(112 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 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 PowerLoc™ Safety Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle-stick safety mechanism. The device is used to access surgically implanted vascular ports. The PowerLoc™ Safety Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with the PowerPort™ device, the PowerLoc™ Safety Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 Ga. and 20 Ga. needles, and 2 ml/s for 22 Ga. needles.
PowerPort™ Implanted Titanium Port Device:
- The PowerPort™ Implanted Titanium Port is a titanium port with attachable open-ended, 45 cm, 8 Fr ChronoFlex® polyurethane catheter.
- The PowerPort™ is designed for power injection of contrast media when used with the power injectable PowerLoc™ SIS. Confirmation of PowerLoc™ and PowerPort™ as a requirement for power injection is directed in all associated literature.
- The purple color of the port body differentiates the PowerPort™ from other implantable vascular access ports, highlighting the power injectable capability of the PowerPort™.
- The unique shape of the PowerPort™ (three sided port with three septum bumps) aids in identification.
PowerLoc™ SIS Device:
- The PowerLoc™ Safety Infusion Set is a standard non-coring Huber type needle and administration set with an integral safety needle-stick prevention feature.
The provided document is a 510(k) summary for the PowerPort™ System, which includes the PowerPort™ Implanted Titanium Port and the PowerLoc™ Safety Infusion Set. This document is a premarket notification for a medical device and therefore describes a non-clinical (bench) study rather than a clinical study involving human subjects. It focuses on demonstrating substantial equivalence to predicate devices and meeting performance criteria based on established FDA guidance and international standards.
Acceptance Criteria and Device Performance for PowerPort™ System
The PowerPort™ System (comprising the PowerPort™ Implanted Port and PowerLoc™ Safety Infusion Set) met all established acceptance criteria for performance testing and design verification testing, demonstrating substantial equivalence to its respective predicates. The key acceptance criteria revolve around the expanded indication for power injection of contrast media.
The original document does not contain a specific table detailing "Acceptance Criteria" and "Reported Device Performance" in a direct comparative format as might be found in a clinical study report. However, based on the provided text, the acceptance criteria are implicitly derived from the FDA guidance documents and international standards referenced, and the reported device performance is that it met these criteria.
Here's an interpretation of the acceptance criteria and implied performance based on the document's content:
| Acceptance Criterion | Performance Metric/Test | Reported Device Performance | Study Type/Reference Standard |
|---|---|---|---|
| PowerPort™ Implanted Port: | |||
| Substantial Equivalence to Predicate | Overall design, material, function for vascular access | Met accepted scientific methods and data demonstrating equivalence to predicate Implanted Titanium Port (K050310). | FDA Guidance on 510(k) Submissions for Implanted Infusion Ports (Oct 1990) |
| Power Injection Capability | Maximum recommended infusion rate of 5 ml/s when used with PowerLoc™ SIS for contrast media. | Met. | Design Verification Testing |
| Biocompatibility | Biological safety for an implanted device. | Met ISO-10993, Biological Evaluation of Medical Devices Part-1. | ISO-10993, Part-1 |
| Sterilization | Ensure sterility of the device. | Met ISO 11135:1994, Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization. | ISO 11135:1994 |
| PowerLoc™ Safety Infusion Set: | |||
| Substantial Equivalence to Predicate | Overall design, material, function for intravascular administration, and safety features. | Met accepted scientific methods and data demonstrating equivalence to predicate MiniLoc™ Safety Infusion Set (K050600). | FDA Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (Apr 2005); ODE Supplementary Guidance on Premarket Notifications for Medical Devices with Sharps Injury Prevention Guards (Dec 2002) |
| Power Injection Capability (19 Ga., 20 Ga. needles) | Maximum recommended infusion rate of 5 ml/s. | Met. | Design Verification Testing |
| Power Injection Capability (22 Ga. needles) | Maximum recommended infusion rate of 2 ml/s. | Met. | Design Verification Testing |
| Biocompatibility | Biological safety for a device in contact with the vascular system. | Met ISO-10993, Biological Evaluation of Medical Devices Part-1. | ISO-10993, Part-1 |
| Sterilization | Ensure sterility of the device. | Met ISO 11135:1994, Medical Devices – Validation and Routine Control of Ethylene Oxide Sterilization. | ISO 11135:1994 |
1. A table of acceptance criteria and the reported device performance
See table above.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document describes "verification testing performed according to protocols," but it does not specify the exact sample sizes (e.g., number of ports or infusion sets) used for these engineering tests. This is typical for bench testing summaries in 510(k) applications, where the focus is on the methodology's rigor rather than statistical power from a large 'test set' of clinical cases.
- Data Provenance: The data is generated from non-clinical (bench) performance testing and design verification testing conducted internally by Bard Access Systems, Inc. (BAS) located in Salt Lake City, UT, USA. The data is prospective in the sense that these tests were performed specifically for this 510(k) submission, but it's not "prospective" in the clinical trial sense. The country of origin of the data is the United States.
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 is a non-clinical (bench) testing summary for a medical device. There are no "experts" in the sense of medical professionals establishing a ground truth for a test set of medical images or patient data. The "ground truth" for these engineering tests is established by the specifications defined in the referenced FDA guidances and ISO standards (e.g., a specific pressure or flow rate should be sustained without failure). The expertise lies in the engineers and quality assurance personnel who designed and executed the tests and analyzed the results according to these predefined criteria. Their qualifications are not specified in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document describes non-clinical, engineering (bench) testing, not a study involving human interpretation or adjudication of results. The results are typically quantitative measurements against predefined 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
- Not applicable. This document relates to a physical medical device (implantable port and infusion set), not an AI-powered diagnostic system. Therefore, no MRMC study, AI assistance, or human reader improvement was evaluated.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This document is about a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance testing is based on established engineering specifications, performance standards, and regulatory guidance documents (e.g., required sterilization levels, biocompatibility, maximum flow rate capacity without failure). It's a quantitative "ground truth" derived from industry and regulatory standards, not clinical outcomes or expert consensus on medical findings.
8. The sample size for the training set
- Not applicable. This document describes non-clinical performance and design verification testing of a physical medical device. There is no "training set" in the context of machine learning or AI models. The testing described is analogous to validation testing against predefined specifications.
9. How the ground truth for the training set was established
- Not applicable. As there is no "training set," the establishment of its ground truth is also not relevant. The "ground truth" for the test data (i.e., the performance testing) was established by adherence to FDA guidance documents and international standards for medical device design verification and performance evaluation.
§ 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.