The device is intended for continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified medical personnel under the direction of a physician.

Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:

positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a mask)
CMV and IMV modes of ventilation
with or without PEEP / CPAP
with oxygen or a mixture of air and oxygen

The ventilator is suitable for use in:

Pre-hospital transport applications including accident scene, emergency rescue vehicles
Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments
Air transport via helicopter or fixed wing

Device Description

Pneuton (pronounced "new-ton") is a small, lightweight transport ventilator designed for use on patients from pediatric to adult in size (10 kg and higher). 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 respiratory rate and tidal volume are 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 at 65 or 100 percent.

Pneuton is a pneumatic ventilator. Electrical power is not required for patient ventilation. The pneumatic system operates at input pressures from 41 to over 66 psi. Various control systems manage the tidal volume and rate control, PEEP / CPAP, and safety svstems / pneumatic alarms.

The Pneuton Ventilator uses accessories for normal operation which are included with this submission. The primary accessory is a patient tubing circuit to attach the ventilator to the patient. The patient circuit is a class 1 device, currently exempt from premarket notification. The patient circuit is a disposable device, not to be sterilized or disinfected (see section 12 of this submission). Additional accessories will be sold with the device including travel case, pole stand and mounting brackets.

AI/ML Overview

The Pneuton Ventilator did not provide specific acceptance criteria or detailed study results with numbers as typically seen in modern device submissions. Instead, the submission relies on compliance with established standards and a general statement of performance.

Here's the information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Standard	Acceptance Criteria (Implied by compliance, performance specification)	Reported Device Performance (Summary from non-clinical testing)
All functions as listed in specifications	Meets specifications	Validated
FDA Reviewer Guidance for Ventilators	Meets all test requirements	Meets all test requirements
ASTM F 1100-90 Ventilators Intended for Use in Critical Care	Compliance with standard	Complies with standard
AHA Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care (Minimum requirements for Automatic Transport Ventilators)	Compliance with minimum requirements	Complies with minimum requirements
MIL STD 810 E Test Method Standard for Environmental Engineering Considerations and Laboratory Tests	Compliance with standard	Complies with standard
ISO 10651-3 Lung Ventilators for Medical Use. Particular requirements for emergency and transport ventilators	Compliance with standard	Complies with standard
Operating Principle	Pneumatic	Pneumatic
Input Gas Pressure	40 to 70 psi	40 to 70 psi (equivalent to predicates)
Patient Circuit	Standard with external expiratory valve	Standard with external expiratory valve (equivalent to predicates)
Enclosure	Rugged, lightweight	Rugged, lightweight (equivalent to predicates)
Displays	Manometer	Manometer (equivalent to one predicate)
Alarms	Low gas source	Low gas source (Pneuton only device with alarm)
Modes of Ventilation	CMV, IMV, CPAP	CMV, IMV, CPAP (substantially equivalent to predicates)
Tidal Volume	360 - 1500	360 - 1500 (equivalent to one predicate)
Respiratory Rate	2 - 50	2 - 50 (equivalent to one predicate)
Flow	36	36 (equivalent to one predicate)
PEEP / CPAP	0 - 20	0 - 20 (equivalent to one predicate)
Peak Pressure	10 - 75	10 - 75 (equivalent to one predicate)
1:E Ratio	Continuously adjustable	Continuously adjustable (equivalent to one predicate)
Internal Oxygen Control	2 position, 100% or 65%	2 position, 100% or 65% (Pneuton only unit with internal oxygen mixing)
Performance as intended according to its performance specification	Performs as intended	Performs as intended

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

Sample Size: Not specified. The document states "The performance of the Pneuton has been comprehensively tested. All functions as listed in the specifications have been validated." This suggests testing of the device itself against its specifications and relevant standards, rather than a clinical dataset.
Data Provenance: Not applicable in the context of clinical data. The testing was non-clinical, involving the device's functional integrity and adherence to engineering and safety standards.

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

Not applicable. The "ground truth" for this ventilator's performance was established by its compliance with engineering specifications and recognized medical device standards, which are objective measures, not subjective interpretations by experts on a test set of data.

4. Adjudication method for the test set:

Not applicable. No human adjudication was performed for a clinical test set. The validation was against predefined technical specifications and standards.

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 device is a mechanical ventilator, not an AI-powered diagnostic tool for human readers.

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

Not applicable. This is a standalone mechanical ventilator, whose performance is inherently "standalone" in its function. It does not involve an algorithm providing outputs for human interpretation.

7. The type of ground truth used:

The ground truth was based on:
- Device Performance Specifications: The device's internal design parameters and intended operational ranges.
- Recognized International and National Standards: Compliance with established medical device safety, performance, and environmental standards (e.g., ASTM, AHA, MIL STD, ISO).
- FDA Reviewer Guidance for Ventilators: Adherence to FDA-specific requirements for ventilators.

8. The sample size for the training set:

Not applicable. This is a mechanical device, not an AI system that undergoes "training" on a dataset.

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

Not applicable. See point 8.

Summary

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JUN - 3 2003

Image /page/0/Picture/1 description: The image shows the logo for Airon. The logo consists of a stylized image of a bird in flight, with the word "Airon" written in a serif font to the right of the bird. The bird is depicted in black and white, and the word "Airon" is also in black.

