The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Device Description

The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC) is similar to the predicate devices, pressure-vacuum swing adsorption based on molecular sieve technology using two containers filled with molecular sieve (sieve beds). Ambient air is drawn into the concentrator via a piston style compressor and compressed into a single sieve bed. As pressure increases nitrogen is adsorbed and concentrated oxygen exits one end of the bed and is collected in a product tank. Simultaneously in the other sieve bed, nitrogen is desorbed as the pressure decreases to a vacuum and is exhausted into the atmosphere. Once the pressure or vacuum reaches a defined maximum a valve switches the compressor connections to the sieve beds. The sieve bed previously connected to the pressure head will be connected to vacuum. The oxygen collected in the product tank is then dispensed to the patient upon detecting a patient inhalation, much like an oxygen conserving device.

The proposed Drive DeVilbiss iGo2 POC provides pulse dose oxygen in the same manner as primary predicate device (DeVilbiss Model 306 POC, K081468). The "Smart Dose" feature has been added to the proposed device, which is substantially equivalent to the feature in the reference device (Model 350G gas conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing.

AI/ML Overview

This document describes the regulatory filing for the Drive DeVilbiss iGo2 Portable Oxygen Concentrator (POC). It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a detailed study proving the device meets specific acceptance criteria in a traditional clinical research sense.

However, based on the provided text, we can extract information regarding acceptance criteria for performance testing (non-clinical) and the types of studies conducted.

Here's a breakdown of the requested information:

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

The document states: "All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection." and "The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator was designed and tested to demonstrate compliance with the applicable sections of the following standards: ... passing all test protocols."

While specific numerical acceptance criteria and precise performance values are not fully detailed in a table format within the provided text, the document lists key performance specifications under the "Comparison of Substantial Equivalence and Differences" table. We can infer the acceptance criteria are met by confirming these specifications are in line with the predicate device or standards.

Characteristic	Acceptance Criteria (Inferred from Predicate/Standards and "Same" or "No different questions")	Reported Device Performance (Subject Device)
Oxygen Performance	90% +/-3% at 1 lpm to 3 lpm at sea level (Predicate K081468)	87-94% at all settings (Subject Device)
Breathing Detection	Functionality as per predicate device (implied as "no different questions of safety or effectiveness")	The device detects patient inhalation and dispenses oxygen (implied, confirmed as "breathing detection" bench test met acceptance criteria). "Smart Dose" feature automatically increases prescription if increased rate of breathing is detected.
Output Capacity/Delivery Modes	Pulse flow settings: 1.0 to 3.0 in 0.5 increments; 3.0 to 6.0 in 1.0 increments (Predicate K081468)	Pulse flow settings: 1.0 to 5.0 in 1.0 increments (Subject Device). Note: "Does not support Continuous flow. Pulse mode like iGo 306DS but supports a smaller set of the patient population because of smaller bolus volume."
Standards Compliance	Compliance with IEC 60601-1 2nd Ed, IEC 60601-1-1, IEC 60601-1-2, ISO 8359, ISO 14971, ISO 13485 (Predicate K081468)	Compliance with IEC 60601-1 3rd Ed, IEC 60601-1-1, IEC 60601-1-2, ISO 80601-2-69, ISO 80601-2-67, ISO 14971, ISO 13485. "New device conforms to newer revisions of standards."
Patient Oxygen Outlet Pressure	5 psig (Predicate K081468)	15 psig (Subject Device). Note: "Higher pulsed output pressure than iGo but lower than 350G. Will deliver oxygen faster than iGo but there is no different questions of safety or effectiveness."
Noise Level	40 dBA at pulse flow setting 3; 47 dBA overall maximum at 3 LPM continuous flow (Predicate K081468)	46 dBA at pulse flow setting 2 (Subject Device). Note: "Louder than iGo 306DS but no different questions of safety or effectiveness."
Power Consumption	31 Watts at 1.0 pulse flow setting (20 BPM); 62 Watts at 6.0 pulse flow setting (20 BPM) (Predicate K081468)	Approximately 30 Watts at setting of 2 (20 BPM) (Subject Device). Note: "Pulse dose efficiency is better."
Battery Run Time	Tested times: 5.8 hours at 1.0 LPM (10 BPM); 2.0 hours at 6.0 LPM (30 BPM) (Predicate K081468)	4.5 hours at a setting of 2 (20 BPM) (Subject Device). Note: "Same as iGo 306DS at equivalent pulse output."
Patient Alert Indications	Concentration <82% (yellow light), <75% (red light/beep), Blocked flow, No breath detected (Predicate K081468)	Concentration <86% (yellow light), <85% (yellow light/beep), Blocked flow, No breath detected (Subject Device). Note: "Same number of Alerts as iGo 306DS."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical bench testing rather than clinical studies with patient test sets. Therefore, the concept of "sample size used for the test set" in the context of human subjects is not applicable here. The testing was conducted on the device itself.

