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510(k) Data Aggregation
(108 days)
Power and Non Power-Injectable Implantable Ports are intended to be an implanted vascular access device designed to provide long-term, repeated access to the vascular system.
PowerPort®
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, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.
When used with a PowerLoc® Brand 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.
Non Power-Injectable Ports
The BardPort®, SlimPort®, and X-Port® implantable ports are 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.
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. Long-Term 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. Groshong® catheters are attached to the port by the physician during implantation.
PowerPort® Implantable Ports can be used for routine vascular access using a noncoring access needle. However, for power injection procedures, PowerPort® ports must be accessed with a Bard PowerLoc® Safety Infusion Set (SIS) to create a powerinjectable system.
Non Power-Injectable Ports
Long-Term 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. Long-Term 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. Groshong® catheters are attached to the port by the physician during implantation.
Long-Term Implantable Ports can be used for routine vascular access using a non-coring access needle.
The provided text describes a 510(k) premarket notification for Bard Access Systems' Power and Non Power-Injectable Implantable Ports with Groshong® Catheters, specifically regarding an extended maintenance protocol. The study aims to support extending the maximum recommended maintenance flushing interval from four weeks to 90 days with saline only.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal "acceptance criteria" in a quantitative, pre-defined manner for the device's performance in the context of this specific 510(k) submission. Instead, the focus is on demonstrating that extending the maintenance flushing protocol does not raise new questions regarding safety or efficacy and that the adverse event rate remains acceptably low.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new safety concerns with extended flushing interval. | "Maintenance flushing of Groshong® port systems has been shown to be safe for a wide variety of time intervals based on the very low adverse event rates noted in the clinical data." |
| Minimal adverse event rate for saline-only maintenance with 90-day interval. | "Only one adverse event was recorded in the saline-only group, yielding an incidence rate of 0.35 adverse events per 10,000 patient-days, with a 95% Poisson confidence interval (0.01, 1.96)." This rate is presented as "very low," supporting the safety of the extended interval. |
| Device remains substantially equivalent to predicate devices. | "Based on the indications for use, technological characteristics, and safety and performance testing, the subject Power and Non Power-Injectable Implantable Ports with Groshong® Catheter met the minimum requirements for its intended use and is substantially equivalent in design, materials, sterilization, principles of operation, and indications for use to the predicate devices cited." This statement implies that the extended maintenance protocol, supported by the clinical data, did not disrupt the substantial equivalence to previously cleared devices which had a shorter maintenance interval. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document mentions "465 saline-only intervals recorded with 28,452 patient-days of follow-up." While not a direct count of unique patients, this indicates a substantial amount of data collected over time. The study subjects consisted of "post-infusional adult males or females ≥ 21 years of age that had a Bard port implanted."
- Data Provenance: The study was conducted at "five major oncology centers" in the United States.
- Retrospective or Prospective: The study states that "clinical data were independently collected from patients... to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval." This phrasing suggests a prospective data collection approach, specifically designed to gather evidence for the extended protocol.
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)
This information is not provided in the document. The study focuses on clinical outcomes (adverse events) rather than expert interpretation of medical images or diagnoses, so a traditional "ground truth" establishment by a panel of experts, as might be seen for an AI diagnostic device, is not applicable or described. Adverse events would typically be recorded by medical staff involved in patient care.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe a formal adjudication method for adverse events in the sense of multiple reviewers and a tie-breaker. It mentions that the study was conducted "Under Institutional Review Board oversight" and that "clinical data were independently collected." This suggests standard clinical trial practices for adverse event reporting and monitoring by the sites and overall study coordination, but no specific adjudication scheme is detailed.
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
No, an MRMC comparative effectiveness study was not done. This submission is not for an AI diagnostic device that assists human readers. It is for a medical device (implantable port) and a change to its maintenance protocol, with the study focusing on clinical safety and efficacy of that protocol change.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This submission is not for an algorithm or AI device. It's for a physical medical device and a revised post-implantation maintenance schedule.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the outcomes data related to adverse events. Specifically, the occurrence or non-occurrence of adverse events during the extended maintenance flushing interval, as observed and recorded in clinical practice, served as the primary measure of safety.
8. The sample size for the training set
Not applicable. This submission does not involve a machine learning algorithm, therefore there is no training set. The study evaluates the performance and safety of an updated maintenance protocol for a medical device through direct clinical observation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an algorithm. The clinical data for the study was collected and monitored under Institutional Review Board (IRB) oversight according to standard clinical research practices.
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