(105 days)
Implantation of a port and catheter is indicated whenever patient therapy requires repeated intravascular injection or continuous infusion of fluids, medications, antibiotics, nutitionals and the withdrawal of venous blood samples. The port kit, which is the subject of this premarket notification, provides procedural components necessary for percutaneous insertion of the implantable vascular access system.
The port kit provides an implantable port and catheter, an introducer sheath/dilator with a hemostasis valve, a 22 Ga. non-coring needle, a 21 Ga. entry needle, a 20 Ga. blunt needle, and 0.018" and 0.035" guidewires. All of these components have been found substantially equivalent through the premarket notification process for the use(s) for which the port vascular assess kit is intended.
What you've provided is a regulatory submission summary for a medical device (Venous Access Port Kit), specifically a "SUMMARY OF SAFETY AND EFFECTIVENESS" for a 510(k) premarket notification.
This type of document is about demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study in the way a new drug or a novel AI diagnostic device might.
Therefore, the requested information about acceptance criteria, study design, sample sizes, expert ground truth, etc., is not applicable to this document because it describes a different regulatory pathway (510(k)) and type of device.
Here's why and what the document does say:
- Nature of the Device: A "Venous Access Port Kit" is a physical medical device (implantable port, catheter, needles, guidewires). It's not a diagnostic algorithm or an AI system.
- Regulatory Pathway (510(k)): The document explicitly states it's a "premarket notification" and discusses "Substantial Equivalence." For a 510(k) submission, the primary goal is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, not necessarily to prove its performance against a new set of clinical acceptance criteria in a dedicated clinical trial.
- No Clinical Study Described: The document focuses on:
- Descriptions of the device components.
- Indications for Use.
- Comparison to predicate devices (Cook's VITAL-PORT MINI, Pharmacia Deltec's PORT-A-CATH).
- Packaging, sterilization, and pyrogenicity.
It does not describe any clinical study designed to establish performance metrics like sensitivity, specificity, or reader improvement with AI assistance.
In summary, your request for specific study details (acceptance criteria tables, sample sizes, ground truth, MRMC studies, standalone performance) cannot be answered from the provided text because this document pertains to a 510(k) submission for a physical medical device, which typically relies on comparisons to predicate devices and bench/non-clinical testing for substantial equivalence, rather than extensive clinical efficacy trials with the parameters you've listed.
The "conclusion" states: "Based on the information presented, Boston Scientific Corporation believes that the proposed venous access port kit meets the minimum requirements that are considered acceptable for its intended use." This is a standard statement for a 510(k) submission, indicating that they believe they have demonstrated substantial equivalence.
§ 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.