Data provenance: Not explicitly stated, but assumed to be internal testing by DeVilbiss Healthcare, LLC, based in Somerset, Pennsylvania, USA. The testing is prospective in the sense that the device was designed and then tested against pre-defined standards and requirements.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. For non-clinical bench testing of a medical device like an oxygen concentrator, "ground truth" is typically established by engineering specifications, validated measurement equipment, and compliance with recognized industry standards (e.g., ISO, IEC). There are no "experts" establishing a "ground truth" for a test set in the way a radiologist would for an imaging study.

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

Not applicable. Adjudication methods are typically employed in clinical studies where there's subjectivity in interpreting results (e.g., by human readers). Bench testing relies on objective measurements against engineering specifications and standards, negating the need for adjudication by multiple experts.

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 medical device for oxygen delivery, not an AI-assisted diagnostic or therapeutic tool with "human readers" or AI components in that sense. The filing is for a physical medical device.

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

Not applicable. The device is a hardware product. While it has software/firmware for control ("Smart Dose" feature operates automatically, "over-pressure protection achieved through software and electronic control"), it's not an AI algorithm that functions standalone in the way a diagnostic AI would. The "standalone" performance here refers to the device's functional operation meeting its specifications.

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

For the non-clinical performance testing, the "ground truth" is established by:

Engineering Specifications: The design parameters and target performance levels set by the manufacturer.
International and National Standards: Compliance with recognized standards such as ISO 80601-2-69 (Oxygen Concentrator Equipment), ISO 80601-2-67 (Oxygen Conserving Equipment), and various IEC 60601 series standards for medical electrical equipment safety and essential performance.
Validated Measurement Equipment: The actual measurements obtained during bench testing using calibrated instruments are compared against these specifications and standards.

8. The sample size for the training set

Not applicable. This device does not use a "training set" in the context of machine learning or AI development.

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

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health and Human Services logo. The logo on the right is the Food and Drug Administration logo. The FDA logo is in blue and contains the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

March 23, 2018

DeVilbiss Healthcare, LLC Sandy Figueroa Manager, Regulatory Affairs 100 DeVilbiss Drive Somerset, Pennsylvania 15501

Re: K172648

Trade/Device Name: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: Class II Product Code: CAW Dated: February 19, 2018 Received: February 20, 2018

Dear Sandy Figueroa:

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.

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 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael J. Ryan -S

for Tina Kiang, Ph.D. 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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Indications for Use

510(k) Number (if known) K172648

Device Name

Drive DeVilbiss iGo2 Portable Oxygen Concentrator

Indications for Use (Describe)

The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indication of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Name and address of the manufacturer andsponsor of the 510(k) submission:	DeVilbiss Healthcare LLC100 DeVilbiss DriveSomerset, PA 15501
Official contact person for allcorrespondence:	Betty MillerRegulatory/Compliance ManagerPhone: 814-443-7606Fax: 814-443-7575
Date Prepared:	March 22, 2018
Device Name:	Drive DeVilbiss iGo2 Portable OxygenConcentrator
Proprietary name of new device:	Drive DeVilbiss iGo2 Portable OxygenConcentrator
Common or usual name of the device:	Generator, Oxygen, Portable
DeVilbiss Model Number	125D, 125K, 125AA
Classification	Class II
Panel Code:	CAW
CFR Regulation Number:	21 CFR 868.5440
Primary Predicate Device Name and 510(k)number:	DeVilbiss iGo 306DS Portable OxygenConcentrator (K081468)
Reference Device Name and 510(k) number:	Model 350G Gas Conserver (K090421)

Description of Device:

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conserver, K090421). Smart Dose will automatically increase the patient's prescription setting by one if the system determines the patient has increased rate of breathing.

