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.

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).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the LifeBorne Infant Resuscitator, based on the provided text:

Acceptance Criteria and Device Performance

TEST	TEST REQUIREMENTS (Acceptance Criteria)	REPORTED DEVICE PERFORMANCE
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.

Study Details

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a separate "test set" sample size. The document refers to "bench testing" as the method for performance evaluation. The tests themselves are functional evaluations of the device's components and overall system.
Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory or simulated environment. The country of origin of the data is not specified, but the submission is from International Biomedical, located in Austin, TX, U.S.A. It is retrospective in the sense that the testing was completed before the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This device's performance was evaluated through bench testing against predefined technical specifications, not by expert interpretation of data. Therefore, no experts were used to establish ground truth in this context.

4. Adjudication method for the test set:

Not applicable. As described above, the evaluation was based on meeting objective technical requirements through bench testing, not on human interpretation requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a medical device (resuscitator) that does not involve "human readers" interpreting medical cases or utilizing AI. Its effectiveness is determined by its mechanical and functional performance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, in a way. The device itself operates "standalone" in performing its functions (e.g., delivering precise FIO2, controlling PIP/PEEP). The "bench testing" represents the performance of the algorithm/device without human intervention during the test itself (though humans operate the test setup). There is no "algorithm" in the sense of AI or image analysis involved.

7. The type of ground truth used:

The ground truth for the device's performance was based on predefined technical specifications and engineering standards. Each test had a specific, measurable requirement (e.g., FIO2 within 5%, dead space less than 7 mL) which served as the objective ground truth against which the device's performance was measured.

8. The sample size for the training set:

Not applicable. This device is a mechanical/electronic system, not one that uses machine learning or AI that would require a "training set" of data.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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K140707

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:

Intended Use:

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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.

	ProposedLifeBorne InfantResuscitator	PredicateK070210 GE Giraffe and Panda	PredicateK892885 F&P NeoPuff
Indications for Use	The LifeBorne InfantResuscitator is intendedto provide the basicequipment required forpulmonary resuscitationof neonatal infants.Pulmonary resuscitationincludes practicesnecessary to establish aclear airway and provideoxygen or air/oxygenmixtures and/or manualventilation to theneonatal infant.	The T-piece resuscitationsystem provides the basicequipment required forpulmonary resuscitation ofinfants. Pulmonaryresuscitation includespractices necessary toestablish a clear airway andprovide oxygen orair/oxygen mixtures and ormanual ventilation to theinfant.	Manually operated, gaspowered resuscitatorwhich providescontrolled and accurateresuscitation of newbornbabies.
Environment for Use	Hospital, delivery suites,nursery, ICU	Hospital, delivery suites,nursery, ICU	Hospital, delivery suites,nursery, ICU
Patient Population	Infant < 10 kg	Infant < 10 kg	Infant < 10 kg
Patient Connection	Face mask; ET tube	Face mask; ET tube	Face mask; ET tube
Air/Oxygen Mixture	21-100%	21-100%	Not specified
Gas Flow Source	Wall gas or cylinder	Wall gas or cylinder	Wall gas or cylinder
Manometer Range	-10 to 80 cm H2O	-10 to 80 cm H2O	-20 to 80 cm H2O

FDA Submission - Resuscitator

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Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014

Peak InspiratoryPressure (PIP)	Max 45 +/- 5 cm H2O	Max 45 +/- 5 cm H2O	2 – 80 cm H2O
Positive EndExpiratory Pressure(PEEP)	0-6 cm H2O	0-6 cm H2O	1-25 cm H2O,depending on flowrate
Vacuum PressureRange	0 - 150 mmHg, negativepressure	0 - 150 mmHg, negativepressure	N/A – suction notavailable
Maximum gas flowrate	15 LPM	15 LPM	15 LPM
Maximum pressurerelief	55 cm H2O	55 cm H2O	40 cm H2O
Features: VenturiVacuum Device	Present, same aspredicate	Present	N/A
Features: Vacuumgauge	Present, same aspredicate	Present	N/A
Features: IntegratedMedical Blender	Present, same aspredicate	Present	Non integrated, butavailable
Features: Flowmetersfor delivery of gas	Present, same aspredicate	Present	Not integrated, butavailable
Features: PIP control	Present, same aspredicate	Present	Present
Features: PEEPcontrol	Present, same aspredicate	Present	Present
Features: Airwaypressure manometer	Present, same aspredicate	Present	Present

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 OFRESULTS
Valve Functionafter Vomitus	The proper function of the circuit shall be verified within20 seconds of becoming disabled by vomitus. Function isverified by verifying flow valve accuracy.	Passed.
InspiratoryResistance	Pressure generated at the patient connection port duringexpiration should not exceed -5 cmH2O with inspiratoryairflow set to 6 L/min.	Passed.
ExpiratoryResistance	Pressure generated at the patient connection port duringexpiration should not exceed 5 cmH2O with expiratoryairflow set to 6 L/min.	Passed.
Dead Space	The deadspace volume of the T-Piece circuit should be lessthan 7 mL.	Passed.

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Traditional 510(k) Submission LifeBorne Infant Resuscitator - March 18, 2014

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 andSecondary FlowValve - 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 ManometerAccuracy	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
ParticulateAnalysis	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.

Conclusion:

In regards to intended use and technology the LifeBorne Infant Resuscitator is substantially equivalent to the listed predicates. Any differences between the LifeBorne Infant Resuscitator and the predicates do not raise any new questions of safety and effectiveness.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2014

International Biomedical, Ltd. Amy Pieper Director of Regulatory Affairs 8206 Cross Park Drive Austin, TX 78754

Re: K140707

Trade/Device Name: LifeBorne Infant Resuscitator Regulation Number: 21 CFR 868.5925 Regulation Name: Powered emergency ventilator Regulatory Class: Class II Product Code: BTL Dated: March 18, 2014 Received: March 24, 2014

Dear Ms. Pieper:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Amy Pieper

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Tejashri Parohit-Sheth, M.D.
Tejashri Purohitt Sheth HD
Chalal Deputy Director
DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name
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LifeBorne Infant Resuscitator

Indications for Use (Describe)

The LifeBome 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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Anva C. Harry -S 1.8.00 2014.05.23 10:09:29 -04'00'

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FORM FDA 3881 (1/14)

Regulation Number and Section

§ 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).