(127 days)
The NorPort CT PC Family of Implanted Vascular Access Devices is indicated for use when the patient requires repeated access to the vascular system for injections, infusion drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
The NorPort CT PC Port is indicated for power injection of contrast media. For rne ron ection of contrast media, the maximum recommended infusion rate is 5 power injection of contained on coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle.
The Lucent Non-Coring needle Infusion Set is intended for the administration of fluids and drugs as well as blood sampling through implanted vascular ports.
When used with the NorPort CT·PC Family of Implanted Vascular Access Devices, the Lucent Non-Coring Needle Infusion Set is also indicated for power injection of contrast media into the central venous system.
The Norfolk Medical NorPort CT-PC Port is composed of a port reservoir with an attachable catheter system. The Port reservoir consists of a titanium or polysulfone chamber with a silicone septum and an outlet pin (510 (k)#102385). The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity.
The NorPort CT·PC comes in standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid in the delivery of large volumes of specialty fluids such as contrast media. The NorPort CT·PC is triangular shaped with a recessed septum ring. The body port has a "CT" symbol machine etched on the bottom end to enable easy recognition of the port with most imaging systems. The port has 3 holes for suture fixation to the tissue. A catheter comes with the port and is inserted in the vascular system. The catheter is usually inserted into a venous vessel and fed down into the superior vena cava. The placement of the catheter is checked by radiographic technique. The catheter is radiopaque to enable visualization for placement. The kit provided to aid in insertion of the catheter and placement of the port may include introducer items like needles, sheathes, vein picks, guidewires, straighteners, and dilators. Likewise the, "cut-down", kit for port placement may contain tunnelers, infusion sets with 90 degree Huber point needles, and syringes along with the port and catheter.
The Lucent Non-Coring Needle Infusion Set is similar to the following predicate devices: Smiths Medical Gripper Plus Power P.A.C Needle (510 (k)# 070116), the Angiodynamics Lifeguard CT Safety Infusion Set (510 (k)#072375), the Bard the rater of the Safety Infusion Set (510 (k)# 082306), and the MEDCOMP CT Injectable Safety Huber Needle (510 (k)# 080544). The Lucent Non-coring and the predicated devices are supplied sterile and non-pyrogenic and are intended for the administration into or withdrawal of fluids from the Norfolk Medical line of implanted ports. When a "Power Injectable" NorPort CT-PC Port is used, the Lucent Non-coring and the predicate devices are indicated for power injection of contrast media.
The Norfolk NorPort CT-PC Port and the Lucent Non-coring Needle Infusion Set underwent non-clinical testing to demonstrate substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Catheter to Port Connection | Functionality and sealing integrity of the connection between the catheter and the port. | "demonstrated that the functionality and performance characteristics of the NorPort CT-PC implanted vascular port and the Lucent Non-coring needle infusion set are comparable to the currently marketed vascular ports and power capable needles." Specific details on acceptance criteria (e.g., pressure limits, leakage rates) are not provided in the document, but the overall conclusion is that performance is comparable. |
| Septum Puncture/Port Leak | Ability of the silicone septum to withstand multiple punctures without leaking. | "The silicone septum is designed to allow multiple needle puncturing while maintaining the leak-tight integrity." "demonstrated that the functionality and performance characteristics of the NorPort CT-PC implanted vascular port and the Lucent Non-coring needle infusion set are comparable to the currently marketed vascular ports and power capable needles." Specific details on acceptance criteria (e.g., number of punctures, maximum leakage) are not explicitly stated, but the device is reported to maintain leak-tight integrity and be comparable to predicates. |
| Patency Verification | Confirmation of open flow through the device after implantation and use. | "demonstrated that the functionality and performance characteristics of the NorPort CT-PC implanted vascular port and the Lucent Non-coring needle infusion set are comparable to the currently marketed vascular ports and power capable needles." Specific details on how patency was verified or its acceptance criteria are not provided, but the overall conclusion is that performance is comparable. |
| High Pressure Static Testing | Ability of the port to withstand high-pressure injections, particularly for contrast media power injection. Maximum recommended infusion rates: 5 ml/s (19 and 20 gauge needle), 2 ml/s (22 gauge needle). | The device "has high-pressure injection capability to aid in the delivery of large volumes of specialty fluids such as contrast media." "When used with the NorPort CT·PC Family of Implanted Vascular Access Devices, the Lucent Non-Coring Needle Infusion Set is also indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s with a 19 and 20 gauge non-coring power injectable needle and 2 ml/s with a 22-gauge non-coring power injectable needle." This indicates the device met the stated high-pressure criteria. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "verification testing was performed according to protocols" and "positive performance examination results available as objective evidence in each category."
The data provenance is not specified. It is a non-clinical study, so it likely involves laboratory testing rather than data from human subjects or a particular country. It is retrospective in the sense that the testing has been completed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This was a non-clinical performance study involving laboratory testing, not human-read interpretations or clinical expert evaluations to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable. As a non-clinical performance study, there was no expert adjudication involved. Performance was measured against pre-defined engineering and functional criteria.
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 is a submission for a medical device (implanted port and needle infusion set), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
The "ground truth" for this non-clinical study was based on established engineering standards and design specifications, and the performance characteristics of legally marketed predicate devices. The listed standards include:
- FDA Guidance on 510(k) Submissions for Implanted Infusion Ports, dated October 1990
- BS EN ISO 10555-1:2009 (Sterile, single-use intravascular catheters Part I: General requirements)
- ISO 11135-1:2007 (Sterilization of health care products -Ethylene oxide-)
- ISO 10993-7:2008 (Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals)
- ISO 14971:2007 (Medical Devices- Application of Risk Management to Medical Devices)
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical medical device.
§ 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.