This device is intended for Adult and Pediatric patients with a bodyweight >10kg.

Indication for Use:

The Drive DeVilbiss iGo2 Portable Oxygen Concentrator is indicated for the administration of supplemental oxygen. The device is not intended for life support, nor does it provide any patient monitoring capabilities.

Substantial Equivalence:

The proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator has the following similarities to those which previously received 510(k) concurrence:

Indications for Use Statement
Operating Principle
Incorporates similar materials, and
Is manufactured and packaged using similar materials and processes.

Design and verification activities were performed on the proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator according to design requirements and risk analysis outputs. All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection.

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Comparison of Substantial Equivalence and Differences:

Characteristics	Predicate DeviceDeVilbiss iGo 306DS PortableOxygen Concentrator -K081468	Reference DeviceModel 350G GasConserverK090421	Subject Device	Nature of Change	LegallyMarketedProduct withsame featureorspecification
ltemDescription/Method ofOperation	1-3 lpm continuous flow (1-6pulse dose), pressure-Vacuumswing adsorption, oxygenconcentrator based onmolecular sieve technology.Ambient air is drawn into theconcentrator via a piston stylecompressor. The air thenpasses through a series offilters that remove dust,bacteria, and other particulate.A poppet-style valve directs airinto one of two sieve beds.Nitrogen is adsorbed in thebed as the pressure increaseswhile oxygen flows through,thereby producing a highlyenriched oxygen product.Simultaneously in the otherbed, nitrogen is absorbed asthe pressure decreases and isexhausted into theatmosphere. A momentaryintermediate pneumaticsequence ties the bedstogether with the exhaustblocked for an enhancednitrogen purge. The cyclecontinues providing a flow ofoxygen to the patient. Oxygenis provided to the patient on acontinuous or pulse-dosebasis.	The InspiredTechnologies 350GGas Conserver isintended as adelivery device formedial-gradeoxygen from high-pressure oxygencylinders.	(1-5 pulse dose), pressure-Vacuum swing adsorption,oxygen concentrator based onmolecular sieve technology.Ambient air is drawn into theconcentrator via a piston stylecompressor. The air thenpasses through a series offilters that remove dust,bacteria, and other particulate.A valve directs air into one oftwo sieve beds. Nitrogen isadsorbed in the bed as thepressure increases whileoxygen flows through, therebyproducing a highly enrichedoxygen product.Simultaneously in the otherbed, nitrogen is absorbed asthe pressure decreases and isexhausted into theatmosphere. A momentaryintermediate pneumaticsequence ties the bedstogether with the exhaustblocked for an enhancednitrogen purge. The cyclecontinues providing oxygen tothe patient. Oxygen isprovided to the patient on apulse-dose basis.	Minorconstructionaldifferences. POCwill be smaller andnot supportcontinuous flow.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
TargetPopulation/Indications forUse	The Model 306 PortableOxygen Concentrator isindicated for the administrationof supplemental oxygen. Thedevice is not intended for lifesupport, nor does it provideany patient monitoringcapabilities.	This is anambulatory device,which allowspatients toambulate longerthan they wouldwith a continuousflow regulator onthe same cylinder.	The Portable OxygenConcentrator is indicated forthe administration ofsupplemental oxygen. Thedevice is not intended for lifesupport, nor does it provideany patient monitoringcapabilities.	Same. Providespulse oxygen topatient. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Where Used/Intended Use	Oxygen concentrators areintended to providesupplemental oxygen topersons requiring low flowoxygen therapy. The patienttypically receives the oxygenthrough a nasal cannula. Thedevice delivers continuousoxygen or oxygen pulsesduring a patients inhalationphase. The pulse flowprovides over 87% oxygenconcentration. It is used at apatient's home or for theirportable needs outside thehome and can also be used ininstitutions such as nursinghomes or sub-acute carefacilities. Oxygenconcentrators are notconsidered life supporting norlife sustaining. The device hasno contraindications.	The 350G GasConserver isintended to beused in thehospital, healthcarefacilities, or homecare environments.	Oxygen concentrators areintended to providesupplemental oxygen topersons requiring low flowoxygen therapy. The patienttypically receives the oxygenthrough a nasal cannula. It isused at a patient's home or fortheir portable needs outsidethe home and can also beused in institutions such asnursing homes or sub-acutecare facilities. Oxygenconcentrators are notconsidered life supporting norlife sustaining. The device hasno contraindications.	Same. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator- K081468
