(30 days)
The NMI PICC IV is indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients, the sampling of blood, for central venous pressure monitoring and for power injection of contrast media.
The NMI PICC IV is a Peripherally Inserted Central Catheter (PICC). It is a percutaneous, implanted, long-term intravascular catheter. It is available in single and multi-lumen configurations in a wide range of sizes from 3F to 6 F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and rated for maximum power injection flow rate up to 6 ml/second based on model. It is available kitted with a range of procedural accessories for user convenience and demonstrates resistance to blood components (platelet and thrombus) accumulation.
The NMI PICC IV device's acceptance criteria and studies are described below:
1. A table of acceptance criteria and the reported device performance:
The provided document describes the NMI PICC IV device as substantially equivalent to predicate devices based on technological characteristics and non-clinical testing. Instead of specific acceptance criteria as thresholds for performance, the document refers to compliance with established standards and guidance documents. The "reported device performance" is essentially that it met these standards and performed similarly to its predicate.
| Performance Characteristic | Acceptance Criteria (Compliance with) | Reported Device Performance |
|---|---|---|
| General Requirements for IV Catheters | EN ISO 10555-1:2009 (Sterile, Single use intravascular catheters Part 1: General Requirements) | Compliant |
| Central Venous Catheter Specific Requirements | EN ISO 10555-3:1997 Corrigendum 1:2002 (Sterile, Single-Use Intravascular Catheters - Part 3: Central Venous Catheters) | Compliant |
| FDA Guidance for IV Catheter Submissions | FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995" | Compliant |
| Power Injection Flow Rate (Maximum) | Established by predicate device and based on model | Rated for maximum flow rates up to 6 ml/second (specific values for different configurations listed in the "Intended Use" section) |
| Power Injection Pressure (Maximum) | Established by predicate device | Rated for maximum pressure up to 325 psi |
| Resistance to Blood Components Accumulation | Not explicitly stated as a numerical criterion, but implied by substantial equivalence to predicate | Demonstrated resistance to platelet and thrombus accumulation |
| Gravity Flow Rate | Not explicitly stated, implied to meet functional requirements | Tested and found acceptable |
| Priming Volume | Not explicitly stated, implied to meet functional requirements | Tested and found acceptable |
| Design and Materials | Identical to predicate devices | Identical materials, design, and components as predicate intravascular catheters (NMI PICC III - K133264, K131942) |
2. Sample size used for the test set and the data provenance:
The document does not specify sample sizes for a "test set" in the context of clinical trials. The evaluation was based on non-clinical tests (bench testing) and comparison to a predicate device. There is no mention of human subject data, retrospective or prospective studies, or country of origin for such data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study described is non-clinical (bench testing) and relies on compliance with engineering standards and comparison to a predicate device, rather than expert-established ground truth from clinical data.
4. Adjudication method for the test set:
This information is not applicable for the same reasons as point 3. There was no clinical test set requiring adjudication.
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:
An MRMC comparative effectiveness study was not conducted. This device is a physical medical device (PICC line) and does not involve AI or human image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
A standalone algorithm performance study was not conducted. This device is a physical medical device and does not involve an algorithm.
7. The type of ground truth used:
The "ground truth" for this device's performance is established by compliance with recognized industry standards (EN ISO 10555-1:2009, EN ISO 10555-3:1997), FDA guidance documents, and demonstrated equivalence to previously cleared predicate devices through non-clinical testing. No clinical "ground truth" (e.g., pathology, outcomes data) was used in the context of this 510(k) submission.
8. The sample size for the training set:
There is no mention of a training set as this is a non-AI, physical medical device. The term "training set" is not relevant to this submission.
9. How the ground truth for the training set was established:
This information is not applicable as there was no training set used for this 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.”