(87 days)
The PFM PICC is indicated for short or long term access to the central venous system. It is designed for administering IV fluids, blood products, drugs and parenteral nutrition solutions, as well as blood withdrawal and power injection of contrast media. The maximum recommended infusion rate is 5 cc/sec. The maximum pressure of power injectors used with the PFM PICC may not exceed 300 psi.
The PFM Medical PFM PICC Catheters are designed for central venous catheterization. The PFM PICC lumen is comprised of a soft radiopaque polyurethane material. The lumen is connected to the extensions via a soft pliable hub with suture wing for secure placement. Cuff attachment to the lumen provides for tissue ingrown. Clamps are provided on the extension tubes to prevent airfluid communication. Female luer connectors provide the connection for intravenous administration. The catheters are available in 3F, 4F, 5F and 6F single lumen versions, and 4F, 5F and 6F in double lumen versions. The catheters are up to 60 cm in length with depth markings in 5 cm increments. Stylet and adaptor sideport is provided to assist in catheter insertion. The catheters can be used in the injection of contrast media. The maximum recommended infusion rate is 5 cc/sec. The maximum pressure of power injectors used with the PFM PICC catheter may not exceed 300psi. The PFM PICC product line is packaged with the necessary accessories for a percutaneous microintroducer introduction (Modified Seldinger or Seldinger technique).
The PFM PICC device's acceptance criteria and performance are detailed in the provided information. Here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance was assessed through in vitro testing covering various physical and chemical properties. The acceptance criteria are implicitly defined by compliance with ISO 10555-1 and 10555-3 standards, and by demonstrating safety and effectiveness comparable to a legally marketed predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Air/Liquid Leakage | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Cuff Shear | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Force at Break | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Elongation | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Gravity Flow | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Static Burst Pressure | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| High Pressure Injection Flow Rate | Maximum infusion rate of 5 cc/sec; maximum pressure of 300 psi. | Testing assures reliable design and performance; specifications are an integral part of the intended use and were verified. |
| Chemical Testing | Compliant with ISO 10555-1 and 10555-3 standards. | Testing assures reliable design and performance. |
| Biocompatibility | Compliant with ISO 10993 for a permanent contact device. | Materials used meet ISO 10993 requirements. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified. The document states "In vitro testing was performed on the PFM PICC." It does not provide specific numbers of devices or tests conducted for each characteristic.
- Data Provenance: The data is from retrospective in vitro testing. The country of origin of the data is not explicitly stated but implies testing conducted by or for PFM Medical, Inc., which is based in Oceanside, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this device's performance was established through in vitro testing against international standards (ISO 10555-1, 10555-3, and 10993) and comparison to a predicate device, not through expert human evaluation of a test set.
4. Adjudication Method (for the test set)
Not applicable. As the evaluation was based on in vitro testing against predefined standards, there was no need for expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an 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."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described is effectively a standalone performance evaluation of the device itself (not an algorithm) without human-in-the-loop interaction in the context of its performance metrics. The in vitro tests measure the device's inherent physical and chemical properties.
7. The Type of Ground Truth Used
The ground truth used for the device's evaluation was:
- International Standards: Compliance with ISO 10555-1 and 10555-3 for performance, and ISO 10993 for biocompatibility.
- Predicate Device Comparison: Demonstrated safety and effectiveness by comparison to a legally marketed predicate device (MedComp PRO-LINE CT Power Injectable CVC, K053345).
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device (PICC catheter), not an artificial intelligence (AI) algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of device submission.
§ 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.”