BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX

• K Number: K982241
• Device Name: BETATRANS INTRAOP I AND II MODEL NUMBERS DS100X AND DS10XX
• Manufacturer: DUXBURY SCIENTIFIC INC.
• Date Cleared: 1998-11-30 ( 158 days)
• Product Code: CAC
• Regulation Number: 868.5830
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The Betatrans Intraoperative Autotransfusion System is designed for the collection and reinfusion of intraoperative drainage blood collected intraoperatively. The system is intended to reduce or eliminate the need for transfusion of homologous blood, which can carry a variety of infectious agent including Hepatitis or HIV.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Betatrans Intraoperative Autotransfusion System. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the given text. The letter only confirms that the device has been found substantially equivalent to a predicate device and can be marketed.

Regulation Number and Section

§ 868.5830 Autotransfusion apparatus.

(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).