LogoFDA 510(k) Search
K Number
K953901
Device Name
SARNS 800 ROLLER PUMP
Manufacturer
3M HEALTH CARE, SARNS
Date Cleared
1996-04-19

(245 days)

Product Code
DWB
Regulation Number
870.4370
Type
Traditional
Panel
CV
Reference & Predicate Devices
K915183
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sarns 8000 Roller Pump is indicated for use in extracorporeal circulation of blood for arterial regional perfusion, and cardiopulmonary bypass procedures only, when used by a qualified perfusionist who is experienced in the operation of Sarns or similar equipment.

Device Description

The Sarns 8000 Roller Pump consists of a Universal Roller Pump, which is a microprocessor controlled 2-roller peristaltic pump with adjustable occlusion, and a power supply. The pump is capable of flows up to 9.99 L/min (depending on pump head tubing used) at pump speeds up to 250 RPM. The Sarns 8000 Roller Pump can be used as a stand-alone device or it is compatible with the Sarns 8000 Modular Perfusion System.

AI/ML Overview

The provided text describes a 510(k) summary for the Sarns 8000 Roller Pump. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.

Instead, the document details a traditional medical device submission for a roller pump, comparing a modified version to a predicate device. The information focuses on design changes (Surface Mount Technology vs. Through-Hole Technology, minor software changes) and states that "Nonclinical tests were performed on the device to determine substantial equivalence. Electromagnetic Compatibility (EMC) tests were also performed to ensure equivalent or better results."

There is no mention of:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes, data provenance, or ground truth for test sets.
  • Experts or adjudication methods.
  • MRMC studies or standalone algorithm performance.
  • Training sets or how their ground truth was established.

Therefore, I cannot provide the requested information for an AI/ML device based on the given text. The text is for a hardware medical device, not an AI/ML system.

§ 870.4370 Roller-type cardiopulmonary bypass blood pump.

(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).