The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

Positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask or nasal prongs)
CMV and IMV mode of ventilation with or without PEEP / CPAP
Provide oxygen or a mixture of medical air and oxygen

Device Description

The pNeuton mini ventilator is a small, lightweight transport ventilator designed for use on patients from neonate to pediatric in size (400 gram to 25 kg). It is a time cycled, flow limited ventilator providing Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV). In these modes of ventilation, an adjustable inspiratory time, expiratory time and pressure is delivered to the patient. The patient is allowed to breath spontaneously between the mandatory breaths with little added work of breathing. A built-in PEEP / CPAP system can be set to provide expiratory positive pressure. The delivered oxygen is adjustable from 21 to 100 percent. The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device. The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use. The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

AI/ML Overview

The pNeuton mini Ventilator is a device designed for providing ventilatory support to critically ill neonate to pediatric patients. Its acceptance criteria and proof of meeting them are detailed in the 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The device's performance is demonstrated through its specifications, which meet or exceed the requirements of relevant voluntary standards. Below is a summary of key performance characteristics and their specifications:

Characteristic	Acceptance Criteria (pNeuton mini Ventilator Specification)	Reported Device Performance (as per non-clinical testing)
Maximum Working Pressure Limitation	80 cm H2O	The device is designed for 80 cm H2O maximum working pressure. No specific deviation is mentioned, implying it met this.
Maximum Inspiratory Flow	20 L/min	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications. Implicitly, this includes flow.
Inspiratory Time Control Setting	0.25 to 2.0 sec	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Inspiratory Time Accuracy	± 10%	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Expiratory Time Control Setting	0.25 to 20.0 sec	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Expiratory Time Accuracy	± 10%	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Peak Patient Pressure Control Setting	15 – 60 cm H2O	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Peak Patient Pressure Accuracy	± 2 cm H2O	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Flow Rate Control Setting	6, 8, 10, 15, 20 L/min	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Flow Rate Accuracy	± 10%	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
CPAP Control Setting	0 - 20 cm H2O	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
CPAP Accuracy	± 2 cm H2O	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Oxygen Control Setting	21 to 100%	The precision air/oxygen blender is noted as being used for neonatal ventilation due to specific requirements, implying greater accuracy than prior models.
Oxygen Accuracy	± 3%	Waveform tests showed accuracy and precision of breath delivery meet or exceed specifications.
Monitored Pressure Parameter Range	-10 to 80 cm H2O	Performance as specified.
Monitored Pressure Accuracy	± 2 cm H2O	Performance as specified.
High Pressure Alarm	10 - 70 cm H2O (settable)	Performance as specified. Implicitly, this alarm range is met.
Environmental Operating Temperature	-15 to 49 °C (5 to 120 °F)	Passed RTCA DO-160G (Temperature Variation, Humidity, Robust Vibrations, Spray Proof) and MIL-STD-810F (Rapid decompression, Jet Aircraft Random Vibration) tests, confirming operation within and beyond listed limits. Endurance tests for 240 hours at environmental extremes.
Humidity	15 to 95 percent humidity	Passed RTCA DO-160G, section 6, Humidity tests using Category A.
MRI Compatibility	MR Conditional 3T	Passed ASTM F2052-06e1 and ASTM F2119-07 testing using a 3 Tesla scanner. No induced displacement force, performance variance, or artifact generated.
Reliability/Lifespan	Not explicitly stated, but implies performance over lifetime	Operated continuously for 2,200 hours at two different clinical simulated conditions, and an additional 240 hours at environmental extremes.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that "Clinical testing was not performed on this device." Therefore, there is no test set in the context of human patient data. The provenance of the data is from non-clinical bench testing and simulated conditions performed by the manufacturer, Airon Corporation, presumably in the USA (where the company is based). The data is retrospective in the sense that it represents controlled lab measurements and simulations based on predefined specifications and standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As clinical testing was not performed and the data is non-clinical bench testing, the concept of "ground truth" derived from expert clinical opinion is not applicable here. The "truth" or reference for performance was established by engineering specifications and recognized industry standards (e.g., ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F). The experts involved would be those who developed these standards and the engineers and technicians at Airon Corporation who conducted the tests and verified compliance. Their qualifications would be in engineering, medical device manufacturing, and testing, rather than medical clinical specialties for patient diagnosis.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring expert adjudication was used. The device's performance was judged against pre-defined engineering specifications and compliance with voluntary standards through measurement and direct verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical testing was not performed on this device." The submission relies on substantial equivalence to predicate devices and non-clinical testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence, the non-clinical testing described represents standalone performance of the device. The pNeuton mini Ventilator is a mechanical, pneumatic device with no electronic controls or software, hence no "algorithm" in the modern AI sense. The testing verified the physical and mechanical performance of the device itself against its specifications in a controlled, simulated environment, without direct human interaction or intervention during the operational tests (e.g., the 2,200 hours of continuous operation).

