(28 days)
The NMI PICC III 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 III is a Peripherally Inserted Central Catheter (PICC). It is available in single and multi-lumen configurations in a wide range of sized from 4F to 6F outside catheter diameter. It is rated for maximum power injector settings up to 325 psi and maximum power injection flow rate up to 5 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 provided document describes a 510(k) premarket notification for the NMI PICC III device, which is a peripherally inserted central catheter. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing a performance study to meet specific acceptance criteria in the context of an AI/ML device. Therefore, many of the requested categories related to AI/ML device performance studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and ground truth establishment methods) are not applicable to this type of regulatory submission.
However, I can extract the information related to the device's technical specifications and the non-clinical tests performed to support its equivalence.
Here's a summary based on the provided text, with "N/A" for sections not applicable to this type of submission:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for an AI/ML device. Instead, it lists technical specifications and performance characteristics that the device is stated to meet, largely by demonstrating equivalence to a predicate device through non-clinical testing.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (NMI PICC III) |
|---|---|
| Intended Use: Short- or long-term peripheral access to central venous system for IV therapy, blood sampling, CVP monitoring, power injection. | Meets intended use. |
| Configurations: Single and multi-lumen in 4F-6F diameter. | Available in single and multi-lumen, 4F-6F. |
| Maximum Power Injector Setting: Up to 325 psi. | Rated for up to 325 psi. |
| Maximum Power Injection Flow Rate (model-dependent). | 4F Single Lumen - 55cm: 3.5 mL/sec |
| 5F Single Lumen - 55cm: 5 mL/sec | |
| 5F Dual Lumen - 55cm: 4 mL/sec | |
| 6F Dual Lumen - 55cm: 5 mL/sec | |
| Resistance to blood components (platelet and thrombus) accumulation. | Demonstrates resistance to blood components accumulation. |
| Compliance with EN ISO 10555-1:2009. | Compliant with EN ISO 10555-1:2009. |
| Compliance with EN ISO 10555-3:1997 Corrigendum 1:2002. | Compliant with EN ISO 10555-3:1997 Corrigendum 1:2002. |
| Compliance with FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995" | Compliant with FDA Guidance. |
| Gravity Flow Rate characteristics. | Gravity Flow Rate evaluated. |
| Priming Volume characteristics. | Priming Volume evaluated. |
2. Sample size used for the test set and the data provenance
N/A. This is a non-clinical testing submission for a physical medical device, not an AI/ML diagnostic system with a "test set" of data in the common AI/ML sense. The testing involved physical device samples (implicitly, as part of standard medical device testing, but specific numbers are not given). The tests were conducted according to international standards and FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. Ground truth in this context refers to engineering specifications and performance characteristics tested against established standards, not diagnostic data adjudicated by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to engineering tests of a physical device.
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
N/A. This is a 510(k) for a physical medical device, not an AI-assisted diagnostic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. Not applicable to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on engineering specifications, established international standards (EN ISO 10555-1, EN ISO 10555-3), and FDA guidance documents. Performance attributes like flow rates, pressure ratings, and material resistance are measured against these objective criteria.
8. The sample size for the training set
N/A. There is no AI/ML "training set" for this physical medical device.
9. How the ground truth for the training set was established
N/A. Not applicable.
§ 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.”