(38 days)
The SportPort™ is indicated for use when the patient requires the following: repeated access to the vascular system for injections, infusion of drugs, administration of blood or blood products, and/or withdrawal of blood as part of the therapy regimen.
When used with a power injectable needle infusion set, the SportPort™ 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 and 2 ml/s with a 22-gauge non-coring power injectable needle.
The devices are to be used by or on the order of a physician. The SportPort™ line of ports has a body/septum retainer made of either commercially pure grade 2 titanium or medical grade polysulfone and has a body/septum chamber with a silicone rubber septum designed for repeated needle puncturing. The SportPort™ comes in a standard design to enable regular use as an infusion/withdrawal port and has high-pressure injection capability to aid to the delivery of large volumes or special fluids such as contrast media. The shape of the base plate of the port body is triangular and is compatible with most imaging systems. The top of the port (septum retainer) has a raised triangle to secure the septum in place during high-pressure use and to enable palpable or image system identification. The port has six (6) elongated holes for suture fixation to the deep fascia tissue during implantation. The fixation is required to prevent migration or flipping of the port. A catheter comes with the port and is inserted into the vascular system. The catheter is assembled to the port and fed into a venous vessel and fed down into the vascular system. The catheter is radiopaque to enable visualization for proper placement. The kit provided to aid in insertion of the catheter and placement of the port may include items like needles, sheaths, vein picks, guidewires, straighteners, and dilators. Likewise, the cut down kit for port placement may contain most infusion sets with Lucent Non-Coring needles, straight pointed Huber needles, blunt needles, and syringes along with the port and catheter.
The Norfolk Medical SportPort™ family of ports provides a simple method for the delivery of volumes of medications, fluids and special fluids like chemotherapy agents via a chamber leading to a catheter and opening into a large vessel in the body. The catheter is inserted into a large vessel that ideally terminates in the superior vena cava/high right atrial junction. The port is surgically implanted subcutaneously in the soft tissue near the clavicle on the patient's right upper chest wall. Medications, fluids, nutritional liquids or chemotherapy agents can then be administered as necessary. The ports are intended for long-term placement.
The Norfolk Medical SportPort™ family of Vascular Access Devices is a group of ports and catheter sets with infusion and withdrawal capabilities via a port and an access catheter to the large vessels in the vascular system. These ports must be properly attached to a catheter during a procedure.
When used with a legally marketed power capable needle infusion set, the SportPort™ 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 19 or 20 gauge needle and 2ml/sec with a 22 gauge needle set.
The provided text describes a 510(k) premarket notification for the SportPort™ medical device, which is an implanted port and catheter system. The submission focuses on demonstrating substantial equivalence to a predicate device (NorPort CT-PC Port - K111101) rather than presenting a detailed study with acceptance criteria and performance data in the format typically seen for novel AI/diagnostic devices.
Based on the information provided, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not specify numerical "acceptance criteria" in the typical sense (e.g., sensitivity, specificity, accuracy targets) because it's for a physical medical device (implantable port) and focuses on mechanical and material equivalence to a predicate. Instead, the "performance" is demonstrated through various mechanical tests to show the device functions as intended and is comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Equivalence | Made from the same biocompatible materials as the predicate device (titanium, polysulfone, silicone rubber septum). |
| Manufacturing Process Equivalence | Utilizes the same manufacturing process as the NorPort product line. |
| Mechanical Integrity (Leaks) | Mechanically tested for leaks. |
| Mechanical Integrity (Septum Puncturing) | Mechanically tested for septum puncturing. |
| Mechanical Integrity (Catheter Tensile Strength) | Catheter tensile strength testing performed. |
| Mechanical Integrity (Catheter to Port Connection) | Catheter to port connection test performed. |
| Mechanical Integrity (Dynamic Failure) | Dynamic failure testing performed. |
| Mechanical Integrity (Patency Verification) | Patency verification testing performed. |
| Mechanical Integrity (Static Burst) | Static burst testing performed. |
| High-Pressure Injection Capability | Engineered to withstand high internal pressures in the chamber, catheter securing mechanism, and port outlet for "pressure injectable" clinical applications (power injection of contrast media). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical studies. The "testing" appears to be entirely bench testing (mechanical testing) of the device prototypes. Therefore, there is no information on:
- Sample size used for a test set (as it relates to patients/data).
- Data provenance (country of origin, retrospective/prospective), as no patient data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for mechanical performance is established through engineering standards and testing protocols, not by expert medical review of a test set.
4. Adjudication Method for the Test Set
Not applicable, as no human adjudication for a test set (e.g., imaging review) is mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No. This type of study is specifically relevant for diagnostic devices where human readers interpret data (e.g., images), often with and without AI assistance, to assess the AI's impact on human performance. The SportPort™ is a physical medical device, not a diagnostic or AI-powered system, so an MRMC study is not relevant or mentioned.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The SportPort™ is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used
The ground truth for the device's performance is established by engineering specifications, material science, and mechanical testing standards. The success of the tests (e.g., no leaks, ability to withstand burst pressure, appropriate tensile strength) serves as the ground truth for validating the device's physical and functional integrity.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI or machine learning device. The development process for the SportPort™ relies on engineering design, material selection, and iterative mechanical testing rather than data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.