{"operation":"document","citation":"11-0229","title":"Inogen, Inc. — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2011-10-12","effective_on":null,"summary":"11-0229 response to Inogen, Inc. concerning 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0229.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0229.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-11-0229","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretations/2011/110229.pdf","body":"<<<PAGE 1>>>\n\nu.s. Department 1200 New Jersey Avenue SE\nof Transportation Washington. DC 20590\nPipeline and Hazardous\nMaterials Safety\nAdministration\nOCT 1 22011\nMr. Matt Scribner\nVice President of Operations\nInogen, Inc.\n326 Bollay Drive\nGoleta, CA 93117\nRef. No. 11-0229\nDear Mr. Scribner:\nThis responds to your September 16,2011 email requesting clarification of the applicability\nofthe Hazardous Materials Regulations (HMR; 49 CFR Parts 171-180) to a portable\noxygen concentrator. You request confirmation that the Inogen One G3portable oxygen\nconcentrator (heretofore referred to as the G3) is not subject to the HMR.\nYour company requested interpretations in 2004 and 2009 on the applicability of the HMR\nto previous generations of the G3. In our August 6, 2009 letter response, we stated that,\nprovided the conditions in § 172.102, Special Provision 188 (SP 188) are met, the Inogen\nOne G2 portable oxygen concentrator is not subject to further requirement under the HMR.\nAccording to information provided with this request, your company has made modifications\nto Inogen One G2 resulting in the G3 design \"without any functional changes that affect the\noverall safety ofthe device or its safe use on commercial aircraft.\" The most significant\nchange to the G3 is a smaller battery. The G3 uses an 8-cell lithium ion battery pack and\nprovides an optional extended life battery consisting of two 8-cell battery packs that are\nelectrically isolated and mechanically separated when enclosed in the device. Specifically,\nyou state: (1) each lithium ion cell has an equivalent lithium content of 0.87 gram; (2) the\ntotal equivalent lithium content of each 8-cell battery pack is 7 grams (-83.5 Wh); (3) the\nbatteries are contained in the device and packaged in a manner to prevent sparks or the\ngeneration ofa dangerous evolution of heat; (4) the pressure of the oxygen in the device is\nlimited to less than 43.8 psia at 20°C (68 OF); and (5) no other hazardous material subject\nto the HMR is contained in the device.\nBased on the information provided, the oxygen in the G3 is not subject to the HMR as a\nDivision 2.2 non-flammable gas. Moreover, it is the opinion ofthis Office that the\nG3 device and the lithium ion batteries contained in the device appear to conform to SP 188\nfor the transportation of small lithium cells and batteries. Note that as one of the conditions\nof SP 188, the lithium ion batteries must be of a type proven to meet the requirements of\ntesting in the UN Manual ofTests and Criteria. Thus, provided the conditions in SP 188\ncontinue to be met, the G3 is not subject to any other requirements in the HMR.\n\n<<<PAGE 2>>>\n\nAs in our previous responses, we note that, even with FAA approval, an air carrier\nultimately determines what mayor may not be carried on its aircraft. We suggest that you\ncheck with the airlines to ensure that the G3 may be carried aboard passenger aircraft.\nI hope this information is helpful. If you have further questions, please do not hesitate to\ncontact this office.\nBen Supko\nActing Chief, Standards Development Branch\nStandards and Rulemaking Division\n\n<<<PAGE 3>>>\n\nSept 16,2011\nStandards and Rule Making PHH 1 0\nEast Building, 2nd floor\nCubicle E24-41 0\n1200 New Jersey Avenue, SE\nWashington, DC 20590\nApplicant:\nMatt Scribner\nVP of Operations\nInogen, Inc.\n326 Bollay Drive\nGoleta, CA 93117\nPhone: (80S) 562-0528\nFax: {80S} 562-0516\nCell: [805) 252-5089\nRe: Petition to Amend SFAR No.1 06 on Portable Oxygen Concentrator Devices\non Passenger Aircraft\nDear Sir or Madam:\nPlease accept this letter as petition to amend the Federal Aviation\nAdministration's (FAA) Special Federal Aviation Regulation [SFAR} No. 106 under\n14 CFR 121 that allows for the use of certain portable oxygen concentrator\n(POC) devices on board passenger aircraft. Inogen Corporation is specifically\nrequesting that the FAA amend Section 2 and Section 3(a) of SFAR No.1 06 by\nadding Inogen One G3 Portable Oxygen Concentrator, manufactured by\nInogen, as one of the POC devices for use on passenger aircraft. The Inogen\nOne and Inogen One G2 POCs have already been approved by the FAA and\nwere added to the SFAR No.1 06 in the final published regulation on July 12,2005\nand January 6,2010 respectively.