(150 days)
ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.
A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.
The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance evaluation. The document describes a medical device (KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE) and its performance data relates to biocompatibility and pyrogenicity tests, not AI/ML model performance.
Therefore, I cannot populate the table or answer the questions related to AI/ML study design, sample sizes, expert ground truth, or adjudication methods based on the provided text.
The only relevant information that can be extracted is about the performance data for the described medical device:
Acceptance Criteria and Device Performance (Biocompatibility/Pyrogenicity)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility Tests (on body fluid contacting material portions) | Device is suitable for its intended use. |
| Limulus Amebocyte Lysate ("LAL") Test (described at "(85) BACTERIAL ENDOTOXINS TEST", USP XXII, PP 1493-1495) | The device meets the LAL test. |
The text explicitly states: "The device meets all biocompatibility and pyrogenicity test requirements."
§ 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.