Search Results

The CT Power Injectable Infusion Ports are indicated for pediatric 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.

The maximum recommended infusion rate is 5 ml/s with a 19 or 20 gauge non-coring power injectable needle. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.

The Dignity™ CT implantable infusion ports are subcutaneously implantable single fluid reservoir ports offered with a polyurethane (5F) catheter either preattached by the manufacturer or attachable for application by the inserting physician in a choice of two kit configurations. Placement of the port is determined by the inserting physician based on patient anatomy and medical judgment. The port can be anchored with sutures in the port pocket for secure seating. The catheter lock provides securement of the catheter to the port stem. The port is accessed by inserting a non-coring needle through the skin into the self-sealing septum. The ports are offered in a Mini or Low Profile design with power injection capabilities.

The base of the port is printed with the letters "CT" in reverse with radiopaque ink to signify that it can be used for power injection on contrast agents (orientation will appear correct under x-ray). Lot numbers are laser etched into the base of the port. The rigid top half of the port centers the silicone septum and aids in locating the implanted device under the skin.

Power injection of contrast media, can be safely administered with a 19 or 20 gauge power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/s and a maximum pressure setting of 300 psi.

A 22 gauge needle can be used at 2 ml/sec with a maximum pressure setting of 300 psi.

The implantable infusion port is packaged with the necessary accessories to facilitate catheter insertion in either a standard or micro-puncture kit.

The provided text describes a 510(k) submission for a medical device, the Dignity™ CT implantable infusion port. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the typical format of a clinical trial or performance study report with statistical outcomes.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through in vitro testing. This is a common approach for 510(k) clearances when clinical studies are not deemed necessary.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. The acceptance is based on demonstrating that the new device performs reliably and safely, and is substantially equivalent to predicate devices.

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

The text explicitly states:

• "In vitro testing was performed on the ports to assure reliable design and performance..."
• The testing was "according to the referenced standards as well as in-house protocols."
• "Clinical studies were not deemed necessary since in vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to legally marketed predicate devices."

Therefore, there was no human "test set" or clinical data. The data provenance is from laboratory in vitro testing rather than human subjects. The sample size for these in vitro tests is not specified in the provided summary.

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

As no human "test set" or clinical study was conducted, there were no experts used to establish ground truth in the traditional sense of clinical trial adjudication. The "ground truth" for the device's performance was established through engineering and material science testing, aligned with regulatory standards and predicate device performance.

4. Adjudication Method for the Test Set

Since no human clinical test set was used, there was no adjudication method applied to clinical data. The assessment was based on compliance with in vitro test protocols and regulatory guidelines.

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 MRMC comparative effectiveness study was done. This device is a physical medical implant (infusion port), not an imaging or diagnostic AI device that would involve human readers or AI assistance in interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This question is not applicable to the device described. The device is a physical implant, not an algorithm. Therefore, no standalone algorithm performance study was done.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance and safety largely relies on:

• Engineering specifications and performance standards: Demonstrated through in vitro testing.
• Regulatory standards: Specifically, FDA's "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990 and ISO 10993 for biocompatibility.
• Performance of legally marketed predicate devices: The new device must demonstrate substantial equivalence to these.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical implant, not a machine learning model, so there is no "training set."

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

This question is not applicable as there is no "training set" for this type of medical device.

Ask a specific question about this device