VITALMIX PLUS EMPTY I.V. CONTAINER

• K Number: K972464
• Device Name: VITALMIX PLUS EMPTY I.V. CONTAINER
• Manufacturer: PACIFIC DEVICE, INC.
• Date Cleared: 1997-11-05 ( 127 days)
• Product Code: KPE
• Regulation Number: 880.5025
• Type: Traditional
• Panel: HO
• Reference & Predicate Devices: N/A

Intended Use

The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications.

Device Description

VITALMIX PLUS I.V. Containers and Transfer Set Components

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Vitalmix Plus I.V. Containers and Transfer Set Components." This letter does not contain information about acceptance criteria or a study proving the device meets those criteria.

The document primarily focuses on:

• Confirming that the device is substantially equivalent to a legally marketed predicate device.
• Stating that the manufacturer can market the device subject to general controls and existing regulations.
• Providing contact information for regulatory inquiries.
• Listing the intended use of the device: "The VITALMIX PLUS Empty I.V. Container is intended for use in the preparation of drug admixtures of compatible medications."

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth information, MRMC study, standalone performance, or training set details) from this document. This typically requires reviewing a more detailed submission or study report, which is not part of this FDA clearance letter.

Regulation Number and Section

§ 880.5025 I.V. container.

(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).