EXPRESS AND OASIS CHEST DRAIN

• K Number: K043140
• Device Name: EXPRESS AND OASIS CHEST DRAIN
• Manufacturer: ATRIUM MEDICAL CORP.
• Date Cleared: 2004-12-08 ( 23 days)
• Product Code: CAC
• Regulation Number: 868.5830
• Type: Special
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

• To evacuate air and/or fluid from the chest cavity or mediastinum. .
• To help re-establish lung expansion and restore breathing dynamics. .
• To facilitate collection of autologous blood from the patient's pleural cavity or . mediastinal area for reinfusion purposes in post-operative and trauma blood loss management.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for medical devices, specifically chest drains. It does not contain information about acceptance criteria or a study proving that a device meets such criteria. The letter acknowledges the company's "premarket notification of intent to market" and states that the device is "substantially equivalent" to legally marketed predicate devices. This is a regulatory clearance based on substantial equivalence, not a clinical study proving pre-defined performance metrics.

Therefore, I cannot provide the requested information from the provided text as it does not contain the details of a study with acceptance criteria and device performance.

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).