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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the Pneuton Ventilator, Model A. The submission focuses on amendments to an existing device rather than a new AI-powered medical device, therefore many of the requested fields are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria for specific performance metrics that are then directly compared to reported device performance in a numerical sense. Instead, the "Substantial Equivalence" table implicitly highlights areas where the modified device (Pneuton model A) is considered either "Equivalent" or "Substantially Equivalent" to predicate devices based on functional characteristics and specifications.

Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance (Pneuton Model A)	Discussion from Document
Intended Use - patient population	Same as predicate (Adult - Pediatric)	Adult - Pediatric	Equivalent
Intended Use - application	Same as predicate (Inter and intra-facility transport, MRI)	Inter and intra-facility transport, MRI	Equivalent
Operating principle	Same as predicate (Pneumatic)	Pneumatic	Equivalent
Input gas pressure	Within range of predicate (37 to 87 psi)	40 to 70 psi	Substantially equivalent
Patient circuit	Same as predicate (Tubing with external expiratory valve)	Tubing with external expiratory valve	Equivalent
Enclosure	Same as predicate (Rugged, lightweight)	Rugged, lightweight	Equivalent
Displays	Same as predicate (Manometer)	Manometer	Equivalent
Safety features	Comparable to predicate	Adjustable high pressure release, internal high pressure release, anti-suffocation valve	Substantially equivalent
Alarms	Comparable to predicate (Low gas source, patient disconnect)	Low gas source, patient disconnect	Substantially equivalent
Modes of ventilation	Comparable to predicate (CMV, IMV, CPAP/PEEP)	CMV, IMV, CPAP	Substantially equivalent
Tidal volume	Comparable to predicate (50-1500)	360 - 1500	Substantially equivalent
Respiratory rate	Comparable to predicate (7-60)	3 - 50	Substantially equivalent
Flow (L/min)	Pneuton uses fixed inspiratory flow	36	Pneuton uses a fixed inspiratory flow
PEEP/CPAP	Comparable to predicate (internal/external)	0 - 20 (internal)	Pneuton has an internal PEEP/CPAP system
Peak pressure	Comparable to predicate (20-80)	15 - 75	Substantially equivalent
I : E ratio	Continuously adjustable by controlling I time and E time	Continuously adjustable by controlling I time and E time using volume and rate controls	Substantially equivalent
Internal oxygen control	Comparable to predicate (2 position, 100% or 50/65%)	2 position, 100% or 65%	Substantially equivalent

The document also states that:

"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."

2. Sample Size Used for the Test Set and the Data Provenance

This is a physical medical device (ventilator) submission, not a software or AI device. Therefore, the concepts of "test set" and "data provenance" in the context of an algorithm or AI model are not directly applicable. The testing described is non-clinical and involves testing the physical ventilator's performance against established standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. Ground truth for a physical ventilator's performance is established through engineering and performance testing against industry standards (e.g., ASTM, ISO, MIL STD) and device specifications, not through expert consensus on data interpretation.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1, 3+1" are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth, which is not the case here.

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. This is not an AI-assisted device.

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

Not applicable. This is a standalone physical ventilator.

7. The Type of Ground Truth Used

For the Pneuton Ventilator, the "ground truth" for its performance is established by:

Engineering Specification Compliance: The device performing according to its design specifications (e.g., tidal volume delivery, respiratory rate accuracy, alarm functionality).
Compliance with Recognized Standards: Meeting the requirements of standards such as ASTM F 1100-90, MIL STD 810 E, and ISO 10651-3. These standards define the expected performance and safety characteristics of medical ventilators.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device that requires a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Pneuton Ventilator Model A meets acceptance criteria is described as "Non-Clinical Testing and Validation."

Methodology: "The performance of the Pneuton Ventilator has been comprehensively tested. All functions as listed in the specifications have been validated." This would involve bench testing, functional testing, and environmental testing.
Standards Compliance: The device demonstrated compliance with the following recognized 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
Conclusion: "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."

The regulatory submission argues that the modifications (patient disconnect alarm, slight changes to min respiratory rate and min peak inspiratory pressure, increased MRI compatibility) do not raise new questions of safety or efficacy and that the device remains "substantially equivalent" to its predicate devices (original Pneuton K024344 and Pneupac Transport Ventilator K030803) based on this non-clinical testing and comparison of characteristics.

Summary

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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.

K043085

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

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Device Description

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

Intended Use

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	ChangedPneuton(model A)	OriginalPneuton(model S)	Pneupac Transport	Discussion
Intended Use -patientpopulation	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
Operatingprinciple	Pneumatic	Pneumatic	Pneumatic	Equivalent
Input gaspressure	40 to 70 psi	40 to 70 psi	37 to 87 psi	Substantiallyequivalent
Patient circuit	Tubing withexternalexpiratory valve	Tubing withexternalexpiratory valve	Tubing with externalexpiratory valve	Equivalent
Enclosure	Rugged,lightweight	Rugged,lightweight	Rugged, lightweight	Equivalent
Displays	Manometer	Manometer	Manometer	Equivalent
Safety features	Adjustable highpressurerelease, internalhigh pressurerelease, anti-suffocation valve	Adjustable highpressurerelease, internalhigh pressurerelease, anti-suffocation valve	Adjustable highpressure release	Substantiallyequivalent
Alarms	Low gas source,patientdisconnect	Low gas source	Low gas source,high pressure,patient disconnect	Substantiallyequivalent

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Characteristic	ChangedPneuton(model A)	OriginalPneuton(model S)	Pneupac Transport	Discussion
Modes ofventilation	CMV, IMV,CPAP	CMV, IMV,CPAP	CMV, PEEP	Substantiallyequivalent
Tidal volume	360 - 1500	360 - 1500	50 - 1500	Substantiallyequivalent
Respiratoryrate	3 - 50	2 - 50	7 - 60	Substantiallyequivalent
Flow (L/min)	36	36	6 - 60	Pneuton uses afixed inspiratoryflow
PEEP/CPAP	0 - 20	0 - 20	external	Pneuton has aninternalPEEP/CPAPsystem
Peak pressure	15 - 75	10 - 75	20 - 80	Substantiallyequivalent
I : E ratio	Continuouslyadjustable bycontrolling I timeand E time usingvolume and ratecontrols	Continuouslyadjustable bycontrolling I timeand E time usingvolume and ratecontrols	Continuouslyadjustable bycontrolling I time andE time	Substantiallyequivalent
Internal oxygencontrol	2 position, 100%or 65%	2 position, 100%or 65%	2 position, 100% or50%	Substantiallyequivalent

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 (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

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Indications For Use Statement

510(k) Number K043085

Device Name: Pneuton Ventilator, Model A

Indications For Use:

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)

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:________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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).