(34 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 with PASV Valve Technology is indicated for short- or long-term 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, and for power injection of contrast media.
The NMI HPICC 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, and for power injection of contrast media. Non-valved lumens are indicated for central venous pressure monitoring.
The proposed device has identical materials, design, components and technological characteristics as the predicate intravascular catheters.
Both the proposed and predicate devices are, in brief,
- . intended for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling and power injection of contrast media,
- available in single and multi-lumen configurations in a wide range of sized from 3 to 6 . FR outside catheter diameter,
- . rated for maximum power injector settings up to 325 psi,
- rated for maximum power injection flow rate up to 6 ml/second based on model, .
- available kitted with a range of procedural accessories for user convenience; and .
- demonstrative of enhanced resistance to blood component (platelet and thrombus) . accumulation.
The provided text describes a 510(k) summary for medical devices (PICC lines) and focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested categories for AI/ML device studies cannot be answered from the provided document.
Here's an analysis based on the information available:
1. Table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the traditional sense for a new software or AI/ML device performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The "performance" is primarily described by the predicate device's characteristics and the non-clinical tests confirming the similarity of the new device.
| Acceptance Criteria (Implied by Substantial Equivalence to Predicate) | Reported Device Performance (NMI PICC III and NMI HPICC III) |
|---|---|
| Intended Use: Short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, CVP monitoring (for some models), and power injection of contrast media. | Meets this intended use. |
| Material, Design, Components, Technological Characteristics: Identical to predicate intravascular catheters. | Confirmed to be identical. |
| Available Configurations: Single and multi-lumen in 3-6FR. | Available in single and multi-lumen configurations in a wide range of sizes from 3 to 6 FR. |
| Maximum Power Injector Settings: Up to 325 psi. | Rated for maximum power injector settings up to 325 psi. |
| Maximum Power Injection Flow Rate: Up to 6 ml/second (model dependent). | Rated for maximum power injection flow rate up to 6 ml/second based on model (detailed in tables). |
| Procedural Accessories: Kitted with a range of accessories. | Available kitted with a range of procedural accessories. |
| Resistance to Blood Component Accumulation: Enhanced resistance to platelet and thrombus accumulation. | Demonstrative of enhanced resistance to blood component (platelet and thrombus) accumulation. |
| Biocompatibility: In accordance with ISO-10933-1. | Biocompatibility testing conducted in accordance with ISO-10933-1. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of human data validation or an AI/ML model test set. The "testing" referred to is non-clinical bench testing (biocompatibility, mechanical properties) of the physical device.
- Data Provenance: Not applicable. The "study" is a non-clinical evaluation of the physical device's characteristics and materials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. There is no mention of human experts establishing ground truth for a test set in this document, as it pertains to a physical medical device.
4. Adjudication method for the test set:
Not applicable. There is no test set or human adjudication described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No. This document describes the substantial equivalence of a physical medical device (PICC lines), not an AI/ML system.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI/ML device.
7. The type of ground truth used:
Not applicable. The "ground truth" for this medical device's performance is based on established engineering principles, material science, and performance standards for intravascular catheters, as demonstrated through non-clinical testing.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
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.”