(173 days)
The Triple Lumen PFM PICC (CT Rated and Non-Rated) is indicated for short or long term peripheral access to the central venous system for infusion, intravenous therapy, blood sampling and power injection of contrast media. The Triple Lumen PFM PICC has a maximum recommended infusion rating of 5 ml/sec. The primary line of the Triple Lumen PFM PICC is also indicated for central venous pressure monitoring. For central venous pressure monitoring, it is recommended that a catheter of lumen of 20 gauge or larger be used.
The Triple Lumen PFM PICC is a 6F triple lumen peripherally inserted central venous catheter designed to perform infusion, intravenous therapy, blood sampling and also power injection of contrast media studies. The catheter is made of radiopaque polyurethane tubing are inserted peripherally. Each Triple Lumen PFM PICC has a kink resistant, reverse tapered catheter design. The Triple Lumen PFM PICC kit includes a catheter and introduction components. The catheter is supplied sterile and non-pyrogenic in a variety of kit configurations. The Triple Lumen PFM PICC is indicated for dwell times shorter or greater than 30 days. The Triple Lumen PFM PICC can be used for venous pressure monitoring. The Triple Lumen PFM PICC catheter assembly has 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. The fully assembled Triple Lumen PFM PICC consists of an extruded triple lumen polyurethane catheter insert molded into an injection molded polyurethane hub (having integral suture tabs) that has extension leg tubing bonded to ISO standard Luer lock fittings for access attachment. The primary lumen is power injectable. The purple extension leg tubing from the hub has the words 'Power Injectable' and the gauge size printed on the tubing. The clamp ID ring on this extension states "5m/sec max' and 'Check Blood Return and Flush'. The two non-power injectable lumens are equivalent in size, but smaller than the power injectable lumen. The extension tubing legs are clear. The clamp ID ring on these extensions state "DO NOT POWER INJECT" on one side and the gauge size printed on the other. The catheter has depth indicating markings to assist in depth of insertion into the peripherally accessed vein. The device has no components made of natural rubber latex.
The provided text is a 510(k) Summary Statement for a medical device called the "Triple Lumen PFM PICC." It details the device's description, intended use, technical characteristics, and safety and performance tests. However, it does not contain the specific information required to complete all sections of your request.
Here's an breakdown of what can and cannot be extracted from the document:
1. A table of acceptance criteria and the reported device performance
The document states: "The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results."
However, it does not explicitly list the specific acceptance criteria or the reported performance metrics for each. It only lists the standards against which the device was tested.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document.
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)
This information is not provided as the type of study described does not involve expert image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the described tests are technical performance tests, not studies requiring adjudication of results from experts.
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
This information is not provided and is not applicable to this type of device (a physical catheter) or the tests described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical medical catheter, not an algorithm. The tests conducted were on the physical properties and performance of the catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance tests mentioned, the "ground truth" would be established by the specified international standards and internal verification/validation protocols for medical device performance (e.g., measuring pressure, flow rates, material strength, biocompatibility, etc.). The document lists standards like ISO 10555-1, ISO 10993-1, etc., which define the methods and criteria for these types of "ground truth" measurements.
8. The sample size for the training set
This is not applicable as the device is a physical catheter, not an AI/ML algorithm. There is no "training set."
9. How the ground truth for the training set was established
This is not applicable for the same reason as above.
Summary of available information:
| Criteria / Information Request | Information from Document |
|---|---|
| 1. Acceptance Criteria & Reported Performance | The document states: "The Triple Lumen PFM PICC met all established acceptance criteria. Verification and Validation testing conducted on the Triple Lumen PFM PICC yielded acceptable results." It also notes: "The Triple Lumen PFM PICC catheter assembly has 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." However, a comprehensive table of all acceptance criteria and their corresponding reported performance values is not provided. |
| 2. Sample Size & Data Provenance | Not provided. |
| 3. Number & Qualifications of Experts (Ground Truth) | Not applicable to this type of device/study. |
| 4. Adjudication Method | Not applicable. |
| 5. MRMC Comparative Effectiveness Study | Not applicable. |
| 6. Standalone Algorithm Study | Not applicable. |
| 7. Type of Ground Truth Used | For the performance tests, ground truth was established by adherence to and measurement against specified international standards for medical devices, particularly intravascular catheters (e.g., ISO 10555-1/-3, ISO 10993 for biocompatibility, ISO 14971 for risk management). These standards define test methods and acceptable limits for physical, chemical, and biological properties. |
| 8. Training Set Sample Size | Not applicable. |
| 9. Ground Truth for Training Set | Not applicable. |
The document primarily focuses on establishing "substantial equivalence" of the Triple Lumen PFM PICC to predicate devices (K083873 and K071875) by demonstrating comparable technical characteristics and meeting established medical device safety and performance standards. The "study" referenced is a series of "Safety and Performance Tests" conducted in accordance with various international standards, rather than a clinical trial or an AI/ML validation study.
§ 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.”