Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard oxygen concentrator technology and compliance with relevant medical device standards.

Therapeutic

Yes
The device is intended for the administration of supplemental oxygen, which is a therapeutic function.

Diagnostic

No

This device is an oxygen concentrator intended for the administration of supplemental oxygen, not for diagnostic purposes. The text explicitly states it "is not intended for life support nor does it provide any patient monitoring capabilities." This indicates it is a therapeutic device rather than a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "portable battery powered oxygen concentrator," which is a hardware device. The performance studies also detail testing related to electrical safety, EMC, and biological evaluation, all indicative of a physical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Deployable Oxygen Generator System - Small (DOGS-S) is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the "administration of supplemental oxygen." This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
Device Description: The device is described as a "portable battery powered oxygen concentrator." Oxygen concentrators are used to provide oxygen directly to a patient, not to analyze biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The DOGS-S is clearly a medical device intended for providing respiratory support, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Deployable Oxygen Generator System - Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.

Product codes (comma separated list FDA assigned to the subject device)

CAW

Device Description

The DOGS-S system is a portable battery powered oxygen concentrator that will be operationally used for ground-based medical assemblages, such as the Expeditionary Medical Support (EMEDS), and En-Route Patient Staging System (ERPSS) in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.

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

The DOGS-S was designed for Military Medical Service use in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations. The DOGS-S will be operated by a trained medical technician with respiratory therapy background. In addition to the normal operation of the DOGS-S, the USER/OPERATOR shall have a working knowledge of oxygen concentrators.

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 DOGS-S has been tested and verified in various phases, internal testing, verification and validation as well as external testing and validation. The design was verified throughout the design process. Risk analysis was done, appropriate measures were implemented and their effectiveness verified. External test house was used to confirm compliance to EMC requirements and standards for electrical safety. The testing confirms the Deployable Oxygen Generator System - Small (DOGS-S) meets the ISO 80601-2-69 standards for Oxygen Concentrator devices. Testing demonstrates that the product is in compliance to: AAMI ES60601-1 3rd Edition Medical electrical equipment—Part:1 General Requirements for Basic Safety and Essential Performance and to IEC 60601-1-2 3rd Edition Medical Electrical Equipment, Part 1: General Requirements for Safety-Collateral Standard: Electrical Compatibility - Requirements and Tests.

The oxygen flow rate and purity at the operating pressure was tested and verified in the Performance Bench Testing section of this submission, the instruction manual and in accordance with:

ISO 80601-2-69 . Medical Electrical Equipment, Part 2-69
IEC 60601-1 Safety Requirements (Medical Electrical Equipment Part 1: General Requirements)
. IEC 60601-1-2 EMC (Electro Magnetic Compatibility Testing)
ISO 62304 Medical Device Software-Software Life-Cycle Processes
Biological Evaluation of Medical Devices . ISO 10993-1
- Cytotoxicity
- Sensitization
- Irritation
. Compliance with USP 93% +/-3%
. Particulate Matter Testing
Volatile Organic Compound Testing .
. Ozone Testing
MIL-STD-810f
MIL-STD-810g
. MIL-STD-461e

The test platform ensures compliance to recognized consensus standards and therefore does not raise new questions of safety and effectiveness. The DOGS-S performance tests demonstrate substantial equivalence to the predicate device. The performance tests results also confirm ability to provide 93% +/- 3% USP oxygen for supplemental oxygen use only.

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.

K083163

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

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).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2015

AirSep Corporation Mr. Ted Vlahopoulos Regulatory Specialist 260 Creekside Drive Buffalo, NY 14228

Re: K150930

Trade/Device Name: Deployable Oxygen Generator System - Small (DOGS-S) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 12, 2015 Received: November 16, 2015

Dear Mr. Vlahopoulos:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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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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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, 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 (if known) K150930

Device Name

Deployable Oxygen Generator System - Small (DOGS-S)

Indications for Use (Describe)

The Deployable Oxygen Generator System - Small (DOGS-S) is intended for the administration of supplemental oxygen. This device is not intended for life support nor does it provide any patient monitoring capabilities. The system will be operated by trained personnel.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary

Submitter:

Airsep Corporation 260 Creekside Drive Buffalo, NY 14228

Phone: (716) 691-0202

Fax: (716) 691-1255

Registration Number: 1319044

Contact person:

Peter Weisenborn Quality & Regulatory Manager Email: peter.weisenborn@chartindustries.com

Preparation Date: 03/31/15

Device Trade Name:

DOGS-S Deployable Oxygen Generation System-Small

Classification Name:	Portable Oxygen Generator
----------------------	---------------------------

Regulation Number:	868.5440
--------------------	----------

Product Code: CAW

Device Class: Class II

Classification Panel: Anesthesiology and Respiratory Therapy Devices

Predicate Devices:

OMNI 2 (SAROS) from SeQual Technologies / A Chart Industries Company Product Code: CAW 510(k) number: K083163

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Device Description:

The DOGS-S system is a portable battery powered oxygen concentrator that will be operationally used for ground-based medical assemblages, such as the Expeditionary Medical Support (EMEDS), and En-Route Patient Staging System (ERPSS) in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.

Oxygen Concentrator Process

Oxygen concentrators were introduced in the mid-1970s and have become the most convenient, reliable source of supplemental oxygen available today.

The air we breathe contains approximately 21% oxygen, 78% nitrogen, and 1% other gases. In the DOGS-S unit, room air passes through a regenerative adsorbent material called molecular sieve. This material separates the oxygen from the nitrogen and other gases. The result is a constant supply of high concentration supplemental oxygen that is delivered to the patient.

User/Operator Profile:

AirSep's Concentrators are intended to supply supplemental Oxygen to patients suffering from discomfort due to ailments which affect the efficiency of ones lungs to transfer the oxygen in air to their bloodstream. Patients can benefit from supplemental oxygen therapy for respiratory care at home, in the hospital, or at a medical facility. Oxygen Concentrator use requires a physician's prescription, and is not intended for life support use.

DOGS-S was designed for Military Medical Service use in deployed scenarios, including wartime operations, deterrence, humanitarian and contingency operations.

The DOGS-S will be operated by a trained medical technician with respiratory therapy background. In addition to the normal operation of the DOGS-S, the USER/OPERATOR shall have a working knowledge of oxygen concentrators.

Technological Characteristics:

DOGS-S will generate 15 litres per minute (LPM) gaseous supply pressure oxygen with a regulated flow adjustment ranging from 0.5 LPM to 15 LPM (ASTM F1464-93) in 0.5 increments will concentrate oxygen from the atmosphere to a purity of 93% (ASTM F1464-93) United States Pharmacopeia (USP). DOGS-S supplies continuous flow of product through a standard patient distribution port. An operator supplied nasal cannula connects to the distribution port to deliver supplement oxygen to the patient. The device includes a detachable battery and internally contained battery charger. The battery charger is capable of charqing the battery while the DOGS-S is off or being used while plugged into AC power source. DOGS-S is a portable unit using handle accessory and/or transit case with handles. DOGS-S will be provided with a non-reusable box for initial shipment and a reusable carrying case.

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Below is the comparison table.

| Substantial Equivalence

Comparison:	DOGS-S	OMNI 2 (SAROS)
Intended Use:	The Deployable Oxygen
Generator System – Small
(DOGS-S)

is intended for the
administration of
supplemental oxygen. The
device is not intended for
life support nor does it
provide any patient
monitoring capabilities. The
system will be operated by
trained personnel. | The Omni 2 Oxygen System