(56 days)
The PowerPort™ Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anti-cancer medicines (chemotherapy), I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with the PowerLoc™ Safety Infusion Set, the PowerPort™ device is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s.
The PowerPort™ Implantable Port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a PowerLoc™ Safety Infusion Set only. The PowerPort™ Implantable Port consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of the septum, which may include three palpation bumps arranged in a triangle, and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort™ Implantable Ports can be identified subcutaneously by feeling the top of each septum; each septum may feature three palpation bumps arranged in a triangle.
The provided FDA 510(k) clearance letter and summary discuss the substantial equivalence of the PowerPort™ Implantable Ports to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of a diagnostic or AI-assisted system performance.
The document is a premarket notification for a medical device (implantable ports) and focuses on demonstrating that the new device is substantially equivalent to existing legally marketed predicate devices. This is a regulatory pathway for devices that do not require clinical trials of the same rigor as novel devices or those with significant changes in technology.
Therefore, many of the requested elements, such as "test set," "ground truth," "MRMC study," "effect size of human readers," and "training set," are not applicable to this type of submission for a physical medical device. The "acceptance criteria" discussed are related to physical performance and material equivalence, not diagnostic accuracy.
However, I can extract the information that is available from the document regarding the device's assessment.
Acceptance Criteria and Device Performance (for physical device modifications)
The study performed is primarily design verification testing to ensure the modifications (dimensional changes, shelf-life extension, alternative locking solutions) do not negatively impact the device's safety and effectiveness compared to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance specifications that were verified. The "Reported Device Performance" column essentially states that the device "performed as intended by meeting product performance specifications." The precise numerical acceptance criteria and specific reported values are not fully detailed in this summary but are implied to have been met.
| Acceptance Criteria (Verification/Validation Method) | Reported Device Performance |
|---|---|
| Stem-Catheter Connection Air Leak Test (NF S 94-370) | Performed as intended, meeting specifications. |
| Stem-Catheter Connection Tensile (NF S 94-370) | Performed as intended, meeting specifications. |
| Stem-Catheter Air Burst (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Port Subassembly Air Leak (FDA Implanted Infusion Port Guidance, NF S 94-370) | Performed as intended, meeting specifications. |
| Lateral Stem Tensile Strength (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Port Subassembly Tensile Strength (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Multiple Power Injections (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Port System Burst, Power Injection (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Catheter Flow Rate (ISO 10555-3, BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Septum Obturation (NF S 94-370) | Performed as intended, meeting specifications. |
| Needle Retention Tensile Strength (NF S 94-370) | Performed as intended, meeting specifications. |
| Stem Catheter Leak I (NF S 94-370) | Performed as intended, meeting specifications. |
| Stem Catheter Leak II (NF S 94-370) | Performed as intended, meeting specifications. |
| Stem Catheter Burst (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Port Sub-assembly Air Burst (FDA Implanted Infusion Port Guidance) | Performed as intended, meeting specifications. |
| Catheter Air Burst (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
| Catheter Tensile Strength (ISO 10555-1, ASTM D412) | Performed as intended, meeting specifications. |
| Port System Flow Rate (BAS Internal Test-Method) | Performed as intended, meeting specifications. |
2. Sample size used for the test set and the data provenance
The document does not specify a discrete "test set sample size" or "data provenance" in the typical sense of a clinical or image-based AI study. The evaluation consists of design verification testing on manufactured units of the device and its components. This testing is conducted on physical samples of the device undergoing mechanical, material, and functional assessments. The provenance is internal to the manufacturer (Bard Access Systems, Inc.). The testing involved simulating aging, exposure to ethylene oxide sterilization, and simulated shipping.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This concept is not applicable to this type of device submission. Ground truth, in the context of diagnostic accuracy, is not directly relevant for the physical performance testing of an implantable port. The "truth" is determined by established engineering standards and test methods.
4. Adjudication method for the test set
This concept is not applicable as it relates to expert review of diagnostic findings, which is not part of this device's evaluation. Performance is assessed against quantitative engineering specifications.
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, an MRMC comparative effectiveness study was not done. This is a physical medical device (implantable port), not a diagnostic imaging or AI assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not an algorithm-based device. It is a physical implantable medical device.
7. The type of ground truth used
For the aspects of the device that are being verified (physical performance, material compatibility, and fluid dynamics), the "ground truth" is established through:
- Established engineering standards and test methods (e.g., NF S 94-370, ISO 10555-3, ASTM D412).
- Internal test methods developed by Bard Access Systems, Inc.
- Compliance with FDA guidance for implanted infusion ports.
- Referenced industry standards like "Infusion Therapy Standards of Practice, 9th Edition (2024)" for locking solutions.
8. The sample size for the training set
This concept is not applicable as this is a physical medical device submission, not an AI/algorithm-based device that would require training data.
9. How the ground truth for the training set was established
This concept is not applicable for the same reasons as above.
§ 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.