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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Deployable Oxygen Generator System - Small (DOGS-S)". This document focuses on demonstrating substantial equivalence to a predicate device (OMNI 2 (SAROS)), not on proving the device meets individual acceptance criteria through a clinical study in the way an AI/ML device would be evaluated for diagnostic accuracy.

Therefore, many of the requested criteria (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and are not present in the document.

The document primarily focuses on bench testing to confirm the device's technical specifications and compliance with relevant engineering and safety standards.

Here's an analysis based on the information available in the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't present "acceptance criteria" in the typical format of a clinical performance study with specific metrics and thresholds (e.g., sensitivity, specificity). Instead, it provides a comparison table of technological characteristics between the DOGS-S device and its predicate, the OMNI 2 (SAROS), to demonstrate substantial equivalence. The "acceptance" here is that the DOGS-S performs comparably or meets the standards for an oxygen concentrator.

Characteristic / "Acceptance Criteria" (Implied)	DOGS-S Performance (Reported)	Predicate (OMNI 2 SAROS) Performance
Intended Use	Administration of supplemental oxygen, not life support or patient monitoring, operated by trained personnel.	Same (minor language differences).
Purity	93% +/-3% USP	93% +/-3% USP
Flow Rate	0.5 to 15 LPM continuous flow	1 to 3 LPM continuous flow
Output Pressure	10.0 psig nominal	5.0 psig nominal
Power Consumption	550 Watts @ 15LPM	128 Watts @ 3LPM
Weight (w/o battery)	37 lbs.	10 lbs.
Diameter	10"	4.4"
Height	33"	26"
Sound Level	<70dBA	<59dBA
Oxygen Purity Warning	<85%	70-85%
Oxygen Purity Low Alarm	<85%	<70%
Electrical Requirements	AC 100/240V 50/60Hz Battery 674 Whr peak	AC (100VAC, 50/60 Hz) Power Cartridge (Battery) 88 Whr
Filtration	Dust, Compressed Inlet, HEPA	Dust, Compressed Inlet, HEPA
Alarm Indicators	Low Oxygen purity, O2 Flow High or Low, Low power indicator (Battery), Unit malfunction	Low Oxygen purity, O2 Flow High or Low, Low power Cartridge (Battery), Unit malfunction
Enclosure Material	G/10 F/R FIBERGLASS TUBE, PC / ABS	G/10 F/R FIBERGLASS TUBE, PC / ABS

2. Sample sized used for the test set and the data provenance

Sample Size: Not explicitly stated in terms of patient/data samples, as this is a physical medical device (oxygen concentrator) and its performance is evaluated through bench testing and compliance with standards rather than clinical data accuracy. The "test set" here refers to the actual manufactured devices and their components being tested.
Data Provenance: Not applicable in the context of clinical data. The tests are "internal testing, verification and validation as well as external testing and validation" on the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This is a hardware device; its ground truth is based on engineering specifications and direct physical measurements (e.g., oxygen purity, flow rate, power consumption) validated against recognized standards, not subjective expert interpretations of images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. As this isn't a diagnostic accuracy study with human interpretation, there's no need for adjudication of human expert opinions.

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 a hardware device, not an AI/ML diagnostic or assistive tool.

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

Not Applicable. This is a standalone physical device, not an algorithm. Its performance is measured intrinsically.

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

The "ground truth" for the device's performance is established by engineering specifications, direct physical measurements (e.g., chemical analysis for oxygen purity, flow meters for flow rate), and compliance with recognized industry standards such as ISO 80601-2-69, IEC 60601-1, MIL-STD-810f/g, and USP 93% +/-3% for oxygen purity.

8. The sample size for the training set

Not Applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable. (See #8)

Summary

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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)

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)

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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
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Regulation Number:	868.5440
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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:

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 EquivalenceComparison:	DOGS-S	OMNI 2 (SAROS)
Intended Use:	The Deployable OxygenGenerator System – Small(DOGS-S)is intended for theadministration ofsupplemental oxygen. Thedevice is not intended forlife support nor does itprovide any patientmonitoring capabilities. Thesystem will be operated bytrained personnel.	The Omni 2 Oxygen Systemis intended for theadministration ofsupplemental oxygen. Thedevice is not intended forlife support nor does itprovide any patientmonitoring capabilities.
TechnologicalCharacteristics:
Major Components:
Compressor:	Brushless DC motor Type - Rotary Swing	Brushless DC motor Type - Scroll
PSA Valve type:	(PSA) Pressure Swing Adsorption Adsorption - Molecular sieve 5 Bed design Type - Rotary	(PSA) Pressure Swing Adsorption Adsorption - Molecular sieve 5 Bed design Type Rotary
Battery:	Lithium Ion	Lithium Ion
Other CharacteristicsComparisons:
Electricalrequirements:	AC 100/240V 50/60Hz Battery 674 Whr peak	AC (100VAC, 50/60 Hz) Power Cartridge (Battery) 88 Whr
Purity:	93% +/-3% USP	93% +/-3% USP
Flow Rate:	0.5 to 15LPM continuous flow control panel readout	1 to 3LPM continuous flow control panel readout
Filtration:	• DustCompressed InletHEPA	• DustCompressed InletHEPA
Output pressure:	• 10.0 psig nominal	• 5.0 psig nominal
Power consumption:	• 550 Watts @ 15LPM	• 128 Watts @ 3LPM
Weight:	• 37 lbs. w/o battery	• 10 lbs. w/o battery
Diameter:	• 10"	• 4.4"
Height:	• 33"	• 26"
Sound Level:	• <70dBA	• <59dBA
Oxygen PurityWarning:	• <85%	• 70-85%
Oxygen Purity Low:	• <85%	• <70%
Alarm indicators:	• Low Oxygen purity	• Low Oxygen purity
	• O2 Flow High or Low	• O2 Flow High or Low
	• Low power indicator(Battery)	• Low power Cartridge(Battery)
	• Unit malfunction	• Unit malfunction
Enclosure:	• MATERIAL: G/10 F/RFIBERGLASS TUBE.	• MATERIAL: G/10 F/RFIBERGLASS TUBE.
	• PC \ ABS	• PC / ABS

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SUMMARY:

This summary demonstrates that the Device has no significant technological differences from the predicate device that would adversely affect product safety and effectiveness, i.e. all technological characteristics are covered.

Accessories:

The following components are part of the DOGS-S submission; a battery pack / lithium ion, power supply, power cord, handle, and manuals. There are no accessories that have received prior FDA 510k clearance.

Intended 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

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provide any patient monitoring capabilities. The system will be operated by trained personnel. The differences in language in the intended use for the SAROS and DOGS-S are minor.

Testing:

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 3° Edition Medical electrical equipment—Part:1 General Requirements for Basic Safety and Essential Performance and to IEC 60601-1-2 3ª Edition Medical Electrical Equipment, Part 1: General Requirements for Safety-Collateral Standard: Electrical Compatibility - Requirements and Tests.

Performance Data:

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 .

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. 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.

Conclusion:

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.

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).