(89 days)
The T-Port HP Infusion Port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, IV fluids, parenteral nutrition solutions, blood products and for the withdrawal of blood samples.
When used with a power injectable needle, the T-Port HP Infusion Port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec with a 19G or 20G non-coring power injectable needle or 2 ml/sec with a 22G non-coring power injectable needle.
The T-Port HP Infusion Port is an implantable device designed to provide repeated access to the vascular system without the trauma associated with multiple vena puncture. The system consists of a self-sealing injection port and a delivery catheter for the receipt and delivery of medications to the selected body site. The T-Port HP Infusion Port is offered with the polyurethane catheter either preattached by the manufacturer or attachable for application by the inserting physician. 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. Introduction of solution into the implanted port and catheter system is through a non-coring needle.
The base of the port has the letters "CT" to signify that it can be used for power injection on contrast agents. The serial number is laser etched into the base of the suture holes may contain clear silicone to prevent tissue in growth to the suture holes.
Power injection of contrast media, can be safely administered with a 19 or 20 qauqe power injectable infusion non-corning needle at a maximum recommended infusion rate of 5 ml/sec or a 22 gauge power injectable non-coring needle at a maximum recommended infusion rate of 2 ml/sec. Maximum pressure should not exceed 300 psi.
The T-Port HP Infusion Port is packaged with the necessary accessories to facilitate catheter insertion.
The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Implantable Infusion Port cleared under K070003.
Components will be assembled into standard configurations specified by the customer and packaged.
The device includes the following components:
- Implantable Port
- Click Connector
- Guide Wire
- Dilator
- Tunneling Needle
- Vein Lifter
- Nurses Guide
- Companion Checklist
- Catheter
- Huber Needle
- Introducing Needle
- Peel Away Sheath
- Syringe
- Instructions for Use
- Patient Guide
- Patient ID Card & Key Ring Card
The provided 510(k) summary for the T-Port HP Infusion Port does not contain information about acceptance criteria or a study proving its performance against acceptance criteria in the manner typically described for AI/ML-based devices or complex diagnostic tools.
This document describes a medical device, specifically an implantable infusion port, and its substantial equivalence to previously marketed devices. The "performance" discussed relates to its physical characteristics and functionality, not to a diagnostic or predictive algorithm.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
However, I can extract information related to the device's technical specifications and how its "performance" (in terms of physical capabilities) is established through comparison to predicate devices.
Explanation of Missing Information:
- Acceptance Criteria & Reported Device Performance (Table): This type of information is typically for devices that perform a measurement or make a diagnostic determination, where criteria like sensitivity, specificity, accuracy, or specific thresholds for a measurement are set. For an infusion port, "performance" is more about structural integrity, flow rates, and biocompatibility, which are verified through engineering tests and material comparisons, not typically reported in terms of specific "acceptance criteria" and "reported device performance" in a 510(k) summary like this. The document states its capabilities (e.g., maximum infusion rates, pressure) but doesn't frame them as acceptance criteria for a study.
- Sample Size, Ground Truth, Adjudication, MRMC, Standalone Study, Training Set Info: These are all concepts relevant to studies evaluating the performance of algorithms, diagnostic devices, or AI/ML systems. They are not applicable to the clearance of an implantable infusion port which relies on demonstrating substantial equivalence to predicate devices through comparisons of material, design, and intended use, often supported by bench testing and sometimes animal studies (though not detailed here beyond biocompatibility).
What the document does provide regarding "performance" and "studies":
The document primarily focuses on demonstrating substantial equivalence to predicate devices. This is the "study" in this context.
Description of Device Capabilities (which could be considered performance specifications):
- Maximum Recommended Infusion Rate:
- 19 or 20 gauge non-coring needle: 5 ml/sec
- 22 gauge non-coring needle: 2 ml/sec
- Maximum Pressure: Not to exceed 300 psi.
- Biocompatibility: Materials are used in legally marketed devices under comparable conditions of use.
Nature of the "Study" (Demonstration of Substantial Equivalence):
The "study" or justification for clearance is based on comparing the T-Port HP Infusion Port to two predicate devices:
- pfm Medical, Inc Manufacturer: MedComp Name: Jet Port Plus Catheter System (Cleared under K000125) - This is for the basic functionality as an implantable infusion port.
- Power Injectable Implantable Infusion Port (Cleared under K070003) - This is for the addition of power injection capability.
The document states: "The port and catheter are manufactured and sterilized at the same manufacturing and sterilization facilities as the predicate device cleared under K000125. The addition of power injection capability is comparable to the currently marketed Power Injectable Implantable Infusion Port cleared under K070003."
This implicitly means that the performance specifications (flow rates, pressure limits) for power injection are comparable to the K070003 predicate device, and the general port functionality (repeated access, material, sterilization) is comparable to the K000125 predicate device.
Therefore, I cannot fill out the requested template in full, but can summarize the device capabilities and the basis of its clearance.
Unavailable Information from the Provided Text:
| Category | Information Reported in Document |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | N/A - Not applicable for this type of device clearance document. |
| The document specifies operational limits (e.g., max infusion rate 5 ml/s, max pressure 300 psi) but does not present these as formal acceptance criteria of a performance study in the context of diagnostic/AI devices. | |
| 2. Sample size and Data Provenance (Test Set) | N/A - Not applicable. No "test set" in the context of an algorithm or diagnostic evaluation. "Performance" is based on substantial equivalence to predicate devices and likely engineering/bench testing (not detailed). |
| 3. Number of Experts & Qualifications (Ground Truth) | N/A - Not applicable. No expert ground truth establishment for an implantable infusion port. |
| 4. Adjudication Method (Test Set) | N/A - Not applicable. No test set requiring adjudication. |
| 5. MRMC Comparative Effectiveness Study (AI improvement) | N/A - Not applicable. Not an AI/ML device. |
| 6. Standalone Performance Study (Algorithm Only) | N/A - Not applicable. Not an algorithm. |
| 7. Type of Ground Truth Used | N/A - Not applicable. No ground truth in the diagnostic sense. Device capabilities are substantiated through engineering design, material properties, and comparison to predicate devices. |
| 8. Sample Size for Training Set | N/A - Not applicable. No training set for an AI/ML device. |
| 9. How Ground Truth for Training Set was Established | N/A - Not applicable. No training set. |
§ 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.