Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
Device Facts
| Record ID | K172648 |
|---|---|
| Device Name | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator |
| Applicant | Devilbiss Healthcare, LLC |
| Product Code | CAW · Anesthesiology |
| Decision Date | Mar 23, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 868.5440 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
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.
Device Story
Portable oxygen concentrator (POC) for home/institutional use; provides supplemental oxygen via pulse dose. Inputs: ambient air drawn via piston compressor. Principle: pressure-vacuum swing adsorption using two molecular sieve beds; nitrogen adsorbed under pressure, oxygen collected in product tank. Output: pulse-dose oxygen delivered to patient upon inhalation detection. Features 'Smart Dose' algorithm to automatically increase oxygen setting if patient breathing rate increases. Operated by patient or caregiver. Healthcare provider uses output to manage oxygen therapy; benefits patient by providing ambulatory oxygen support. Device includes LCD for status/alerts; powered by AC or DC/battery.
Clinical Evidence
No clinical testing performed. Substantial equivalence demonstrated via bench testing using patient simulation models to verify oxygen output, breathing detection, and compliance with ISO/IEC standards.
Technological Characteristics
Pressure-vacuum swing adsorption; lithium-based zeolite molecular sieve. Piston compressor. Pulse-dose delivery. Power: 100-240 VAC or 12-24 VDC. Dimensions: 9.6"H x 8.75"W x 3.6"D. Weight: <6 lbs. Connectivity: None. Standards: IEC 60601-1 (3rd Ed), IEC 60601-1-2, ISO 80601-2-69, ISO 80601-2-67, ISO 14971, ISO 13485. Software: Microprocessor-based control for valve timing, oxygen monitoring, and Smart Dose algorithm.
Indications for Use
Indicated for adult and pediatric patients (>10kg) requiring supplemental oxygen. Not for life support; no patient monitoring capabilities.
Regulatory Classification
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).
Predicate Devices
- DeVilbiss iGo 306DS Portable Oxygen Concentrator (K081468)
Reference Devices
- Model 350G Gas Conserver (K090421)
Submission Summary (Full Text)
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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 and<br>sponsor of the 510(k) submission: | DeVilbiss Healthcare LLC<br>100 DeVilbiss Drive<br>Somerset, PA 15501 |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Official contact person for all<br>correspondence: | Betty Miller<br>Regulatory/Compliance Manager<br>Phone: 814-443-7606<br>Fax: 814-443-7575 |
| Date Prepared: | March 22, 2018 |
| Device Name: | Drive DeVilbiss iGo2 Portable Oxygen<br>Concentrator |
| Proprietary name of new device: | Drive DeVilbiss iGo2 Portable Oxygen<br>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)<br>number: | DeVilbiss iGo 306DS Portable Oxygen<br>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
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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 Device<br>DeVilbiss iGo 306DS Portable<br>Oxygen Concentrator -<br>K081468 | Reference Device<br>Model 350G Gas<br>Conserver<br>K090421 | Subject Device | Nature of Change | Legally<br>Marketed<br>Product with<br>same feature<br>or<br>specification |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| ltem<br>Description/<br>Method of<br>Operation | 1-3 lpm continuous flow (1-6<br>pulse dose), pressure-Vacuum<br>swing adsorption, oxygen<br>concentrator based on<br>molecular sieve technology.<br>Ambient air is drawn into the<br>concentrator via a piston style<br>compressor. The air then<br>passes through a series of<br>filters that remove dust,<br>bacteria, and other particulate.<br>A poppet-style valve directs air<br>into one of two sieve beds.<br>Nitrogen is adsorbed in the<br>bed as the pressure increases<br>while oxygen flows through,<br>thereby producing a highly<br>enriched oxygen product.<br>Simultaneously in the other<br>bed, nitrogen is absorbed as<br>the pressure decreases and is<br>exhausted into the<br>atmosphere. A momentary<br>intermediate pneumatic<br>sequence ties the beds<br>together with the exhaust<br>blocked for an enhanced<br>nitrogen purge. The cycle<br>continues providing a flow of<br>oxygen to the patient. Oxygen<br>is provided to the patient on a<br>continuous or pulse-dose<br>basis. | The Inspired<br>Technologies 350G<br>Gas Conserver is<br>intended as a<br>delivery device for<br>medial-grade<br>oxygen from high-<br>pressure oxygen<br>cylinders. | (1-5 pulse dose), pressure-<br>Vacuum swing adsorption,<br>oxygen concentrator based on<br>molecular sieve technology.