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K Number
K130131
Device Name
EDRAIN CHEST DRAINAGE SYSTEM
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2013-02-28

(41 days)

Product Code
BTA
Regulation Number
878.4780
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Evacuate air and/or fluid from the chest cavity or mediastinum
Help re-establish lung expansion and restore breathing dynamics
Facilitate postoperative collection and reinfusion of autologous blood from the patient's pleural cavity or mediastinal area.

Device Description

Not Found

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for the "Atrium eDrain Chest Drainage System." It does not contain information about acceptance criteria, device performance, study details, ground truth, or sample sizes for an AI/ML powered device. The letter is a regulatory document confirming clearance for a traditional medical device (a powered suction pump) and references general manufacturing and labeling requirements.

Therefore, I cannot extract the requested information from this document.

§ 878.4780 Powered suction pump.

(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.