The OGL is intended to be used by emergency response personnel in military and commercial applications to produce emergency source of 93% USP liquid oxygen (LOX) which will be transferred into portable LOX systems. The portable LOX systems are used as an emergency source of supplemental oxygen for patient(s) while being transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.

Device Description

The OGL is a device that generates 93% USP oxygen gaseous, liquefy it into LOX and store up to 40 liters of LOX. It OGL is a single module that weighs approximately 730 LBS empty or 830 full of LOX. The system is 52" long, 33" wide and 48" tall if the wheels are deployed). The system has to forklift pockets to allow the system to be moved by a forklift. The system also has retractable wheels that allows for one or two persons to easily move the device on a flat smooth surface.

The OGL requires only 200-240 VAC, 50/60 Hz 30 amp single phase power supply for operation. The system is very simple to operate. The control panel has a mode switch that allows the user to make liquid oxygen (LOX), generate gaseous oxygen for the oxygen gas port or transfer the liquid oxygen to a separate device. The control panel also has fault indicators if there is a problem with the system, emergency stop button, hour meter, Dewar pressure gauge and LOX quantity gauge.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Performance/Characteristics	Acceptance Criteria (Predicate Device K022684)	Reported Device Performance (OGL)
Oxygen Purity	93% USP	93% USP
Operating Temperature	32°F to 90°F	0°F to 120°F
Storage Temperature	-40°F to 158°F	0°F to 130°F
Humidity	Up to 95%	Up to 95%
Storage Humidity	Up to 100%	Up to 100%
Oxygen Gas Outlet - Flow Rate	45 LPM	11 LPM
Oxygen Gas Outlet - Pressure	50 PSIG	7 PSI
Power (Compressor Module A & B)	208-220 VAC, 60 Hz, Three Phase, 6.93 kW MAX	200-240 VAC, 50/60 Hz, Single Phase, 6.3 kW MAX
Oxygen Concentrator Module Power	110 VAC, 50/60 Hz, 100 W	Not applicable (integrated system)
High Pressure Fill Module Power	110 VAC, 60 Hz, 600 W	Not applicable (integrated system)

The OGL is largely compared to its predicate device (PTOCS K022684) based on a variety of functional and environmental parameters. The acceptance criteria are implicitly defined by the predicate device's characteristics. The OGL's reported performance is then compared to these, demonstrating both similarities and some differences that the manufacturer argues are insignificant for safety and effectiveness.

2. Sample Size and Data Provenance for Test Set:
The document does not explicitly mention a "test set" in the context of a clinical study or a labeled dataset for AI model evaluation. Instead, the performance evaluation relies on bench testing of the OGL device itself, comparing its physical and functional specifications against those of the predicate device.

Sample Size: Not applicable in the typical sense of a data sample for AI training/testing. The "sample" is the manufactured OGL device itself.
Data Provenance: The data comes from the internal bench tests conducted by Essex Industries, Inc. d/b/a Essex Cryogenics of MO as described in their Qualification Test Report (OTR-50C-0103-5 .- 7). The country of origin for this testing is presumably the United States, given the company's location in St. Louis, Missouri. The testing is prospective in the sense that it evaluates the device's performance post-manufacture according to predefined specifications.

3. Number of Experts and Qualifications for Test Set Ground Truth:
Not applicable. The ground truth for the device's technical specifications and performance characteristics (e.g., oxygen purity, flow rate, environmental tolerances) is established through instrumentation and measurement according to engineering and quality assurance standards, not by human expert consensus or interpretation of images/data.

4. Adjudication Method for Test Set:
Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. The testing involves objective measurements and functional verification against established engineering specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic or screening devices where human reader performance is a key metric. The OGL is a medical device for oxygen generation and liquefaction, and its evaluation focuses on its technical and functional performance, not its impact on human reader accuracy.

6. Standalone (Algorithm Only) Performance:
Not applicable. The OGL is a physical medical device; it is not an algorithm that performs a standalone function (e.g., image analysis) without human interaction. While it contains software with a microprocessor, its "performance" is evaluated as an integrated system, not as a standalone algorithm in the AI sense.

7. Type of Ground Truth Used:
The ground truth used for evaluating the OGL's performance is based on engineering specifications, objective physical measurements, and functional tests to ensure compliance with design requirements and comparability to the predicate device. For example:

Oxygen Purity: Measured by a purity analyzer.
Dimensional Examination: Measured with appropriate tools.
Weight: Measured on a scale.
Operating Temperature/Humidity: Tested under controlled environmental conditions.
Functional Testing: Verifying delivery rates, pressure, normal evaporation rate, liquid transfer, and fault indicator operation.

8. Sample Size for the Training Set:
Not applicable. This device is not an AI/ML system that utilizes a training set of data. Its design and manufacturing are based on engineering principles and established medical device regulations, not machine learning.

9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set for this device.

