The 2300 Series mGO Portable Oxygen Generalor is 1-3 1./min continuous flow (1-6 1./min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based in molecular sieve technology. The patient the oxygen through a nasal cannula.

The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.

A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow serings should be adjusted only under the direction of a Physician.

WARNING: Federal Law restricts this device to sale by or on order of a Physician

Device Description

The 2300 Series mGO Portable Oxygen Generator delivers supplementary oxygen to casualties and patients at the point of need, eliminating the need for oxygen cylinders. It is designed to function in harsh environments for military users and agencies engaged in humanitarian and relief operations.

The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32. The 2300 Series mGO can deliver oxygen at flow rates between 1 and 3 litres per minute (L/min), continuous flow, or, in pulse dose mode, an oxygen bolus of up to 84 millilitres (ml) (14 ml multiplied by the setting value, maximum of 6) equivalent to a continuous flow of 6 L/min in response to breath demand. This is termed Pulse Oximetry.

The 2300 Series mGO is based on the pressure swing adsorption (PSA) principle. The 2300 Series mGQ delivers supplemental oxygen for patients through molecular sieve beds and is designed to conserve the use of oxygen in pulse dose mode. In pulse dose mode, oxygen is delivered to the patient through a pulse dose valve when a patient starts to inhale.

Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor.

A poppet-style solenoid valve directs air into one of two sieve beds. Nitrogen is adsorbed in the bed as the pressure increases, while oxygen flows out of the sieve bed, thereby producing a highly enriched oxygen product. Simultaneously, in the second sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. The cycle continues by alternately swapping the absorption/desorption process from one sieve bed to the other, providing a flow of oxygen to a receiver and the patient through a bacteria filter.

The 2300 Series mGO consists of pneumatic and electrical components, a pressure and vacuum compressor, a pressure vessel, Synthetic Zeolite molecular sieve beds, two lithium ion batteries, dust separator and particulate inlet filter, valve assemblies, an outlet bacteria filter, electronic flow control, touch control pad, a cooling fan assembly, and audible/visual alarms.

The 2300 Series mGO operates from 100-240 Volts AC mains power, 24-28 Volts DC power or two removable rechargeable batteries. The 2300 Series mGO may be carried manually (weight <10Kg) and transported by military or civilian vehicles on land, air and sea.

The device is provided with a 4.76 mm hose tail that is used to attach a cannula tube.

AI/ML Overview

The provided text describes the 510(k) summary for the 2300 Series mGO Portable Oxygen Generator. It details the device's characteristics, comparison to predicate devices, and non-clinical testing. However, it explicitly states that no clinical tests were submitted and therefore, it does not contain a study proving the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on:

Analogy and substantial equivalence to a predicate device (DeVilbiss Healthcare iGO Portable Oxygen Generator, K081468) and a second predicate device (SeQual Technologies Inc. SAROS 3000, K083163).
Non-clinical testing to demonstrate performance and safety.

Given the lack of a clinical study, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, standalone performance, ground truth for test set/training set) cannot be answered as they pertain to clinical or algorithm-based performance evaluations.