Characteristics	Predicate DeviceDeVilbiss iGo 306DS PortableOxygen Concentrator –K081468	Reference DeviceModel 350G GasConserverK090421	Subject Device	Nature of Change	LegallyMarketedProduct withsame featureorspecification
OperatingPrinciple	Pressure-vacuum-swingadsorption / pressurecontrolled oxygen separationprocess	Integral highpressure regulatorDosing device andalgorithm Valves	Pressure-vacuum-swingadsorption / pressurecontrolled oxygen separationprocess	Same as iGo306DS. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
StandardsCertification	IEC 60601-1 2nd EditionIEC 60601-1-1IEC 60601-1-2ISO 8359ISO 14971ISO 13485	FCC CFR47 Parts15B and 18Industry CanadaBS EN 55011:2007IEC 60601-1IPX I	IEC 60601-1 3rd EditionIEC 60601-1-1IEC 60601-1-2ISO 80601-2-69ISO 80601-2-67ISO 14971ISO 13485	New deviceconforms to newerrevisions ofstandards. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
OutputCapacity andDelivery Modes	3 LPM maximum continuousflow.Continuous flow settings: 1 to3.0 LPM in 0.5 LPMincrementsPulse flow settings: 1.0 to 3.0in 0.5 increments; 3.0 to 6.0 in1.0 increments	16.0 cc/lpm xsetting value( i.e.16x 1=16, 16 x 2=32 etc) at 1.0, 1.5,2.0, 2.5, 3.0, 4.0,5.0, and 6.0 Lpmflow settings Sportmode I is settingvalue + 16 cc SportMode 2 is settingvalue +32 cc/lpm	Pulse flow settings: 1.0 to 5.0in 1.0 increments	Does not supportContinuous flow.Pulse mode likeiGo 306DS butsupports a smallerset of the patientpopulation becauseof smaller bolusvolume.Supports SmartDose (Sport Mode)	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468Model 350GGasConserverK090421
VoltageRequired	AC operation: 100-240 VAC,50-60 HzDC operation: 12-24 VDC	4 "AA" batteries	AC operation: 100-240 VAC,50-60 HzDC operation: 10 - 15 VDC	Minimal difference.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator— K081468
Dimensions	15"H x 12"W x 9"DCube volume: 1620 cu. in.	6"H x 3.5"W x 4"D	9.6"H x 8.75"W x 3.6"DCube volume: 302.4 cu. in.	Smaller moreportable devicethan iGo 306DS.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator- K081468
Weight	17.9 lbs, including battery,19.9 lbs with lightweight cart	1.39 lbs	Less than 6 lbs, including astandard battery pack.	Lighter moreportable devicethan iGo 306DS.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
02PerformanceSpecification	90% +/-3% at 1 Ipm to 3 Ipmat sea level	N/A - Uses bottledgas	87-94% at all settings	Same as iGo306DS. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator- K081468
Noise Level @2 Ipm	40 dBA at pulse flow setting 3;47 dBA overall maximum at 3LPM continuous flow	N/A – Uses bottledgas	46 dBA at pulse flow setting 2	Louder than iGo306DS but nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator- K081468
PowerConsumption	42 Watts at 1.0 LPMcontinuous flow104 Watts at 3.0 LPMcontinuous flow31 Watts at 1.0 pulse flowsetting (20 BPM)62 Watts at 6.0 pulse flowsetting(20 BPM)		Approximately 30 Watts atsetting of 2 (20 BPM)	Pulse doseefficiency is better.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Characteristics	Predicate DeviceDeVilbiss iGo 306DS PortableOxygen Concentrator –K081468	Reference DeviceModel 350G GasConserverK090421	Subject Device	Nature of Change	LegallyMarketedProduct withsame featureorspecification
Patient OxygenOutletPressure	5 psig	19-25 PSIG	15 psig	Higher pulsedoutput pressurethan iGo but lowerthan 350G. Willdeliver oxygenfaster than iGo butthere is no differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Filtration	Patient-maintainable grossparticle filter	None	Gross particle filter	Same as iGo306DS. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Battery RunTime	Tested times:4.1 hours at 1.0 LPM1.7 hours at 3.0 LPM5.8 hours at 1.0 LPM (10BPM)2.0 hours at 6.0 LPM (30BPM)	NA	4.5 hours at a setting of 2 (20BPM)	Same as iGo306DS atequivalent pulseoutput. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
