MODIFICATION TO: PNEUTON VENTILATOR

K043085 · Airon Corporation · CBK · Dec 20, 2004 · Anesthesiology

Device Facts

• Record ID: K043085
• Device Name: MODIFICATION TO: PNEUTON VENTILATOR
• Applicant: Airon Corporation
• Product Code: CBK · Anesthesiology
• Decision Date: Dec 20, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

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 .

Device Story

Pneuton Ventilator is a small, lightweight, pneumatic-powered transport ventilator; requires no electrical power. Operates on input gas pressures (41-66+ psi). Delivers CMV or IMV ventilation; provides adjustable respiratory rate, tidal volume, and PEEP/CPAP. Features include patient disconnect alarm, high-pressure release, and anti-suffocation valve. Used by qualified medical personnel in pre-hospital, hospital (ICU, surgery, MRI), and air transport environments. Provides invasive (ET tube) or non-invasive (mask) support. Output is monitored via manometer. Benefits include portable, MRI-compatible (up to 3 tesla) ventilatory support for patients ≥23 kg.

Clinical Evidence

No clinical data. Safety and efficacy established through non-clinical bench testing, including compliance with ASTM F 1100-90, MIL STD 810 E, and ISO 10651-3 standards. All device functions and specifications were validated.

Technological Characteristics

Pneumatic-powered ventilator; no electrical power required. Input pressure: 41-66+ psi. Tidal volume: 360-1500 mL; Respiratory rate: 3-50 bpm. MRI compatible up to 3 tesla. Features internal PEEP/CPAP system (0-20 cm H2O). Connectivity: None (pneumatic). Sterilization: Not specified. Software: None (purely pneumatic control).

Indications for Use

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

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

• Pneuton Transport Ventilator (K024344)
• Pneupac Transport Ventilator (K030803)

Submission Summary (Full Text)

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K043085

# Pneuton Ventilator

## Special 510(k) Summary

#### Contact Information

G. Eric Gjerde President Airon Corporation 17 East Melbourne Ave Melboume, FL 32901 Tel: [phone] Fax: [phone] email: [e-mail]

# Application Date

November 5, 2004

#### Device Trade Name Pneuton Ventilator

Common Name Transport ventilator

## Device Classification

Continuous Ventilator (21 CFR 868.5895, Product Code CBK)

#### Device Class Class II

Classification Panel Anesthesiology

#### Predicate Devices

Pneuton Transport Ventilator

- manufactured by Airon Corporation .
- . 510(k) number K024344

Pneupac Transport Ventilator

- manufactured by Pneupac Ltd .
- . 510(k) number K030803
- currently marketed in the USA through Smiths Medical .

Airon Corporation 17 East Melbourne Avenue Melbourne, FL 32951 USA tel [phone] fax [phone]

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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 (23 kg and higher). It is a time cvcled, 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 systems / pneumatic alarms.

This premarket submission makes the following changes to the Pneuton Ventilator:

- adds a patient disconnect alarm system to the ventilator. The alarm includes . audible and visual indication of patient disconnect
- changes the minimum respiratory rate from 2 to 3 breaths per minute .
- changes to the minimum peak inspiratory pressure from 10 to 15 cm H₂O .
- . increases the MRI compatibility to 3 tesla

The ventilator will be marketed as a finished component, both with and without the changes identified above. The Pneuton Ventilator model A includes the changes; model S is the original device without the changes.

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 the same circuit included with the previously cleared Pneuton Ventilator K024344. Additional external accessories will be sold with the device including a remote alarm adapter, travel case, pole stand, mounting brackets, oxygen hose and oxygen tanks.

