(69 days)
No
The document describes a gas-powered manual resuscitation system and does not mention any AI or ML components or capabilities.
Yes
The device is intended for pulmonary resuscitation of neonatal infants, including clearing airways, providing oxygen/air mixtures, and manual ventilation, which are therapeutic interventions.
No
Explanation: The device is intended for pulmonary resuscitation, providing oxygen/air and/or manual ventilation. It does not perform any diagnostic function to identify a disease or condition.
No
The device description explicitly states it is a "gas powered emergency resuscitation system" and provides "basic equipment required for pulmonary resuscitation," indicating it includes hardware components beyond just software.
Based on the provided information, the LifeBorne Infant Resuscitator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the LifeBorne Infant Resuscitator is used for pulmonary resuscitation of neonatal infants, which involves providing respiratory support directly to the patient.
- The device description focuses on mechanical and gas delivery functions. It describes providing oxygen/air mixtures, manual ventilation, and airway clearance. These are all actions performed on the patient's respiratory system, not on a biological sample.
- There is no mention of analyzing biological specimens. The document does not describe any process of collecting, preparing, or analyzing blood, urine, tissue, or any other bodily fluid or sample.
Therefore, the LifeBorne Infant Resuscitator is a medical device used for direct patient care, specifically respiratory support, and does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
Product codes (comma separated list FDA assigned to the subject device)
BTL
Device Description
The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
neonatal infants
Intended User / Care Setting
trained medical professionals / inside the hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Pulmonary resuscitation of infants includes well established clinical practices; clinical testing is not necessary to support safety and effectiveness. Conformance of the LifeBorne Infant Resuscitation System to performance specifications has been established through bench testing.
| TEST | TEST REQUIREMENTS | SUMMARY OF RESULTS |
|---|---|---|
| Valve Function after Vomitus | The proper function of the circuit shall be verified within 20 seconds of becoming disabled by vomitus. Function is verified by verifying flow valve accuracy. | Passed. |
| Inspiratory Resistance | Pressure generated at the patient connection port during expiration should not exceed -5 cmH2O with inspiratory airflow set to 6 L/min. | Passed. |
| Expiratory Resistance | Pressure generated at the patient connection port during expiration should not exceed 5 cmH2O with expiratory airflow set to 6 L/min. | Passed. |
| Dead Space | The deadspace volume of the T-Piece circuit should be less than 7 mL. | Passed. |
| FIO2 accuracy | The proper function of the FIO2 adjustment knob shall be verified by comparing the FIO2 setting value with the output oxygen concentration. Values shall be within 5%. | Passed. |
| Primary and Secondary Flow Valve - Peak Flow | The proper function of the primary and secondary flow valves shall be verified by comparing the flow setting with the actual measured output flow. | Passed. |
| Airway Manometer Accuracy | The proper function of the airway manometer shall be verified by comparing the pressure readings with the actual measured output pressure. | Passed. |
| VOC Testing | The device should not add volatile organic compounds (VOCs) to the output gas delivered to the patient. | Passed |
| Particulate Analysis | The output of particulate matter sizes 2.5 microns or less are no more than 12 micrograms/cubic meter of air at one atmospheric pressure. | Passed |
The LifeBorne Infant Resuscitator met all the performance requirements as outlined above and thus can be found to be substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5925 Powered emergency ventilator.
(a)
Identification. A powered emergency ventilator is a demand valve or inhalator intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).
0
Traditional 510(k) Submission MAY 28 2014 LifeBorne Infant Resuscitator - March 18, 2014
510(k) SUMMARY
Submitter Information:
International Biomedical 8206 Cross Park Drive Austin, TX 78754 U.S.A.
Regulatory Affairs Contact:
Amy Pieper Director of Regulatory Affairs (512) 873-0033 - phone (512) 873-9090 - fax
Date Summary Prepared: March 18, 2014
Device Identification:
Trade Name: LifeBorne Infant Resuscitator Common Name: Ventilator, Emergency Gas Powered (Resuscitator) Regulatory Class: II Regulation: 868.5925 Product Code: BTL Panel: Anesthesiology
Predicate Device:
GE - Giraffe and Panda T-Piece Resuscitation System - K070210 Fisher & Paykel - NeoPuff - K892885
Device Description:
The resuscitation system provides the basic equipment required for pulmonary resuscitation of neonatal infants. The LifeBorne Infant Resuscitator is a gas powered emergency resuscitation system. It is intended to be used inside the hospital by trained medical professionals to provide precise FIO2 delivery, manual ventilation, and emergency airway clearance as established by resuscitation guidelines to neonates and infants weighing less than 10 kg (22 lb).
Intended Use:
The LifeBorne Infant Resuscitator is intended to provide the basic equipment required for pulmonary resuscitation of neonatal infants. Pulmonary resuscitation includes practices necessary to establish a clear airway and provide oxygen or air/oxygen mixtures and/or manual ventilation to the neonatal infant.
1
Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014
Functional Description and Technological Characteristics:
The LifeBorne Infant Resuscitation System incorporates the following components for neonatal resuscitation:
- Venturi vacuum device for suctioning airways (no 510k) .
- Vacuum gauge for monitoring suction pressures (no 510k) .
- . Medical blender to mix air and oxygen to a precise FIO2 (K883038 or K925982)
- . Flowmeters for the delivery of oxygen or air/oxygen mixtures (no 510k)
- . Peak Inspiratory Pressure (PIP) control to set the maximum pressure delivered during an inspiratory phase of a manual breath (no 510k)
- . Peak End Expiratory Pressure (PEEP) control located on a provided T-piece circuit to set the maximum pressure during the expiratory phase of a manual breath (K093913)
- . An airway pressure manometer to monitor both PIP and PEEP airway pressure (no 510k)
Substantial Equivalence:
The LifeBorne Infant Resuscitator described in this submission is, in our opinion, substantially equivalent to the predicate device, in regards to intended use and safety and effectiveness. The intended use of the LifeBorne Infant Resuscitator is identical to the intended use of the predicate K070210.
| | Proposed
LifeBorne Infant
Resuscitator | Predicate
K070210 GE Giraffe and Panda | Predicate
K892885 F&P NeoPuff |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The LifeBorne Infant
Resuscitator is intended
to provide the basic
equipment required for
pulmonary resuscitation
of neonatal infants.
Pulmonary resuscitation
includes practices
necessary to establish a
clear airway and provide
oxygen or air/oxygen
mixtures and/or manual
ventilation to the
neonatal infant. | The T-piece resuscitation
system provides the basic
equipment required for
pulmonary resuscitation of
infants. Pulmonary
resuscitation includes
practices necessary to
establish a clear airway and
provide oxygen or
air/oxygen mixtures and or
manual ventilation to the
infant. | Manually operated, gas
powered resuscitator
which provides
controlled and accurate
resuscitation of newborn
babies. |
| Environment for Use | Hospital, delivery suites,
nursery, ICU | Hospital, delivery suites,
nursery, ICU | Hospital, delivery suites,
nursery, ICU |
| Patient Population | Infant Anva C. Harry -S 1.8.00 2014.05.23 10:09:29 -04'00'
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