The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

Device Description

The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient.

The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.

Standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.

The Invacare Flyer uses a molecular sieve and pressure swing adsorption methodology to produce the oxygen gas output. Ambient air enters the device, is filtered and then compressed. This compressed air is then directed toward one of two nitrogen adsorbing sieve beds. Concentrated oxygen exits the opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.

The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.

AI/ML Overview

The provided document is a 510(k) summary for the Invacare Flyer, Model XPO100, an oxygen concentrator. It establishes substantial equivalence to a predicate device, the Inogen One Oxygen Concentrator (K032818). This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing de novo clinical studies with acceptance criteria in the way one might for a novel AI/ML device.

Therefore, the following information about acceptance criteria and studies (especially those relating to AI/ML device performance) is not applicable in this context. The "study" here is generally a comparison to a predicate and adherence to recognized standards.

Here's an analysis based on the provided text, addressing the points where information is available or noting its N/A status:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" are not reported as specific performance metrics with thresholds in the way a diagnostic AI might have. Instead, substantial equivalence is demonstrated through comparative features and adherence to recognized standards. The "reported device performance" is implicitly shown by meeting these standards and having comparable features to the predicate.

Feature/Standard	Acceptance Criteria (Implied)	Reported Device Performance
Functional
Intended Use	Same as predicate (supplemental oxygen for respiratory disorders)	Meets intended use
Oxygen Purity	Comparable to predicate ("Approximately 90%")	87% minimum at all flow rates
Flow Rates	Same as predicate (Pulse Flow - 1, 2, 3, 4, 5)	Pulse Flow - 1, 2, 3, 4, 5
Technology	Same as predicate (molecular sieve, pressure swing adsorption)	Molecular sieve, pressure swing adsorption
Safety/EMC	Adherence to listed standards	Tested in accordance with listed standards (e.g., IEC 60601-1, IEC 60601-1-2)
Physical	Similar to predicate (weight, size)	Weight < 7.0 lbs, Height 10.0" +/- 1", Width 7.0" +/- 1", Depth 4.3" +/- 1"

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

This information is not applicable. The submission does not detail a "test set" or specific patient data in the context of diagnostic performance. Performance testing refers to engineering and electrical safety standards testing, not clinical studies with patient data.

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 is not applicable. There is no "ground truth" establishment in the context of diagnostic accuracy for this device, nor a test set requiring expert adjudication.

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

This is not applicable. No test set or adjudication method is described.

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

This is not applicable. This is an oxygen concentrator, not an AI-assisted diagnostic device.

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

This is not applicable. This is an oxygen concentrator, not an algorithm-only device. Its operation is standalone in the sense that it produces oxygen, but it doesn't perform diagnostic or interpretive functions that would be evaluated in this manner.

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

This is not applicable. "Ground truth" in the context of medical device performance studies (particularly for AI/ML) is not a concept applied to oxygen concentrators. The device's "truth" is its ability to produce oxygen within specified parameters and operate safely according to engineering standards.

8. The sample size for the training set

This is not applicable. There is no "training set" for an oxygen concentrator. The device's design is based on established engineering principles and technology, not machine learning or data training.

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

This is not applicable. As there is no training set, there is no ground truth for it.

Summary of the "Study" (Demonstration of Substantial Equivalence):

The "study" in this 510(k) submission is primarily a comparative analysis against a legally marketed predicate device (Inogen One Oxygen Concentrator; K032818) and adherence to recognized performance and safety standards.

