November 6, 2014 

U.S. Department ofTransportation 

Docket Management System 

400 71

h Street, S.W. 

Room PL401 

Washington, DC 20591-0001 

Yes, you can: 

Attention: Ms. Jodi L. Baker, Deputy Assistant Manager, 

Air Transportation Division, AFS-200 

Dear Ms. Baker, 

We received your letter dated October 8, 2014 denying a perceived petition to add the Invacare 

XPO 100 and XPO 1 OOB portable oxygen concentrators to the list of approved devices in SF AR 

No. 106. We believe that there has been a misunderstanding and wish to clarify the purpose of 

Invacare's August 5, 2014 submission. Our use of the terms "XP0100" and "XPOIOOB" may 

have been confusing. 

The Invacare® XP02TM Portable Oxygen Concentrator (POC) with Model Name XP02 was 

added to SF AR No. 106 as published in the Federal Register on January 15, 2009: pages 2351 to 

2355. Ordering codes XPO 100 and XPO l OOB include the XP02 portable oxygen concentrator 

and in fact, they are the only ordering codes for the XP02 portable oxygen concentrator. Both 

ordering codes were included in the original petition submitted to FAA asking that the XP02 

oxygen concentrator be added to SF AR No. 106. 

When SF AR I 06 was amended on January 15, 2009 to add the Invacare XP02 POC, only the 

trade name XP02 was noted in the Federal Register; ordering codes XPO 100 and XPO 1 OOB 

were not cited. Please see the letter provided in Attachment A of this submission. Unfortunately, 

a copy of the original letter could not be located so the draft letter written by Mr. Carroll Martin 

is provided. 

The FDA 51 O(k) clearance letter, also included in the original FAA petition, notes model number 

XPOIOO as the same as XP02 (Attachment B of this submission). 

The XP02 portable oxygen concentrator associated with both of these ordering codes is 

identical. The only difference is that the order code XPO 1 OOB has a supplemental battery. 

Please refer to the sales brochure provided in Attachment C. 

INVACARE CORPORATION 

One lnvacarc Way P.O. Box 4028 Elyria. Ohio 44036·2 125 USA 

440-329-6000 Fax: 866-462-9950 www.invacarc.com 
The table below is provided to show the differences in the two ordering codes: 

XPOIOO XPOJOOB 

XP02 Oxygen ~ ~ 

Concentrator 

Carrying Case ~ 

AC Adapter ~ " ~ 

DC Adapter 

Accessory Bag, " ~ " ~ 

Supplemental 

Battery " 

The August 5, 2014letter of notification of improvements along with the updated RTCA D0-

160 emissions testing data described minor improvements, quality updates and the latest EMC 

testing data for the internal and external batteries along with internal circuitry improvements of 

the Model XP02 oxygen concentrator. These are not new model numbers as noted in the third 

paragraph of the denial letter; these improvements are being made to the existing model 

numbers. The information was submitted because we believed that lnvacare was obligated to 

inform the agency that the devices were being updated for quality improvements and to update 

the RTCA DO-l GO emissions data as posted on the FAA website for the Invacare XP02 POC. 

We hope that this clarifies that Invacare is not petitioning the FAA to add any new oxygen 

concentrators to SF AR No. 106. The August 2014 submission was intended to inform the 

agency that the XP02 devices were being improved as \.veil as provide an update to the FAA 

posted emissions testing data. 

Compliance with FAA regulations is very important to lnvacare. We would appreciate a letter 

from the agency acknowledging receipt of our RTCA DO-1 60 emissions testing data submission 

for the purposes of updating the FAA's EMC test data on your website for POCs. We would also 

appreciate acknowledgement that the Invacare XP02 POC is already a listed product covered 

under the SF AR 106 approval dated January 15, 2009. 

Please contact us at your earliest convenience if you have any requirements for additional 

information. 

Sincerely, 

Carol ~L~~ Vierling V 

Acting Regulatory Affairs Manager 

Invacare Corporation 

One Invacare Way 

Elyria, Ohio 44035 

Phone: 706-476-2938 

Email: cvierling@invacarecontractor.com 

2 
Attachment A 

3 
[Date] 

U.S. Department ofTransportation 

Docket Management System 

400 7111 Street, S.W. 

