CT rated). | "All PICC products have a maximum recommended infusion rating of 5 ml/sec." and "The CT rated PICC has a maximum recommended infusion rating of 5 ml/sec." This was likely verified through "dynamic flow" and "power injection performance" testing. |
| - Withstand life cycle power injection (for CT Rated PICC, implied by testing section). | "life cycle power injection" testing was performed. |
| Overall Conclusion (met acceptance criteria for performance and design verification): | "The PICC (CT Rated and Non-Rated) met all established acceptance criteria for performance testing and design verification testing. This testing demonstrated that the PICC (CT Rated and Non-Rated) is safe and effective for its intended use, and is substantially equivalent to the following predicate devices: V-Cath Power PICC (HDC Corp, SE-K071875) and PFM PICC (PFM Medical, SE-072391)" |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the specific sample sizes for the "in vitro testing." It mentions "testing includes tensile strength, dynamic flow, dynamic failure, static burst, power injection performance and life cycle power injection."
- Sample Size: Not explicitly stated for each test.
- Data Provenance: The studies were in vitro (laboratory-based) testing. There is no information about the country of origin, but it's implied to be conducted by or for PFM Medical, Inc. The studies are prospective in the sense that they were conducted for the purpose of demonstrating the device's performance for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this submission. The "ground truth" for this device relied on engineering specifications, material standards (ISO 10993), and performance metrics derived from physical testing, rather than expert interpretation of medical images or patient outcomes. No experts were used in the traditional sense of clinical review for establishing ground truth as there were no clinical studies.
4. Adjudication Method for the Test Set
This is not applicable. Since the testing was in vitro and based on measurable physical and mechanical properties, there was no need for human adjudication of results in the way it's done for clinical or imaging studies. Results would be determined by whether the measured values met pre-defined acceptance thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate device." Therefore, there is no information about the effect size of human readers improving with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical catheter, not an algorithm or AI system. Therefore, standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The "ground truth" for this device was established based on:
- Engineering Specifications and Performance Metrics: Acceptable force, flow rates, pressure resistance, burst strength, and life cycle durability as defined by engineering principles and industry standards (e.g., ability to withstand 300 psi at 5 ml/sec).
- Biocompatibility Standards: Compliance with ISO 10993 for permanent contact devices.
- Predicate Device Performance: Implicitly, the performance of the legally marketed predicate devices serves as a benchmark for what constitutes an acceptable "safe and effective" device.
8. The Sample Size for the Training Set
This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering, materials science, and physical prototypes, not statistical training on data sets.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
§ 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.”