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K Number
K172648
Device Name
Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Manufacturer
DeVilbiss Healthcare, LLC
Date Cleared
2018-03-23

(203 days)

Product Code
CAW
Regulation Number
868.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
More Information

K081468

K081468,K090421

No
The description of the "Smart Dose" feature indicates a rule-based system that increases oxygen based on detected breathing rate, not a system that learns or adapts from data. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.

Yes
The device is intended to provide supplemental oxygen for individuals requiring low flow oxygen therapy, which is a therapeutic intervention.

No

The text explicitly states: "The device is not intended for life support, nor does it provide any patient monitoring capabilities." It describes a device that delivers supplemental oxygen, which is a treatment, not a diagnostic function.

No

The device description clearly outlines hardware components like a compressor, sieve beds, and valves, indicating it is a physical medical device with integrated software, not a software-only device.

Based on the provided information, the Drive DeVilbiss iGo2 Portable Oxygen Concentrator is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to provide supplemental oxygen to patients requiring low flow oxygen therapy. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
  • Device Description: The description details a mechanical process for concentrating oxygen from ambient air and delivering it to a patient. There is no mention of analyzing biological samples or performing tests on them.
  • Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Detecting or measuring substances in biological samples
    • Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly described as a medical device used for treatment (providing oxygen), not for diagnosis (analyzing samples).

N/A

Intended Use / Indications 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.

Product codes

CAW

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Adult and Pediatric patients with a bodyweight >10kg.

Intended User / Care Setting

Used at a patient's home or for their portable needs outside the home and can also be used in institutions such as nursing homes or sub-acute care facilities.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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
  2. AAMI / ANSI / IEC 60601-1-2:2014. Ed. 4.0
  3. IEC 60601-1-8 Ed. 2.1 b.2012 Medical electrical equipment Part 1-8
  4. IEC 60601-1-11 Edition 2.0 2015-01Medical electrical equipment Home healthcare environment
  5. ISO 80601-2-69:2014 Medial electrical equipment Oxygen Concentrator Equipment
  6. ISO 80601-2-67:2014 Medical electrical equipment Oxygen Conserving Equipment
  7. 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. All bench tests confirmed that the predetermined acceptance criteria were met. This includes oxygen output and breathing detection.

Key Metrics

Not Found

Predicate Device(s)

DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468)

Reference Device(s)

Model 350G Gas Conserver (K090421)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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).

0

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.

1

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

2

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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3

| Name and address of the manufacturer and
sponsor of the 510(k) submission: | DeVilbiss Healthcare LLC
100 DeVilbiss Drive
Somerset, PA 15501 |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Official contact person for all
correspondence: | Betty Miller
Regulatory/Compliance Manager
Phone: 814-443-7606
Fax: 814-443-7575 |
| Date Prepared: | March 22, 2018 |
| Device Name: | Drive DeVilbiss iGo2 Portable Oxygen
Concentrator |
| Proprietary name of new device: | Drive DeVilbiss iGo2 Portable Oxygen
Concentrator |
| 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 Oxygen
Concentrator (K081468) |
| Reference Device Name and 510(k) number: | Model 350G Gas Conserver (K090421) |

Description of Device:

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

4

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.

5

Comparison of Substantial Equivalence and Differences:

