(135 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 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.
The NMI PICC III are flexible radiopaque catheters with suture wing for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with and without a pressure activated safety valve (PASV), available in single lumen and multi-lumen configurations and a reverse tapered shaft to aid in staunching bleeding at the insertion site.
The lumens are differentiated by proximally located colored extension tube clamps and/or colored luer adaptors, which identify lumen size, if the lumen is rated for power injection the maximum power injection flow rates, and "NO CT" for non-power injectable lumens.
All NMI PICC III models have been designed with the option of being used with power injectors for the administration of contrast media for imaging studies such as Computerized Tomography (CT) scans and Magnetic Resonance Imaging (MRIs). Models with at least one non-valved lumen are also indicated for central venous pressure monitoring. All catheters are available packaged with a variety of procedural accessories as a convenience to suit specific clinician preference that meet of the PICC placement practice at their institution and in standard kit configurations.
Endexo technology has been shown to be effective in reducing thrombus accumulation. Reduction of thrombus accumulation was evaluated using in vitro and in vivo models. Preclinical in vitro and in vivo evaluations do not necessarily predict clinical performance with respect to thrombus formation.
The acceptance criteria for the NMI PICC III device and the studies that demonstrate its performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary primarily focuses on establishing substantial equivalence to predicate devices and demonstrating compliance with relevant standards through various tests. The 'acceptance criteria' are implicitly defined by successful completion of these tests, which ensure the device meets specified functional and safety requirements. The reported device performance is generally qualitative (e.g., successful passed testing) rather than specific numerical metrics, with the exception of maximum power injection flow rates.
Acceptance Criteria (Implied by successful testing) & Reported Device Performance
| Acceptance Criteria (Study Type) | Reported Device Performance and Remarks |
|---|---|
| Material & Design Equivalence | Outcome: Device has similar materials, design, and components to predicate devices. |
| Compliance with EN ISO 10555-1:2009 | Outcome: Successfully passed requirements for sterile, single-use intravascular catheters. |
| Compliance with EN ISO 10555-3:1997 Corrigendum 1:2002 | Outcome: Successfully passed requirements for central venous catheters. |
| Compliance with FDA Guidance (March 16, 1995) | Outcome: Successfully passed all applicable requirements outlined in the "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters." |
| Biocompatibility (ISO 10993-1) | Outcome: Successfully passed biocompatibility requirements. |
| Internal Product Specification Requirements | Outcome: Successfully passed all internal product specifications. |
| Luer Connection / Strength | Outcome: Successfully passed testing for Luer connection integrity and strength. |
| Power Injection Performance | Outcome: The device is rated for maximum power injector settings up to 325 psi. Specific maximum power injection flow rates are:- Non-Valved: 4F SL 3.5 mL/s, 5F SL 5 mL/s, 5F DL 4 mL/s, 6F DL 5 mL/s- Valved (PASV): 3F SL 1 mL/s, 4F SL 3.5 mL/s, 5F SL 5 mL/s, 5F DL 4 mL/s, 6F DL 5 mL/s, 6F TL 6 mL/s. All models achieved intended flow rates. |
| Valve Integrity | Outcome: Successfully passed testing for valve integrity. |
| Catheter Interface Compatibility | Outcome: Successfully passed testing for compatibility with various interfaces. |
| Central Venous Pressure Monitoring | Outcome: Models with at least one non-valved lumen successfully demonstrated capability for central venous pressure monitoring. |
| Chemical / Vesicant Compatibility | Outcome: Successfully passed testing for compatibility with various chemicals/vesicants. |
| In-Vitro Thrombus Reduction | Outcome: Demonstrated enhanced resistance to blood component (platelet and thrombus) accumulation compared to commonly used PICCs. This was quantified via 2-hour blood loop testing. |
| In Vivo Thromboresistance Study | Outcome: Demonstrated enhanced resistance to blood component accumulation compared to a heparin-based thromboresistant control catheter over 14 and 31 days. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes (number of devices or animal subjects) used for each individual test (e.g., Luer connection strength, power injection, in-vitro blood loop, in-vivo ovine study). It only states that the testing was "successfully passed."
- Data Provenance: The studies are described as preclinical ("in vitro and in vivo models") and conducted by the sponsor (Navilyst Medical, Inc.) to support the 510(k) submission. The in-vivo study used an "ovine model," indicating animal testing. The country of origin for the data is not specified beyond being generated by the sponsor for a US FDA submission. The studies are prospective in design for the purpose of evaluating the device's performance against pre-defined criteria.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For the technical and performance tests (e.g., Luer connection, power injection, valve integrity, chemical compatibility), the "ground truth" is established by the specified engineering standards (ISO, FDA guidance) and internal product specifications. These usually involve objective measurements and calibrated equipment, rather than expert human interpretation.
- For the in-vitro and in-vivo thrombus reduction studies, the "ground truth" would be the measured thrombus accumulation. The document does not mention the involvement of external experts to establish this ground truth; it is assumed to be determined by the study investigators. No specific number or qualifications of experts are mentioned for establishing ground truth for any of the performance studies.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method (like 2+1 or 3+1 consensus) for the test sets. The performance evaluation relies on objective measurements against established standards and internal specifications, along with direct quantitative or comparative outcomes from in-vitro and in-vivo studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is a medical catheter, not an imaging AI diagnostic tool that would typically involve human readers interpreting images. The studies conducted are focused on the physical and biological performance of the catheter itself.
6. Standalone Performance Study (Algorithm Only)
Not applicable. The NMI PICC III is a physical medical device (catheter), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only without human-in-the loop performance)" does not apply.
7. Type of Ground Truth Used
The ground truth for the performance studies is based on:
- Objective Measurements: For tests like Luer connection strength, power injection flow rates, and central venous pressure monitoring capabilities, the ground truth is obtained through direct instrumental measurements.
- Compliance with Standards: Meeting the requirements of international standards (EN ISO 10555-1, EN ISO 10555-3, ISO 10993-1) and FDA guidance documents.
- In-vitro Quantifiable Data: For thrombus reduction, the ground truth is based on quantitative measurements of thrombus accumulation in in-vitro blood loop models.
- In-vivo Observational Data: For thromboresistance, the ground truth is derived from observations and measurements in an ovine animal model over specified indwelling times.
8. Sample Size for the Training Set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or artificial intelligence. The device's design and manufacturing processes are developed through engineering and material science principles, not through data-driven training sets.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this physical medical device.
§ 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.”