Evidence Type: Bench testing, adherence to national and international standards for medical electrical equipment (e.g., ASTM, ISO, UL, IEC standards for electromagnetic compatibility, safety, and oxygen concentrator-specific requirements), and a comparison of technical specifications.
Key Finding: The Invacare Flyer performs as intended and is substantially equivalent to the predicate device, with differences in physical dimensions and weight determined not to affect safety or effectiveness.
No specific sample sizes (e.g., patients, images) are mentioned as this is not a clinical performance study in the typical sense for AI/ML.
Data Provenance (for comparative data): The performance data is derived from direct testing of the Invacare Flyer against engineering standards and comparison of its specifications to the publicly available specifications of the predicate device.
Experts/Ground Truth/Adjudication: Not applicable in the context of diagnostic performance. The "experts" are likely the engineers and regulatory professionals who conducted the tests and compared the specifications. The "ground truth" is adherence to the scientific and engineering principles embodied in the referenced standards.

Summary

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510(K) SUMMARY FOR THE INVACARE FLYER, Model XPO100

This summary of 510(k) safety and effectiveness information is being supplied in accordance with the requirements of the SMDA of 1990 and 21 CFR 807.92

The assigned 510(k) number is ________________________________________________________________________________________________________________________________________________

Date: July 10, 2007

Submitted by: Invacare Corporation Registration No. 1525712 One Invacare Way Elyria, Ohio 44035-4190

DEC 1 2 2007

Telephone: 440-326-6356 Fax: 440-326-3458

Contact Person: Mr. Carroll Martin

Trade Name: The Flyer

Model: XPO100

Common Name: Oxygen Concentrator

Classification Name: Generator, Oxygen, Portable per 21 CFR 868.5440

Legally Marketed Predicate Device(s): Inogen One Oxygen Concentrator; K032818, May 13, 2004

Device Description: The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device can be used in the home, an institutional environment or in a vehicle or other mobile environment. The device is not intended to sustain or support life. The device is used with a nasal cannula to direct oxygen from the device to the patient.

The Invacare Flyer provides oxygen in pulsed demand flow dosages at settings of 1 through 5. The oxygen concentration level of the output gas ranges from 87% to 95.6%.

510(k) K071928 Response

Page 18

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opposite end of the active sieve bed and is directed into an oxygen reservoir where it is delivered to the patient in specific volumes during the inhalation portion of a detected breath.

The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device.

Intended Use: The Invacare Flyer is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

Features	The Invacare Flyer	Predicate DeviceInogen One Oxygen Concentrator
510(k) Number	TBD	K032818
Date Cleared	TBD	05/13/2004
Intended Use	The Invacare Flyer is intended to be usedby patients with respiratory disorders whorequire supplemental oxygen. It supplies ahigh concentration of supplementaloxygen and is used with a nasal cannula tochannel oxygen from the concentrator tothe patient. The Invacare Flyer can beused in a home, institution, vehicle andvarious mobile environments. TheInvacare Flyer does not nor is it intendedto sustain or support life.	The Inogen One Oxygen Concentrator isused on a prescriptive basis by patientsrequiring supplemental oxygen. Itsupplies a high concentration of oxygenand is used with a nasal cannula tochannel oxygen from the concentrator tothe patient. The Inogen One OxygenConcentrator may be used in a home.institution, vehicles and various mobileenvironments.
Method by whichOxygen is Released	Molecular sieve (mechanical)	Molecular sieve (mechanical)
Process by whichOxygen is Released	Pressure swing adsorption	Pressure swing adsorption
Sieve Bed Material	Synthetic zeolite	Synthetic zeolite
Software/Hardware	Analog and digital electronics withmicroprocessor	Analog and digital electronics withmicroprocessor
Flow Control	Microprocessor controlled valves	Microprocessor controlled valves
Weight	< 7.0 lbs. ( with non-removable internalbattery)	9.8 lbs. (device 8.3 lbs .; battery 1.5 lbs.)
Size
Height	10.0" +/- 1"	12.39"
Width	7.0" +/- 1"	6.00"
Depth	4.3" +/- 1"	11.62"
Oxygen Purity	87% minimum at all flow rates	"Approximately 90%"

Substantial Equivalence:

