(28 days)
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 maximum power injection flow rate for the NMI HPICC III is 6 mL/sec.
The NMI HPICC III are flexible radiopaque catheters with suture wings for catheter securement, extension tubes(s) which connect to proximally located luer lock adapter(s) with two pressure activated safety valves (PASV™), available in a triple lumen configuration; a reverse tapered shaft to aid in staunching bleeding at the insertion site and a non-valved lumen for central venous pressure monitoring.
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.
The NMI HPICC III is 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).
The catheters are available as single, sterile packages with a variety of procedural accessories in standard kit configurations and as a convenience to suite specific clinical needs.
Here's an analysis of the provided text regarding the NMI HPICC III, focusing on acceptance criteria and the supporting study:
The provided document, K122882, is a 510(k) Summary for a medical device (NMI HPICC III) and details its substantial equivalence to predicate devices. As such, it primarily focuses on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing new, standalone effectiveness criteria through clinical trials.
Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, ground truth types for AI, etc.) are not applicable to this type of submission, which relies on non-clinical performance data and comparison to predicates.
Here's a breakdown of the information that is available based on your request:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance and How it Meets Criteria |
|---|---|---|
| General Catheter Design & Function | Substantial equivalence to predicate devices in terms of materials, design, components, and technological characteristics. | "The proposed device has similar materials, design, components and technological characteristics as the predicate intravascular catheters." |
| "The NMI HPICC III is substantially equivalent to predicate devices based on comparison of technological characteristics and the results of non-clinical tests." | ||
| Intended Use | Indicated for short- or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, and power injection of contrast media. Non-valved lumens for central venous pressure monitoring. | Device indications align exactly with the intended use statement. This is a functional requirement met by the device's design. |
| Power Injection Capabilities | Rated for maximum power injector settings up to 325 psi with maximum power injection flow rate up to 6 ml/second. | The device is designed with this capability and states "The maximum power injection flow rate for the NMI HPICC III is 6 mL/sec." The performance data included a "Power Injection" test. |
| Catheter Features (Common with Predicates) | - Flexible radiopaque catheters |
- Suture wings for securement
- Extension tubes with luer lock adaptors and two pressure activated safety valves (PASV™)
- Triple lumen configuration (available)
- Reverse tapered shaft
- Non-valved lumen for CVP monitoring
- Multi-lumen configurations with 6 Fr outside diameter
- Available kitted with procedural accessories | The device description outlines these features as inherent to the NMI HPICC III. The "Summary of Similarities and Differences" explicitly states these are shared with predicate devices, implying these are accepted design features for this type of catheter. |
| Biocompatibility | Compliant with ISO-10993-1. | "Biocompatibility per ISO-10993-1" is listed as one of the non-clinical tests conducted, indicating compliance. |
| Physical/Mechanical Properties (Non-Clinical Standards) | Compliant with: - EN ISO 10555-1:2009 (Sterile, Single use intravascular catheters – Part 1: General Requirements)
- EN ISO 10555-3:1997 COR 2002 (Sterile, Single-Use Intravascular Catheters Part 3: Central Venous Catheters)
- FDA's "Guidance on Premarket Notification [510(K)] Submissions for Short-Term and Long-Term Intravascular Catheters dated March 16, 1995" | The "Performance Data" section explicitly states that performance evaluation was conducted "in accordance with the following FDA guidance document, international standards and testing," and lists these ISO standards and FDA guidance. This implies the device met the requirements outlined in these documents for characteristics like material integrity, sterility, etc. |
| Additional Specific Performance | - Luer Connection / Strength - Catheter Interface Compatibility
- Central Venous Pressure Monitoring (for non-valved lumens)
- Internal Product Specification Requirements | These are listed as "testing which included" items in the Performance Data section, indicating that the device was tested against and met internal and industry-standard specifications for these critical performance aspects. |
Study Details
Given this is a 510(k) submission based on substantial equivalence and non-clinical testing, specific details applicable to clinical studies or AI algorithm validation are mostly not applicable (N/A).
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Sample sizes used for the test set and the data provenance:
- N/A. The submission relies on non-clinical (bench) testing, not a "test set" of patient data for AI validation or clinical trials in the traditional sense. The provenance would be the test labs/facilities where the bench testing was performed.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This information pertains to studies where human experts annotate data for AI model training or evaluation. This submission does not involve such a study. Bench tests usually follow industry standards and internal specifications, and "ground truth" is typically defined by the test parameters themselves (e.g., a certain force applied, a specific flow rate observed).
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Adjudication method for the test set:
- N/A. Adjudication is relevant for reconciling expert opinions, which isn't applicable here.
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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 device is a catheter, not an AI diagnostic tool. No MRMC study was performed on human readers using this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI algorithm. Its performance is inherent to its physical and functional characteristics.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering/Bench Test "Ground Truth": For the non-clinical tests mentioned, the "ground truth" refers to the established specifications, standards, and expected performance levels defined by the ISO standards (e.g., EN ISO 10555-1, EN ISO 10555-3), FDA guidance, and internal product specifications. For instance, for "Power Injection," the ground truth is that the device should safely withstand and facilitate flow at 6 mL/sec. For "Biocompatibility," the ground truth is compliance with ISO 10993-1.
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The sample size for the training set:
- N/A. This information is for AI algorithm development.
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How the ground truth for the training set was established:
- N/A. This information is for AI algorithm development.
In summary: The K122882 submission for the NMI HPICC III asserts substantial equivalence to predicate devices based on extensive non-clinical (bench) testing that demonstrates compliance with relevant international standards and FDA guidance documents. The "acceptance criteria" are effectively those defined by the referenced standards and the characteristics of the predicate devices. The "study" is the collection of these non-clinical tests. This type of submission does not involve clinical trials, AI, or expert consensus in the same way a diagnostic device would.
§ 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.”