CompressorPressure ReliefValve	Pressure Relief valve	NA	Over-pressure protectionachieved through softwareand electronic control.	No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
PneumaticValve	Two Three way valves	NA	Two Three way valves	Off the shelf valves– No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
MolecularSieve Material	Zeochem lithium-based zeolite	NA	Zeochem lithium-based zeolite	Same as iGo306DS. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Flow Controller	Proportional control valveused for continuous flow andpulse flow	Pulse Valve	Pulse Valve only. Usesoftware to regulate output.	Same as iGo306DS. No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
InsulationClass	IEC Class 1, Type BF	Not Published	IEC Class 2, Type BF	Improved requiredby ISO standard.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Water Ingress	IPX0 – bare unitIPX1 – Unit with battery	IPX1	IPX1Or IPX22	Improved liquidingress capability.No differentquestions of safetyor effectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Hour meter	Mechanical Hour meter	None	Microprocessor or othernonvolatile memory.	Used for serviceand dealer. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Characteristics	Predicate DeviceDeVilbiss iGo 306DS PortableOxygen Concentrator –K081468	Reference DeviceModel 350G GasConserverK090421	Subject Device	Nature of Change	LegallyMarketedProduct withsame featureorspecification
OxygenMonitor	Ultrasonic oxygen and flowsensing device (FDAapproved Re: K913392/B)	None	Ultrasonic oxygen and flowsensing device (FDAapproved Re: K913392/B)	Same as iGo306DS. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Patient AlertIndications	Concentration <82% - yellowlightConcentration <75% - redlight/beepBlocked flow - blinkgreen/beepNo breath detected in pulseflow mode - after 30 seconds,unit beeps/yellow no-breath-detected light; 1 minute afterfirst beep, unit shiftsautomatically to continuousflow.Low battery - yellow light onbattery gaugeBattery communication error(to main control PCB) – blinkyellow light/beepPatient indicator check atstart-up	Low BatteryIndicator :Flashes red whenbatteries are low, &should be replaced.(Typically 8 hoursremain)Solid red whenbatteries are belowusable range.	Concentration <86% - yellowlightConcentration <85% - yellowlight/beepBlocked flow - blinkgreen/beepNo breath detected unitbeeps/yellow no-breath-detected light.Low battery - yellow light onbattery gaugeBattery communication error(to main control PCB) – blinkyellow light/beepPatient indicator check atstart-up	Same number ofAlerts as iGo306DS. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
Unit shutdownconditions	Battery shutdown or hotbattery -no external powerpresent - blinking red/steadytone.Loss of external power - nocharged battery present -flash green light; steady tone"Service Required" - steadyred light and audible tone(checksum error, batterycommunication error, badOSD piezo data, OSDthermistor failure, high systempressure; motor controllercommunication error; purgevalve failure)High temperature measured inOSD - red light; audible tone;shut downLong cycle time (indicatesleaks, loss of compressorpiston seal, etc.) - red light;audible tone; shut down	Unit does not pulland patientswitches tocontinuous flow.	Battery shutdown or hotbattery -no external powerpresent - blinking red/steadytone."Service Required" - steadyred light and audible tone(System Leaks, checksumerror, battery error, thermistorfailure, bad system pressure;purge valve failure)High temperature - red light;audible tone; shut down	No differences fromiGo 306DS. LongCycle time errorcovered underService Required.If iGo2 has loss ofexternal power withno battery the unitwill not run. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator– K081468
User interfaces	Digital indications foroperational status, batterystatus and alert indications.Push buttons for statuschanges on front panel.	Digital indicationsfor operationalstatus, batterystatus and alertindications. Pushbuttons for statuschanges on frontpanel.	LCD with indications foroperational status, batterystatus and alert indications.Push buttons for statuschanges on front panel.	Same informationwill be displayedwith either LCD ordigital keypadoverlay. Nodifferent questionsof safety oreffectiveness.	DeVilbiss iGo306DSPortableOxygenConcentrator- K081468