| Characteristics | Predicate Device
DeVilbiss iGo 306DS Portable
Oxygen Concentrator -
K081468 | Reference Device
Model 350G Gas
Conserver
K090421 | Subject Device | Nature of Change | Legally
Marketed
Product with
same feature
or
specification |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| ltem
Description/
Method of
Operation | 1-3 lpm continuous flow (1-6
pulse dose), pressure-Vacuum
swing adsorption, oxygen
concentrator based on
molecular sieve technology.
Ambient air is drawn into the
concentrator via a piston style
compressor. The air then
passes through a series of
filters that remove dust,
bacteria, and other particulate.
A poppet-style valve directs air
into one of two sieve beds.
Nitrogen is adsorbed in the
bed as the pressure increases
while oxygen flows through,
thereby producing a highly
enriched oxygen product.
Simultaneously in the other
bed, nitrogen is absorbed as
the pressure decreases and is
exhausted into the
atmosphere. A momentary
intermediate pneumatic
sequence ties the beds
together with the exhaust
blocked for an enhanced
nitrogen purge. The cycle
continues providing a flow of
oxygen to the patient. Oxygen
is provided to the patient on a
continuous or pulse-dose
basis. | The Inspired
Technologies 350G
Gas Conserver is
intended as a
delivery device for
medial-grade
oxygen from high-
pressure oxygen
cylinders. | (1-5 pulse dose), pressure-
Vacuum swing adsorption,
oxygen concentrator based on
molecular sieve technology.
Ambient air is drawn into the
concentrator via a piston style
compressor. The air then
passes through a series of
filters that remove dust,
bacteria, and other particulate.
A valve directs air into one of
two sieve beds. Nitrogen is
adsorbed in the bed as the
pressure increases while
oxygen flows through, thereby
producing a highly enriched
oxygen product.
Simultaneously in the other
bed, nitrogen is absorbed as
the pressure decreases and is
exhausted into the
atmosphere. A momentary
intermediate pneumatic
sequence ties the beds
together with the exhaust
blocked for an enhanced
nitrogen purge. The cycle
continues providing oxygen to
the patient. Oxygen is
provided to the patient on a
pulse-dose basis. | Minor
constructional
differences. POC
will be smaller and
not support
continuous flow.
No different
questions of safety
or effectiveness. | DeVilbiss iGo
306DS
Portable
Oxygen
Concentrator
– K081468 |
| Target
Population/
Indications for
Use | The Model 306 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. | This is an
ambulatory device,
which allows
patients to
ambulate longer
than they would
with a continuous
flow regulator on
the same cylinder. | The 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. | Same. Provides
pulse oxygen to
patient. No different
questions of safety
or effectiveness. | DeVilbiss iGo
306DS
Portable
Oxygen
Concentrator
– K081468 |
| Where Used/
Intended Use | Oxygen concentrators are
intended to provide
supplemental oxygen to
persons requiring low flow
oxygen therapy. The patient
typically receives the oxygen
through a nasal cannula. The
device delivers continuous
oxygen or oxygen pulses
during a patients inhalation
phase. The pulse flow
provides over 87% oxygen
concentration. It is used at a
patient's home or for their
portable needs outside the
home and can also be used in
institutions such as nursing
homes or sub-acute care
facilities. Oxygen
concentrators are not
considered life supporting nor
life sustaining. The device has
no contraindications. | The 350G Gas
Conserver is
intended to be
used in the
hospital, healthcare
facilities, or home
care environments. | Oxygen concentrators are
intended to provide
supplemental oxygen to
persons requiring low flow
oxygen therapy. The patient
typically receives the oxygen
through a nasal cannula. It is
used at a patient's home or for
their portable needs outside
the home and can also be
used in institutions such as
nursing homes or sub-acute
care facilities. Oxygen
concentrators are not
considered life supporting nor
life sustaining. The device has
no contraindications. | Same. No different
questions of safety
or effectiveness. | DeVilbiss iGo
306DS
Portable
Oxygen
Concentrator

