(230 days)
The CT Power Injectable Implantable Infusion 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 power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media. For power injection of contrast media, 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.
- Titanium port designed for subcutaneously implantable single fluid reservoir port . offered in a mid-size, low profile or mini version with a 5F, 6.6F, 8F or 9.6French radiopaque polyurethane or silicone catheter either pre-attached by the manufacturer or attachable for application by the inserting physician.
- Placement of the port is determined by the inserting physician based on patient o anatomy and medical judgment.
- The port can be anchored with sutures in the port pocket for secure seating. o
- The catheter lock provides securement of the catheter to the port stem. o
- The port is accessed by inserting a non-coring needle through the skin into the . self sealing septum.
- Port base has radiopaque text "CT" on the underside visible by x-ray o
- Lot numbers are laser etched into the base of the port.
- Power iniection 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. The maximum recommended infusion rate is 2 ml/s with a 22 gauge non-coring power injectable needle.
- The device is recognized as part of the Medcomp power injectable product line by its anodized purple titanium housing.
- CT and MR compatible .
- The port is compatible with non-coring Huber deffected point septum penetration style . needles.
The provided 510(k) summary for the Dignity® Power Injectable Titanium Port (K170281) describes the device, its intended use, and claims substantial equivalence to predicate devices based on in vitro testing. However, it does not contain the detailed information requested regarding specific acceptance criteria and the comprehensive study results to confirm those criteria were met.
Here's an analysis based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly state specific numerical acceptance criteria for performance parameters. Instead, it broadly states that "Verification testing, determined to be applicable to the safety and efficacy of the devices, was shown to meet predetermined acceptance criteria listed therein." This implies these criteria were defined in internal protocols, but they are not provided in this public summary.
The reported device performance is described qualitatively:
| Performance Characteristic | Reported Device Performance |
|---|---|
| Power Injectability | Maximum recommended infusion rate: 5 ml/s (with 19 or 20 gauge non-coring needle); 2 ml/s (with 22 gauge non-coring needle). |
| Biocompatibility | Met requirements of ISO 10993. |
| Design & Construction | Equivalent to predicate devices in basic design, generic materials, and construction. |
| Risk Management | Analysis did not identify any new types of safety or efficacy questions (in accordance with ISO 14971: 2000). |
| Sterilization | Substantially equivalent to predicate devices. |
| Radiopacity | "CT" text on underside visible by x-ray; device is "CT and MR compatible". |
| Access | Compatible with non-coring Huber deflected point septum penetration style needles. |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "In vitro testing was performed on the Power Injectable, Implantable Infusion Port..." and "Verification testing and performance testing performed according to the referenced standards as well as in accordance with in-house protocols."
- Test Set Sample Size: The specific sample sizes for the in vitro tests are not provided in this summary.
- Data Provenance: The testing was "in vitro," implying laboratory studies. The country of origin of the data is not explicitly stated, but the submitter is MEDCOMP® in Harleysville, PA, USA. The data is retrospective in the sense that it's from completed tests presented to the FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not applicable as the studies were in vitro (laboratory tests) and did not involve human experts establishing ground truth for a test set in the way an AI model would. The "ground truth" for these tests would be the established scientific and engineering principles and the performance standards defined in the test protocols.
4. Adjudication Method for the Test Set
- This information is not applicable as the studies were in vitro and did not involve a human test set requiring adjudication.
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 type of study is relevant for AI-powered diagnostic devices involving human readers interpreting medical images. The Dignity® Power Injectable Titanium Port is an implanted medical device, not a diagnostic AI tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical implanted port, not a software algorithm. The "standalone" performance refers to the device's physical functions, which were evaluated through in vitro testing.
7. The Type of Ground Truth Used
The "ground truth" for the in vitro testing was established based on:
- Engineering specifications and design requirements: The device's ability to maintain integrity under pressure, flow rates, and repeated access.
- Applicable FDA guidance and FDA recognized international standards: Specifically mentioned are "Guidance on 510(k) Submissions for Implanted Infusion Ports" dated October 1990 and ISO 10993 (Biocompatibility), and ISO 14971: 2000 (Risk Management).
8. The Sample Size for the Training Set
- This information is not applicable. The device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set for a physical device.
In summary: The 510(k) submission for the Dignity® Power Injectable Titanium Port relies on in vitro performance testing and comparison to predicate devices to demonstrate substantial equivalence. It confirms that the device meets "predetermined acceptance criteria" derived from FDA guidance and international standards, but the specific, quantifiable details of these criteria and the direct results of the tests (e.g., exact number of cycles passed, precise pressure ratings achieved) are not disclosed in this summary document. The information requested regarding AI model evaluation (like sample sizes, expert ground truth, MRMC studies) is not relevant to this type of medical device submission.
§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.
(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.