Summary

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Premarket Notification 510(k) Section 5-510(k) Summary

FEB 2 1 2014 Essex Industries OGL

510(k) Summary
Page 1 of 7
6/27/2013

Essex Industries, Inc. d/b/aEssex Cryogenics of MO8007 Chivvis Drive
St. Louis, Missouri 63123	Tel: (314) 338-8533
	Fax: (314)832-8208
Official Contact:	Kenneth L. Seise - Quality Assurance/RegulatoryCompliance Manager
Proprietary or Trade Name:	OGL
Common/Usual Name:	Portable Oxygen Generator
Classification Name/Code:	CAW- Portable Oxygen Generator21CFR 868.5440Class II
Device:	Oxygen Generator Liquefier- (OGL)
Predicate Device:	Portable Therapeutic Oxygen Concentrator System(PTOCS) - K022684

Device Description:

Intended User

Healthcare providers

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510(k) Summary Page 2 of 7 6/27/2013

Patient Population

This device generates liquid oxygen to be transferred into portable LOX systems, so a patient population is not indicated.

Indications for Use:

Environment of Use:

Environments of Use: Locations where LOX oxygen generation is desired, e.g. military, hospital.

Contraindications:

There are no known contraindications.

Predicate Device Comparison:

The OGLwas compared to the predicate PTOCS (K022684) in the device comparison table below.

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510(k) Summary Page 3 of 7

6/27/2013

Device Comparison Table 5.1

Performance/Characteristics	OGL	PTOCS K022684(PREDICATE DEVICE)
Indications for Use	The OGL is intended to be used byemergency response personnel inmilitary and commercialapplications to produce emergencysource of 93% USP liquid oxygen(LOX) which will be transferredinto portable LOX systems. Theportable LOX systems are used asan emergency source ofsupplemental oxygen for patient(s)while being transported for a crisissituation to a health care facility.This medical device is forsupplemental oxygen and is notintended to sustain or support life.	Provides supplemental therapeuticoxygen to a patient in a military fieldhospital setting.
Environment of use	Used by emergency responsepersonnel in military andcommercial applications and bymilitary medical personnel.	Used by emergency response personnein military and commercialapplications and by military medicalpersonnel.
Energy Used	200-240, 50/60 Hz	110, 60 Hz & 208-220, 60 Hz
Technology	Oxygen is concentrated by the useof molecular sieve beds / PressureSwing Adsorption (PSA)	Oxygen is concentrated by the use ofmolecular sieve beds and PressureSwing Adsorption (PSA)
Portability/HumanFactors	Forklift portable or can be move byone person with the wheelsdeployed on a level surface.	Compressor Module "A"4 man portableCompressor Module "B"4 man portableOxygen Concentrator Module4 man portableHigh Pressure Fill Module4 man portable
Standards Met	IEC 60601-1, IEC 60601-1-2	IEC60601-1
Sterility / Shelf Life	N/A	N/A
Electrical Safety	Tested IA W MIL-STD-810, &IEC60601-1	Tested IA W MIL-STD-810, &IEC60601-1
Operating Temperature	0°F to 120°F	32°F to 90°F
Storage Temperature	0°F to 130°F	-40°F to 158°F
Humidity	Up to 95%	Up to 95%
Storage Humidity	Up to 100%	Up to 100%
Performance/Characteristics	OGL	PTOCS K022684(PREDICATE DEVICE)
Dimensional Envelope	OGLHeight (Wheels Retracted) = 48.0"Height (Wheels Deployed) = 54.5"Width = 33.0"Depth = 52.0"See Figure 12-7	Compressor Module "A"Height = 28"Width = 27"Depth = 44"See Figure 12-8Compressor Module "B"Height = 27"Width = 24"Depth = 44"See Figure 12-8Oxygen Concentrator ModuleHeight = 42"Width = 22"Depth = 31"See Figure 12-8High Pressure Fill ModuleHeight = 27.5"Width = 23.5"Depth = 34.5"See Figure 12-8
System Weight	OGLEmpty = 730 LBSFull (with LOX) = 830 LBS	Compressor Module "A" = 298.8 LBSCompressor Module "B" = 149.6 LBSOxygen Concentrator Module = 283.3 LBSHigh Pressure Fill Module = 153.0 LBS
Power Requirements	OGLPower = 200-240 VACSupply Frequency = 50/60 HzPhase = Single PhaseWatts = 6.3 kW MAX	Compressor Module "A" & "B"Power = 208-220 VACSupply Frequency = 60 HzPhase = Three PhaseWatts = 6.93 kW MAXOxygen Concentrator ModulePower = 110 VACSupply Frequency = 50/60 HzWatts = 100 WHigh Pressure Fill ModulePower = 110 VACSupply Frequency = 60 HzWatts = 600 W
Oxygen Purity	93% USP	93% USP

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Premarket Notification 510(k) Section 5 - 510(k) Summary

510(k) Summary

Page 4 of 7

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Premarket Notification 510(k) Section 5 - 510(k) Summary