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

Engineering specifications: The target performance parameters (e.g., flow rates, pressure ranges, time accuracies) defined by Airon Corporation for the pNeuton mini Ventilator.
Voluntary industry standards: Specific requirements and test methodologies outlined in standards such as ASTM F1100-90, ISO 10651-3:1997, RTCA DO-160G, MIL-STD-810F, and CGA V-5:2008. These standards define acceptable ranges and test environments for ventilators.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this device is a mechanical ventilator and does not involve machine learning algorithms that would typically require a training dataset.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Airon. The logo consists of a stylized graphic to the left of the word "Airon". The graphic appears to be a circle with an abstract design inside, possibly representing a bird or an airplane. The word "Airon" is written in a simple, sans-serif font.

OCT 11 2012

pNeuton mini Ventilator

510(k) Summary - K121379 14 September 2012 Page 1 of 8

Contact Information

G. Eric Gjerde President Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 Tel: 321-821-9433 Fax: 321-821-9443 email: egjerde@AironUSA.com

Device Trade Name

pNeuton mini Ventilator

Device Classification

Continuous Ventilator (21 CFR 868.5895, Product Code CBK)

Device Class

Class II

Predicate Devices

pNeuton Transport Ventilator model A

manufactured by Airon Corporation .
510(k) number K043085 .

BabyPAC 100 Ventilator

manufactured by Smiths Medical International Ltd. .
510(k) number K043495 .

Millennium Infant Ventilator

manufactured by Sechrist Industries Inc. .
510(k) number K993167 .

Babi Plus Nasal Cannula System

manufactured by A Plus Medical .
510(k) number K110471 .

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary - K121379 14 September 2012 Page 2 of 8

Device Description

The pNeuton mini ventilator is a pure pneumatic ventilator. Electrical power is not used. The ventilator operates from oxygen and medical grade air input pressures from 40 to 70 psi. The various control systems that manage the time controls, PEEP / CPAP, and safety systems / pneumatic alarms is powered with pure oxygen to maintain stability and accuracy. There are no electronic controls or software in this device.

The device provides ventilation and CPAP support for the care of individuals who require respiratory assistance. The device is a restricted medical device for use by qualified medical personnel under the direction of a physician. The device may be used in prehospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital including the MRI (NOT for use in the presence of flammable anesthetics). The mini ventilator has been specifically designed for ruggedness and ease of use.

The pNeuton mini ventilator uses accessories during normal operation. The primary accessory is a patient tubing circuit to attach the device to the patient. The patient circuit is a single-use disposable device. The patient circuit uses the same major component (expiratory valve) included with the predicate pNeuton Ventilator K043085 with smaller diameter hoses.

Intended Use

The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

Positive pressure ventilation delivered invasively (via an ET Tube) or non-. invasively (via a mask or nasal prongs)
CMV and IMV mode of ventilation with or without PEEP / CPAP .
Provide oxygen or a mixture of medical air and oxygen .

Patient population:

Neonates, infants, and children, from 400 g to 25 kg in weight

Environments of Use

· Inter and intra-hospital patient transport
Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary - K121379 14 September 2012 Page 3 of 7

Air & ground transport Pressurized and non-pressurized aircraft (to . 15.000 ft)
Intensive care units (short term use only associated with patient . transport)
Emergency Departments .
Radiology suites including MRI (MR Conditional 3T) .
Operating rooms (short term use only associated with patient transport) ●

Substantial Equivalence

The pNeuton mini ventilator shares substantial equivalency with the pNeuton model A Ventilator, the BabyPAC 100 Ventilator and the Millennium Infant Ventilator across the spectrum of patient population for which each was designed.

The pNeuton mini ventilator utilizes many similar components as found in the pNeuton model A Ventilator including an identical timing and pressure control system with patient / gas supply alarms. Due to the requirements of neonatal ventilation a precision air / oxygen blender is used instead of the air entrainment based oxygen mixing of the model A ventilator.