Room PL 401 

Washington, DC 20591-000 I 

Applicant: 

Mr. Carroll Martin 

Regulatory Affairs Manager 

Jnvacare Corporation 

One Invacare Way 

Elyria, Ohio 44035-4 190 

Carroli.Martin@invacare.com 

Phone:440-329-6356 

Fax: 440-326-3458 

Re: Petition to Amend SFAR No. 106 on Portable Oxygen Concentrator Devices on Passenger 

Aircraft 

Dear Sir or Madam: 

Please accept this letter as petition to amend the Federal Aviation Administration's (FAA) Special 

Federal Aviation Regulation (SF AR) No. I 06 under 14 CFR 12 1 that allows for the use of certain 

portable oxygen concentrator (POC) devices onboard passenger aircran. lnvacare is specifically 

requesting that the FAA amend Section 2 and Section 3(a) of SF AR No. I 06 by adding lnvacare's 

portable oxygen concentrator, the XP02 (models XPOlOO and XPO l OO B), as one ofthe approved 

POC devices for use on passenger aircraft. 

Background 

Invacare Corporation is a manufacturer of home medical equipment, which includes oxygen 

concentrators. Invacare is currently preparing for the market introduction of our XP02, a small, 

lightweight, battery powered POC intended for patients with respiratory disorders who require 

supplemental oxygen. It is lnvacare's intent to provide for these patients an oxygen system that will 

substantially improve their quality of life and to provide an additional choice of p011able oxygen 

concentrator for those patients who require supplemental oxygen and intend to use passenger aircraft 

for travel. 

INV ACARE CORPORATION 

One lnvacarc Way P.O. Box 4028 Elyria, Ohio 44036-2 125 USA 

440-329-6000 Pax: 440-366-1 R03 www. invacare.corn 4 
Invacare's XP02 provides oxygen by separating oxygen from room air utilizing a molecular sieve 

and pressure swing adsorption methodology. The resultant concentrated oxygen is directed toward 

an oxygen reservoir for delivery to the patient. The XP02 delivers the oxygen to the patient through 

the pulse delivery method for maximum effectiveness and operational time. This means that the 

XP02 delivers oxygen only when a breath is detected. If no breath is detected (i.e. the cannula 

detaches from the device or the patient takes the cannula oft), no oxygen is delivered. This feature of 

delivering oxygen only when a breath is detected prevents oxygen saturation of the surrounding area 

or materials when the cannula is not connected to the concentrator or the patient. 

The U.S. Food and Drug Administration has issued to lnvacare a written determination that the 

XP02 is I) substantially equivalent in safety and effectiveness to a device currently on the market 

(referred to as a predicate device and in this case, the device is the Inogen One Oxygen concentrator, 

a device the FAA has already granted permission to be used on board passenger aircraft) and 2) the 

XP02 can be marketed to persons requiring supplemental oxygen (see Exhibit A- please note in 

this exhibit, the name of the device, The Flyer, Model XPO 100, is quoted. This is the exact same 

device that is the subject of this submission.). 

Invacare's Request for PHMSA Letter of Interpretation 

On January 30, 2008, Invacare submitted a letter to the Pipeline and Hazardous Materials Safety 

Administration (PHMSA) requesting a written interpretation that the XP02 is not subject to the U.S. 

hazardous material regulations (HMR) pursuant to the requirements referenced in 49 CFR 

173.115(b)(l) for Class 2, Division 2.2 gases and 49 CFR 173.185(c)(2) for lithium ion batteries. 

The Jetter is attached as Exhibit B. We expect confirmation from PHMSA by early April that the 

XP02 is not subject to the HMR. 

Power Source for the Invacare XP02 

The XP02 device can be powered by an internally captive lithium ion battery pack that is not 

customer removable or replaceable, an external AC to DC power adapter, an external DC to DC 

power adapter, or an external accessory lithium ion battery pack. This allows for maximum 

flexibi lity and operational time with multiple power sources. Recharging of either the internal or 

external accessory batteries is only available with the use of the Invacare supplied AC/DC or DC/DC 

power adapters. 

The internally captive lithium ion battery pack (see Exhibit C) consists of 8 cylindrical 2.6 amp-hour 

lithium ion cells (see Exhibits D and E) with a total lithium equivalent content of 6.24 grams of 

lithium. The internally captive battery pack is not user accessible and not replaceable by a 

patient/user. It is securely captured in the product and has passed all applicable UN Manual of Tests 

and Criteria requirements for lithium battery packs (see Exhibits F and G). The internally captive 

mechanism of the Invacare XP02 also prevents any user from generating sparks or short-circuiting 

INV A CARE CORPORATION 

One lnvacarc Way P.O. Box 4028 Elyria. Ohio 44036-2125 USA 

440-329-6000 Fax: 440-366-1803 www.invacarc.com 

5 
as it is not externally accessible. The battery pack terminals are not exposed to any outside contact 

by virtue of being totally integrated into the product (see Exhibit H). 