Here's a summary of the information that can be extracted related to acceptance criteria and performance, primarily from non-clinical testing and analogy:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (from Nonclinical Test Conclusions)	Reported Device Performance and Conclusion
EMC & Electrical Safety (IEC 60601-1-2: 2007): Device will not interfere with its environment to a dangerous level and is immune to electrical interference.	The 2300 Series mGO passed all EMC and electrical safety tests for emissions and immunity.
Basic Safety (IEC 60601-1:1988): Compliance with general medical electrical equipment safety requirements.	The 2300 Series mGO passed all the requirements of these tests.
Oxygen Enrichment during system leakage (IEC 60601-1:2005 Paragraph 11.2.2 related to Oxygen Rich Environment): Oxygen concentration due to leakage must be below 25%.	The worst-case Oxygen concentration is 22.66% caused by O2 leakage from the O2 reservoir, which is safely below the 25% limit. An Oxygen Rich Environment cannot exist, therefore IEC 60601-1:2005 Paragraph 11.2.2 does not apply.
Sieve bed life: Performance should not degrade significantly.	No evidence to suggest performance degradation with time. After 2010 hours of continuous running without significant change in performance. A service life of 1000 hours can be given. (Based on analogy and read-across from predicate device testing and extended life testing on 2300 Series mGO).
Compressor seal life: Durable for intended use.	Service life in excess of 10,000 hours. (Based on analogy and read-across from predicate device testing as it uses the same compressor under the same operating conditions).
Relief valve life: Durable for intended use.	Life of at least 100,000 cycles. (Based on analogy with relief valve testing on the predicate device as it uses the same relief valve with the same opening pressure).
Outlet Gas Purity: Will not contribute VOCs, CO, CO2, O3, or fine particulate matter to the oxygen stream.	Will not contribute VOCs, CO, CO2, O3 or fine particulate matter to the output stream. (Based on analogy to the 306 Series iGO, where test parameters indicated lower or non-detected concentrations of target analytes in the Oxygen Generator process stream than in ambient intake air).
Filter / Accumulator pressure test (IEC 60601-1:2005 Paragraph 9.7.5 "Pressure Vessels"): Sustain 75 psig (3 times max working pressure) without burst, deformation, or leakage.	Met the requirements of IEC 60601-1:2005 Paragraph 9.7.5. Sustained a pressure of 75 psig without burst, permanent deformation or leakage.
Extended Life Test: No significant degradation or failure over extended use.	Currently operating at 3778 hours with no sign of further degradation or failure. Two failures occurred, one a known issue corrected in assembly, and the second at 1.8 times the recommended service life (1840 hours), after which it ran for over 1900 hours with no further failures. Mechanical Pressure Regulator and Pressure Transducer exceeded the 100,000-cycles test requirement for IEC 60601-1 approval.
Fire Mitigation (ISO 8359 Amendment A1:2012, section 56.12): O2 outlet connection prevents flame propagation back into the concentrator.	The aluminium O2 outlet connection prevented the flame from propagating back into the oxygen concentrator.
Oxygen tubing and cannula flow test: Operates correctly with maximum specified tubing length in both continuous and pulse dose modes.	Operated to specification, in both continuous and pulse dose modes, when fitted with the maximum tubing lengths specified in the Instructions for Use (2300-4388).
Oxygen Concentration: Delivers 93% ± 3% oxygen.	The device description states: "The 2300 Series mGO administers supplemental oxygen at a concentration of 93% ± 3% to USP32." This is a stated performance characteristic rather than an acceptance criterion within the listed non-clinical tests, but it is a fundamental functional requirement. The tests listed do not specify how this specific criterion was proven, instead relying on analogy for the overall function.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The studies are non-clinical, primarily engineering and performance tests on the device itself or components, or reliance on "analogy and read-across" from predicate device testing. For example, the Extended Life Test mentions one device operating for 3778 hours with 2 failures, or a pressure test on one "Accumulator & Filter Housing Assembly."
- Data Provenance: The provenance is primarily laboratory testing conducted by Intertek Testing and Certification Limited and internal reports. Where analogy is used, the data provenance traces back to tests performed on the predicate device (DeVilbiss Healthcare 306 Series iGO, K081468). These are retrospective for the predicate device and inherently non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no human-interpreted "ground truth" for these non-clinical engineering and performance tests.
Adjudication method for the test set: Not applicable, as there is no human-interpreted "ground truth" requiring adjudication.
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 not an AI-based device, and no clinical or comparative effectiveness study involving human readers was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device. The non-clinical tests are standalone in the sense that they evaluate the device's physical and functional performance directly.
The type of ground truth used:
- For non-clinical tests, the "ground truth" is defined by the measured physical properties and performance characteristics of the device or its components, as per established engineering standards (e.g., IEC 60601-1, ISO 8359).
- For aspects relying on analogy, the "ground truth" is inferred from the documented performance of the predicate device.
The sample size for the training set: Not applicable. This is not a machine learning/AI device that requires a training set.
How the ground truth for the training set was established: Not applicable, as there is no training set.