The pNeuton mini ventilator shares common modalities with the BabyPAC 100 Ventilator and the Millennium Infant Ventilator with significant overlap in the clinical range of function for their target population. The essential clinical function of each device is significantly similar and mimics each other in the typical frame of use by the health care providers. All are pneumatic based and applicable for the same areas of use.

Characteristic	pNeuton miniVentilator	pNeuton AVentilator	BabyPACVentilator	MillenniumVentilator
510(k) numberIntended Use –application	Provide continuous orintermittentmechanicalventilation and / orCPAP for neonate tochild patients (400 gto 25 kg) via mask,nasal prongs orendo-tracheal tube	K043085Provide continuous orintermittent mechanicalventilation and / orCPAP for pediatric toadult patients via maskor endo-tracheal tube	K043495Provide continuousor intermittentmechanicalventilation and / orCPAP for neonateto child patients upto 20 kg	K993167Provide continuousor intermittentmechanicalventilation and / orCPAP for neonate topediatric patients upto 50 kg
Environments of use	Hospital, pre-hospitaland transportenvironments	Hospital, pre-hospital,transport and sub-acute/alternate sitefacility environments	Ambulance,hospital,emergency andtransportenvironments	Hospital environment
Operationenvironmentalrequirements	-15 to 49 °C (5 to 120°F), 15 to 95 percenthumidity	-5 to 40 °C (23 to 104°F), 15 to 95 percenthumidity	-10 to 40°C (14 to104 °F)	-10 to 40°C (14 to104 °F), 15 to 95 percenthumidity

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary – K121379 14 September 2012 Page 4 of 8

PersonnelRequirements	Training as physician,nurse, respiratorytherapist	Training as physician,nurse, respiratorytherapist, EMT	Training asqualified medicalcaregiver,paramedics andother trainedpersonnel	Training asphysician, nurse,respiratory therapist
Operating principle	Pneumatic driven andcontrolled withpneumatic alarms	Pneumatic driven andcontrolled withpneumatic alarms	Pneumatic drivenand controlled withelectronic alarms	Pneumatic drivenand electronicallycontrolled
Gas Input(s)	40 to 70 psi	40 to 70 psi	40 to 87 psi	40 to 60 psi
Patient circuit	Tubing with externalexpiratory valve andproximal pressureline	Tubing with externalexpiratory valve	Tubing withexternal attachedexpiratory valve	Tubing with externalattached expiratoryvalve
Enclosure	Rugged, lightweight	Rugged, lightweight	Rugged, lightweight	Single enclosure onstand for hospital use
Displays	Manometer	Manometer	Manometer	Electronic screen
Safety features	Internal high pressurerelease, spontaneousbreathing safetyvalve	Internal high pressurerelease, spontaneousbreathing safety valve	None	Internal highpressure release
MRI compatibility	MRI Conditional 3T	MRI Conditional 3T	MRI Conditional 3T	None
Patient supportmodes	CMV, IMV, CPAP	CMV, IMV, CPAP	CMV, IMV, CPAP	Assist / Control,SIMV / IMV, CPAP
Maximum workingpressure limitation	80 cm H2O	80 cm H2O	80 cm H2O	70 cm H2O
Maximum inspiratory	20 L/min	Mandatory - 36 L/min	10 L/min	40 L/min

Maximum workingpressure limitation	80 cm H2O	80 cm H2O	80 cm H2O	70 cm H2O
Maximum inspiratoryflow	20 L/min	Mandatory - 36 L/minSpontaneous - 140 L/min	10 L/min	40 L/min
Inspiratory timeControl setting:Accuracy:	0.25 to 2.0 sec± 10%	label as tidal volume0.6 to 2.0 sec± 10%	0.25 to 2.0 sec± 0.8 sec	0.1 to 3.0 sec
Expiratory timeControl setting:Accuracy:	0.25 to 20.0 sec± 10%	label as resp rate0.6 to 20.0 sec± 10%	0.25 to 40 sec± 0.8 sec	0.3 to 30.0 sec
Peak patientpressureControl setting:Accuracy:	15 – 60 cm H2O± 2 cm H2O	15 – 75 cm H2O± 10%	10 – 70 cm H2O± 15%	5 – 70 cm H2O

・

な

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510(k) Summary – K121379 14 September 2012 Page 5 of 8

