(59 days)
The NMI Port II with and without PASV Valve Technology is 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 Port II is 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 Port II with and without PASV Valve Technology is 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.
NMI Port II is 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) 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 catheter shaft incorporates Endexo polymer for improved resistance to thrombus accumulation and/or formation on the catheter.
Here's an analysis of the acceptance criteria and study information for the NMI Port II, based on the provided text:
Acceptance Criteria and Device Performance for NMI Port II (K131694)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list quantitative acceptance criteria for each performance test. Instead, it states that the device "successfully passed relevant testing per the above Guidance, standards, and pre-established acceptance criteria." The identified performance tests and the reported outcome are:
| Performance Test Category | Acceptance Criteria (Explicitly Stated) | Reported Device Performance |
|---|---|---|
| General Compliance | Adherence to: | Successfully passed |
| - FDA Guidance (Oct 1990) | - FDA guidance on 510(k) Submissions | |
| - EN ISO 10555-1:2009 | - Standard requirements | |
| - EN ISO 10555-3:1997 COR 2002 | - Standard requirements | |
| - Biocompatibility (ISO 10993-1) | - Standard requirements | |
| Specific Performance Tests | Pre-established acceptance criteria | Successfully passed |
| - Internal Product Specification | (Not explicitly defined in document) | |
| - Power Injection | (Not explicitly defined in document) | |
| - Valve Integrity | (Not explicitly defined in document) | |
| - Catheter Compatibility | (Not explicitly defined in document) | |
| - Port Septum Testing | (Not explicitly defined in document) | |
| - Chemical / Vesicant Compatibility | (Not explicitly defined in document) | |
| - Thromboresistance | (Not explicitly defined in document) |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on the sample sizes used for any of the performance tests (Internal Product Specification, Power Injection, Valve Integrity, etc.).
It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature) for these tests. Based on the context of a 510(k) submission, these tests would typically be conducted by the manufacturer in a controlled laboratory setting (i.e., prospective engineering and bench testing) rather than involving human subject data from a specific country.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The disclosed information does not involve a "test set" in the context of expert-reviewed data (e.g., medical images). The "tests" mentioned are primarily engineering and bench performance evaluations of the device itself. Therefore, the concept of "experts used to establish ground truth" with specific qualifications like radiologists with years of experience is not applicable to the studies described. The ground truth for these engineering tests would be established by the physical and chemical properties of the device and its interaction with test fluids and equipment, according to established industry standards and internal specifications.
4. Adjudication Method for the Test Set
Since the studies described are engineering and bench tests rather than studies involving expert review of data, the concept of an "adjudication method" (like 2+1 or 3+1) is not applicable. The outcome of these tests would be determined by whether the device met the pre-defined engineering specifications and performance metrics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided document describes bench and engineering tests, not studies involving human readers or comparative effectiveness of AI (or any other technology) with or without human assistance.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical device (an implanted port catheter), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to evaluate.
7. The Type of Ground Truth Used
For the performance tests mentioned, the "ground truth" would be established by:
- Engineering Specifications: Internal product specification requirements.
- International Standards: The pass/fail criteria defined within EN ISO 10555-1, EN ISO 10555-3, and ISO 10993-1.
- Regulatory Guidance: The requirements outlined in FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports."
- Bench Test Results: Measurable outcomes from laboratory tests (e.g., pressure resistance during power injection, flow rates, material compatibility, integrity assessments).
8. The Sample Size for the Training Set
This question is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for a physical medical device.
§ 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.