AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE

• K Number: K973760
• Device Name: AFFINITY HOLLOW FIBER OXYGENATOR WITH TRILLIUM BIOPASSIVE SURFACE
• Manufacturer: AVECOR CARDIOVASCULAR, INC.
• Date Cleared: 1998-02-18 ( 139 days)
• Product Code: DTZ
• Regulation Number: 870.4350
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

The Affinity™ Hollow Fiber Membrane Oxygenator Systems are intended to be used in an extracorporeal perfusion circuit to oxygenate and remove carbon dioxide from the blood and to cool or warm the blood during routine cardiopulmonary bypass procedures up to 6 hours in duration.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for a medical device (Affinity™ Hollow Fiber Oxygenator with Trillium™ Biopassive Surface, K973760). It signifies that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, this document does NOT contain information regarding acceptance criteria or a study proving the device meets those criteria. Medical device clearance documents like this typically do not include detailed performance study results or acceptance criteria.

These details would be found in the manufacturer's 510(k) submission to the FDA, which is a much more extensive document that typically includes:

• Detailed descriptions of the device and its intended use.
• Performance data from various tests (e.g., in vitro, animal, and sometimes human clinical studies) to demonstrate substantial equivalence. This data would be compared against the performance of a predicate device or against pre-defined acceptance criteria.
• Risk analysis.
• Labeling information.

Therefore, I cannot provide the requested information based solely on the provided FDA clearance letter. To answer your questions, one would need access to the full 510(k) submission or the underlying studies conducted by AVECOR Cardiovascular, Inc. for the Affinity™ Hollow Fiber Oxygenator.

Regulation Number and Section

§ 870.4350 Cardiopulmonary bypass oxygenator.

(a)
Identification. A cardiopulmonary bypass oxygenator is a device used to exchange gases between blood and a gaseous environment to satisfy the gas exchange needs of a patient during open-heart surgery.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance for Cardiopulmonary Bypass Oxygenators 510(k) Submissions.”