### 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 Ibs.) 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

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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 changes to the Pneuton Ventilator share substantial equivalency with the original Pneuton Ventilator and the Pneupac Ltd. Pneupac Transport Ventilator across the spectrum of patient population for which each was designed. The devices share common modalities (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. The alarm system added to the Pneuton Ventilator is substantially equiralnt to the alarm system in the Pneupac Transport Ventilator.

| Characteristic | Changed<br>Pneuton<br>(model A) | Original<br>Pneuton<br>(model S) | Pneupac Transport | Discussion |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------|
| Intended Use -<br>patient<br>population | Adult - Pediatric | Adult - Pediatric | Adult - Pediatric | Equivalent |
| Intended Use --<br>application | Inter and intra-<br>facility transport,<br>MRI | Inter and intra-<br>facility transport,<br>MRI | Inter and intra-<br>facility transport,<br>MRI | Equivalent |
| Operating<br>principle | Pneumatic | Pneumatic | Pneumatic | Equivalent |
| Input gas<br>pressure | 40 to 70 psi | 40 to 70 psi | 37 to 87 psi | Substantially<br>equivalent |
| Patient circuit | Tubing with<br>external<br>expiratory valve | Tubing with<br>external<br>expiratory valve | Tubing with external<br>expiratory valve | Equivalent |
| Enclosure | Rugged,<br>lightweight | Rugged,<br>lightweight | Rugged, lightweight | Equivalent |
| Displays | Manometer | Manometer | Manometer | Equivalent |
| Safety features | Adjustable high<br>pressure<br>release, internal<br>high pressure<br>release, anti-<br>suffocation valve | Adjustable high<br>pressure<br>release, internal<br>high pressure<br>release, anti-<br>suffocation valve | Adjustable high<br>pressure release | Substantially<br>equivalent |
| Alarms | Low gas source,<br>patient<br>disconnect | Low gas source | Low gas source,<br>high pressure,<br>patient disconnect | Substantially<br>equivalent |

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| Characteristic | Changed<br>Pneuton<br>(model A) | Original<br>Pneuton<br>(model S) | Pneupac Transport | Discussion |
|----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------|
| Modes of<br>ventilation | CMV, IMV,<br>CPAP | CMV, IMV,<br>CPAP | CMV, PEEP | Substantially<br>equivalent |
| Tidal volume | 360 - 1500 | 360 - 1500 | 50 - 1500 | Substantially<br>equivalent |
| Respiratory<br>rate | 3 - 50 | 2 - 50 | 7 - 60 | Substantially<br>equivalent |
| Flow (L/min) | 36 | 36 | 6 - 60 | Pneuton uses a<br>fixed inspiratory<br>flow |
| PEEP/CPAP | 0 - 20 | 0 - 20 | external | Pneuton has an<br>internal<br>PEEP/CPAP<br>system |
| Peak pressure | 15 - 75 | 10 - 75 | 20 - 80 | Substantially<br>equivalent |
| I : E ratio | Continuously<br>adjustable by<br>controlling I time<br>and E time using<br>volume and rate<br>controls | Continuously<br>adjustable by<br>controlling I time<br>and E time using<br>volume and rate<br>controls | Continuously<br>adjustable by<br>controlling I time and<br>E time | Substantially<br>equivalent |
| Internal oxygen<br>control | 2 position, 100%<br>or 65% | 2 position, 100%<br>or 65% | 2 position, 100% or<br>50% | Substantially<br>equivalent |

# Summary of Non-Clinical Testing and Validation

The performance of the Pneuton Ventilator 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 .
- 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 Ventilator model A performs as intended according to it's performance specification and is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three wavy lines, which may represent a flag or banner.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 2004

Mr. G Eric Gjerde President Airon Corporation 17 East Melbourne Avenue Melbourne, Florida 32901

Re: K043085

Trade/Device Name: Pneuton Ventilator, Model A Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: December 9, 2004 Received: December 10, 2004

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 vour 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,

Chiu Lin, Ph.D.

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 K043085

Device Name: Pneuton Ventilator, Model A

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 .

Prescription Use XX (Per 21 CFR 801.109)

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)

iuy Suerom
(Division Sign-Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:________________________________________________________________________________________________________________________________________________________________