(226 days)
The Provena™ Midline Catheters are indicated for short term access to the peripheral venous system for selected intravenous therapies, blood sampling, and power injection of contrast media. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of the procedure. The Provena™ Midline Catheters are suitable for use with power injectors.
Provena™ Midline Catheters are a family of peripherally placed catheters made from radiopaque body-softening polyurethane materials. Each Provena™ Midline Catheter is designed with kink-resistant, reverse taper design. Catheters are packaged in a tray with accessories for reliable short term (less than 30 days) vascular access. The Provena™ Midline Catheters are suitable for use with power-injectors.
The provided FDA 510(k) summary for the Provena™ Midline Catheter does not describe a study involving an AI/Machine Learning device or an analysis of clinical images. Instead, it details a traditional medical device submission focused on demonstrating substantial equivalence to a predicate device through material, dimensional, and performance characteristic comparisons.
Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test set, number of experts, MRMC studies, ground truth establishment) are not applicable to the content provided.
However, I can extract and present the device performance characteristics and the type of testing performed to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for a non-AI/ML device in this context.
Here's a breakdown based on the provided document, addressing the applicable points:
Device: Provena™ Midline Catheter (Non-AI/ML Device)
1. A Table of Acceptance Criteria and the Reported Device Performance (as demonstrated by testing against the predicate):
This table compares the characteristics of the subject device (Provena™ Midline Catheter) to the predicate device (PowerMidline™ Catheter) to demonstrate substantial equivalence, rather than defining specific statistical performance metrics against a clinical ground truth as would be done for an AI/ML device. The "reported device performance" is the equivalency shown through these characteristics and the results of specified performance tests.
| Attribute | Subject Devices: Provena™ Midline Catheters | Predicate Devices: Dual Lumen PowerMidline™ Catheters | Acceptance Criterion (Implicit: Substantial Equivalence) | Reported Device Performance (as Compared to Predicate) |
|---|---|---|---|---|
| Indications for Use | Short term access to peripheral venous system for selected IV therapies, blood sampling, and power injection of contrast media. Suitable for power injectors. | Same as subject. | Same | Equivalent |
| Duration of Use | Short term ( |
§ 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).