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The PowerPort® Implantable Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications including anticancer medicines (chemotherapy), 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. 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. Catheters, included with the port, are pre-attached or may be 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 provided text describes specific acceptance criteria and the studies conducted to demonstrate that the Bard Power-Injectable Implantable Ports (PowerPorts®) meet these criteria, primarily focusing on the expansion of their indications for use to explicitly include anti-cancer medicines.

Here's an analysis of the acceptance criteria and the supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document details performance testing (bench tests) and clinical analysis (literature review and retrospective studies).

• Bench Tests (Test Set): The document does not specify an exact number of devices used for each individual bench test. It states "the devices underwent chemical conditioning" and "the testing also demonstrated that devices were able to further withstand and pass all of the robust physical testing." This implies a representative sample of each device type was used.

  • Data Provenance: This is in-house laboratory testing at Bard Access Systems (C.R. Bard, Inc.). It is prospective in nature as it was designed and performed specifically for this submission.

• Clinical Analysis (Test Set - Retrospective Studies):

  • Study 1 (DiMatteo C, Nishimoto B, Thomas I. 2014): "multicenter, retrospective database review" to determine AE/malfunction rates.
    • Sample Size: "subjects consisted of adult males and females ≥21 years of age who had infusions through a Bard port or any PIV." No specific number is provided in this summary.
    • Data Provenance: Retrospective, multicenter study. The country of origin is not explicitly stated but generally sponsored studies by US companies often involve US data.
  • Study 2 (McDonald M. 2017): "retrospective multicentered study to assess the complication rates of oncology patients accessed with peripheral intravenous lines versus implantable ports."
    • Sample Size: "Patient data was collected from five different clinical sites for patients who were at least 21 years of age, had a Bard® Groshong® Port Catheter, had completed cancer therapy, and had maintenance flushes." No specific number is provided in this summary.
    • Data Provenance: Retrospective, multicenter study from five different clinical sites. Country of origin not explicitly stated.
  • Health Claims Data Analysis: "retrospective analysis of US health care claims data."
    • Sample Size: Not specified beyond "US health care claims data."
    • Data Provenance: Retrospective, US.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Bench Tests: The "ground truth" for the bench tests is defined by established engineering and material science principles, as well as predefined acceptance criteria derived from FDA guidance documents ("FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, October 1990" and "FDA Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, March 16, 1995") and in-house protocols. No external experts are mentioned for establishing the ground truth of these physical tests; it's based on objective measurement against specifications.

• Clinical Analysis (Retrospective Studies and Literature Review):

  • Literature Review: The ground truth comes from the published clinical literature itself, assessed by the "clinical analysis" team at Bard/C.R. Bard, Inc. The qualifications of these reviewers are not stated.
  • Retrospective Studies: The ground truth for these studies would be derived from the patient medical records/databases used. This medical information is typically established by treating physicians and other healthcare professionals (e.g., nurses administering infusions, radiologists performing imaging, pathologists for cancer diagnoses). The number and specific qualifications of clinicians establishing these initial patient records are not provided, as these are secondary analyses of existing data.

4. Adjudication Method for the Test Set

• Bench Tests: No adjudication method is described beyond successful completion of the tests against predetermined acceptance criteria.
• Clinical Analysis (Retrospective Studies and Literature Review): No explicit adjudication method (e.g., 2+1, 3+1) is mentioned for the literature review or the retrospective data analysis. The studies are described as reviewing existing data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done & Effect Size

No MRMC comparative effectiveness study is mentioned for this submission. The submission is not for a diagnostic imaging AI device but for an implantable port. Thus, the concept of human readers improving with AI assistance is not applicable here.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable as the device is an implantable port, not an algorithm or AI system. Its performance is evaluated through physical characteristics, ability to withstand power injection, and clinical utility for drug delivery.

7. The Type of Ground Truth Used

• Bench Tests: Objective physical measurements and functional performance against engineering specifications and regulatory guidance.
• Clinical Analysis (for expanded Indications):
  • Literature Review: Published clinical evidence and scientific consensus from existing randomized controlled trials, prospective registries, and retrospective analyses.
  • Retrospective Studies: Patient medical record data / health care claims data, which reflects real-world clinical outcomes and diagnoses from healthcare professionals.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set." The development of the port itself relies on engineering design principles, material science, and manufacturing processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for a physical device like this implantable port.

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