Summary

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APR 2 5 20 1

K134023

Traditional 510(k) Submission for the 2300 Series mGO Portable Oxygen Generator (Concentrator)

Section 5

510(k) Summary

Written By	Title	Signature	Date
Callum Berryman	Mechanical Engineer		24 April 2014

Approval
Approved By	Title / Department	Signature	Date
A.N. Chilton	New Products Manager		24 April 2014
John Evans	Quality Engineer / QualityAssurance Department		24 April 2014

Revision History
DocumentVersion	Reason for Update	Date
01	Official issue	23rdDecember2013
02	paras 5.1.3 & 5.1.5 amended;additional predicate device reference added("SAROS 3000, K083163")	24th April 2014

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5 Scope

This document details the 510(k) Summary for the 2300 Series mGO Portable Oxygen Generator (Concentrator) and constitutes part of Ultra Electronics Precision Air & Land System's Traditional 510(k) submission.

There have been no prior submissions for the 2300 Series mGO Portable Oxygen Generator (Concentrator).

5.1 510(k) Summary

This 510(k) summary has been prepared in accordance with the requirements of 21 CFR Part 807, Section 807.92 Content and Format of a 510(k) Summary. Responses to 807.92 (a) sections (1) to (6) and 807.92 (b) sections (1) to (3) are detailed below:

5.1.1 Submitter's Information

Submitter'sName	Ultra Electronics Limited Precision Air & LandSystems
Submitter'sAddress	Arle CourtHatherley LaneCheltenhamGL51 6PNUnited Kingdom
TelephoneNumber	Phone: 44 (0) 1242 221166 (Switchboard)Fax: 44 (0) 1242 221167
Contact Person	Alistair BarkerAlistair. Barker@ultra-pals.com
SummaryPreparationDate	24 April 2014 (Issue 2)

5.1.2 Product Information

Proprietary Name:	2300 Series mGO Portable OxygenGenerator (Concentrator)
Common Name:	2300 Series mGO
Classification of Device:	Portable Oxygen Generator
	Class II
Classification Panel	Anesthesiology
CFR Regulation Number	21 CFR 868.5440
Panel Code	CAW

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5.1.3 Predicate Device(s)

Ultra Electronics Limited Precision Air & Land Systems claims equivalence to the following legally marketed predicate device:

Company Name	DeVilbiss Healthcare
Trade Name	iGO Portable Oxygen Generator
Model Number	306 Series
Contact Name	Joseph E. Olsavsky
510(k) Number	K081468

The 2300 Series mGO Portable Oxygen Generator is a ruggedized development of the 306 Series iGO Portable Oxygen Generator that uses many components common with the 306 Series iGO. The 2300 Series mGO Portable Oxygen Generator has been created with the full co-operation and support of DeVilbiss Healthcare.

Ultra Electronics Limited Precision Air & Land Systems claims equivalence to a second legally marketed predicate device, cleared to operate in a similar environment, as follows:

Company Name	SeQual Technologies Inc.
Trade Name	SAROS 3000(aka OMNI 2 Oxygen System)
Model Number	OMNI 2
Contact Name	Brian Jarrell
510(k) Number	K083163 (Oct 20 2009)

5.1.4 Description

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Ambient air is drawn into the generator via a piston style compressor. The air first passes through a series of filters that remove dust, and other particulate matter before entering the compressor.

The device is provided with a 4.76 mm hose tail that is used to attach a cannula tube.

5.1.5 Statement of Intended Use

The 2300 Series mGO Portable Oxygen Generator is 1-3 L/min continuous (1-6 L/min Pulse Flow), pressure vacuum swing adsorption, supplemental oxygen concentrator, based on molecular sieve technology. The patient typically receives the oxygen through a nasal cannula.

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The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.

A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow settings should be adjusted only under the direction of a Physician.

Warning: Federal Law restricts this device to sale by or on order of a Physician.

Type of use:

الا Prescription Use (Part 21 CFR 801 subpart D)

5.1.6 Comparison of Device Technological Characteristics to Predicate Device

As the 2300 Series mGO is a development of the predicate 306 Series iGO. in terms of technological characteristics, it is identical. However there are differences at a detail level. For Substantial Equivalence Discussion - See Section 12.

In order to make the 2300 Series mGO more suited for use by the military or in disaster areas, some changes had to be made to the predicate device. The changes involved in the development of the 2300 Series mGO Portable Oxygen Generator, from the DeVilbiss Healthcare 306 Series iGO, are; ruggedizing the structure and housings, reducing the overall size and changing the shape to long and slender as opposed to rectangular. None of these developments have altered the technological characteristics of operation. The 2300 Series mGO has a fundamentally similar architecture.