\nBackground\n326 Bollay Drive. Goleta, CA 93117 • 805-562-0500 (T) • 805-562-0516\n(F) • www.inogen.net\n\n<<<PAGE 4>>>\n\nInogen manufactures portable oxygen concentrators and has had the Inogen\nOne available for commercial distribution since receiving the 51 Ok clearance on\nMay 13, 2004. The Inogen portable oxygen concentrators are lightweight,\nbattery powered POCs intended for patients with respiratory disorders that\nrequire the use of supplemental oxygen. The devices are ideal for those\npatients who wish to have improved mobility and freedom to travel. The ability\nto travel on passenger aircraft is an important part of the quality of life that\nInogen wishes to provide for its customers. All of Inogen's portable oxygen\nconcentrator models are designed to be CSA certified to IEC-60601 for product\nsafety and conform to all MOD requirements\nInogen has made design improvements to the Inogen One G2 which will be\nmarketed as the Inogen One G3 Portable Oxygen Concentrator. These\nchanges will improve the usability of the device for its customers. These\nchanges are minor, but should help the user's mobility by providing a smaller,\nlighter-weight device {less than 5 pounds). As with the Inogen One and Inogen\nOne G2, the G3 will fit under the seat and in the overhead bin of the smallest\nregional jets.\nThe Inogen One, Inogen One G2 and Inogen One G3 provide oxygen in the\nsame manner, by separating oxygen from ambient air utilizing a molecular sieve\nand pressure swing adsorption methodology. The resultant concentrated\noxygen is accumulated in an oxygen reservoir for delivery to the patient. This\npressure in thelnogen One G3 is controlled in the same manner as the previous\ntwo models to limit the pressure to less than 40.6 psia. Aliinogen POCs deliver\noxygen to the patient through the pulse delivery method for maximum\neffectiveness and operational time. This means that a sensor in the Inogen One\nG3 detects the inhalation of the patient and delivers the oxygen in a bolus at\nthat time. If no breath is detected because the patient takes the cannula off,\nno oxygen is delivered. Similarly, no oxygen is delivered during the exhalation\nwhich minimized the waste of oxygen. This feature of delivering oxygen on\ndemand also minimizes accumulation of concentrated oxygen in the vicinity of\nthe device.\nThe Inogen One G3 is an enhancement to the Inogen POC line without any\nfunctional changes that affect the overall safety of the device or its safe use on\ncommercial aircraft. All of the components of the device relevant to the use on\naircraft remain essentially the same. The most significant difference in the G3 is\nthe smaller battery. Rather than having 12 cell battery packs like the Inogen\nOne and Inogen One G2 batteries, the Inogen One G3 batteries are 8 cell\npacks and contain less lithium ion content per battery than either the G 1 or G2\nbatteries which are 98Wh lithium ion batteries. Like the G2, the Inogen One G3\nalso has an optional extended life battery. This battery consists of two 8 cell\n326 Bollay Drive • Goleta, CA 93117 • 805-562-0500 (T) • 805-562-0516\n(F) • www.inogen.net\n\n<<<PAGE 5>>>\n\nbattery packs that are electronically isolated and mechanically separated.\nEach lithium ion cell in the G3 battery contains the equivalent lithium ion\ncontent of .870 grams. Each battery pack has a IHhium ion content of 7 grams\nor 83.5 Wh and is designed and packaged to prevent sparks or the generation\nof a dangerous evolution of heat. Like the Inogen One G2 batteries, the G3\nbatteries are also individually CSA safety tested per IEC62133/UL1642.\nFDA 510(kj Clearance Letter\nThe Inogen One Portable Oxygen Concentrator was determined by the FDA to\nbe substantially equivalent to its legally marketed predicate devices on May 13,\n2004. The device was granted clearance under K032818 under regulation\nnumber 21 CFR 868.5440, \"Portable Oxygen Generator\".