SAGE CONTRAST MANAGEMENT SYSTEM

• K Number: K991112
• Device Name: SAGE CONTRAST MANAGEMENT SYSTEM
• Manufacturer: SAGE LABORATORIES, INC.
• Date Cleared: 1999-09-02 ( 154 days)
• Product Code: FPA
• Regulation Number: 880.5440
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The Sage Contrast Management System is recommended for controlled IV administration of contrast media.

Device Description

Sage Contrast Management System

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Sage Contrast Management System. It does not contain the detailed technical information, study design, or results that would allow for a comprehensive description of acceptance criteria and device performance as requested.

Therefore, I cannot provide the requested information from the provided text. The document primarily states that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets or data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. Information about MRMC comparative effectiveness studies or standalone performance.
5. Details on the type of ground truth used or training set information.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.