MACS CPAP SYSTEM

K080692 · Airon Corporation · BTL · Jun 20, 2008 · Anesthesiology

Device Facts

• Record ID: K080692
• Device Name: MACS CPAP SYSTEM
• Applicant: Airon Corporation
• Product Code: BTL · Anesthesiology
• Decision Date: Jun 20, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5925
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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.

Device Story

MACS CPAP System provides continuous positive airway pressure (CPAP) to spontaneously breathing patients. Device is pneumatic, demand-flow system requiring 40-70 psi input gas pressure. Operates via patient tubing circuit and face mask or endotracheal tube. Includes manometer for pressure display, internal high-pressure release, and anti-suffocation valve. Used in hospital, pre-hospital (EMS), and sub-acute settings by physicians, nurses, respiratory therapists, or EMTs. Device is essentially the CPAP subsystem of the Pneuton Ventilator housed in a dedicated enclosure. Provides CPAP levels 0-20 cm H2O and oxygen concentration control (100% or 65%). Benefits patients by providing respiratory support during transport or clinical care. Healthcare providers monitor pressure via manometer to adjust therapy.

Clinical Evidence

No clinical data. Safety and efficacy established through non-clinical bench testing and validation. Device performance validated against FDA Draft Emergency Resuscitator Guidance (1993) and voluntary standards including ISO 10651-5:2006, ISO 5356-1:2004, and CGA V-5:2005.

Technological Characteristics

Pneumatic, demand-flow system; 40-70 psi input gas pressure; 0-20 cm H2O CPAP range; 140 L/min peak flow; 100% or 65% oxygen control. Features manometer display, high-pressure release, and anti-suffocation valve. Single-use disposable patient circuit/mask. Complies with ISO 10651-5, ISO 5356-1, and CGA V-5 standards.

Indications for Use

Indicated for spontaneously breathing patients requiring oxygen assistance in hospital, pre-hospital (EMS), and sub-acute/alternate site facilities. Administered via face mask or endotracheal tube.

Regulatory Classification

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.

Predicate Devices

• Pneuton Transport Ventilator (K024344, K043085)
• PortO2Vent CPAPos (K021520)
• Whisperflow Oxygen Flow Generator (K982283)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] email: [e-mail]

#### 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 [phone] fax [phone]

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## 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.

#### 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 | Pneuton<br>Ventilator | PortO₂Vent<br>CPAPos | Whisperflow<br>Oxygen Flow<br>Generator |
|-------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Intended Use -<br>application | Provide CPAP for<br>spontaneous<br>breathing patients<br>via mask or endo-<br>tracheal tube | Provide continuous<br>or intermittent<br>mechanical<br>ventilator support<br>for the care of<br>individuals who<br>require mechanical<br>ventilation. The<br>CPAP subsystem<br>provides CPAP for<br>spontaneous<br>breathing patients<br>via mask or endo-<br>tracheal tube | Provide CPAP for<br>spontaneous<br>breathing patients<br>via mask | Provide CPAP for<br>spontaneous<br>breathing patients<br>via mask or endo-<br>tracheal tube |

Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel [phone] fax [phone]

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| Characteristic | MACS CPAP | Pneuton<br>Ventilator | PortO₂Vent<br>CPAPos | Whisperflow<br>Oxygen Flow<br>Generator |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Environments<br>of use | Hospital, pre-<br>hospital (EMS) and<br>sub-acute/alternate<br>site facility<br>environments | Hospital and pre-<br>hospital (EMS)<br>environments | Hospital and pre-<br>hospital (EMS)<br>environments | Hospital and pre-<br>hospital (EMS)<br>environments |
| Personnel<br>Requirements | Training as<br>physician, nurse,<br>respiratory<br>therapist, EMT | Training as<br>physician, nurse,<br>respiratory<br>therapist, EMT | Training as<br>physician, nurse,<br>respiratory<br>therapist, EMT | Training as<br>physician, nurse,<br>respiratory<br>therapist, EMT |
| Operating<br>principle | Pneumatic,<br>demand flow<br>system | Pneumatic,<br>demand flow<br>system | Pneumatic<br>demand flow<br>system | Pneumatic<br>continuous flow<br>system |
| Input gas<br>pressure | 40 to 70 psi | 40 to 70 psi | 40 to 70 psi | 60 psi |
| Patient circuit | Tubing with<br>external expiratory<br>valve and mask | Tubing with<br>external expiratory<br>valve and mask | Tubing with<br>external expiratory<br>valve and mask | Tubing with<br>external CPAP<br>valve and mask |
| Enclosure | Rugged, lightweight | Rugged, lightweight | Rugged, lightweight | None - venturi<br>device |
| Displays | Manometer | Manometer | Manometer | None |
| Safety features | Internal high<br>pressure release,<br>anti-suffocation<br>valve | Internal high<br>pressure release,<br>anti-suffocation<br>valve | Internal high<br>pressure release,<br>anti-suffocation<br>valve | None |
| | | | | |
| Patient support<br>modes | CPAP | CMV, IMV, CPAP | CPAP | CPAP |
| Peak Flow on<br>demand (L/min) | 140 | 140 | 100 | 140 |
| CPAP levels (cm<br>H2O) | 0 - 20 | 0 - 20 | 0 - 20 | 0 - 20 |
| Internal oxygen<br>control | 2 position, 100% or<br>65% | 2 position, 100% or<br>65% | 100% only | 28% to 100% |
| Materials in gas<br>pathway | Identical to<br>Pneuton ventilator | Cleared in<br>K024344 and<br>K043085 | Unknown | Stainless steel,<br>PVC |
| Accessories | Disposable patient<br>circuit with mask,<br>head strap, mobile<br>stand, rail / pole<br>mount bracket,<br>travel bag, oxygen<br>hose and oxygen<br>tank | Disposable patient<br>circuit with mask,<br>mobile stand, pole<br>mount bracket,<br>travel bag, oxygen<br>hose and oxygen<br>tank | Disposable patient<br>circuit with mask,<br>head strap, pole<br>mount bracket,<br>travel bag, oxygen<br>hose and oxygen<br>tank | Disposable patient<br>circuit with CPAP<br>valve, mask and<br>head strap |

:

Airon Corporation 129 W. Hibiscus Blvd., Suite S Melbourne, FL 32901 USA tel [phone] fax [phone]

:

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 [phone]. 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 [phone] or [phone] 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