The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations. peacetime engagement, crisis response and humanitarian relief operations by trained personnel.

The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining.

This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized.

There are no contraindications.

Device Description

The AMOGS system is designed to provide supplemental oxygen meeting USP93% requirements using the Pressure Swing Adsorption (PSA) process on the HH-60M MEV AC helicopter. It is comprised of an oxygen concentrator, monitor panel, backup oxygen cylinder and heat exchanger and filter assembly. The AMOGS utilizes engine bleed air and electrical power from the aircraft resources to provide oxygen-enriched breathing gas for medical evacuation applications. The bleed air is conditioned by the heat exchanger and filter assembly and then routed to the concentrator which produces oxygen-enriched breathing gas. The backup oxygen cylinder provides oxygen-enriched breathing gas during periods in which the concentrator is not operating or the peak demand exceeds the concentrator rated capacity. The monitor panel provides operational status of the concentrator and back up cylinder.

AI/ML Overview

The provided document describes the Aircraft Medical Oxygen Generation System (AMOGS), which is a physical device, not an AI/ML powered medical device. Therefore, the questions related to AI/ML specific criteria such as 'Multi Reader Multi Case (MRMC) comparative effectiveness study', 'standalone (i.e. algorithm only) performance', 'training set sample size', and 'ground truth for training set' are not applicable.

Here's an analysis of the available information based on the device's performance and the study conducted:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Produce USP 93% oxygen	The system is capable of producing USP 93% oxygen. Independent laboratory testing verified oxygen purity was in accordance with USP 93%.
Deliver oxygen to downstream medical devices at specified pressures	The system is capable of delivering oxygen to downstream medical devices at pressures of 55 psig.
Total gaseous hydrocarbons and halogenated hydrocarbons below accepted standards	Independent laboratory testing verified that total gaseous hydrocarbons and halogenated hydrocarbons were below accepted standards.
Particulates below accepted standards	Independent laboratory testing verified that particulates were below accepted standards.
Substantial equivalence to predicate devices (Deployable Oxygen Generation System - Medium (DOGS-M) and Total O2)	Based on testing and analysis, the AMOGS is stated to be substantially equivalent to the predicate devices. The primary differences are output capacity and pressure, but it uses the same core technology (pressure swing adsorption) and has the same intended use (supplemental oxygen).

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

Sample Size: The document does not specify a numerical sample size for the "non-clinical bench and flight testing" or "independent laboratory testing." It mentions "the system" in a singular sense, implying the testing was performed on at least one AMOGS unit.
Data Provenance: The testing was conducted by "Carleton Life Support Systems, Inc. and the US Army." "Independent laboratory testing" was also performed. This suggests testing was internal to the manufacturer and by a governmental entity (US Army), as well as by an external, unaffiliated lab. The location of these tests (e.g., country) is not specified but is implicitly within the US given the FDA submission. The tests are prospective in nature, as they were conducted to verify performance of the AMOGS device.

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

This question is not directly applicable in the context of a physical oxygen generation system that produces a measurable output (oxygen purity, pressure, contaminants). "Ground truth" here is defined by physical measurements against established standards (USP 93% for oxygen purity, accepted standards for contaminants). The "experts" would be the scientists, engineers, and technicians performing and validating these measurements in the specified test environments. Their qualifications would involve expertise in gas analysis, pressure measurement, and relevant engineering principles, rather than medical interpretation. The document does not specify the number or detailed qualifications of these individuals.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are used in scenarios where human interpretation (e.g., of medical images) requires consensus or resolution of disagreement. For a device producing physical outputs, the "truth" is determined by objective measurement against pre-defined, quantitative standards.

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 versus without AI assistance:

Not applicable. This device is a physical system, not an AI/ML diagnostic tool, and involves no "human readers" or AI assistance in its primary function.

