(240 days)
FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)
The DEVICE, the subject of this 510(k), Normal Saline I. V. Flush Syringes (0.9% Sodium Chloride Injection, USP) will be terminally sterilized as compared to its predicate device which was aseptically filled. The DEVICE will be marketed in various sizes and fill volumes similar to its predicate device.
This document is a 510(k) premarket notification for a medical device called "MEDEFIL'S NORMAL SALINE I. V. FLUSH SYRINGE". It focuses on establishing substantial equivalence to a predicate device, primarily due to a change in the sterilization process and polypropylene material.
Therefore, this document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. This is not a study or performance report for an AI device.
Instead, it's a regulatory submission demonstrating that the modified device (now terminally sterilized) is as safe and effective as its previously cleared version, which was aseptically filled. The "performance standard" mentioned refers to general regulatory standards, not specific performance metrics for an AI algorithm.
To directly answer your request based on the type of document provided, which is a 510(k) summary for a physical medical device (flush syringe), not an AI diagnostic tool:
Since the provided document is a 510(k) summary for a physical medical device (Normal Saline I.V. Flush Syringe) and not an AI diagnostic device, the requested information about acceptance criteria, study details, and AI-specific metrics (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or present in this document.
The document states:
- "No performance standard(s) applicable to this device has been promulgated under Section 514 of the Food, Drug, and Cosmetic Act."
- The device "shall be pyrogen free per the LAL test method for bacterial endotoxin." This is a quality control test, not a performance study in the context of diagnostic accuracy.
The submission aims to demonstrate "substantial equivalence" of the new manufacturing process and material to the previously cleared predicate device (Medefil, Inc. Normal Saline I. V. Flush Syringe K020999), not to prove performance against specific diagnostic accuracy criteria through a study.
Therefore, the specific elements you've asked for (such as a table of acceptance criteria vs. device performance, sample sizes for test/training sets, details on expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not included within this type of regulatory submission for this particular device.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).