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K Number
K013308
Device Name
VENTLAB HYPERINFLATION BAG SYSTEM
Manufacturer
VENTLAB CORP.
Date Cleared
2001-12-20

(77 days)

Product Code
NHK
Regulation Number
868.5905
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

Device Description

Ventlab Corporation's Hyperinflation Bag System is a pulmonary-assist device intended to provide controlled or assisted ventilation to patients. It is designed for patients suffering from respiratory insufficiency. The system's mode of operation is to hyper-ventilate a patient by forcing a volume of fresh gas into the patient via compression of the reservoir bag. Typical treatment consists of hyper-inflating the patient's lung(s) over several respiration cycles. The operating clinician controls peak pressure and monitors pressure in the lungs by means of a user-supplied manometer.

AI/ML Overview

This document is a 510(k) clearance letter for the Ventlab Hyperinflation Bag System. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed devices. It outlines regulatory requirements and provides contact information for further inquiries.

Therefore, I cannot provide the requested information about acceptance criteria and the study based on the provided text.

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).