The external accessory battery module XPO 11 0 (see Exhibit I) for extended operating time is a selfcontained power accessory for the Invacare XP02 device. The external battery module contains a 

separate lithium battery pack that consists of 8 cylindrical 2.6 amp-hour lithium ion cells with a total 

lithium equivalent content of 6.24 grams of lithium (see Exhibit J). The lithium battery pack is not 

user accessible and is not replaceable by a patient/user. It is securely captured in the external module 

and has passed all applicable UN Manual of Tests and Criteria requirements for lithium battery 

packs (Exhibits rand G). The captive mounting mechanism of the external battery module also 

prevents any user from generating sparks or short-circuiting the lithium battery pack. The battery 

pack terminals are not exposed to any outside contact as they are connected to an intervening power 

switching and charging circuit board (see Exhibit K) that interfaces to the Invacare XP02 device. 

The external battery module connection cable (see Exhibit L) contains a connector that prevents 

accidental shorting or generation of sparks during handli ng or storage. 

lnvacare feels that these features of the internal captive battery and the external accessory battery 

module meet the requirements contained in Section 3, provision (b)(6) ofSFAR No. 106. The Travel 

Manual will a lso contain detailed instructions on the regulatory requirements for carrying these types 

of batteries on board commercial aircraft. 

Instructions for Passengers Using the Invacarc XP02 Oxygen System Onboard Commercial 

Passenger Aircraft 

To meet FAA's requirements noted in SFAR No. 106, Jnvacare's Travel Manual for the XP02 and 

our website will contain the following instructions (see Exhibit M as an example) for 

patients/passengers that intend to use the Invacare XP02 onboard passenger aircraft: 

I. The user must have a written statement, to be kept in that person's possession, signed by a 

licensed physician, that states: 

(i). Whether the user of the Invacare XP02 has the physical and cognitive ability to see, 

hear and understand the device's aural and visual cautions and warnings and is able, 

without assistance, to take the appropriate action in response to those cautions and 

warnings; 

(ii). Whether or not oxygen use is medically necessary for a ll or a portion of the duration of 

the trip; and 

(iii). The maximum oxygen flow rate corresponding to the pressure in the cabin of the 

aircraft under normal operating conditions. 

2. The user must inform the aircraft operator, pilot in command and crew that the Invacare 

XP02 may be used on board the aircraft and have the physician's statement available that 

specifies the duration of oxygen use required. 

INVACARE CORPORATION 

One lnvacarc Way P.O. Box 4028 Elyria, Ohio 44036-2 125 US/\ 

440-329-6000 Fax: 440-366- 1803 www.invacarc.com 6 
3. If the lnvacare XP02 is not in use during movement on the ground, takeoff and landing, it 

must either be stowed under the seat in front of the user or in another approved stowage 

location so that it does not block the aisle way or the entryway into the row. 

4. Users of the lnvacare XP02 are prohibited from sitting in exit rows. 

5. If the user of the Invacare XP02 is not capable of hearing the unit's alarms, seeing the alarm 

light indicators or have the cognitive ability to take the appropriate action in response to the 

various caution and warning alarms and alarm light indicators, they must travel with 

someone who is capable of performing these functions. 

6. The user must ensure the Invacare XP02 is free of oil, grease or other petroleum products 

and is in good condition, free from damage or other signs of excessive wear or abuse. 

7. The user of the Invacare XP02 must ensure that all lotions or salves applied to his/her person 

are oxygen approved. 

8. The user whose physician statement specifies the duration of oxygen use, must obtain from 

the aircraft operator, or by other means, the duration of the plmmed flight. The user then must 

carry on the flight a sufficient number of batteries to power the Invacare XP02 for the 

duration of the oxygen use specified in the user's physician statement, including a 

conservative estimate of any unanticipated delays. 

9. The user must ensure that the Invacare XPO 110 external battery modules carried on board the 

aircraft in carry-on baggage are packaged in such a way to prevent short circuits or 

generating a dangerous quantity of heat and are protected from physical damage. 

10. If the user does not intend to use the Invacare XP02 on board during the flight, the external 

battery module must be disconnected and packaged separately to prevent accidental 

operation. 