510(k) K071928 Response

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Flow Rates	Pulse Flow - 1, 2, 3, 4, 5	Pulse Flow - 1, 2, 3, 4, 5
Power Options	AC power supply 100-240 V, 50/60 Hz;DC power supply 11-16 V	AC power supply 100-240V, 50/60 Hz;Mobile Power Charger for mobile DC use.
Battery	Li-ion, 14.8 Volt, 5.2 Ah	Li-ion, 14.8 Volt, 6.6 Ah

Design Standards: The Invacare Flyer has been designed referencing the following standards:

Standard or Agency	Title
ASTM 1464-93 (2005)	Standard Specification for Oxygen Concentrators for Domiciliary Use
ISO 8359; 1996	Oxygen Concentrators for Medical Use - Safety Requirements
UL 1097, 5th ed., 2004	UL Standard for Safety for Double Insulation Systems for Use inElectrical Equipment, UL 1097
UL 1431, 2nd ed., 1996	UL Standard for Safety for Personal Hygiene and Health CareAppliances, UL1431 (with revisions from 2003)
EN 55011:1998	Limits and methods of measurement of radio disturbance characteristicsand medical (ISM) radio-frequency equipment
IEC 60601-1; 3rd ed. 2006	Medical Electrical Equipment - Part 1 - General requirements for basicsafety and essential performance
IEC 60601-1-2; 3rd ed. 2007	Medical Electrical Equipment -- Part 1-2 -- Collateral standard:Electromagnetic compatibility
IEC 61000-3-2: 2005	Electromagnetic compatibility (EMC). Limits. Limits for harmoniccurrent emissions (equipment input current up to and including 16 A perphase)
EN 61000-3-3: 2005	Electromagnetic compatibility (EMC). Limits. Limitation of voltagechanges, voltage fluctuations and flicker in public low-voltage supplysystems, for equipment with rated current <= 16 A per phase and notsubject to conditional connection
IEC61000-4-2; 1.2 ed. 2001	Electrostatic Discharge Immunity Test w/ Amendments 1&2
IEC61000-4-3; 3rd ed. 2006	Radiated, RF, Electromagnetic Field Immunity Test

0(k) K071928 Respon

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IEC61000-4-5; 2nd ed. 2005 Surge Immunity Test

IEC61000-4-6; 1st ed. 2006	Immunity to Conducted Disturbances Induced by RF fields w/Amendments 1&2
IEC61000-4-8; 1.1 ed. 2001	Power Frequency Magnetic Field Immunity Tests
IEC61000-4-11; 4th ed. 2004	Voltage Dips, Short Interruptions and Voltage Variations ImmunityTests w/ Amendment 1
FDA Reviewer's Guide 93	Reviewer Guidance for Premarket Notification Submissions

Performance Testing: The Invacare Flyer has been tested in accordance with the following:

Standard or Agency	Title
EN 60601-1-2; 2nd ed. 2001	Medical Electrical Equipment - Sec 1.2 - Collateral standard:Electromagnetic compatibility
IEC 60601-1-2; 2.1 ed.	Medical Electrical Equipment - Sec 1.2 - Collateral standard:Electromagnetic compatibility
EN 55011:1998	Limits and methods of measurement of radio disturbance characteristicsand medical (ISM) radio-frequency equipment
CISPR 11: 2003	Limits and methods of measurement of radio disturbance characteristicsand medical (ISM) radio-frequency equipment
EN61000-4-3; 2002IEC61000-4-3; 2006	Radiated, RF, Electromagnetic Field Immunity Test
EN 61000-4-4; 1995IEC 61000-4-4; 2004	Electrical Fast Transient/Burst Immunity Test
EN 61000-4-5; 1995IEC 61000-4-5; 2005	Surge Immunity Test
EN 61000-4-6; 1996IEC 61000-4-6; 2006	Immunity to Conducted Disturbances Induced by RF fields
EN 61000-4-8; 2001	Power Frequency Magnetic Field Immunity Tests

