Search Results

The TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for 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 TidalPort-AP™ Implantable Apheresis Vascular Access Port is indicated for power injection of contrast media. For power injection of contrast media, the maximium recommended infusion rate is 5 mL/s.

The TidalPort-AP™ has one port size (Standard) and one catheter size (9.6F Polyurethane). It 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 TidalPort-APTM is available as a standard profile totally implantable, titanium port-based design and is accessed perpendicularly to the skin like a typical, conventional access port. For the purpose of apheresis, high-flow procedures, it is accessed with using the FDA Cleared 16G or 18G high-flow, non-coring needle Tidal High-Flow Non-coring Needle (K151341).

The TidalPort-APTM can also be used for routine vascular access infusion or withdrawal using Huber point needle. For power injection infusion procedures, the subject device can be accessed with a power injection rated needle to create a power-injectable system.

The design of the TidalPort-AP™ utilizes a spherical reservoir and an elongated radius contoured septum to achieve the design purpose of creating a port with a smaller reservoir and less clearance volume. The TidalPort-APTM comes with a number of kit components to aid in the implantation procedure and/or access of the device once implanted. The TidalPort-AP™ and necessary kit components are provided sterile (EtO).

The overall implanted port system consists of three primary components: the titanium port body with a silicone septum, an attachable radiopaque polyurethane catheter, and a catheter lock which secures the catheter to the port body stem. Once implanted, the method of accessing the subject TidalPort-APTM device is the exact same as the predicate TidalPort™ device. After the implanted device has been identified and access is prepped per institutional policy, the user palpates the uniquely shaped port. Once the port is palpated, providing the location of the septum, the 16G or 18G high-flow needle (K151341) is inserted into the reservoir for apheresis procedure use. After the reservoir floor is reached, the stylet is unlocked and pulled back slightly, and the needle is once again advanced forward until contacting the reservoir floor again. The stylet is then completely removed, leaving the hollow cannula with luer lock fitting in place. After stylet removal, the cannula is attached to the appropriate extension set and secured for the necessary infusion or withdrawal procedure.

The provided text describes a 510(k) premarket notification for the TidalPort-AP™ Implantable Apheresis Vascular Access Port. This document details the device's indications for use, technological characteristics, and non-clinical tests performed to demonstrate substantial equivalence to predicate devices. However, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment in a format typically used for evaluating the performance of AI/ML-driven devices.

The document focuses on engineering and material performance testing of a physical medical device, not a diagnostic or prognostic AI/ML algorithm. Therefore, many of the requested fields are not applicable in this context.

Here's an attempt to extract the relevant information based on the provided text, while acknowledging the limitations:

1. A table of acceptance criteria and the reported device performance

The document lists performance tests but does not explicitly state quantitative "acceptance criteria" and "reported performance" in a structured table for each test. It states that "The TidalPort-AP™ Implantable Apheresis Vascular Access Port has met all predetermined acceptance criteria of design verification evaluations through testing examination." This implies that the device did meet the criteria for each performed test.

Key Performance Tests Mentioned:

• Catheter to Port Connection
• Catheter Tensile Strength
• Radiopacity
• Gravity Flow Rate
• Port System Burst under Power Injection
• Stem Tensile Strength
• Corrosion Resistance
• Septum Puncture / Port Leak (w/both Huber point and 2-part large bore needles)
• Port Clearance Volume
• Power Injection / Multi-Power Injection
• Simulated Apheresis Testing- comparison to predicate (PowerFlow)
• Recirculation, Forward and Reverse Flow- comparison to predicate (PowerFlow)
• Hemolysis, Forward and Reverse Flow- comparison to predicate (PowerFlow)
• MRI Safety Testing
• Packaging Ship Testing
• Pyrogenicity Testing

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes bench testing and biocompatibility assessments of a physical device, not a test set of medical images or patient data.

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)

Not applicable. This is not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from a test set of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 not an AI-assisted diagnostic or prognostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of AI/ML ground truth. For this physical device, the "ground truth" would be established by validated engineering specifications, accepted international standards (ISO, ASTM), and FDA guidance documents (e.g., FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, standards listed in the document). Performance was evaluated against these predefined physical and functional requirements.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML algorithm that undergoes a "training set."

9. How the ground truth for the training set was established

Not applicable.

Ask a specific question about this device

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.

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.

Ask a specific question about this device

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:

• 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.

Ask a specific question about this device