K024344

Pneuton Ventilator

510(k) Summary

Contact Information

G. Eric Gjerde President Airon Corporation 102 East New Haven Avenue, Suite 146 Melbourne, FL 32901 Tel: 321-723-0019 Fax: 321-722-1894 email: egjerde@pneuton.com

Application Date

December 26, 2002

Device Trade Name Pneuton Ventilator

Common Name Transport ventilator

Device Classification

Continuous Ventilator (21 CFR 868.5895, Classification number 73 CBK)

Device Class Class II

Classification Panel Anesthesiology

Predicate Devices

Pneupac 2-R Ventilator

manufactured by Pneupac Ltd .
510(k) number K862830 .
currently marketed through Pneupac USA as the paraPAC Responder Ventilator ● IC-2A MRI Ventilator
manufactured by Bio-Med Devices ●
FDA 510(k) number K896380 .

200

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Device Description

Intended Use

Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:

positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively . (via a mask)
CMV and IMV modes of ventilation .
. with or without PEEP / CPAP
with oxygen or a mixture of air and oxygen .

The ventilator is suitable for use in:

Pre-hospital transport applications including accident scene, emergency rescue ● vehicles
Hospital ICU and transport applications including emergency, radiology, surgery, recovery and MRI departments
. Air transport via helicopter or fixed wing

Substantial Equivalence

The Pneuton Ventilator shares substantial equivalency with the Pneupac Ltd. Pneupac 2-R Ventilator and the Bio-Med Devices IC-2A MRI across the spectrum of patient population for which each was designed. All of the devices share common modalities

Airon Corporation 102 East New Haven Avenue Suite 146 Melbourne, FL 32951 USA tel (321) 723-0019 fax (321) 722-1894

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(CMV, IMV, PEEP / CPAP) and significantly 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 provider. Each are pneumatic controlled and applicable for the same areas of use.

Characteristic	Pneuton	2-R	IC-2A	Discussion
Operating principle	Pneumatic	Pneumatic	Pneumatic	Equivalent
Input gas pressure	40 to 70 psi	37 to 87 psi	45 to 55 psi	Substantially equivalent
Patient circuit	Standard with external expiratory valve	Special with external expiratory valve	Standard with external expiratory valve	Equivalent
Enclosure	Rugged, lightweight	Rugged, lightweight	Rugged, lightweight	Equivalent
Displays	Manometer	None	Manometer	Pneuton and IC-2A are equivalent
Alarms	Low gas source	None	None	Pneuton only device with alarm
Modes of ventilation	CMV, IMV, CPAP	CMV, PEEP	CMV, SIMV, CPAP	Substantially equivalent
Tidal volume	360 - 1500	340 - 1450	0 - 3000	Pneuton and 2-R are equivalent
Respiratory rate	2 - 50	11 - 21	1 - 66	Pneuton and IC-2A are equivalent
Flow	36	40	0 - 75	Pneuton and 2-R are equivalent
PEEP / CPAP	0 - 20	external	0 - 25	Pneuton and IC-2A are equivalent
Peak pressure	10 - 75	40 or 60 pre-set	0 - 75	Pneuton and IC-2A are equivalent
1 : E ratio	Continuously adjustable	1:1.5 to 1:5 based on setting of volume / rate control	Continuously adjustable	Pneuton and IC-2A are equivalent
Internal oxygen control	2 position, 100% or 65%	External	External	Pneuton only unit with internal oxygen mixing

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Summary of Non-Clinical Testing and Validation

The performance of the Pneuton has been comprehensively tested. All functions as listed in the specifications have been validated. The ventilator meets all test requirements as identified in the FDA Reviewer Guidance for Ventilators.

The Pneuton complies with the following standards:

ASTM F 1100-90 Ventilators Intended for Use in Critical Care ●
Minimum requirements for Automatic Transport Ventilators as described in the . Guidelines for Cardiopulmonary Resuscitation (CPR) and Emergency Cardiac Care from the American Heart Association (AHA), pages 2200 and 2201 JAMA, October 28, 1992 - Vol 268, No.16.
MIL STD 810 E Test Method Standard for Environmental Engineering . Considerations and Laboratory Tests
ISO 10651-3 Lung Ventilators for Medical Use. Particular requirements for ● emergency and transport ventilators

Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing. The Pneuton performs as intended according to it's performance specification. The Pneuton is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 3 2003

Mr. G. Eric Gjerde President Airon Corporation 102 East New Haven Avenue, Suite 146 Melbourne, Florida 32901

Re: K024344

Trade/Device Name: Pneuton Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: April 17, 2003 Received: April 18, 2003

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Mr. Eric Gjerde

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Rurser

Susan Runner, DDS, MA Interim 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 Statement

¥024344 510(k) Number

Device Name: Pneuton Ventilator

Indications For Use:

Specifically, the ventilator is applicable for adult and pediatric patients, 23 kg (50 lbs.) and greater who require the following general types of ventilatory support:

positive pressure ventilation delivered invasively (via an ET Tube) or non-invasively (via a ● mask)
CMV and IMV modes of ventilation
with or without PEEP / CPAP ●
with oxygen or a mixture of air and oxygen ●

The ventilator is suitable for use in:

Pre-hospital transport applications including accident scene, emergency rescue vehicles ●
Hospital ICU and transport applications including emergency, radiology, surgery, recovery . and MRI departments
. Air transport via helicopter or fixed wing

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ryan

sion Sig -- Off) Islon of Anesthesiology, General Hospital, fection Control, Dental Devices

510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

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).