  • K081468 |
    | Characteristics | Predicate Device
    DeVilbiss iGo 306DS Portable
    Oxygen Concentrator –
    K081468 | Reference Device
    Model 350G Gas
    Conserver
    K090421 | Subject Device | Nature of Change | Legally
    Marketed
    Product with
    same feature
    or
    specification |
    | Operating
    Principle | Pressure-vacuum-swing
    adsorption / pressure
    controlled oxygen separation
    process | Integral high
    pressure regulator
    Dosing device and
    algorithm Valves | Pressure-vacuum-swing
    adsorption / pressure
    controlled oxygen separation
    process | Same as iGo
    306DS. No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Standards
    Certification | IEC 60601-1 2nd Edition
    IEC 60601-1-1
    IEC 60601-1-2
    ISO 8359
    ISO 14971
    ISO 13485 | FCC CFR47 Parts
    15B and 18
    Industry Canada
    BS EN 55011:2007
    IEC 60601-1
    IPX I | IEC 60601-1 3rd Edition
    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. No
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Output
    Capacity and
    Delivery Modes | 3 LPM maximum continuous
    flow.
    Continuous flow settings: 1 to
    3.0 LPM in 0.5 LPM
    increments
    Pulse flow settings: 1.0 to 3.0
    in 0.5 increments; 3.0 to 6.0 in
    1.0 increments | 16.0 cc/lpm x
    setting 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 Lpm
    flow settings Sport
    mode I is setting
    value + 16 cc Sport
    Mode 2 is setting
    value +32 cc/lpm | Pulse flow settings: 1.0 to 5.0
    in 1.0 increments | Does not support
    Continuous flow.
    Pulse mode like
    iGo 306DS but
    supports a smaller
    set of the patient
    population because
    of smaller bolus
    volume.
    Supports Smart
    Dose (Sport Mode) | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468
    Model 350G
    Gas
    Conserver
    K090421 |
    | Voltage
    Required | AC operation: 100-240 VAC,
    50-60 Hz
    DC operation: 12-24 VDC | 4 "AA" batteries | AC operation: 100-240 VAC,
    50-60 Hz
    DC operation: 10 - 15 VDC | Minimal difference.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    — K081468 |
    | Dimensions | 15"H x 12"W x 9"D
    Cube volume: 1620 cu. in. | 6"H x 3.5"W x 4"D | 9.6"H x 8.75"W x 3.6"D
    Cube volume: 302.4 cu. in. | Smaller more
    portable device
    than iGo 306DS.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
  • K081468 |
    | Weight | 17.9 lbs, including battery,
    19.9 lbs with lightweight cart | 1.39 lbs | Less than 6 lbs, including a
    standard battery pack. | Lighter more
    portable device
    than iGo 306DS.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | 02
    Performance
    Specification | 90% +/-3% at 1 Ipm to 3 Ipm
    at sea level | N/A - Uses bottled
    gas | 87-94% at all settings | Same as iGo
    306DS. No
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
  • K081468 |
    | Noise Level @
    2 Ipm | 40 dBA at pulse flow setting 3;
    47 dBA overall maximum at 3
    LPM continuous flow | N/A – Uses bottled
    gas | 46 dBA at pulse flow setting 2 | Louder than iGo
    306DS but no
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
  • K081468 |
    | Power
    Consumption | 42 Watts at 1.0 LPM
    continuous flow
    104 Watts at 3.0 LPM
    continuous flow
    31 Watts at 1.0 pulse flow
    setting (20 BPM)
    62 Watts at 6.0 pulse flow
    setting
    (20 BPM) | | Approximately 30 Watts at
    setting of 2 (20 BPM) | Pulse dose
    efficiency is better.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Characteristics | Predicate Device
    DeVilbiss iGo 306DS Portable
    Oxygen Concentrator –
    K081468 | Reference Device
    Model 350G Gas
    Conserver
    K090421 | Subject Device | Nature of Change | Legally
    Marketed
    Product with
    same feature
    or
    specification |
    | Patient Oxygen
    Outlet
    Pressure | 5 psig | 19-25 PSIG | 15 psig | 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. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Filtration | Patient-maintainable gross
    particle filter | None | Gross particle filter | Same as iGo
    306DS. No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Battery Run
    Time | Tested times:
    4.1 hours at 1.0 LPM
    1.7 hours at 3.0 LPM
    5.8 hours at 1.0 LPM (10
    BPM)
    2.0 hours at 6.0 LPM (30
    BPM) | NA | 4.5 hours at a setting of 2 (20
    BPM) | Same as iGo
    306DS at
    equivalent pulse
    output. No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Compressor
    Pressure Relief
    Valve | Pressure Relief valve | NA | Over-pressure protection
    achieved through software
    and electronic control. | No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Pneumatic
    Valve | Two Three way valves | NA | Two Three way valves | Off the shelf valves
    – No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Molecular
    Sieve Material | Zeochem lithium-based zeolite | NA | Zeochem lithium-based zeolite | Same as iGo
    306DS. No
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Flow Controller | Proportional control valve
    used for continuous flow and
    pulse flow | Pulse Valve | Pulse Valve only. Use
    software to regulate output. | Same as iGo
    306DS. No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Insulation
    Class | IEC Class 1, Type BF | Not Published | IEC Class 2, Type BF | Improved required
    by ISO standard.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Water Ingress | IPX0 – bare unit
    IPX1 – Unit with battery | IPX1 | IPX1
    Or IPX22 | Improved liquid
    ingress capability.
    No different
    questions of safety
    or effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Hour meter | Mechanical Hour meter | None | Microprocessor or other
    nonvolatile memory. | Used for service
    and dealer. No
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Characteristics | Predicate Device
    DeVilbiss iGo 306DS Portable
    Oxygen Concentrator –
    K081468 | Reference Device
    Model 350G Gas
    Conserver
    K090421 | Subject Device | Nature of Change | Legally
    Marketed
    Product with
    same feature
    or
    specification |
    | Oxygen
    Monitor | Ultrasonic oxygen and flow
    sensing device (FDA
    approved Re: K913392/B) | None | Ultrasonic oxygen and flow
    sensing device (FDA
    approved Re: K913392/B) | Same as iGo
    306DS. No
    different questions
    of safety or
    effectiveness. | DeVilbiss iGo
    306DS
    Portable
    Oxygen
    Concentrator
    – K081468 |
    | Patient Alert
    Indications | Concentration