(111 days)
Not Found
No
The summary describes a mechanical breathing circuit with a PEEP valve and does not mention any computational or learning capabilities.
Yes.
The device is described as a "Resuscitation Circuit," used for "emergency neonatal resuscitation," and adds "positive end expiratory pressure breathing capability," which are all therapeutic interventions.
No
The device is an accessory to add PEEP breathing capability to a resuscitator, used for emergency neonatal resuscitation. Its purpose is therapeutic, not diagnostic.
No
The device description clearly indicates it is a physical breathing circuit with a PEEP control valve, intended for use with manual resuscitation devices. It is a hardware accessory, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an accessory to a T-Piece Resuscitator for adding PEEP capability during neonatal resuscitation. This is a therapeutic and life-support function, not a diagnostic one.
- Device Description: The description reinforces its use with manual resuscitation devices for emergency neonatal resuscitation, again pointing to a therapeutic application.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device's function is to assist with breathing during resuscitation, which is a direct intervention, not a diagnostic test.
N/A
Intended Use / Indications for Use
The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients
§ 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).
0
K103f33
510(k) Summary of Safety and Effectiveness
APR 2 0 2011
Applicant:
Neoforce Group, Inc. 35 Commerce Drive lvyland, Pa. 18974 Owner/Operator number: 9083179 Registration Number: 3005599562
Contact Person:
Neoforce Group, Inc. 35 Commerce Drive lvyland, Pa. 18974
Monica Ferrante Ph 215-672-6800 x203 Fax 215-672-1123
Device trade/proprietary name:
NeoPIP™ Resuscitation Circuit with PEEP
Device common/usual/classification name:
Attachment, Breathing, Positive End Expiratory Pressure
Classification:
Anesthesiology 21 CFR 868.5965 Attachment, Breathing, Positive End Expiratory Pressure, BYE, Class II
Performance Standards:
None applicable
Predicate Device:
K070416 NeoPEEP Neonatal Resuscitation Circuit with PEEP
1
Device Description
The NeoPIP™ Resuscitation Circuit with PEEP control valve is a breathing circuit intended for use with manual resuscitation devices for emergency neonatal resuscitation.
Intended Use
The NeoPIP™ Resuscitation Circuit with PEEP is indicated as an accessory to add positive end expiratory pressure breathing capability to a T-Piece Resuscitator. The PEEP valve is incorporated into the breathing circuit T-Piece with a standard fitting for face mask, laryngeal mask or endotracheal tube. The NeoPIP Resuscitation Circuit with PEEP is indicated for use in neonatal patients