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K Number
K981415
Device Name
0-20 CM H20 PEEP VALVE
Manufacturer
CHEEN HOUNG ENT. CO. LTD.
Date Cleared
1998-07-14

(85 days)

Product Code
BYE
Regulation Number
868.5965
Type
Traditional
Panel
AN
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cheen Houng 0-20 Cm H2O PEEP Valve is indicated as an accessory to add positive end expiratory pressure breathing capability to a Manual Resuscitator.

Device Description

The Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are similar in intended use, design, material selection, performance and function to Life Design PEEP FLO PEEP Valves which are currently legally and safely marketed in the United States.

AI/ML Overview

The provided document is a 510(k) summary for the Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves. This document asserts the substantial equivalence of the device to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria for a novel device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, types of ground truth, and training set information is not available within this 510(k) summary.

The document states:

"The Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are similar in intended use, design, material selection, performance and function to Life Design PEEP FLO PEEP Valves which are currently legally and safely marketed in the United States. No new technological characteristics that could affect safety or effectiveness have been introduced. Therefore, it is our conclusion that the Cheen Houng Enterprise Co., Ltd. 0-20 Cm H2O PEEP Valves are safe and effective for their intended function."

This statement indicates that the submission relies on the established safety and effectiveness of a predicate device ("Life Design PEEP FLO PEEP Valves") due to the substantial equivalence of the new device. It does not present a de novo study with specific acceptance criteria and performance data for the Cheen Houng PEEP Valve itself.

§ 868.5965 Positive end expiratory pressure breathing attachment.

(a)
Identification. A positive end expiratory pressure (PEEP) breathing attachment is a device attached to a ventilator that is used to elevate pressure in a patient's lungs above atmospheric pressure at the end of exhalation.(b)
Classification. Class II (performance standards).