II. The user must ensure there is no open flame or smoking within 10 fee t of the seat row where 

the portable oxygen concentrator is being used. 

Compliance with RTCA/D0-160F 

The lnvacare XP02 has successfully undergone testing pursuant to the requirements of RTCA/D0-

160F, Section 21, Category M to demonstrate that the device will not interfere with an aircraft's 

electrical, navigation or communication equipment. A copy of the test report is attached (Exhibit N) 

and the data will be submitted to air catTiers for verification. 

INVACARE CORPORATION 

One lnvacarc Way P.O. 13ox 4028 Elyria, Ohio 44036-2125 US/\ 

440-329-6000 Fax: 440-366-1803 www.iuvacarc.com 

7 
Summary 

Invacare believes the information contained in this petition provides sufficient information for the 

FAA to determine that the Invacare XP02 is safe to be carried and used on board passenger aircraft. 

We therefore request that Section 2 and Section 3(a) of SF AR No. 106 be amended by adding the 

Invacare XP02 as an approved POC device for use onboard passenger aircraft. 

Should you need additional information or have any questions regarding our product, please do not 

hesitate to call me at the contact information below. 

Respectfully submitted, 

Carroll L. Martin 

Regulatory Affairs Manager 

Invacare Corporation 

One Invacare Way 

Elyria, Ohio 44035 

Phone:440-329-6356 

Fax: 440-326-3458 

Email: Carroii.Martin@invacare.com 

INVACARE CORPORATION 

One lnvacarc Way P.O. 13ox 4028 Elyria, Ohio 44036-2125 USA 

440-329-6000 Fax: 440-366-11"!03 www.invacarc.com 8 
Attachment B 

9 
12/ 13/07 THU 17:32 FAX CDRU FDA ODE ~001 

~ ~~~~~ 

DEPARTMENT OP HEALTH &.HUMAN SERVICES Public Health Service 

Exhibit A Food and Drug Administration 

9200 Corporate Boule\lard 

Rodc'lille MD 20850 

Mr. Curroll L. Martin 

Regulatory Affairs Manager 

Invacare Corporation 

One Invacarc Wny 

P.O.Box 4028 

Elyria, Ohio 44036-2125 

Re: 1<071928 

DEC 1 2 Z007 

Trade/Device Name: Invacare Flyer, Model XP<? 100 

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 

referenc~d above and have determined the device is substantially equivalent (for the 

indications for use stateq in the enclosure) to legally marketed predicate devices marketed in 

interstate commerce prior to May 28, 1976, the enactment date of the Medkal Device 

Amendments, or to devices that have been rec.:lassified in accordance with the provisions of 

the Federal Food, Drug. and Cosmetic Act (Act) that do not require approval of a premarket 

approval application (~MA). 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, FQA may publish further announcements concerning your device in the Federal 

Register. 

10 
12/13/07 THU 17:32 FAX CDRII FDA ODE 

Att achment A 

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 829); and if 

applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 

21 CFR 1000-1050. 

This letter willullow 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 oblain other general information on your responsibilities under the Act from the 

Division of Small Manufacturers, International and Consumer Assistnnce at its toll-free 

number (800) 638-2041 or (301) 443-6591 or ut its Internet address 

http://www.fda.gov/cdrhlindustry/supportlindex.html. 

Enclosure 

Sincerely yours, 

~_tDffJ; J'4 cu.<'C:::I-t<2l 

Director 

Division of Anesth.c:siology, Gc:~eral Hospital, 

Infection Control and Dental Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

@ 002 

11 
12/13/ 07 THU 17 : 32 F~~ CDRII FDA ODE ~00 3 

Attachment A 

Indications for Use 

SlO(k) Number (if known): 

Device Name: Invacare Flyer, Model XPO!OO 

Indications for Use: The Invacare Flyer (Model XPOIOO) is intended to be used by patients 

with respira~ory disorders who require supplem!=ntal 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) 

~ Conc=ad.Rll, Office of Device Evaluation (ODE) 

~1 . 

51 O(k) Number: -~K~b~JwlL-q:u:z_::::...;t{~-- Page 1 of __ 

510(k) ~071928 Response 

P:=tnP. 17 

12 
Attachment C 

13 
INVACARE0 

PORTABLE OXYGEN 

XP02

CONCENTRATOR 

TM ~ Yes, you can: 

With the lnvacare•xro2- Portable Concentrator, providers and patients have a choice of ambulatory oxygen systems from 

lnvacare Corporation, the world leader in home oxygen equipment. Named for its extreme portability, the XP02 concentrator is 

designed to be lightweight, clinically robust and easy to operate. The supplemental battery and AC/OC power options make it easy 

for patients to go just about anywhere without the fear of running out of oxygen. 