{4}------------------------------------------------

EN 61000-4-11; 1995	Voltage Dips, Short Interruptions and Voltage Variations ImmunityTests
IEC 61000-4-11; 2004	Voltage Dips, Short Interruptions and Voltage Variations ImmunityTests
EN 61000-3-2: 2000	Limits for Harmonic Current Emissions
IEC 61000-3-2: 2005	Limits for Harmonic Current Emissions
EN 61000-3-3: 1995	Voltage fluctuations and flicker Tests
IEC 61000-3-3: 2005	Voltage fluctuations and flicker Tests
IEC 60601-1: 2nd ed. 1998	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
with Amendment 1: 1991
with Amendment 2: 1995
UL 60601-1: 1st ed. 2003	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
CSA 601.1 M90	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
Quasi-Static Electric Field	Reviewer Guidance for premarket notification submissions 1993
FDA Reviewer's Guide:1993 Electrostatic Discharge Immunity Test per Sec. m,7,ii,a.
FDA Reviewer's Guide:1993 Reviewer Guidance for Premarket Notification Submissions

Performance Data: The performance data found in this submission shows that the Invacare Flyer performs as intended and in a manner that is substantially equivalent to the predicate device.

Conclusion: The data presented in this submission shows that the Invacare Flyer performs as intended and in a manner that is substantially equivalent to the predicate devices.

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Executive Summary

Device Description

The Invacare Flyer is used by patients with respiratory disorders who require supplemental oxygen. The device is not intended to sustain or support life.

The basic technology of the Invacare Flyer is equivalent to other approved oxygen concentrators. The principles of operation are equivalent to the noted predicate device. The oxygen concentration level of the output gas ranges from 87% to 95.6%. The oxygen is delivered to the patient through the use of a nasal cannula. When the demand for oxygen is detected, the oxygen is delivered through pulsed flow with pulse flow settings of 1 through 5.

The Invacare Flyer is capable of operation by the patient in a home environment, in an institutional environment, in a vehicle or other mobile environment. Device standard power options include an AC to DC switching power supply operating from AC power outlet (120 VAC/ 60 Hertz nominal), a DC to DC switching power supply operating from accessory outlets typically found in a mobile vehicle type environment (12 VDC nominal) and an external rechargeable battery.

The Invacare Flyer has several lights and indicators providing the user with information regarding the operation of the device:

1. Start-Up Indicator the Flyer will briefly light all LEDs and output a brief audible beep when first turned on to indicate the unit is operational.
1. Breath Detect Indicator the Flyer will output a defined pulse of oxygen each time it detects an inhalation. The blue flow setting indicator light will blink each time an inhalation is detected and the Flyer outputs a pulse of oxygen.
1. Internal Battery Charging Indicator the battery gauge will be illuminated during charging to indicate the internal batter charge status. When the battery is fully charged, all four battery gauge display LEDs will illuminate continuously.
1. Low Battery Warning when the Flyer's internal battery (or external battery, if applicable) charge level falls to 25% capacity, a brief audible beep will sound and the lowest level battery gauge display LED will blink.
1. Low Battery Alarm when the Flyer's internal battery (or external battery, if applicable) charge level falls to 15% capacity, a brief audible double beep will sound and the lowest level battery gauge display LED will blink rapidly..

