Search Results

The PowerPort" Polymeric Port is a totally implantable vascular access device designed to provide long-term. repeated access to the vascular system long-term, repeated access to the vascular system.

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 m}/s.

The PowerPort™ device consists of a plastic port and an 8 Fr open-ended single lumen ChronoFlex® The rower of - device ocables of a pith a cathlock. The port is triangular in shape and has three palpation bumps to distinguish it as power injectable. Purple colorants have been added to the port and parpater materials to provide the device with an appearance that allows the placing physician to identify the PowerPort device as power injectable.

The provided text describes a 510(k) premarket notification for a medical device, the PowerPort™ Implanted Polymeric Port with 8 Fr ChronoFlex® Catheter. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo study with strict acceptance criteria and performance metrics.

Therefore, the document does not contain the specific information requested in the prompt, such as:

• A table of acceptance criteria and reported device performance (in terms of specific performance metrics like sensitivity, specificity, accuracy, etc.)
• Details about a test set, including sample size, data provenance, ground truth establishment, or expert qualifications.
• Information on MRMC studies or standalone algorithm performance.

Instead, the submission focuses on demonstrating that the new device has the same intended use and indications for use as the predicate device, and that technological differences do not raise new questions of safety or effectiveness. The "study" mentioned is primarily a series of verification tests based on established guidance documents and standards to show that the new polymeric port performs equivalently to the titanium predicate port.

Here's an breakdown of the information that is present, addressing the prompt's questions where applicable:

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

• Acceptance Criteria for Equivalence: The primary "acceptance criteria" for this 510(k) submission is demonstrating substantial equivalence to the predicate device, the PowerPort™ Implanted Titanium Port with 8 Fr ChronoFlex® Catheter (K060812). This means showing that the new device shares the same intended use, indications for use, and that any technological differences do not raise new questions of safety or effectiveness, and that performance data demonstrates equivalence.
• Reported Device Performance: The document states, "Performance data gathered in design verification testing demonstrated that the subject PowerPort™ Polymeric Port device is substantially equivalent to the predicate device..." However, it does not provide a table with specific quantitative performance metrics (e.g., durability, flow rates, biocompatibility results) from these tests, nor specific acceptance thresholds for those metrics. The verification testing was done to demonstrate that the new polymeric material performs comparably to the titanium in terms of relevant physical, chemical, and biological properties.

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

• Not Applicable in the provided text: This type of information (sample size for a test set, data provenance, retrospective/prospective) is associated with clinical studies or performance evaluations that generate specific metrics for a novel device. For a 510(k) based on substantial equivalence, the "testing" refers to design verification tests against industry standards rather than a clinical efficacy or accuracy study. The document does not specify sample sizes for these verification tests, nor does it refer to "data provenance" in the context of clinical 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: "Ground truth" establishment by experts is relevant for diagnostic or AI-assisted devices where human interpretation or pathology is the reference standard. This device is an implanted infusion port, and its performance evaluation does not involve ground truth established by medical experts in this manner.

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

• Not Applicable: Adjudication methods are used in clinical studies, particularly for subjective endpoints or when expert consensus is required for labeling. This document describes design verification testing, not a clinical study requiring adjudication of patient outcomes or image interpretation.

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 device is a physical medical implant (an infusion port), not an AI algorithm or a diagnostic tool that involves human readers interpreting cases. Therefore, MRMC studies and AI assistance are not relevant.

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

• Not Applicable: This device is a physical medical implant, so "standalone algorithm performance" is not relevant.

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

• Not Applicable: As stated in point 3, the concept of "ground truth" as typically applied to diagnostic or AI devices, is not relevant for the evaluation of this physical medical implant. The "ground truth" for its performance would be its conformance to specifications and established standards through design verification testing.

8. The sample size for the training set

• Not Applicable: There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable: As there is no training set, this question is not relevant.

Summary of "Study" and Equivalence Documentation from the provided text:

The "study" that proves the device meets the acceptance criteria (of substantial equivalence) consists of:

• Verification Testing: "Verification testing was performed according to protocols based on the above-referenced guidance documents recommendations and additional standards." These guidance documents and standards include:
  • Guidance on 510(k) Submissions for Implanted Infusion Ports (October 1990)
  • Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (March 1995)
  • BS/EN/ISO 10555-1: 1997 (Sterile, single-use intravascular catheters, Part 1: General requirements)
  • ISO 10555-1: 1995 Amendment 1: 1999
  • BS/EN/ISO 10555-3: 1997 (Sterile, single-use intravascular catheters, Part 3: Central venous catheters)
  • AAMI/ANSI/ISO 11135: 1994 (Medical Devices -- Validation and Routine Control of Ethylene Oxide Sterilization)
  • AAMI/ANSI/ISO 10993-1: 2003 (Biological Evaluation of Medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile)
  • NF S 94-370 (French Standard, Surgical Implants, implantable catheter chambers)
• Basis for Equivalence: The submission argues that the technological characteristics of the new polymeric port are "similar to" those of the predicate titanium port in terms of intended use, indications for use, application, user population, basic design, performance, and labeling. While the material is different (polymeric vs. titanium), the claim is that this change "may affect safety or effectiveness" but does not raise "new types of safety and effectiveness questions" because accepted scientific methods (the listed standards and guidance) exist to assess these effects, and performance data demonstrated equivalence.

Ask a specific question about this device