The DOGS-M system is intended to provide supplemental oxygen enriched gas to patients who may have difficulty extracting oxygen from air that they breathe. 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 military personnel.

The DOGS-M has the capability to supply pressurized oxygen to fill gas cylinders that can be transported to remote locations away from the DOGS-M system or to fill cylinders for patient ambulatory use.

The oxygen supplied by the DOGS-M 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 Deployable Oxygen Generation System – Medium (DOGS-M) is a point of use oxygen generation system designed to meet the needs of the Air Force for ground based medical support. The DOGS-M consists of an oxygen generation system, a low pressure oxygen compressor, high pressure oxygen compressor, cylinder evacuation pump and integral back up oxygen storage cylinders in a single module. The oxygen generation system uses an integral air compressor and Pressure Swing Adsorption (PSA) technology to separate up to 120 liters per minute of oxygen meeting the requirements of USP93% from ambient air. The high pressure compressor is designed to charge cylinders to 2250 psig at approximately 60 liters per minute. To insure that there are no contaminants in the cylinders prior to filling, the system is provided with an evacuation pump that can evacuate an H cylinder down to 25 inches mercury in less than 10 minutes.

AI/ML Overview

Here's an analysis of the provided text regarding the Deployable Oxygen Generation System - Medium (DOGS-M), structured to address your specific questions about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Produce up to 120 liters per minute (lpm) of oxygen.	The system is capable of producing up to 120 lpm.
Oxygen purity meets USP 93% requirements.	Oxygen purity was in accordance with USP 93%.
Charging cylinders up to 2250 psig.	The system is capable of charging cylinders up to 2250 psig.
Evacuate an H cylinder down to 25 inches mercury in less than 10 minutes.	The system is provided with an evacuation pump that can evacuate an H cylinder down to 25 inches mercury in less than 10 minutes.
Total gaseous hydrocarbons, halogenated hydrocarbons, and particulates are below accepted standards.	Independent laboratory testing verified that total gaseous hydrocarbons and halogenated hydrocarbons and particulates were below accepted standards.

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

The provided text does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). The performance claims are stated generally as capabilities verified through testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not mentioned in the document. The testing described appears to be technical bench testing of the device's physical and chemical output, rather than a clinical study requiring expert assessment of patient outcomes or imagery.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not mentioned in the document. Adjudication methods are typically used in clinical trials where there's a need to resolve discrepancies in expert opinions, which isn't relevant for the type of technical performance testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

An MRMC comparative effectiveness study was not performed and is not applicable to this device. This type of study is relevant for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance is being evaluated. The DOGS-M is an oxygen generation system, not a diagnostic tool.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, a standalone study was performed in the sense that the device's technical capabilities were tested independently. The performance section states: "Non-clinical bench testing by Carleton Life Support Systems, Inc. verified that the system is capable of producing... Independent laboratory testing also verified that oxygen purity was in accordance with USP 93% and that total gaseous hydrocarbons and halogenated hydrocarbons and particulates were below accepted standards." This indicates the device's performance was assessed directly, without human interaction in a clinical setting to interpret its output in relation to patient care.

7. The Type of Ground Truth Used

The ground truth used for this device's performance assessment was based on objective, measurable criteria and established standards. Specifically:

USP 93%: United States Pharmacopeia standards for oxygen purity.
Pressures: Engineering specifications for psig (pounds per square inch gauge) and inches mercury.
Flow Rates: Engineering specifications for liters per minute (lpm).
Contaminant Standards: "Accepted standards" for total gaseous hydrocarbons, halogenated hydrocarbons, and particulates (though the specific standards are not cited, they would be objective, scientific measurements).

8. The Sample Size for the Training Set

This information is not mentioned and is not applicable. The DOGS-M is a physical medical device (an oxygen concentrator) and does not involve AI or machine learning algorithms that require a "training set" in the computational sense.

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

This information is not mentioned and is not applicable for the reasons stated above (no AI/ML training set).

Summary of the Study Proving Acceptance Criteria:

The study described is primarily non-clinical bench testing and independent laboratory testing. This testing was conducted by Carleton Life Support Systems, Inc. (the applicant) and an unnamed independent laboratory. The purpose was to verify the technical specifications and output quality of the DOGS-M against predefined engineering and regulatory standards (like USP 93%). The testing demonstrated that the device could produce the specified volume and purity of oxygen, charge cylinders to the required pressures, and meet contaminant limits. The absence of details regarding sample sizes for testing or expert involvement is typical for this type of technical device clearance, where the focus is on objective physical and chemical performance. The clearance was granted based on substantial equivalence to a predicate device (DOCS), indicating that the validated performance was considered comparable and raised no new questions of safety and effectiveness.

Summary

{0}------------------------------------------------

K071904

SECTION 11: PREMARKET NOTIFICATION [510(K)] SUMMARY

0CT 25 2007

Date: June 7. 2007

Applicant: Carleton Life Support Systems, Inc. 2734 Hickory Grove Road Davenport, IA 52804

Phone: 563-383-6299 FAX: 563-383-6107

Contact: Gary Byrd, Medical Oxygen Engineering Manager

Trade Name: Deployable Oxygen Generation System - Medium (DOGS-M)

Common Name: Oxygen Concentrator

Classification Name: Generator, Oxygen, Portable

Establishment Registration Number: 3002840531

Legally Marketed Device to which Substantial Equivalence is claimed: Deployable Oxygen Concentration System (DOCS) developed by Pacific Consolidated Industries and cleared under submittal K020330.

Description

Indications for Use

{1}------------------------------------------------

peacetime engagement, crisis response and humanitarian relief operations by trained military personnel.

The oxygen supplied by the DOGS-M 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 DOGS-M is to provide supplemental oxygen for military medical applications. The DOGS-M uses the same technology, the pressure swing adsorption process, as the predicate device to produce USP 93% oxygen. Both the predicate device and the DOGS-M use similar means to compress the gas to 100 psig for low pressure applications and to 2250 psig for storage in cylinders. The technological characteristics of the device and its intended use to supply supplemental oxygen are basically the same as the predicate device and raise no new questions of safety and effectiveness.

The primary difference between the DOGS-M and the predicate device is in the smaller size, lower weight and power requirements with a corresponding reduction in output capacity.

Performance

Non-clinical bench testing by Carleton Life Support Systems, Inc. verified that the system is capable of producing up to 120 lpm of of USP 93% oxygen at pressures of 100 psig and charging cylinders up to 2250 psig. Independent laboratory testing also verified that oxygen purity was in accordance with USP 93% and that total gaseous hydrocarbons and halogenated hydrocarbons and particulates were below accepted standards.

Conclusions

Based upon the testing and analysis provided, the DOGS-M is substantially equivalent to the predicate device DOCS.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

007 25 2007

Mr. Gray Byrd Mechanical Engineering Manager Carleton Life Support Systems, Incorporated 2734 Hickory Grove Road Davenport, Iowa 52804-1299

Re: K071904

Trade/Device Name: Deployable Oxygen Generation System-Medium (DOGS-M) Regulation Number: 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: August 7, 2007 Received: October 16, 2007

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.

{3}------------------------------------------------

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 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/industry/support/index.html.

Sincerely vours.

Nil R. Ogden

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

{4}------------------------------------------------

Indications for Use

510(k) Number: K071904

Device Name: Deployable Oxygen Generation System - Medium (DOGS-M)

Indications For Use:

The oxygen supplied by the DOGS-M 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 (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)

Mint Thulut

Civision of Anesthesiology, General Hospital. Intection Control Dental Device

510(k) Number: K071964

Page 1 of 1

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).