{6}------------------------------------------------

1. Battery Discharged Alarm when the Flyer's internal battery (or external battery, if applicable) charge level falls to a minimum capacity, a brief audible triple beep will sound, the lowest level battery gauge display LED will blink very rapidly and the unit will shutdown.
1. No Breath Detect Alarm when the Flyer is operating but does not sense breathing within a predetermined time period (e.g 60 seconds), a constant audible alarm sounds and the red alarm indicator light will illuminate continuously.
1. Breath Rate Over Capacity Alarm if the breathing rate exceeds the capacity of the Flyer, a rapid audible beep sounds and the red alarm indicator light will illuminate intermittently.
1. System Too Hot/Cold for Start Alarm if the Flyer senses temperatures outside factory set levels upon start-up, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 2 blue indicator lights will illuminate.
1. System Too Hot/Cold Running Alarm if the Flyer senses temperatures outside factory set levels during operation, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 3 blue indicator lights will illuminate.
1. Battery Too Hot/Cold Alarm if the Flyersinternal battery senses temperatures outside a factory defined temperature range while the unit is operating, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will stop running and the flow setting 1 & 4 blue indicator lights will illuminate.
1. Stuck Button Alarm During power up of the unit, if it detects that a button is stuck or being pressed too early, the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 1 & 5 blue indicator lights will illuminate.
1. Operating Alarm If units detects abnormal operating conditions in the unit (such as over and under pressure), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 3 & 4 blue indicator lights will illuminate.
1. Compressor Alarm If units detects abnormal compressor conditions (such as Locked Rotor or RPM error), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 4 & 5 blue indicator lights will illuminate.
1. System Alarm If units detects abnormal system conditions (such as Watchdog Timer error), the unit will alarm with a rapid audible beep, the red alarm indicator light will illuminate continuously, the unit will not operate and the flow setting 3,4 & 5 blue indicator lights will illuminate.

510(k) K071928 Response

{7}------------------------------------------------

nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

Features	The Invacare Flyer	Predicate DeviceInogen One Oxygen Concentrator
510(k) Number	TBD	K032818
Date Cleared	TBD	05/13/2004
Intended Use	The Invacare Flyer is intended to be usedby patients with respiratory disorders whorequire supplemental oxygen. It supplies ahigh concentration of supplementaloxygen and is used with a nasal cannula tochannel oxygen from the concentrator tothe patient. The Invacare Flyer can beused in a home, institution, vehicle andvarious mobile environments. TheInvacare Flyer does not nor is it intendedto sustain or support life.	The Inogen One OxygenConcentrator is used on a prescriptivebasis by patients requiringsupplemental oxygen. It supplies ahigh concentration of oxygen and isused with a nasal cannula to channeloxygen from the concentrator to thepatient. The Inogen One OxygenConcentrator may be used in a home,institution, vehicles and variousmobile environments.
Method by whichOxygen isReleased	Molecular sieve (mechanical)	Molecular sieve (mechanical)
Process by whichOxygen isReleased	Pressure swing adsorption	Pressure swing adsorption
Sieve BedMaterial	Synthetic zeolite	Synthetic zeolite
Software/Hardware	Analog and digital electronics withmicroprocessor	Analog and digital electronics withmicroprocessor

Device Comparison Table

{8}------------------------------------------------

Features	The Invacare Flyer	Predicate DeviceInogen One Oxygen Concentrator
Flow Control	Microprocessor controlled valves	Microprocessor controlled valves
Weight	< 7.0 lbs. (with internal battery)	9.8 lbs. (device 8.3 lbs., insertablebattery 1.5 lbs.)
Size:
Height	10.0" +/- 1"	12.39"
Width	7.0" +/- 1"	6.00"
Depth	4.3" +/- 1"	11.62"
Oxygen Purity	87% minimum at all flow rates	"Approximately 90%"
Flow Rates	Pulse Flow - 1, 2, 3, 4, 5	Pulse Flow - 1, 2, 3, 4, 5
Power Options	AC power supply 100-240 V, 50/60 Hz;DC power supply 11-16 V	AC power supply 100-240V, 50/60Hz; Mobile Power Charger for mobileDC use.
Battery	Li-ion, 14.8 Volt, 5.2 Ah	Li-ion, 14.8 Volt, 6.6 Ah

As the chart above shows, the Invacare Flyer is comparable to its predicate. Both devices have the same intended use for the same patient population, extract oxygen from air using the same methodology, provide comparable oxygen purity and are powered in the same manner. The main differences between the two devices are the weight and physical dimensions. Testing shows that these differences have no effect on safety or effectiveness.

