PNEUTON VENTILATOR

K024344 · Airon Corporation · CBK · Jun 3, 2003 · Anesthesiology

Device Facts

• Record ID: K024344
• Device Name: PNEUTON VENTILATOR
• Applicant: Airon Corporation
• Product Code: CBK · Anesthesiology
• Decision Date: Jun 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

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 Story

Pneuton is a lightweight, pneumatic transport ventilator; requires no electrical power; operates on input gas pressures 41-66 psi. Designed for pediatric (≥23 kg) to adult patients; provides CMV and IMV ventilation modes; includes adjustable respiratory rate, tidal volume, and PEEP/CPAP system. Delivers 65% or 100% oxygen. Operated by qualified medical personnel in pre-hospital, ICU, surgery, and MRI settings. Device uses patient tubing circuit; includes manometer for pressure monitoring and low gas source alarm. Provides mechanical support to patients requiring invasive (ET tube) or non-invasive (mask) ventilation; assists in maintaining respiratory function during transport or emergency care.

Clinical Evidence

No clinical data. Safety and efficacy established through bench testing and validation against FDA Reviewer Guidance for Ventilators, ASTM F 1100-90, ISO 10651-3, and MIL-STD-810E.

Technological Characteristics

Pneumatic, time-cycled, flow-limited ventilator. No electrical power required. Input pressure 41-66 psi. Features: manometer, low gas source alarm, internal oxygen mixing (65%/100%). Dimensions/form factor: rugged, lightweight. Connectivity: none. Sterilization: patient circuit is disposable. Standards: ASTM F 1100-90, ISO 10651-3, MIL-STD-810E.

Indications for Use

Indicated for adult and pediatric patients ≥ 23 kg (50 lbs.) requiring continuous or intermittent mechanical ventilation (invasive or non-invasive) via CMV or IMV modes, with or without PEEP/CPAP, using oxygen or air/oxygen mixtures. Suitable for pre-hospital, ICU, transport, and MRI environments.

Regulatory Classification

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.

Predicate Devices

• Pneupac 2-R Ventilator (K862830)
• IC-2A MRI Ventilator (K896380)

Submission Summary (Full Text)

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

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

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.

### Intended Use

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

### 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 [phone] fax [phone]

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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 [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,

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:

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

(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)

OR

Over-The-Counter Use