(42 days)
Not Found
No
The device description focuses on pneumatic and mechanical control systems, with no mention of AI or ML. The changes described are hardware-based (alarms, pressure/rate limits, MRI compatibility).
Yes
The device is a ventilator, which provides mechanical ventilation to patients, directly supporting and improving their respiratory function. This falls under the definition of a therapeutic device as it treats a health condition.
No
Explanation: The device is described as a "mechanical ventilator" intended for delivering ventilatory support to patients. Its function is to provide breathing assistance, not to diagnose medical conditions.
No
The device description clearly states it is a "pneumatic ventilator" and details its physical components and operation, including input pressures, control systems, and accessories like tubing circuits and oxygen tanks. This indicates it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "continuous or intermittent mechanical ventilator support for the care of individuals who require mechanical ventilation." This describes a device that directly interacts with the patient's respiratory system to provide breathing assistance.
- Device Description: The description details a "small, lightweight transport ventilator" that provides "Continuous Mechanical Ventilation (CMV) or Intermittent Mandatory Ventilation (IMV)." It describes how it delivers air/oxygen to the patient and manages breathing parameters.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. IVDs are used for diagnosis, monitoring, or screening based on analyzing biological samples.
This device is a ventilator, which is a life-support medical device used to assist or replace spontaneous breathing. It falls under a different regulatory category than IVDs.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
CBK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified medical personnel under the direction of a physician.
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
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the date "DEC 20 2004". The text is written in a simple, sans-serif font. The date is likely part of a document or label, providing a timestamp or reference point.
Pneuton Ventilator
Special 510(k) Summary
Contact Information
G. Eric Gjerde President Airon Corporation 17 East Melbourne Ave Melboume, FL 32901 Tel: 321-821-9433 Fax: 321-821-9443 email: egjerde@pneuton.com
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 (321) 821-9433 fax (321) 821-9443
1
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
2
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
Pneuton
(model A) | Original
Pneuton
(model S) | Pneupac Transport | Discussion |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|---------------------------------------------------------|-----------------------------|
| Intended Use -
patient
population | Adult - Pediatric | Adult - Pediatric | Adult - Pediatric | Equivalent |
| Intended Use --
application | Inter and intra-
facility transport,
MRI | Inter and intra-
facility transport,
MRI | Inter and intra-
facility transport,
MRI | Equivalent |
| Operating
principle | Pneumatic | Pneumatic | Pneumatic | Equivalent |
| Input gas
pressure | 40 to 70 psi | 40 to 70 psi | 37 to 87 psi | Substantially
equivalent |
| Patient circuit | Tubing with
external
expiratory valve | Tubing with
external
expiratory valve | Tubing with external
expiratory valve | Equivalent |
| Enclosure | Rugged,
lightweight | Rugged,
lightweight | Rugged, lightweight | Equivalent |
| Displays | Manometer | Manometer | Manometer | Equivalent |
| Safety features | Adjustable high
pressure
release, internal
high pressure
release, anti-
suffocation valve | Adjustable high
pressure
release, internal
high pressure
release, anti-
suffocation valve | Adjustable high
pressure release | Substantially
equivalent |
| Alarms | Low gas source,
patient
disconnect | Low gas source | Low gas source,
high pressure,
patient disconnect | Substantially
equivalent |
3
| Characteristic | Changed
Pneuton
(model A) | Original
Pneuton
(model S) | Pneupac Transport | Discussion |
|----------------------------|--------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|---------------------------------------------------|
| Modes of
ventilation | CMV, IMV,
CPAP | CMV, IMV,
CPAP | CMV, PEEP | Substantially
equivalent |
| Tidal volume | 360 - 1500 | 360 - 1500 | 50 - 1500 | Substantially
equivalent |
| Respiratory
rate | 3 - 50 | 2 - 50 | 7 - 60 | Substantially
equivalent |
| Flow (L/min) | 36 | 36 | 6 - 60 | Pneuton uses a
fixed inspiratory
flow |
| PEEP/CPAP | 0 - 20 | 0 - 20 | external | Pneuton has an
internal
PEEP/CPAP
system |
| Peak pressure | 15 - 75 | 10 - 75 | 20 - 80 | Substantially
equivalent |
| I : E ratio | Continuously
adjustable by
controlling I time
and E time using
volume and rate
controls | Continuously
adjustable by
controlling I time
and E time using
volume and rate
controls | Continuously
adjustable by
controlling I time and
E time | Substantially
equivalent |
| Internal oxygen
control | 2 position, 100%
or 65% | 2 position, 100%
or 65% | 2 position, 100% or
50% | Substantially
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.
4
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.
5
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 (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,
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
6
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:________________________________________________________________________________________________________________________________________________________________