The lnvaca e~ XPOi" concentrator features lnvacaree Sensi-Pulse- Technology that customizes the size of each bolus of 

oxygen to meet patient demand. Whether sleeping, relaxing or exercising, Sensi-Pulse technology adapts to the patient's 

oxygen needs. Sensitive conserver. sensible design ... Sensi-Pulse Technology. Sensi-Pulse technology provides constant 

minute-volume. This means that regardless of a patient's breath rate at any given setting. the same amount of oxygen is 

provided per minute. As the breath rate decreases. the bolus size increases. 

14 
--

Features 

Pulse dose settings 1-5 meet the needs 

of a broad range of patients 

Battery, AC or DC operation for patient 

convenience 

No separate battery recharger; charge 

internal and external batteries w ith 

either the AC or DC adapter 

Supplemental battery pack allows for 

extended battery power 

Small compact design 

HCPCS Code: E1390/E1392 

1. AC IXP0130) and DC IXP0 1401 power adapter 

Provider Benefits 

Significantly reduces operating costs by 

virtually eliminating cylinder deliveries, 

w ithout sacrificing patient care 

Encourages compliance with oxygen 

therapy as patients have no worries 

about running out of oxygen 

Simple control panel is easy for patients 

to use and understand 

Patient Benefits 

Small. lightweight, non-medical looking 

package provides comfort. convenience 

and increased independence 

Enjoy life's experiences anywhere. 

any time w ithout heavy cylinders and 

excessive tubing 

FAA approved for in-llight use. Visit 

www.invacare.com for a list of airlines 

that allow the use of the XP02 Portable 

Oxygen Concentrator 

Average Pulse Volume 

Setting @ 20 BPM 

1 15ml 

2 23 ml 

3 31 ml 

4 37 ml 

5 42 ml 

lnvacare Corporation 

www.invacare.com 

USA 

One lnvacare Way 

Elyria. Ohio 

44035·4190 

(800) 333. 6900 

Canada 

570 Matheson Blvd. E .. 

Unit 8 

2. Wheeled cart IXP01201 and carrying case IXP0 1501 Mississauga. Ontario 

L4Z 4G4 Canada 

(800)668 -5324 

3. Supplemental battery (XP01101 with case 

(included with model ff XP0100Bl 

4. Accessory bag IXP0160 not pictured! 

XPOlOOB Concentrator. carrying case. supplemental 

battery. AC adapter. DC adapter and accessory bag 

XP0100 Concentrator. carrying case. AC adapter. DC 

adapter and accessory bag 

11111111111111 

Model # Dimensions Weight Oxygen Flow Oxygen Maximum DC Power DC Adapter 

Purity 0 2 capacity Input Input 

XP0100 10'H 61b. 1·5 Pulse 95.6o/o-87o/o 900ML 18VC0 @ 11-16V 

TW 131b. Settings 3.3A 12.6 V Nominal 

4'D Batte!)' 

IlliG 

ACAdapter 

Input 

100.240VAC 

50160 Hz 

1 A@ 120VAC 

Balle!)' 

Duration 

2.5 Hours@ 

Sening 2 

Recharge 

Time 

3 hrs.' 

• Recharge time increases if unit is running while charging. 

Operating 

Altitude 

Up To 

10,000ft. 

Sound 

Level 

45db @ 

Setting 2 

FAA 

Approved 

Yes 

1\1! reference:; to !ICPCS codos- Providers are responsible fm determinirg the ~p;;to(1!iaw brlhog codes when su:XOiuiug clarms to the 

Medicare program. and should consult an auomey or au,er advisor to discuss specific ions rn fu er detail. 

Limited 

Warranty 

3Year 

Ccncentrator 

12Year 

Compressor) 

1 Year Sattel)'/ 

Accessories 

©2013 

lnvacare Corporation. 

All rights reserved. 

Trademarks are identified 

by the symbols ru and 

®. All trademarks are 

owned by or licensed 

to lnvacare Corporation 

unless otherwise noted. 

Specifications are subject 

to change without 

notification. 

Form No.07 ·067 

Rev. 04/13 

130340 

ClQ} 

Yes, you can: 

15