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Ruggedizing:

The case material for the 2300 Series mGO is a vacuum cast, fire retardant (UL94 V-0), Polyurethane whereas the 306 Series iGO case material was Norvl grade PX1005X. The change to the case material itself was to suite lower volume production methods rather than to ruggedize however the two case materials are a close equivalent in terms of mechanical properties. The design of the case has given it additional strength compared to the predicate due to additional internal webs. In addition the shape has significantly reduced the size of any flat panel areas compared to the predicate device.

Added protection has been provided by the fitting of bump strips along each exposed edge of the case and additional mouldings at each at each end to protect the case from bumps and drops. The material of all the added bump protectors is again fire retardant (UL94 V-0) Polyurethane but it has an elastomeric nature to absorb the shocks when bumped or dropped.

A high air flow fan has been fitted and heat sinks have been added to strategic electrical components to improve the cooling of the 2300 Series mGO over the 306 Series iGO.

Vortex filters have been added and mesh screens improved to decrease the ingress of contamination through the cooling air inlet.

Sealed electrical connectors have been used and the PCB assemblies given conformal coatings to prevent damage from water and general impurity, and the sealing of the outer housing has been improved to better equip the 2300 Series mGO to tolerate sand, dust and water damage.

Reducing the Overall Size

The main pcb has been approximately halved in size by using a 6 laver PCB for the 2300 Series mGQ as opposed to the original 2 laver PCB for the 306 Series iGO. The circuit and functionality remains the same for both devices.

For the 2300 Series mGO the overall space taken up by the 2 separate sieve bed filter columns and one O2 reservoir has been reduced by combining the 3 items into one using a single aluminium extrusion with the 3 chambers within it. This enabled the cross section of the sieve bed filter columns and reservoir to be non-cylindrical and the 3 items to be closely nested, with the required shape and without wasting an space between them. Apart from the change of cross section and a change of length the volumes, amounts of sieve material used, operating function and method remains the same.

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Smaller, higher energy density, batteries have been used in the 2300 Series mGQ. However the battery capacity is similar in both this and the predicate device and the battery technology is Lithium lon in both cases.

Changing the Shape

The case shape of the 306 iGO was rectangular but the 2300 Series mGO is required to be a long slender shape so that: it can be mounted in places where a "D" sized oxygen cylinder has previously been fitted, it can be carried on a stretcher/litter either between a patient's leg or beside them.

Other Changes

The software from the Predicate Device, 306 Series iGO Portable Oxygen Generator, has been imported to the 2300 Series mGO Portable Oxygen Generator. However, due to the differences in operating environments of the 2300 Series mGO compared to the 306 Series iGO, some small changes to the software were made. These changes consist of: removing the "automobile adapter" power scheme (there is no requirement for the 2300 Series mGO to operate from 12 Volt DC Vehicles) and widening of the temperature calibration table for the oxygen sensing device.

An additional "battery communications" software feature has been incorporated into the 2300 Series mGO Portable Oxygen Generator. This software resides on a separate Printed Circuit Board (PCB) and its purpose is to translate between the industry standard SMBus protocol used by the off the shelf battery packs and the custom battery protocol used by the main РСВ.

A simple software program has been added to change the brightness of the control panel LEDs. This software is covered by its own set of documentation and testing.

A low temperature cut out threshold has been added to the motor control PCB on the 2300 Series mGO. This was added to ensure that an open circuit fault of the thermistor would be detected (a high temperature threshold was already present). Apart from this and the addition of a heat sink, the motor control PCB is identical to that of the predicate device.

5.1.7 Nonclinical Tests

The 2300 Series mGO has been tested in accordance with the requirements of the following specifications and standards:

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IEC 60601-1:1988	Medical electrical equipment - Part 1: Generalrequirements for safety - Collateral standard -Safety requirements for medical electricalsystems. Includes amendments A1, A11 andA12
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - Collateral standard:

ISO 8359:2009 +A1:2012 Oxygen concentrators for medical use - Safety requirements (ISO 8359:1996).

Electromagnetic compatibility - Requirements

The majority of the non-clinical testing has been carried out by Intertek Testing and Certification Limited, a recognised notified body for medical equipment.

and tests.

