(232 days)
The NMI Ports with and without PASV Valve Technology are indicated for patients who require long-term 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 Ports are indicated for power injection of contrast media. The maximum recommended infusion rate is 5 ml/sec with a 19G or 20G noncoring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
The NMI Ports are subcutaneous implantable venous access devices with one reservoir and are 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.
NMI Ports are available in plastic or titanium single lumen and valved or non-valved 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) as a power injectable port. 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 provided text is a 510(k) summary for the NMI Port, an implanted infusion port. As such, it describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating the device's diagnostic performance or comparative effectiveness against human readers.
Therefore, the information requested in your prompt regarding acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, standalone performance, and AI-related metrics is not available in the provided document. The device in question is a medical hardware component, not an AI-powered diagnostic tool.
However, I can extract the information related to the performance data and "acceptance criteria" (in this context, meaning successful completion of specified tests for product safety and functionality) as described in the 510(k) submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Test/Standard) | Reported Device Performance |
|---|---|
| Internal Product Specification Requirements | Successfully passed relevant testing |
| Power Injection | Successfully passed relevant testing |
| Valve Integrity | Successfully passed relevant testing |
| Port Septum Testing | Successfully passed relevant testing |
| Chemical/Vesicant Compatibility | Successfully passed relevant testing |
| Biocompatibility (per ISO 10993-1) | Successfully passed relevant testing |
| EN ISO 10555-1:2009 (Sterile, Single Use Intravascular Catheters - Part 1: General Requirements) | Successfully passed relevant testing |
| EN ISO 10555-3:1997 COR 2002 (Sterile, Single Use Intravascular Catheters Part 3: Central Venous Catheters) | Successfully passed relevant testing |
| FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports dated October 1990" | Successfully passed relevant testing (compliance with guidance) |
| FDA's "Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheter dated March 16, 1995" | Successfully passed relevant testing (compliance with guidance) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document refers to "relevant testing" without detailing the number of units tested for each criterion.
- Data Provenance: The tests were conducted according to FDA guidance documents and international standards. The document doesn't specify countries of origin for test data, but typically such testing is performed in accredited labs, often within the manufacturer's region (Marlborough, MA, USA for the sponsor). The nature of these tests (e.g., power injection, valve integrity) suggests laboratory-based, prospective testing of manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the study involves physical device testing against engineering and biocompatibility standards, not the establishment of ground truth from expert clinical interpretation.
4. Adjudication method for the test set:
- This is not applicable for the type of performance testing described. Adjudication methods are typically relevant for human interpretation of medical images or clinical data.
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:
- No. This is an implanted medical device, not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm, but a physical medical device. The "standalone" performance refers to the device's operational characteristics as tested (e.g., flow rates, septum integrity).
7. The type of ground truth used:
- The "ground truth" for this type of device testing consists of established engineering specifications, safety standards (e.g., ISO 10993-1 for biocompatibility), and performance limits defined by the guidance documents mentioned (e.g., maximum infusion rates, pressure limits). The device either met these predefined, objective criteria or it did not.
8. The sample size for the training set:
- Not applicable. There is no AI model or algorithm being trained described in this document.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI model.
§ 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.