510(k) SummaryPage 5 of 76/27/2013
Performance/Characteristics	OGL	PTOCS K022684(PREDICATE DEVICE)
Oxygen Gas Outlet	# of Ports = 1Port Type = Male DISS 1240Flow Rate = 11 LPMPressure = 7 PSI	# of Ports = 3Port Type = Female Schrader QuickDisconnectFlow Rate = 45 LPMPressure = 50 PSIG
Medical DevicesCompatibility	High Pressure Cylinder Fill	Commercial MaskCommercial CannulaFlow Control Valve (0.5-15 LPM, with12 settings)
LOX Quantity Indicator	Mechanical Gauge	None
Fill Connection	Standard Military CRU-59/Econnection which connects with themilitary standard CRU-50/Aconnector on all the portable LOXstorage systems	None
LOX Storage Capacity	40 Liters of LOX	None
Alarms/Indicators	Three Fault Indicators. (If anyproblem occurs with system, thesystem will shut down and it willlight the appropriate faultindicators.)	Compressor Module "A" & "B"Low Pressure IndicatorPower Out of Phase IndicatorOxygen Concentrator ModuleLow Pressure IndicatorHigh Pressure IndicatorLow Oxygen Purity IndicatorOxygen Sensor Fault IndicatorHigh Pressure Fill ModuleLow Pressure IndicatorBack up Activated Indicator
Software	Has software with a microprocessorthat controls the entire system.

510/11 €

Differences Between Other Legally Marketed Predicate Devices:

The OGL is viewed as substantially equivalent to the predicate device because: The OGL uses the exact same technology and has similar indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Indications -

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510(k) Summary Page 6 of 7 6/27/2013

transported for a crisis situation to a health care facility. This medical device is for supplemental oxygen and is not intended to sustain or support life.

Discussion - These indications are similar to the predicate PTOCS (K022684).

Prescriptive - The OGL and predicate are both prescriptive.

Design and Technology - The OGL has equivalent design and features as the predicate and has the identical technology to the predicate.

Performance and Specifications - The OGL has equivalent specifications of performance as the predicate.

Compliance with standards - The OGL and predicate device declare compliance with IEC 60601-1 and IEC 60601-1-2.

Materials -

The air contacting materials have been cleared in prior 510(k)s as described in Section 15

Patient Population -

Neither the OGL or predicate have a define patient population.

Non-Clinical Testing Summary:

We have performed bench tests and found that the OGL met all requirements specifications and standards requirements and was found to be equivalent in comparison to the predicate.

Testing is documented in the Qualification Test Report (OTR-50C-0103-5 .- 7) in Section 18 - Performance Bench Testing.

Functional testing, e.g. pressure, delivery rate, normal evaporation rate and environmental testing, e.g. vibration testing, of the OGL was acceptable and proves that the device functions as intended and functions safely. Functional testing, e.g. display readout accuracy and fault indicator testing, and environmental testing, e.g. high and low temperature operation and storage testing, was acceptable and proves that the device functions as intended and functions safely. Testing includes:

Visual Examination .
. Oxygen Purity
Liquefaction Rate and Capacity .

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510(k) Summary Page 7 of 7 6/27/2013 ·

Liquid Transfer .
Dimensional Examination .
Weight .
Power .
. Normal Evaporative Rate (NER)
Component Bonding .
High Temperature Operation .
Low Temperature Operation .
High Temperature Storage .
. Humidity
� Rain
Salt Fog
Shipping Vibration ●
ISO 8359:1996 Oxygen concentrators for medical use Safety requirements .

Clinical Testing Summary:

No clinical testing

Substantial Equivalence Conclusion

Essex maintains that the OGL is substantially equivalent to the predicate PTOCS (K022684) in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards

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Image /page/7/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all capital letters. The text is written in a bold, sans-serif font. The text is centered horizontally and vertically in the image. The background of the image is white.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

February 21, 2014

Essex Industries, Incorporated Mr. Paul Dryden Regulatory Consultant 8007 Chivvis Drive St. Louis. MO 63123

Re: K131990

Trade/Device Name: Oxygen generator Liquefier (OGL) Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: February 18, 2014 Received: February 19, 2014

Dear Mr. Dryden:

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 10 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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Page 2 - Mr. Dryden

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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Sincerely vours.

Erin I. Keith, M.S. Acting 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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4 Indications for Use Statement

As required, we have prepared the Indications for Use statement on a separate page.

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Indications for Use Statement

Page 1 of 1

510(k) Number:

K131990 (To be assigned)

Device Name:

Essex Industries Oxygen Generator/Liquefier (OGL)

Indications for Use:

Device Name: Oxygen Generator/Liquefier

Environments of Use: Locations where LOX oxygen generation is desired, e.g. military, hospital.

Prescription Use XX (Part 2) CFR 801 Subpart D)

or 、

Over-the-counter use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

K131990

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Anya C. Harry -S 2014.02.21 14:27:30 -05'00'

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).