(171 days)
The Bard PowerFlow™ Implantable Apheress 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, I.V. fluids, parenteral nutrition solutions, blood and blood products.
The Bard PowerFlow™M Implantable Apheresis 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 Bard PowerFlow 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 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 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 catheters used with infusion ports are essentially the same design as externalized, stand-alone intravascular catheters. Once implanted, the method of accessing the subject Bard PowerFlow Apheresis IV Port is the exact same as the predicate Bard CathLink 20 Titanium 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 Peripheral IV 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 document describes the premarket notification for the "PowerFlow™ Implantable Apheresis IV Port" and its substantial equivalence to a predicate device. Below is an analysis of the acceptance criteria and the studies performed.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a direct table of acceptance criteria with quantitative thresholds for each test, followed by the reported device performance against those specific thresholds. Instead, it lists various performance tests and then states a general conclusion for each section.
However, based on the information provided, we can infer the acceptance criteria was that the device must meet the requirements of the listed standards and guidance documents, and demonstrate performance "substantially equivalent" to the predicate device.
Here's an inferred summary:
| Test/Characteristic | Inferred Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Mechanical/Physical Performance | Meet standards/guidance for: | "The subject device met all pre-determined acceptance criteria and demonstrated substantial equivalence as compared to the predicate device." This applies to: Port Subassembly Inspection, Port Subassembly MR Compatibility, Port Subassembly Radiopacity, Stem-Catheter Connection Air Leak, Peripheral IV Insertion Force, Peripheral IV Retention Force, Stem-Catheter Connection Tensile Strength, Stem-Catheter Connection Hydraulic Burst, Catheter Inspection, Catheter Radiopacity, Catheter Dimensions, Catheter Vacuum Collapse, Catheter Tensile Strength / Catheter Elongation, Catheter Hydraulic Burst, Tunneler-Catheter Connection Tensile, Gravity Flow Rate, Clearance Kinetics, Apheresis Flow Rate, Multiple Power Injection, Device System Burst (Power Injection), Recirculation, Hemolysis, Packaging Ship Testing, Silicone Boot Retention, Suture Retention, Stem Tensile Strength, Corrosion Resistance, Peripheral IV Catheter Duration. |
| Biocompatibility | Compliance with ISO 10993-1 and FDA Guidance for biocompatibility. | "All biological tests were conducted by Bard or by independent testing contract laboratories in accordance with Good Laboratory Practice (GLP) standards." All recommended tests (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Subchronic systemic toxicity, Genotoxicity, Hemocompatibility, Pyrogenicity, Subcutaneous implantation, Extractables and leachates) were conducted and evaluated. |
| Clinical Performance (Apheresis) | Safe and effective for long-term apheresis, comparable to predicate. | Clinical data from three studies on the predicate device (CATHLINK 20) are presented, showing: |
- Low complication rates (e.g., thrombotic occlusion rate of 0.16 per 1,000 catheter patient days).
- Median length of continuous port use of 45 months.
- Successful access by apheresis personnel (1.23 ± 0.6 attempts per port).
- Adequate whole blood and plasma flow rates.
- No adverse effects from use and no hospitalizations for plasma exchange. The report concludes that "Significant design similarities... suggest that this clinical data can provide reasonable expectations for the safety and effectiveness of the PowerFlow™ device." |
| Power Injectability | Meet safety and functionality for power injection. | "The same test methods and acceptance criteria utilized for the Bard Titanium PowerPort ISP Implanted Port cleared through K072215 was used." This implies the PowerFlow device met these criteria, specifically mentioning a maximum recommended infusion rate of 5 mL/s. |
| Substantial Equivalence | Device is substantially equivalent to the predicate device. | "Based on the indications for use, technological characteristics, performance testing and biocompatibility testing the subject PowerFlow Implantable Apheresis IV Port... demonstrates that the subject device is substantially equivalent to the predicate device." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set (Bench Testing/Non-Clinical): The document does not specify exact sample sizes for each of the numerous performance and biocompatibility tests. It broadly states that "Final, finished, sterile samples of the subject Bard PowerFlow Implantable Apheresis IV Port assembly were used for all recommended biocompatibility tests." For other tests (e.g., flow rates, tensile strength), standard engineering and quality control practices typically involve specific sample sizes to ensure statistical significance, but these are not enumerated in this summary.
