To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.

Device Description

The device provides CPAP support for the care of spontaneously breathing individuals who require oxygen 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 pre-hospital environments, inter and intra-hospital patient transport, air and ground transport, and all areas of the hospital (NOT for use in the presence of flammable anesthetics or in the MRI). MACS has been specifically designed for ruggedness and ease of use.

The MACS CPAP device uses accessories during normal operation. The primary accessory is a patient tubing circuit and positive airway pressure face mask to attach the device to the patient. The patient circuit and face mask are single-use disposables. The patient circuit is the same circuit included with the previously cleared Pneuton Ventilator K024344 and K043085.

AI/ML Overview

The provided text describes the MACS CPAP System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner described by the request points (e.g., performance metrics, sample sizes, expert adjudication, MRMC studies, or training sets for AI/algorithm performance).

The document details the device's description, intended use, and a comparison with predicate devices in terms of characteristics like environments of use, personnel requirements, operating principle, and safety features. It then summarizes non-clinical testing and validation.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing. The document states: "All functions as listed in the specifications have been validated. The device meets all test requirements as identified in the FDA Draft Emergency Resuscitator Guidance (April, 1993)." However, it does not provide a table outlining specific acceptance criteria values (e.g., pressure accuracy within X mmHg, flow rate within Y L/min) or the exact reported performance values achieved by the MACS CPAP system against these criteria. It only makes a general statement of compliance.

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

Missing. The document states, "Clinical testing was not performed on this device. Safety and efficacy were established through non-clinical testing." This implies that no human patient data (test set) was used in the evaluation for this 510(k) submission.

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

Missing. Since clinical testing was not performed and no human data test set was used, there's no mention of experts establishing ground truth for evaluating the device's performance in a clinical context.

4. Adjudication method for the test set

Missing. No clinical test set means no adjudication method was used.

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

Not applicable/Missing. This device is a CPAP system, not an AI or imaging diagnostic device that would involve human "readers" or an MRMC study comparing human performance with and without AI assistance.

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

Not applicable/Missing. This is a hardware medical device, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Missing/Not applicable in the AI/algorithm context. For regulatory purposes, the "ground truth" for a device like this would typically be established by validated test equipment and simulation environments per engineering and performance standards. The document mentions compliance with ISO standards (ISO 10651-5:2006, ISO 5356-1:2004, CGA V-5:2005) and the FDA Draft Emergency Resuscitator Guidance, implying that performance was measured against these technical benchmarks.

8. The sample size for the training set

Not applicable/Missing. This is not an AI/algorithm device, so there is no "training set."

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

Not applicable/Missing. No training set exists for this type of device.

In summary, the provided document focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant non-clinical standards and guidance documents for a mechanical CPAP system. It does not provide the detailed information requested regarding acceptance criteria and performance evaluation methodology that would be typical for an AI/algorithm-based medical device.

Summary

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10 80692

Image /page/0/Picture/1 description: The image shows the logo for Airon. The logo consists of a stylized circle with a line going through it, and a shape that looks like a bird inside the circle. To the right of the logo is the word "Airon" in a bold, sans-serif font.

JUN 2 0 2008

MACS CPAP System

510(k) Summary

Contact Information

G. Eric Gjerde President Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 Tel: 321-821-9433 Fax: 321-821-9443 email: egjerde@pneuton.com

Application Date

March 7, 2008

Device Trade Name

MACS CPAP System

Common Name

CPAP device

Device Classification

Powered Emergency Ventilator and Positive End Expiratory Pressure Breathing Apparatus (21 CFR 868.5925 and 868.5965, Product Code BTL and BYE)

Device Class

Class II

Classification Panel

Anesthesiology

Predicate Devices

Pneuton Transport Ventilator

manufactured by Airon Corporation .
. 510(k) number K024344 and K043085

PortO2Vent CPAPos

manufactured by Emergent Respiratory Products
· 510(k) number K021520

Whisperflow Oxygen Flow Generator

manufactured by Caradyne Limited (now Respironics) ●
♣ 510(k) number K982283

Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443

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Device Description

Intended Use

To provide CPAP to spontaneously breathing patients in the hospital, pre-hospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endo-tracheal tube.

Substantial Equivalence

The MACS CPAP shares substantial equivalency with the Pneuton Ventilator, the PortO2Vent CPAPos device and the Whisperflow Oxygen Flow Generator across the spectrum of patient population for which each was designed.

The MACS CPAP device utilizes identical components as found in the Pneuton Ventilator, being simply the CPAP subsystem inside of the Pneuton Ventilator put into it's own enclosure.

The MACS CPAP shares common modalities with the PortOsVent CPAPos and Whisperflow Oxygen Flow Generator 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 tvpical frame of use by the health care providers. All are pneumatic controlled and applicable for the same areas of use.