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Discussion of Substantial Equivalence and Differences:

The proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator is identical to the predicate device DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468) in the following characteristics:

Indications for Use Statement ●
Operating Principle
Oxygen Performance
Oxygen Monitoring capability ●
Operating Temperature/ Humidity Range ●
Operating atmospheric pressure range ●
IEC 60601-1 Classification ●
- o Shock and Vibration
- o Storage Temperature Range

The proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator is similar to the predicate device Model 350G Gas Conserver K090421 with regard to the following characteristic:

. Smart Dose Feature (Called Sport Mode in predicate)

Modifications made to the proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator:

Delivery Mode and Pulse Volumes

The DeVilbiss Model 306 POC supports continuous flow and pulse dose. The proposed Drive DeVilbiss iGo2 POC supports only pulse dose. The proposed Drive DeVilbiss iGo2 POC is designed to be small and light weight and therefore has smaller pulse volumes than the DeVilbiss Model 306 POC.

The proposed Drive DeVilbiss iGo2 POC will support a smaller set of patients. The oxygen delivery setting has to be determined for each patient individually with the configuration of the equipment to be used, including accessories.

This modification has no different questions of safety or effectiveness.

Power Requirements

Predicate device requires a larger power supply. This modification has no different questions of safety or effectiveness.

Both predicate and modified device battery options employ Lithium Ion Battery technology that complies with current US and international hazardous material shipping regulations. This modification has no different questions of safety or effectiveness.

Sieve Material

The predicate uses a different sieve material than the modified devices use a zeolite molecular sieve but they are different formulas. This modification has no different questions of safety or effectiveness.

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Smart Dose Feature

The proposed Drive De Vilbiss iGo2 POC implements a feature called "Smart Dose" feature that is equivalent to a feature implemented in the predicate device Model 350G Gas Conserver called "Sport Mode." This modification has no different questions of safety or effectiveness.

Performance Testing:

Non-Clinical Testing:

This device has been tested to appropriate ISO, ASTM, and IEC standards and other applicable requirements passing all test protocols. The proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator was designed and tested to demonstrate compliance with the applicable sections of the following standards:

1. AAMI / ANSI ES60601-1:2005/(R)2012 Ed 3.1 and A1:2012 Basic Safety and Essential Performance
1. AAMI / ANSI / IEC 60601-1-2:2014. Ed. 4.0
1. IEC 60601-1-8 Ed. 2.1 b.2012 Medical electrical equipment Part 1-8
1. IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment Home healthcare environment
1. ISO 80601-2-69:2014 Medial electrical equipment Oxygen Concentrator Equipment
1. ISO 80601-2-67:2014 Medical electrical equipment Oxygen Conserving Equipment
1. ISO 62304

Clinical Testing:

No clinical testing was necessary to demonstrate the substantial equivalence of the proposed Drive DeVilbiss iGo2 Portable Oxygen Concentrator. Patient simulation models were used for bench testing

Statement of Substantial Equivalence:

Comparing the proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator with the predicate device (DeVilbiss iGo 306DS Portable Oxygen Concentrator, K081468) and reference device (Model 350G Gas Conserver, K090421), we believe the device, as tested, to be substantially equivalent to the predicate device in terms of meeting performance criteria and functioning as intended.

Conclusion:

Given the similarity between the proposed (modified) Drive DeVilbiss iGo2 Portable Oxygen Concentrator with the predicate device, we believe the device, as changed, does not raise different questions of safety and effectiveness and is substantially equivalent to the predicate device previously cleared.

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).