A summary of the non-clinical tests and the conclusions is provided in the table below: ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Nonclinical Test:	Test Summary	Test Conclusions
ER2486 -Qualification TestReport: EMC &electrical safety	This reports on theElectromagnetic Compatibility(EMC) and the Electrical Safetytesting conducted in accordancewith the requirements of IEC60601-1-2: 2007 on the 2300Series mGO. These tests wereperformed by Intertek.	The 2300 Series mGO haspassed all EMC and electricalsafety tests performed byIntertek for emissions andimmunity. The test resultsconclude that the 2300 SeriesmGO will not interfere with itsenvironment to a dangerouslevel, and is immune to anyelectrical interference which mayaffect its intended operation.
ER2487 -Qualification TestReport: BasicSafety Tests to IEC60601-1:1988	This reports on the Safetytesting conducted in accordancewith the requirements of IEC60601-1:1988 on the 2300Series mGO. These tests wereperformed by Intertek.	The 2300 Series mGO passedall the requirements of thesetests.
ER2499 - Oxygenenrichment duringsystem leakageanalogy	This report examines thepotential for an Oxygen RichEnvironment to exist underfailure conditions of the 2300	The worst case Oxygenconcentration is 22.66% causedby O2 leakage from the O2reservoir. This is safely below
Nonclinical Test:	Test Summary	Test Conclusions
	Series mGO in areas containingpotential ignition sources, andtherefore that IEC 60601-1:2005Paragraph 11.2.2 does not applyto the 2300 Series mGO.	the 25% limit that defines anOxygen Rich Environment. AnOxygen Rich Environmentcannot therefore exist in the2300 Series mGO in areascontaining potential ignitionsources, therefore IEC 60601-1:2005 Paragraph 11.2.2 doesnot apply in the case of the 2300Series mGO.
ER2501 - Sievebed life analogyreport	Through analogy and readacross from accelerated filterbed life testing on the predicatedevice and from extended lifetesting conducted on the 2300Series mGO, this reportexamines the long term effectson the Accumulator & FilterHousing Assembly in 2300Series mGO and establishes it'sservice life.	There is no evidence to suggestthat the performance of thesieve column assembly (drg. No.2300-4347) will degrade withtime.After 2010 hours of continuousrunning without significantchange in performance.A service life of 1000 hours canbe given.
ER2502 -Compressor seallife analogy report	Through analogy and readacross from the compressor lifetesting conducted on thepredicate device, this reportexamines the predicted life ofthe compressor seals for the2300 Series mGO. This ispossible because the 2300Series mGO uses the samecompressor under the sameoperating conditions as thepredicate device.	The compressor seals in the2300 Series mGO will have aservice life in excess of 10,000hours.
ER2503 - Reliefvalve life analogyreport	This report details, throughanalogy with relief valve testingconducted on the predicatedevice, the predicted life of thepressure relief valve built intothe 2300 Series mGO. This is	Based on the evidence shown inthis report, the pressure reliefvalve in the 2300 Series mGOwill have a life of at least100,000 cycles.
Nonclinical Test:	Test Summary	Test Conclusions
ER2507 – OutletGas Purity analogyreport	possible because the 2300Series mGO uses the samerelief valve with the sameopening pressure as thepredicate device.This report evaluates, byanalogy, the Outlet Gas Purity ofthe 2300 Series mGO, againstvolatile organic compounds(VOC), carbon dioxide (CO2),carbon monoxide (CO), Ozone(O3) and fine particulate matter,to ensure that it does notcontribute or add any of these tothe oxygen stream to thepatient.	This evaluation concludes, byanalogy, that the 2300 SeriesmGO will not contribute VOCs,CO, CO2, O3 or fine particulatematter to the output stream.Results from all test parametersindicated lower (or non-detected) concentrations oftarget analytes in the OxygenGenerator process stream thanwere observed in ambient intakeair. These results are based onthe tests conducted on the 306Series iGO, as reported in I-2489 (appendix A), and applyequally to the 2300 SeriesmGO.
ER2580 – Filter /Accumulatorpressure test report	This report details the pressuretests, and results thereof,conducted on the Accumulator &Filter Housing Assembly (PartNo. 2300-4347) fitted in the2300 Series mGO.	The Accumulator & FilterAssembly met the requirementsof IEC 60601-1:2005 Paragraph9.7.5 "Pressure Vessels". Itsustained a pressure of 75 psig(3 times its maximum workingpressure under single faultconditions) without burst,permanent deformation orleakage:
ER2650 –Extended Life TestReport	This report describes themethodology, equipment andtest results of extended lifetesting on the 2300 Series mGOwith the intention of investigatingany degradation in theperformance or materials.	The extended life test iscurrently operating at 3778hours and shows no sign offurther degradation or failure.There have been two failures sofar, the first is a known issue,corrected during assemblyprocesses, and the secondoccurred at 1.8 times therecommended service life. After
Nonclinical Test:	Test Summary	Test Conclusions
		the second failure at 1840hours, the 2300 Series mGOhas continued to run for over1900 hours with no furtherfailures.Regarding the MechanicalPressure Regulator andPressure Transducer, they haveboth exceeded the 100,000-cycles test requirement for IEC60601-1 approval.
ER2689 - FireMitigation Test toISO 8359AmendmentA1:2012	This test report documents theresults from verification testingcarried out to demonstrate thatthe 2300 Series mGO O2 outletconnection (DRG No. 2300-4274) prevents a flame frompropagating back through theoutlet into the oxygenconcentrator, in accordance withsection 56.12 of ISO 8359Amendment A1:2012.	The aluminium O2 outletconnection prevented the flamefrom propagating back into theoxygen concentrator.
ER2695 – Oxygentubing and cannulaflow test report	The 2300 Series mGO isdesigned to deliver oxygen tothe patient via a nasal cannula.This report defines the testsconducted, and results thereof,to establish that the 2300 SeriesmGO operates correctly with themaximum length of oxygentubing specified in the IFU.	The 2300 Series mGO PortableOxygen Generator operated tospecification, in both continuousand pulse dose modes, whenfitted with the maximum tubinglengths specified in theInstructions for Use (2300-4388).