<br>Ambient air is drawn into the<br>concentrator via a piston style<br>compressor. The air then<br>passes through a series of<br>filters that remove dust,<br>bacteria, and other particulate.<br>A valve directs air into one of<br>two sieve beds. Nitrogen is<br>adsorbed in the bed as the<br>pressure increases while<br>oxygen flows through, thereby<br>producing a highly enriched<br>oxygen product.<br>Simultaneously in the other<br>bed, nitrogen is absorbed as<br>the pressure decreases and is<br>exhausted into the<br>atmosphere. A momentary<br>intermediate pneumatic<br>sequence ties the beds<br>together with the exhaust<br>blocked for an enhanced<br>nitrogen purge. The cycle<br>continues providing oxygen to<br>the patient. Oxygen is<br>provided to the patient on a<br>pulse-dose basis. | Minor<br>constructional<br>differences. POC<br>will be smaller and<br>not support<br>continuous flow.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Target<br>Population/<br>Indications for<br>Use | The Model 306 Portable<br>Oxygen Concentrator is<br>indicated for the administration<br>of supplemental oxygen. The<br>device is not intended for life<br>support, nor does it provide<br>any patient monitoring<br>capabilities. | This is an<br>ambulatory device,<br>which allows<br>patients to<br>ambulate longer<br>than they would<br>with a continuous<br>flow regulator on<br>the same cylinder. | The Portable Oxygen<br>Concentrator is indicated for<br>the administration of<br>supplemental oxygen. The<br>device is not intended for life<br>support, nor does it provide<br>any patient monitoring<br>capabilities. | Same. Provides<br>pulse oxygen to<br>patient. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Where Used/<br>Intended Use | Oxygen concentrators are<br>intended to provide<br>supplemental oxygen to<br>persons requiring low flow<br>oxygen therapy. The patient<br>typically receives the oxygen<br>through a nasal cannula. The<br>device delivers continuous<br>oxygen or oxygen pulses<br>during a patients inhalation<br>phase. The pulse flow<br>provides over 87% oxygen<br>concentration. It is used at a<br>patient's home or for their<br>portable needs outside the<br>home and can also be used in<br>institutions such as nursing<br>homes or sub-acute care<br>facilities. Oxygen<br>concentrators are not<br>considered life supporting nor<br>life sustaining. The device has<br>no contraindications. | The 350G Gas<br>Conserver is<br>intended to be<br>used in the<br>hospital, healthcare<br>facilities, or home<br>care environments. | Oxygen concentrators are<br>intended to provide<br>supplemental oxygen to<br>persons requiring low flow<br>oxygen therapy. The patient<br>typically receives the oxygen<br>through a nasal cannula. It is<br>used at a patient's home or for<br>their portable needs outside<br>the home and can also be<br>used in institutions such as<br>nursing homes or sub-acute<br>care facilities. Oxygen<br>concentrators are not<br>considered life supporting nor<br>life sustaining. The device has<br>no contraindications. | Same. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>- K081468 |
| Characteristics | Predicate Device<br>DeVilbiss iGo 306DS Portable<br>Oxygen Concentrator –<br>K081468 | Reference Device<br>Model 350G Gas<br>Conserver<br>K090421 | Subject Device | Nature of Change | Legally<br>Marketed<br>Product with<br>same feature<br>or<br>specification |
| Operating<br>Principle | Pressure-vacuum-swing<br>adsorption / pressure<br>controlled oxygen separation<br>process | Integral high<br>pressure regulator<br>Dosing device and<br>algorithm Valves | Pressure-vacuum-swing<br>adsorption / pressure<br>controlled oxygen separation<br>process | Same as iGo<br>306DS. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Standards<br>Certification | IEC 60601-1 2nd Edition<br>IEC 60601-1-1<br>IEC 60601-1-2<br>ISO 8359<br>ISO 14971<br>ISO 13485 | FCC CFR47 Parts<br>15B and 18<br>Industry Canada<br>BS EN 55011:2007<br>IEC 60601-1<br>IPX I | IEC 60601-1 3rd Edition<br>IEC 60601-1-1<br>IEC 60601-1-2<br>ISO 80601-2-69<br>ISO 80601-2-67<br>ISO 14971<br>ISO 13485 | New device<br>conforms to newer<br>revisions of<br>standards. No<br>different questions<br>of safety or<br>effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Output<br>Capacity and<br>Delivery Modes | 3 LPM maximum continuous<br>flow.<br>Continuous flow settings: 1 to<br>3.0 LPM in 0.5 LPM<br>increments<br>Pulse flow settings: 1.0 to 3.0<br>in 0.5 increments; 3.0 to 6.0 in<br>1.0 increments | 16.0 cc/lpm x<br>setting value( i.e.<br>16x 1=16, 16 x 2<br>=32 etc) at 1.0, 1.5,<br>2.0, 2.5, 3.0, 4.0,<br>5.0, and 6.0 Lpm<br>flow settings Sport<br>mode I is setting<br>value + 16 cc Sport<br>Mode 2 is setting<br>value +32 cc/lpm | Pulse flow settings: 1.0 to 5.0<br>in 1.0 increments | Does not support<br>Continuous flow.<br>Pulse mode like<br>iGo 306DS but<br>supports a smaller<br>set of the patient<br>population because<br>of smaller bolus<br>volume.<br>Supports Smart<br>Dose (Sport Mode) | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468<br>Model 350G<br>Gas<br>Conserver<br>K090421 |
