(94 days)
The Bard PowerFlow™ Implantable Apheresis IV Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for long-term therapeutic apheresis, withdrawal of blood, and infusion of medications, IV fluids, parenteral nutrition solutions, blood and blood products.
The Bard PowerFlow™M Implantable Apheress IV Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.
The PowerFlow™ Implantable Apheresis IV Port with 9.6 Fr. ChronoFlex™ Catheter is designed to provide repeated access to the vascular system without the need for repeated venipuncture or the daily care of an external catheter. The PowerFlow™ Implantable Apheresis IV Port is a low profile totally implantable, angled access titanium port-based design and is accessed through an angled opening which consists of a funnel shaped entrance designed to guide the peripheral intravenous (P.I.V.) access needle and catheter into the subject device. The PowerFlow™ Implantable Apheresis IV Port comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The PowerFlow™ Implantable Apheresis IV Port and necessary kit components are provided sterile (EtO).
The overall implanted system consists of three primary components: the port body with a silicone layered septum, an attachable radiopaque polyurethane catheter lock which secures the catheter to the port body stem. The method of implantation and access of the subject PowerFlow™ Implantable Apheresis IV Port is the exact same as the predicate PowerFlow™ Implantable Apheresis IV Port device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped angled entry funnel. Once the funnel is palpated, providing the location of the introducer needle access path, the 14 or 16Ga introducer needle is inserted into the funnel. After the Introducer Needle Stop is reached, the Introducer Needle is pulled back slightly and the P.I.V. Catheter is advanced forward. The P.I.V. Catheter is then advanced through the silicone layered septum and the Introducer Needle is removed. After needle removal, the P.I.V. Catheter is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.
The PowerFlow™ Implantable Apheresis IV Port can be used for routine vascular access infusion or withdrawal using a BD Insyte™ Autoguard™ Shielded IV Catheter. For power injection infusion procedures, the subject device can be accessed with a power injection rated IV catheter to create a power-injectable system.
This is a 510(k) summary for a medical device and therefore does not include the detailed information typically found in a clinical study report that directly proves the device meets acceptance criteria. The document asserts substantial equivalence to a predicate device based on performance tests and technological comparisons, rather than a prospective clinical study involving human patients.
However, based on the provided text, here's what can be extracted and inferred regarding "acceptance criteria" and "proof":
1. A table of acceptance criteria and the reported device performance:
The document states: "The results demonstrate that the subject device met all pre-determined acceptance criteria and that it performs equivalently to the predicate device." However, the specific quantitative acceptance criteria for each test and the precise reported device performance are not explicitly provided in a table format. The tests performed are listed, indicating that for each of these, acceptance criteria existed and were met.
| Acceptance Criteria (Inferred from tests) | Reported Device Performance (Inferred) |
|---|---|
| Port Subassembly Radiopacity met | Met pre-determined acceptance criteria |
| Corrosion Resistance acceptable | Met pre-determined acceptance criteria |
| Silicone Boot Retention acceptable | Met pre-determined acceptance criteria |
| Stem Tensile Strength acceptable | Met pre-determined acceptance criteria |
| Stem-Catheter Connection Air Leak acceptable | Met pre-determined acceptance criteria |
| Valve Life acceptable | Met pre-determined acceptance criteria |
| Cytotoxicity acceptable | Biocompatible, toxicologically equivalent to predicate |
| Chemical Characterization acceptable | Biocompatible, toxicologically equivalent to predicate |
| Sterility Assurance Level met (EtO) | Adopted into validated sterilization cycle |
| Endotoxin (LAL) acceptable | Will be routinely performed (implies initial testing was acceptable or routine check confirms this) |
| EO residual testing acceptable | Will be routinely performed (implies initial testing was acceptable or routine check confirms this) |
| Implantation - 13 week intramuscular acceptable | Acceptable (leverages data from same MIM titanium material) |
| Implantation - 13 week bone acceptable | Acceptable (leverages data from same MIM titanium material) |
| Sensitization acceptable | Acceptable (leverages data from same MIM titanium material) |
| Intracutaneous irritation acceptable | Acceptable (leverages data from same MIM titanium material) |
| Acute systemic toxicity acceptable | Acceptable (leverages data from same MIM titanium material) |
| Genotoxicity (Ames) acceptable | Acceptable (leverages data from same MIM titanium material) |
| Genotoxicity (Chromosomal Aberrations) acceptable | Acceptable (leverages data from same MIM titanium material) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only lists the types of tests performed.
- Data Provenance: The tests are described as "verification tests" and "non-clinical testing of medical devices," implying they were conducted in a laboratory setting. There is no mention of human subject data, so it is not retrospective or prospective in that sense. The "provenance" refers to the manufacturer's internal testing or contracted lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This information pertains to studies where human experts establish ground truth, typically in AI/ML performance evaluations or clinical trials. This document describes non-clinical engineering and biocompatibility testing. The "ground truth" for these performance tests is based on established engineering standards, guidance documents, and internal risk assessment procedures.
4. Adjudication method for the test set:
- Not applicable. This applies to expert review processes, which are not relevant for the described non-clinical performance and biocompatibility testing. The "adjudication" is determined by whether the test results meet the pre-defined acceptance criteria based on scientific and engineering principles.
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 is a non-AI medical device (an implantable port). MRMC studies are relevant for diagnostic AI tools involving human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used:
- For the performance tests (e.g., radiopacity, corrosion resistance, tensile strength, air leak, valve life, silicone boot retention): The "ground truth" is defined by predetermined acceptance criteria based on engineering standards, guidance documents, and internal risk assessments. This is a form of engineering/technical specification compliance.
- For biocompatibility tests (cytotoxicity, chemical characterization, sensitization, etc.): The "ground truth" is established by scientifically validated methods and endpoints that assess the material's interaction with biological systems according to ISO and ASTM standards and regulatory guidance for biocompatibility. Leveraging data from a component made of the same MIM titanium material suggests that the material properties are the ground truth for biocompatibility conclusions.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML product and does not involve a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set for this 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.