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5.1.8 Clinical Tests

No clinical tests have been submitted - see Attachment 20, Performance Testing - Clinical, where report number ER2493 "Clinical Evaluation by Analogy" concludes that a clinical evaluation is not required because oxygen therapy is mature and because of substantial equivalence with the predicate device.

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5.1.9 Conclusion

The 2300 Series mGO Portable Oxygen Generator (Concentrator) is substantially equivalent to the predicate devices listed in this Summary and the device does not raise any new issues of safety and/or effectiveness.

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Image /page/12/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

Public Health Service

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

April 25, 2014

Ultra Electronics Precision Air & Land Systems Ian Bradley Head of Management System/Quality Assurance Dept. Arle Court Hatherley Lane Cheltenham Gloucestershire GL51 6PN England

Re: K134023

Trade/Device Name: 2300 Series mGO Portable Oxygen Generator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: March 28, 2014 Received: March 28, 2014

Dear Mr. Bradley:

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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Page 2 - Mr. Ian Bradley

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 (2 1 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 (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 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.

Sincerely vours.

Tejashri Purohit-Sheth, M.D.
Clinical Deputy Director
DAGRID

Erin I. Keith Acting Division Director Division of General Hospital, Respiratory, Anesthesiology Infectious Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known) K134023

Device Name 2300 Series mGO Portable Oxygen Generator

Indications for Use (Describe)

The device is not intended for life support, nor does it provide any patient monitoring capabilities.

The device is intended for use in environments found in medical facilities, military deployment situations or disaster areas for humanitarian relief.

A Physician has prescribed a specific oxygen flow setting to meet an individual's needs. Oxygen flow serings should be adjusted only under the direction of a Physician.

WARNING: Federal Law restricts this device to sale by or on order of a Physician

Type of Use (Select one or both, as applicable)

X Prescription Use (Parl 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpan C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
James J. Lee	Digitally signed by James J. LeeDN: c=US, o=U.S. Government, ou=HHS,ou=FDA, ou=People, cn=James J. Lee,0.9.2342.19200300.100.1.1=2000954859Date: 2014.04.24 16:31:58 -04'00'	For Anya Harry MD PhD
FORM FDA 3881 (9/13)	Page 1 of 2

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FORM FDA 3881 (9/13)

Page 2 of 2

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).