Flow Rate
Control setting:	6, 8, 10, 15, 20 L/min± 10%	Non adjustable @ 36	Non adjustable @ 10	2 to 32 L/min
CPAP
Control setting:	0 - 20 cm H2O± 2 cm H2O	0 - 20 cm H2O± 5%	0 - 20 cm H2O± 15%	0 - 20 cm H2O
Oxygen
Control setting:	21 to 100%± 3%	2 choices, 65 or 100± 10%	21 to 100%± 8%	21 to 100%
Measurements
Pressure sensortype:	Mechanical gaugeUse proximal airway signal	Mechanical gaugeUse internal signal	Mechanical gaugeUse internal signal	TransducerProximal airway
Volume sensor type:	None	None	None	None
Monitoredparameters
Parameter / range:	Pressure -10 to 80± 2 cm H2O	Pressure -10 to 80± 2 cm H2O	Pressure -10 to 100± 2 cm H2O	Pressure -10 to 70I:E ratio 4:1 to 1:10Resp rate 0 to 150
Alarms
Parameter / range:	High pressure10 - 70 cm H2O	No adjustable alarms	High pressure12 - 80 cm H2O	High pressure5 - 70 cm H2OHigh rate2 to 150
Default setting:	30 cm H2O	N/A
Non-adjustable:	Patient disconnect,low gas supply	Patient disconnect, lowgas supply	Patient disconnect,low gas supply, lowbattery	Patient disconnect,low PEEP, apnea,low gas supply, lowelectrical power, ventinop
Battery
Type:	None	None	3/3.6 volt lithium	None
Operating time:	N/A	N/A	1 year	N/A
Materials in gaspathway	Identical to Pneutonventilator	Cleared in K043085

The pNeuton mini Ventilator can provide non-invasive and invasive ventilation to the intended patient population. To provide invasive ventilation the Airon patient breathing circuit includes a wye piece with a standard 15 mm ID fitting for connection to an endotracheal tube. To provide non-invasive ventilation (NIV), accessory kits are used to

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary - K121379 14 September 2012 Page 6 of 8

replace the wye piece with appropriate tubing and patient interfaces (nasal prongs or mask).

Two NIV kits are available for use with the Airon patient breathing circuit. One NIV kit is called the NIC CK CPAP Kit. This is the same device as the Babi Plus Infant Nasal Cannula System cleared under K110471 by A Plus Medical.

The other NIV kit is called the NIC FM CPAP Kit. The NIC FM CPAP Kit is substantially equivalent in the indications for use, environment of use, patient population, material and function to the A Plus Medical Nasal Cannula Kit (K110471). The NIC FM CPAP Kit includes both nasal pronos and nasal masks while the A Plus Medical Nasal Cannula Kit only has nasal prongs. The addition of the nasal mask, which is Class 1 exempt under 21 CFR 868.5580 and Product Classification BYG – Oxygen mask, allows for the patient interface pressure points to be switched from inside of the nares (prongs) to outside (mask). . The essential clinical function of each device is significantly similar and mimics each other in the typical frame of use by the health care providers

Characteristic	NIC FM CPAP Kit	Babi Plus NasalCannula System
510(k) number		K110471
Intended Use -application	Single patient use deviceintended for use with neonates,infants and children under 10 Kgrequiring a non-invasive nasalinterface during intermittent orcontinuous gas flow therapy	Single patient use deviceintended for use with neonates,infants and children under 10 Kgrequiring a nasal prong interfaceduring intermittent or continuousgas flow therapy
Environments of use	Hospital critical care unit	Hospital critical care unit
Connection to Aironpatient circuit	10 mm male connectors in kit fit10 mm female connectors inpatient circuit. Length of tubingto patient interface is 10 mm.	10 mm male connectors in kit fit10 mm female connectors inpatient circuit. Length of tubingto patient interface is 10 mm.
Patient interfaces	6 sizes of nasal prongs and 4sizes of nasal mask	8 sizes of nasal prongs
Inspiratory flowresistance	1.0 to 1.7 cm H2O	1.1 to 1.3 cm H2O
Expiratory flowresistance	1.2 to 1.4 cm H2O	1.2 to 1.4 cm H2O
Materials in gaspathway	Silicone, K-resin, Polypropylene	Silicone, K-resin, Ethyl VinylAcetate (EVA) tubing, Polyvinylchloride (DEHP, DAP free)

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary - K121379 14 September 2012 Page 7 of 8

Summary of Non-Clinical Testing and Validation

The performance of the pNeuton mini ventilator has been comprehensively tested. All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Reviewer Guidance for Ventilators (April, 1995).

