(88 days)
Not Found
No
The description focuses on the physical components and the Pressure Swing Adsorption process for oxygen generation, with no mention of AI or ML technologies.
Yes
The "Intended Use" section states the system is "intended to provide oxygen enriched gas... to patients who may have difficulty extracting oxygen from air that they breathe." This directly indicates a therapeutic purpose.
No
The device is an oxygen concentrator that provides supplemental oxygen to patients; it does not diagnose medical conditions.
No
The device description clearly outlines multiple hardware components including an oxygen concentrator, monitor panel, backup oxygen cylinder, and heat exchanger and filter assembly.
Based on the provided text, the AMOGS system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The AMOGS system provides oxygen-enriched gas to patients for breathing. It does not analyze any biological samples.
- The intended use clearly describes providing oxygen to patients. This is a therapeutic or supportive function, not a diagnostic one.
- The device description focuses on the process of generating oxygen from air. This is a mechanical and chemical process, not a biological or analytical one.
Therefore, the AMOGS system falls under the category of a medical device that provides respiratory support, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
OLF
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.
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
Not Found
Intended User / Care Setting
trained personnel, on board the HH-60M MEDEVAC helicopter
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)
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.
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
§ 868.5440 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).
0
SECTION 12: PREMARKET NOTIFICATION [510(K)] SUMMARY
082929
| Date: | December 19, 2008 | ||
|---|---|---|---|
| Applicant: | Carleton Life Support Systems, Inc. | ||
| 2734 Hickory Grove Road | |||
| Davenport, IA 52804 | DEC 22 2008 | ||
| Phone: | |||
| FAX: | 563-383-6299 | ||
| 563-383-6107 | |||
| 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
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.
Indications for Use
1
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.
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.
2
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
4
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
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