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

Not applicable. This is not an algorithm, but a physical device. Its performance is inherently "standalone" in the sense that it operates to produce oxygen without human interpretive input for its core function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth used for performance validation was based on:

Quantitative Standards: USP 93% for oxygen purity, and "accepted standards" for total gaseous hydrocarbons, halogenated hydrocarbons, and particulates.
Physical Measurements: Bench and flight testing directly measured the device's output (oxygen purity, pressure) against these quantitative standards.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is a physical device, not an AI/ML algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary

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SECTION 12: PREMARKET NOTIFICATION [510(K)] SUMMARY

082929

Date:	December 19, 2008
Applicant:	Carleton Life Support Systems, Inc.2734 Hickory Grove RoadDavenport, IA 52804	DEC 22 2008
Phone:FAX:	563-383-6299563-383-6107
Contact:	Gary Byrd, Mechanical Engineering Manager
Trade Name:	Aircraft Medical Oxygen Generation System (AMOGS)

Common Name: Oxygen Concentrator

Classification Name: MEDEVAC Use Oxygen Generator

Product Code: OLF

Regulation Number: 8685440

Establishment Registration Number: 3002840531

Legally Marketed Devices to which Substantial Equivalence is claimed:

Deployable Oxygen Generation System - Medium (DOGS-M) developed by Carleton Life Support Systems, cleared under submittal K020330 and Total O2 manufactured by Chad Therapeutics, cleared under submittal K971889.

Description

Indications for Use

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The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining.

This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized.

There are no contraindications.

Technological Summary

The primary function of the AMOGS is to provide supplemental oxygen for military medical evacuation applications. The AMOGS uses the same technology, the pressure swing adsorption process, as the predicate devices to produce USP 93% oxygen. Both the Total O2 and the AMOGS use pneumatic pressure intensifiers to compress the gas while the DOGS-M uses an electrically driven compressor to provide the same function. The technological characteristics of the AMOGS and its intended use to supply supplemental oxygen, are basically the same as the predicate devices and raises no new questions of safety or effectiveness.

The primary difference between the AMOGS and the predicate devices are the output capacity and pressure.

Performance

Non-clinical bench and flight testing by Carleton Life Support Systems, Inc. and the US Army verified that the system is capable of producing USP 93% oxygen and delivering it to downstream medical devices at pressures of 55 psig. Independent laboratory testing also verified that oxygen purity was in accordance with USP 93% and that total easeous hydrocarbons and halogenated hydrocarbons and particulates were below accepted standards.

Conclusions

Based upon the testing and analysis provided, the AMOGS is substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally oriented. The words are stacked on top of each other.

Image /page/2/Picture/2 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 that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

DEC 2 2 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Gary Byrd Engineering Manager Carleton Life Support Systems, Incorporated 2734 Hickory Grove Road Davenport, Iowa 52804-1203

Re: K082829

Trade/Device Name: Aircraft Medical Oxygen Generation System (AMOGS) Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: OLF Dated: September 11, 2008 Received: September 25, 2008

Dear Mr. Byrd:

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. Byrd

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Clint S. Lanier, Ph.D.

Chiu S. Lin, Ph. D Division Director Division of Ancsthesiology, 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

510(k) Number: TBD

Device Name: Aircraft Medical Oxygen Generation System (AMOGS)

Indications For Use:

The AMOGS system is intended to provide oxygen enriched gas generated by the pressure swing adsorption process to patients who may have difficulty extracting oxygen from air that they breathe while on board the HH-60M MEDEVAC helicopter. The system may be used to provide medical support to the full spectrum of deployed scenarios including wartime operations, deterrence and contingency operations, peacetime engagement, crisis response and humanitarian relief operations by trained personnel.

The oxygen supplied by the AMOGS is supplemental and is not considered to be life supporting or life sustaining.

This device is not intended to be used in the presence of flammable anesthetics nor is it intended to be sterilized.

There are no contraindications.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Zam Mzi

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(K) Number: K052829

Regulation Number and Section

§ 868.5440 Portable oxygen generator.

(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).