The pNeuton mini ventilator complies with the following voluntary standards:

ASTM: F1100 90 Ventilators Intended for Use in Critical Care .
ISO: 10651-3: 1997 Lung Ventilators for Medical Use- Particular requirements . for emergency and transport ventilators
RTCA DO-160G Environmental Conditions and Test Procedures for Airborne . Equipment, as applicable
MIL-STD-810F Environmental Engineering Considerations and Laboratory . · Tests, as applicable
CGA V-5:2008 Diameter-Index Safety System (Noninterchangeable Low ● Pressure Connections for Medical Gas Applications)
ASTM F2052 06e1 Standard Test Method for Measurement of Magnetically . Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment
ASTM F2119 07 Standard Test Method for Evaluation of MR Image Artifacts . from Passive Implants

Specific non-clinical tests included:

Specification verification and waveform tests. Following the requirements of . ASTM F1100 90, all operational functions were tested to meet required specifications. This included operation at the extremes of input gas pressures as specified. Waveform tests using Pressure / Time, Flow / Time and Volume / Time graphics showed that the accuracy and precision of breath delivery meets or exceeds specifications during four different clinical simulated conditions.
Reliability and endurance tests. Tests were performed to demonstrate reliability . of performance during the entire device lifetime, under conditions comparable to the clinical environment as specified. Following the requirements of ASTM F1100 90. the device operated continuously for 2,200 hours at two different clinical simulated conditions. In addition, reliability tests were performed for an additional 240 hours at the extremes of environmental conditions which may be encountered during clinical use of this transport ventilator. Following these tests operation was verified using specification verification and waveform tests as described above.
- Environmental and mechanical safety. The device was tested and passed the . environmental / mechanical safety tests identified in the following standards:
  - RTCA DO-160G, section 4, Altitude and Overpressure tests using Category o A2

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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510(k) Summary - K121379 14 September 2012 Page 8 of 8

RTCA DO-160G, section 4 & 5, Temperature Variation tests of Procedure o 5.3.1 using Category A4
RTCA DO-160G, section 6, Humidity tests using Category A o
RTCA DO-160G, section 8, Robust Vibrations Tests for Category R o
RTCA DO-160G, section 10, Spray Proof Test using Procedure 10.3.3 O
ISO 10651-3: 1997, section 21.6c}, Bump test in accordance with IEC 68-2-O 29, test Eb
MIL-STD-810F, section 500.4, Procedure III, Rapid decompression o
MIL-STD-810F, section 514.5, Procedure I, Jet Aircraft Random Vibration O Test
Testing for MRI environments. All tests were performed according to ASTM . F2052 - 06e1 and ASTM F2119 - 07 using a 3 Tesla scanner. There was no induced displacement force, performance variance or artifact generated in the scans. The pNeuton mini ventilator is not intended for implant so the assessment of magnetic field interactions for this product specifically involved evaluations of translational attraction and function in relation to exposure to a 3 Tesla MR system only.

Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing and risk analysis. The pNeuton mini ventilator performs as intended according to its performance specification and is substantially equivalent to the predicate devices.

Airon Corporation 751 North Drive, Unit 6 Melbourne, FL 32934 USA tel (321) 821-9433 fax (321) 821-9443

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the emblem.

Public Health Service

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

OCT 1 1 2012

Airon Corporation
G. Eric Gjerde
President & CEO
751 North Drive, Unit 6
Melborne, Fl 32934

Re: K121379

Trade/Device Name: pNeuton mini Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 17, 2012 Received: September 18, 2012

Dear Mr. Gjerde :

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.

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

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Page 2 - Mr. Gjerde

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

510(k) Number: K121379

Device Name: pNeuton mini Ventilator

Indications For Use: The pNeuton mini is intended to provide ventilatory support for critically ill patients who require the following general types of ventilatory support:

Positive pressure ventilation delivered invasively (via an ET Tube) or non-. invasively (via a mask or nasal prongs)
CMV and IMV mode of ventilation with or without PEEP / CPAP .
Provide oxygen or a mixture of medical air and oxygen .

Patient population:

Neonates, infants, and children, from 400 g to.25 kg in weight

Environments of Use

Inter and intra-hospital patient transport .
Air & ground transport Pressurized and non-pressurized aircraft (to 15,000 ft) .
Intensive care units (short term use only associated with patient transport)
Emergency Departments
Radiology suites including MRI (MR Conditional 3T)
Operating rooms (short term use only associated with patient transport)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Z. Schullk

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: icl 21379

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).