(28 days)
The NMI Port and NMI Port II with and without PASV Valve Technology are indicated for patients who require longterm access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal. When used with a power injectable needle, the NMI Port II are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
The NMI Port and NMI Port II with and without PASV Valve Technology are a subcutaneous implantable venous access device with one reservoir and is designed for optional power injection of contrast media, CECT. The ports are designed to be accessed using a non-coring Huber needle introduced through the skin into the self-sealing silicone septum covering the reservoir. The NMI Port and NMI Port II are available in plastic or titanium single lumen and valved or nonvalved configurations. The ports are available with either silicone filled or non-filled suture fixation holes. Ports with non-filled suture fixation holes are generally utilized based on clinical need to anchor the port to the subcutaneous tissue; whereas ports with filled suture holes, designed to prevent tissue in-growth to the suture holes, are generally utilized when not anchoring the port to the subcutaneous tissue. If needed, filled suture holes are accessed through the silicone. All port configurations have a radiopaque identifier (CT mark) to identify the port as power injectable. The radiopaque catheter has graduated marks at 1 centimeter intervals and can be cut to the desired length by the clinician. Ports are provided with a variety of procedural accessories. The NMI Port II catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.
This document is a 510(k) premarket notification for a medical device, specifically, the NMI Port and NMI Port II, which are subcutaneous implantable venous access devices. The purpose of this type of submission is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to prove its clinical effectiveness in AI-assisted diagnosis.
Therefore, the information typically requested for AI/ML device studies (such as MRMC studies, expert qualifications, ground truth establishment for training sets, etc.) is not applicable to this document. This document focuses on the physical and performance characteristics of an implantable medical device.
However, I can extract the acceptance criteria and performance data related to the device's physical and functional properties based on the provided text.
1. Table of acceptance criteria and the reported device performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Power Injection and Burst | Port assembly must withstand 15 power injection cycles without any failures (leaking, fracturing and bursting) with an 11.8cp fluid at 300 psi maximum pressure setting and a 5 mL/sec flow rate setting for a 19 or 20 ga infusion set, and a 2 mL/sec flow rate setting for a 22 g infusion set. The port must then have a static burst strength of 50 psi minimum. Record burst strength. | All samples tested met the acceptance criteria. Average static burst pressures were 138.7, 148.8 and 149.2 psi. |
| Aspiration Strength - Open Ended | Port must be able to be aspirated (no occlusions or wall collapses preventing aspiration) using a 10 mL syringe on an open ended catheter without leaking or bursting post 4 hour conditioning at 37°C +/- 2ºC. Record as PASS/FAIL. | All samples tested met the acceptance criteria. |
| Aspiration Strength - Closed Ended | No leaks during aspiration with a 10 mL syringe for 15 seconds (leak = ingress of air bubbles to the syringe) post 4 hour conditioning at 37°C +/- 2°C without leaking or bursting on an occluded catheter. Record as PASS/FAIL. | All samples tested met the acceptance criteria. |
| CT Ink Durability | CT printing shall not flake or chip off. Additional requirements: soaking port in saline at body temperature for 24 hours and perform an alcohol rub. Record as PASS/FAIL. | All samples tested met the acceptance criteria. |
| Port body height | 1.29 +/- 0.21 cm | All samples tested met the acceptance criteria (implying measurements were within the specified range, though specific measurements are not provided beyond 'met criteria'). |
| Port Body Break Strength | Must not break at less than 636 lb force. Record as PASS/FAIL. | All samples tested met the acceptance criteria. |
2. Sample size used for the test set and the data provenance:
- Power Injection and Burst Test: 3 lots of 15 each (45 total).
- Aspiration Strength - Open Ended Test: 3 lots of 75 each (225 total).
- Aspiration Strength - Closed Ended Test: 3 lots of 75 each (225 total).
- CT Ink Durability Test: 3 lots of 75 each (225 total).
- Port body height Test: 3 lots of 75 each (225 total).
- Port Body Break Strength Test: 3 lots of 75 each (225 total).
Data Provenance: The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective or prospective clinical data. However, given this is an engineering and material performance test for a 510(k) submission, the "data" refers to physical measurements and tests conducted on manufactured device samples, not patient data. These are likely prospective tests conducted on new production lots.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This document does not describe the use of human experts to establish "ground truth" for a test set in the context of diagnostic performance. The tests are engineering and material performance assessments, likely conducted by qualified testing personnel or automated equipment, following established international standards (EN ISO 10555-1:2013, EN ISO 10555-3:2013) and FDA guidance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is not a study involving human interpretation or adjudication of diagnostic images or clinical outcomes.
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:
Not applicable. This document is for an implantable medical device (infusion port), not an AI/ML diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This document is for an implantable medical device, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" in this context refers to the defined physical and functional specifications and performance standards established for the device. These are objective measurements (e.g., burst pressure, freedom from leaks, physical dimensions, breaking force) and visual inspections (e.g., no flaking/chipping of ink). The "truth" is determined by whether the device's performance meets these pre-established quantitative and qualitative acceptance criteria. It's based on engineering principles and regulatory standards.
8. The sample size for the training set:
Not applicable. There is no AI/ML model training discussed in this document.
9. How the ground truth for the training set was established:
Not applicable. There is no AI/ML model training discussed in this document.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.