\nThe Inogen One G3 Portable Oxygen Concentrator is an extension of the Inogen\nPOC product line. It has minor modifications to improve its ability to meet the\nneeds of the users. The Indications for Use for the device are identical to those\nof the Inogen One. The basic operating principle for the device, that it provide\noxygen therapy through the pulse technology, remains unchanged with the\nInogen One G3.\nInogen considers the Inogen One G3 POC to be a non-significant change from\nthe Inogen One and Inogen One G2 design and materials. Under the FDA\nrequirements for the Food, Drug and Cosmetic Act, Section 510(k) and the FDA\nGuidance Document K97-1 \"Deciding when to Submit a 510(k) for a Change to\nan Existing Device\", the Inogen One G3 device does not require a new 510(k)\nnotification to the FDA. It does require documentation to Inogen's regulatory\nfiles and is then legally marketed under the existing cleared 51 O(k), K032818.\nThe Inogen One G3 will be available for sale under FDA clearance letter\nK032818. It is equivalent in design and use to the original Inogen One POC and\nthe Inogen One G2, which have already been granted permission for use by\nFAA and passenger aircraft through amendments of SFAR 106. With the FDA\nclearance letter K032818 and the written documentation on file for the Inogen\nOne G3, the Inogen One G3 will be marketed to persons requiring supplemental\noxygen and who desire greater mobility.\nPHMSA Letter of Interpretation\nIn 2004 and in 2009, Inogen submitted requests to the US Department of\nTransportation and to the Pipeline and Hazardous Material Safety Agency asking\nfor written interpretation that the Inogen One POC and Inogen One G2 POC\nwere not subject to the U.S. Hazardous Materials Regulation (HMR) as\n326 Bollay Drive • Goleta, CA 93117 • 805-562-0500 (T) • 805-562-0516\n(F) • www.inogen.net\n\n<<<PAGE 6>>>\n\nreferenced in 49 CFR Parts 171-180. On March 2004 and August 2009, Inogen\nreceived confirmation that the Inogen One POC and Inogen One G2 POC were\nnot subject to the HMR.\nBecause the operating specifications for the Inogen One G3 do not exceed any\nof the specifications of the Inogen One or Inogen One G2 and the batteries\nused by the Inogen One G3 contain less equivalent lithium ion content than the\nInogen One or Inogen One G2, batteries Inogen is confident that the G3 is not\nsubject to the Hazardous Material Regulation. Attached is a copy of the 3/24/04\nletter from Edward Mazzullo, DOL stating that the Inogen One is not subject to\nthe Hazardous Material Regulations and also a copy of the August 6, 2009 letter\nfrom Charles E. Betts, Chief, Standards Development, Office of Hazardous\nMaterials Standards confirming that the Inogen One G2 is also not subject to the\nHMR as a division 2.2 non-flammable gas and that the batteries conform to the\nprovisions of Special Provision 188.\nSummary\nInogen believes that the information contained in this petition provides sufficient\ninformation for the PHMSA to determine that the Inogen One G3 Portable\nOxygen Concentrator, by design, does not meet the criteria for hazardous\nmaterial and the batteries of the Inogen One G3 conform to the provisions of\nSpecial Provision 188. The availability of this concentrator will benefit those\npatients who require supplemental oxygen on a regular basis and who want to\nbe able to travel on aircraft. The Inogen line extension to its portable oxygen\nconcentrator has made the device lighter weight, smaller and easier for\npatients to use. The ability to carry the unit onboard aircraft will enhance the\nquality of life for the users of the device.\nThe Inogen One G3 is a non-significant change in function and operation when\ncompare to the earlier generations of the Inogen One POCs that have already\nbeen approved for use on aircraft by the FAA. We therefore respectfully\nrequest that the section 2 and section 3 of the SFAR No.1 06 be amended by\nadding the Inogen One G3 as an approved POC for use onboard passenger\naircraft.\nShould you need any additional information or have any questions regarding\nthis product, please feel free to contact me by phone or email.\nRespectfully submitted.\nMatt Scribner\nVP Operations\nInogen, Inc.\n326 Bollay Drive • Goleta, CA 93117 • 805-562-0500 (T) • 805-562-0516\n(F) • www.inogen.net\n\n<<<PAGE 7>>>\n\nBollay Drive\nGoleta, CA 9311 7\nPhone: (805) 562-0528\nCell: (805) 252-5089\nFax: (805) 562-0516\nEmail: mscribner@inogen.net\nWebsite: www-inogenone.com\n326 Bollay Drive • Goleta, CA 93117 • 805-562-0500 (T) • 805-562-0516\n(F) • www.inogen.net","truncated":false,"body_characters":12633}