(266 days)
The PowerPort® implanted port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a 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.
PowerPort® Implantable Ports are designed to provide repeated access to the vascular system without the need for repeated venipuncture or daily care of an external catheter. Long-Term Implantable Ports consist of a rigid housing and a self-sealing septum. The catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Polyurethane catheters are attached to the port by the physician during implantation.
PowerPort® Implantable Ports can be used for routine vascular access using a non-coring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a power-injectable system.
The ChronoFlex® Polyurethane Catheters maintain an average root mean square catheter surface profilometry of less than 0.5µm.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Catheter Surface Profilometry (RMS Value) | ≤ 0.5µm |
| Maximum Recommended Infusion Rate for Power Injection of Contrast Media | 5 mL/s |
| Compliance with FDA Guidance Documents and ISO Standards | Met all pre-determined acceptance criteria |
| Biocompatibility | Met all pre-determined acceptance criteria |
| Sterilization | Met all pre-determined acceptance criteria |
| Packaging | Met all pre-determined acceptance criteria |
| Bacterial Endotoxins | Met all pre-determined acceptance criteria |
| MRI Safety | Met all pre-determined acceptance criteria |
| Overall Substantial Equivalence to Predicate Device | Demonstrated substantial equivalence |
Study Details
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Sample sizes used for the test set and the data provenance:
- The document does not explicitly state specific sample sizes for the test set or the number of units tested for each criterion. It mentions "Verification and validation activities were designed and performed in accordance with Design Controls as per 21 CFR §820.30."
- Data Provenance: Not specified, but given it's a submission to the US FDA by a US-based company (Bard Access Systems, Inc. in Salt Lake City, Utah), it's highly likely the pre-clinical testing was conducted in the US. The document does not indicate if the data is retrospective or prospective, but as it pertains to device performance testing before market approval, it would be considered prospective data generation for the purpose of the submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The document describes engineering and performance testing based on standards, not studies involving human interpretation or clinical ground truth establishment in the typical sense of AI/reader studies.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable and therefore not provided. The testing described is for physical device performance and adherence to standards, not for expert-based assessment that would require adjudication.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for AI diagnostic or decision support tools, where human readers interact with AI. The device in question is a physical medical device (implantable port and catheter), not an AI system.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. The device is a physical product, not an algorithm. The "standalone" performance here refers to the device's physical and functional attributes.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is established by engineering specifications, validated measurement methods, and compliance with recognized industry standards and FDA guidance documents for medical devices (e.g., ISO 10555, AAMI/ANSI/ISO 10993, ASTM F2503). The listed performance tests (e.g., surface profilometry, infusion rate, biocompatibility) are measured against these pre-defined, objective standards.
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The sample size for the training set:
- Not applicable. The device is a physical medical device, not a machine learning algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As the device is not an AI algorithm, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.