Characteristic	MACS CPAP	PneutonVentilator	PortO₂VentCPAPos	WhisperflowOxygen FlowGenerator
Intended Use -application	Provide CPAP forspontaneousbreathing patientsvia mask or endo-tracheal tube	Provide continuousor intermittentmechanicalventilator supportfor the care ofindividuals whorequire mechanicalventilation. TheCPAP subsystemprovides CPAP forspontaneousbreathing patientsvia mask or endo-tracheal tube	Provide CPAP forspontaneousbreathing patientsvia mask	Provide CPAP forspontaneousbreathing patientsvia mask or endo-tracheal tube

Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443

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Characteristic	MACS CPAP	PneutonVentilator	PortO₂VentCPAPos	WhisperflowOxygen FlowGenerator
Environmentsof use	Hospital, pre-hospital (EMS) andsub-acute/alternatesite facilityenvironments	Hospital and pre-hospital (EMS)environments	Hospital and pre-hospital (EMS)environments	Hospital and pre-hospital (EMS)environments
PersonnelRequirements	Training asphysician, nurse,respiratorytherapist, EMT	Training asphysician, nurse,respiratorytherapist, EMT	Training asphysician, nurse,respiratorytherapist, EMT	Training asphysician, nurse,respiratorytherapist, EMT
Operatingprinciple	Pneumatic,demand flowsystem	Pneumatic,demand flowsystem	Pneumaticdemand flowsystem	Pneumaticcontinuous flowsystem
Input gaspressure	40 to 70 psi	40 to 70 psi	40 to 70 psi	60 psi
Patient circuit	Tubing withexternal expiratoryvalve and mask	Tubing withexternal expiratoryvalve and mask	Tubing withexternal expiratoryvalve and mask	Tubing withexternal CPAPvalve and mask
Enclosure	Rugged, lightweight	Rugged, lightweight	Rugged, lightweight	None - venturidevice
Displays	Manometer	Manometer	Manometer	None
Safety features	Internal highpressure release,anti-suffocationvalve	Internal highpressure release,anti-suffocationvalve	Internal highpressure release,anti-suffocationvalve	None

Patient supportmodes	CPAP	CMV, IMV, CPAP	CPAP	CPAP
Peak Flow ondemand (L/min)	140	140	100	140
CPAP levels (cmH2O)	0 - 20	0 - 20	0 - 20	0 - 20
Internal oxygencontrol	2 position, 100% or65%	2 position, 100% or65%	100% only	28% to 100%
Materials in gaspathway	Identical toPneuton ventilator	Cleared inK024344 andK043085	Unknown	Stainless steel,PVC
Accessories	Disposable patientcircuit with mask,head strap, mobilestand, rail / polemount bracket,travel bag, oxygenhose and oxygentank	Disposable patientcircuit with mask,mobile stand, polemount bracket,travel bag, oxygenhose and oxygentank	Disposable patientcircuit with mask,head strap, polemount bracket,travel bag, oxygenhose and oxygentank	Disposable patientcircuit with CPAPvalve, mask andhead strap

Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel (321) 821-9433 fax (321) 821-9443

ترا

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Summary of Non-Clinical Testing and Validation

The performance of the MACS CPAP System 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 Emergency Resuscitator Guidance (April, 1993).

The MACS CPAP Device complies with the following voluntary standards:

. ISO 10651-5:2006 Lung ventilators for medical use — Particular requirements for basic safety and essential performance -- Part 5: Gas-powered emergency resuscitators
. ISO 5356-1:2004 Anesthetic and respiratory equipment - Conical connectors: Part 1: Cones and sockets
. CGA V-5:2005 Diameter-Index Safety System (Noninterchangeable Low Pressure Connections for Medical Gas Applications)

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

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The eagle faces left and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 20 2008

Mr. G. Eric Gjerde President and Chief Executive Officer Airon Corporation 129 West Hibiscus Boulevard, Suite S Melbourne, Florida 32901

Re: K080692 Trade/Device Name: MACS CPAP System Regulation Number: 21 CFR 868.5925 Regulation Name: Powered Emergency Ventilator Regulatory Class: II Product Code: BTL, BYE Dated: June 10, 2008 Received: June 18, 2008

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. 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 (240) 276-0120. 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.

Suette G. Michaud.

Chiu Lin, Ph.D. 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

510(k) Number: K080692

Device Name: MACS CPAP System

Indications For Use: To provide CPAP to spontaneously breathing patients in the hospital, prehospital (EMS) and sub-acute / alternate site facility environments via Face Mask or endotracheal tube.

Prescription Use X OR .

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Üff) (Division Sign-Chi)
Division of Anesthesiology, General Hospital
Division of Anesthesional Davison Division Control, Dental Devices

510(k) Number: K080692

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).