- Data Provenance (Clinical - for Predicate Device):
- The clinical data presented is for the predicate device, CATHLINK 20, not the subject device (PowerFlow).
- The studies were retrospective or prospective clinical observations.
- Country of Origin: Not explicitly stated, but the referenced academic journals often span international research. The institutions involved in the studies (e.g., Pediatry Blood Cancer, J Clin Apher) suggest clinical settings, likely within professional healthcare systems.
- Study 1 (Raj et al.): 18 CATHLINK 20 ports implanted in 15 patients.
- Study 2 (Pertine et al.): Six patients.
- Study 3 (Gonzalez et al.): Four patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For Non-Clinical Tests (Performance & Biocompatibility): The "ground truth" for these tests are the established international standards and FDA guidance documents (e.g., ISO 10555-1, ISO 10993-1, ASTM standards, FDA guidances). The experts involved would be the engineers, scientists, and technicians at Bard Access Systems (or independent contract laboratories) who designed, performed, and interpreted these tests according to the specified methodologies. Their qualifications are not individually listed but are implied by their adherence to GLP standards and relevant regulatory frameworks.
- For Clinical Data (Predicate Device): The "ground truth" here is the clinical outcomes reported by the studies. The experts are the medical professionals (e.g., physicians, nurses, apheresis personnel) involved in conducting the studies, implanting the devices, performing procedures, and collecting data. Their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in this summary, but they are implied to be clinical specialists in relevant fields (e.g., hematology, neurology, apheresis).
4. Adjudication Method for the Test Set
- For Non-Clinical Tests: Adjudication is not typically performed by external experts in this context. The results are evaluated against predetermined acceptance criteria specified by the standards and internal protocols. Any discrepancies or failures would lead to further investigation and potentially design changes, followed by re-testing.
- For Clinical Data (Predicate Device): The document does not describe adjudication methods for the clinical studies of the predicate device. Clinical studies generally involve independent verification of data and outcomes, but specific adjudication processes (like 2+1 reads for imaging) are not mentioned as these were clinical outcome studies, not diagnostic device studies.
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 performed for this device. This type of study is primarily relevant for diagnostic imaging devices where different readers evaluate the same cases with and without AI assistance to measure reader performance improvement. The PowerFlow™ Implantable Apheresis IV Port is a medical device for vascular access, and its evaluation centers on physical performance, biocompatibility, and clinical outcomes for the intended use, not diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone (algorithm-only) performance study was not done. This concept is not applicable to an implantable vascular access port, which is a physical medical device and not an AI algorithm.
7. The Type of Ground Truth Used
- For Performance Tests (Mechanical, Flow Rates, etc.): The ground truth is based on objective measurements against engineering specifications and industry and regulatory standards.
- For Biocompatibility Tests: The ground truth is determined by the biological responses observed in standardized in-vitro and in-vivo tests, evaluated against established toxicity, irritation, and sensitization profiles defined by ISO 10993.
- For Clinical Data (Predicate Device): The ground truth is based on clinical outcomes data (e.g., complication rates, duration of use, successful access attempts, flow rates, patient-reported experiences) observed during the actual use of the predicate device in a patient population.
8. The Sample Size for the Training Set
This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and validation of the device rely on engineering principles, materials science, and conformity to established standards and clinical performance of predicate devices.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the AI/ML sense for this device, this question is not applicable. The "ground truth" for the device's design and validation is established through:
* Literature review and understanding of clinical needs (for indications).
* Engineering design specifications.
* Compliance with recognized national and international standards (e.g., ISO, ASTM).
* Performance data from similar legally marketed predicate devices.
§ 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.