| Voltage<br>Required | AC operation: 100-240 VAC,<br>50-60 Hz<br>DC operation: 12-24 VDC | 4 "AA" batteries | AC operation: 100-240 VAC,<br>50-60 Hz<br>DC operation: 10 - 15 VDC | Minimal difference.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>— K081468 |
| Dimensions | 15"H x 12"W x 9"D<br>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<br>Cube volume: 302.4 cu. in. | Smaller more<br>portable device<br>than iGo 306DS.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>- K081468 |
| Weight | 17.9 lbs, including battery,<br>19.9 lbs with lightweight cart | 1.39 lbs | Less than 6 lbs, including a<br>standard battery pack. | Lighter more<br>portable device<br>than iGo 306DS.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| 02<br>Performance<br>Specification | 90% +/-3% at 1 Ipm to 3 Ipm<br>at sea level | N/A - Uses bottled<br>gas | 87-94% at all settings | Same as iGo<br>306DS. No<br>different questions<br>of safety or<br>effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>- K081468 |
| Noise Level @<br>2 Ipm | 40 dBA at pulse flow setting 3;<br>47 dBA overall maximum at 3<br>LPM continuous flow | N/A – Uses bottled<br>gas | 46 dBA at pulse flow setting 2 | Louder than iGo<br>306DS but no<br>different questions<br>of safety or<br>effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>- K081468 |
| Power<br>Consumption | 42 Watts at 1.0 LPM<br>continuous flow<br>104 Watts at 3.0 LPM<br>continuous flow<br>31 Watts at 1.0 pulse flow<br>setting (20 BPM)<br>62 Watts at 6.0 pulse flow<br>setting<br>(20 BPM) | | Approximately 30 Watts at<br>setting of 2 (20 BPM) | Pulse dose<br>efficiency is better.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Characteristics | Predicate Device<br>DeVilbiss iGo 306DS Portable<br>Oxygen Concentrator –<br>K081468 | Reference Device<br>Model 350G Gas<br>Conserver<br>K090421 | Subject Device | Nature of Change | Legally<br>Marketed<br>Product with<br>same feature<br>or<br>specification |
| Patient Oxygen<br>Outlet<br>Pressure | 5 psig | 19-25 PSIG | 15 psig | Higher pulsed<br>output pressure<br>than iGo but lower<br>than 350G. Will<br>deliver oxygen<br>faster than iGo but<br>there is no different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Filtration | Patient-maintainable gross<br>particle filter | None | Gross particle filter | Same as iGo<br>306DS. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Battery Run<br>Time | Tested times:<br>4.1 hours at 1.0 LPM<br>1.7 hours at 3.0 LPM<br>5.8 hours at 1.0 LPM (10<br>BPM)<br>2.0 hours at 6.0 LPM (30<br>BPM) | NA | 4.5 hours at a setting of 2 (20<br>BPM) | Same as iGo<br>306DS at<br>equivalent pulse<br>output. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Compressor<br>Pressure Relief<br>Valve | Pressure Relief valve | NA | Over-pressure protection<br>achieved through software<br>and electronic control. | No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Pneumatic<br>Valve | Two Three way valves | NA | Two Three way valves | Off the shelf valves<br>– No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Molecular<br>Sieve Material | Zeochem lithium-based zeolite | NA | Zeochem lithium-based zeolite | Same as iGo<br>306DS. No<br>different questions<br>of safety or<br>effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Flow Controller | Proportional control valve<br>used for continuous flow and<br>pulse flow | Pulse Valve | Pulse Valve only. Use<br>software to regulate output. | Same as iGo<br>306DS. No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Insulation<br>Class | IEC Class 1, Type BF | Not Published | IEC Class 2, Type BF | Improved required<br>by ISO standard.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Water Ingress | IPX0 – bare unit<br>IPX1 – Unit with battery | IPX1 | IPX1<br>Or IPX22 | Improved liquid<br>ingress capability.<br>No different<br>questions of safety<br>or effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Hour meter | Mechanical Hour meter | None | Microprocessor or other<br>nonvolatile memory. | Used for service<br>and dealer. No<br>different questions<br>of safety or<br>effectiveness. | DeVilbiss iGo<br>306DS<br>Portable<br>Oxygen<br>Concentrator<br>– K081468 |
| Characteristics | Predicate Device<br>DeVilbiss iGo 306DS Portable<br>Oxygen Concentrator –<br>K081468 | Reference Device<br>Model 350G Gas<br>Conserver<br>K090421 | Subject Device | Nature of Change | Legally<br>Marketed<br>Product with<br>same feature<br>or<br>specification |
| Oxygen<br>Monitor | Ultrasonic oxygen and flow<br>sensing device (FDA<br>approved Re: K913392/B)…