Performance Testing: The Invacare Flyer has been tested in accordance with the following:

EN 60601-1-2; 2nd ed. 2001	Medical Electrical Equipment – Sec 1.2 - Collateral standard:Electromagnetic compatibility
IEC 60601-1-2; 2.1 ed.	Medical Electrical Equipment - Sec 1.2 - Collateral standard:Electromagnetic compatibility
EN 55011:1998	Limits and methods of measurement of radio disturbance characteristicsand medical (ISM) radio-frequency equipment
CISPR 11: 2003	Limits and methods of measurement of radio disturbance characteristicsand medical (ISM) radio-frequency equipment
EN61000-4-3; 2002IEC61000-4-3; 2006	Radiated, RF, Electromagnetic Field Immunity TestRadiated, RF, Electromagnetic Field Immunity Test
EN 61000-4-4; 1995IEC 61000-4-4; 2004	Electrical Fast Transient/Burst Immunity TestElectrical Fast Transient/Burst Immunity Test
EN 61000-4-5; 1995IEC 61000-4-5; 2005	Surge Immunity TestSurge Immunity Test
EN 61000-4-6; 1996IEC 61000-4-6; 2006	Immunity to Conducted Disturbances Induced by RF fieldsImmunity to Conducted Disturbances Induced by RF fields

510(k) K071928 Response

{9}------------------------------------------------

EN 61000-4-8; 2001	Power Frequency Magnetic Field Immunity Tests
EN 61000-4-11; 1995IEC 61000-4-11; 2004	Voltage Dips, Short Interruptions and Voltage Variations Immunity TestsVoltage Dips, Short Interruptions and Voltage Variations Immunity Tests
EN 61000-3-2: 2000IEC 61000-3-2: 2005	Limits for Harmonic Current EmissionsLimits for Harmonic Current Emissions
EN 61000-3-3: 1995IEC 61000-3-3: 2005	Voltage fluctuations and flicker TestsVoltage fluctuations and flicker Tests
IEC 60601-1: 2nd ed. 1998with Amendment 1: 1991with Amendment 2: 1995	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
UL 60601-1: 1st ed. 2003	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
CSA 601.1 M90	Medical Electrical Equipment, Part 1: General requirements for basicsafety and performance
Quasi-Static Electric Field	Reviewer Guidance for premarket notification submissions 1993
FDA Reviewer's Guide:1993	Electrostatic Discharge Immunity Test per Sec. m,7,ii,a.FDA Reviewer's Guide:1993 Reviewer Guidance for Premarket Notification Submissions

The results of the testing have shown that the Invacare Flyer is safe and effective for its intended use and substantially equivalent to its predicate.

{10}------------------------------------------------

Image /page/10/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three horizontal lines representing the bird's body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the eagle.

DEC 1 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Carroll L. Martin Regulatory Affairs Manager Invacare Corporation One Invacare Way P.O.Box 4028 Elyria, Ohio 44036-2125

Re: K071928

Trade/Device Name: Invacare Flyer, Model XPO100 Regulation Number: 21 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: II Product Code: CAW Dated: November 8, 2007 Received: November 9, 2007

Dear Mr. Martin:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

{11}------------------------------------------------

Page 2 - Mr. Martin

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutite Y. Michau Omd
Chin Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Invacare Flyer, Model XPO100

Indications for Use: The Invacare Flyer (Model XPO100) is intended to be used by patients with respiratory disorders who require supplemental oxygen. It supplies a high concentration of supplemental oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The Invacare Flyer can be used in a home, institution, vehicle and various mobile environments. The Invacare Flyer does not nor is it intended to sustain or support life.

Prescription Use < (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

K071928 510(k) Number: _______________________________________________________________________________________________________________________________________________________________

Page 1 of

510(k) K071928 Response

Page 17

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).