{"operation":"document","citation":"08-0237","title":"OxLife LLC — Hazardous Materials Safety Interpretation","source_type":"guidance","agency":"Pipeline and Hazardous Materials Safety Administration","status":"guidance","official":true,"published_on":"2008-12-10","effective_on":null,"summary":"08-0237 response to OxLife LLC concerning 173.115, 173.185.","machine_formats":{"json":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0237.json","markdown":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0237.md"},"app_url":"https://regulus.evalyn.ai/document/phmsa-interpretation-08-0237","source_url":"https://www.phmsa.dot.gov/sites/phmsa.dot.gov/files/legacy/interpretations/Interpretation%20Files/2008/080237.pdf","body":"<<<PAGE 1>>>\n\nU.S. Department\nof Transportation\nPipeline and Hazardous Materials\nSafety Administration\n1200 New Jersey Ave.. SE\nWash~ngton. DC 20590\nMr. Stuart H. Bassine\nPresident and Senior Technical Engineer\nOxLife LLC\n14 1 Twin Springs Rd.\nHendersonville, NC 28792\nRef. No. 08-0237\nDear Mr. Bassine:\nThis is in response to your September 25, 2008 letter regarding the applicability of the Hazardous\nMaterials Regulations (HMR; 49 CFR Parts 100- 180) to a device your company calls the Oxlife\nIndependence Oxygen Concentrator.\nYou state in your letter, supporting documentation, and a subsequent conversation with a member\nof my staff that the device is a portable oxygen concentrator intended to supply concentrated\noxygen for adult patients requiring supplemental oxygen. This device consists of a lightweight,\nportable oxygen concentrator with an integrated oxygen delivery valve for continuous flow or\npulse delivery. The process by which oxygen is provided is called molecular sieve absorption\ntechnology. The maximum pressure of the oxygen exerted within the device is less than 17 psia\nduring normal operation at a range from -10\" C to 131° C. The device can be powered by multiple\npower sources, including AC, DC or rechargeable battery power. The battery pack consists of 7\ncells with 1.14 grams of lithium content each, or a total of 7.98 total equivalent lithium content,\nand no other hazardous materials. The lithium polymer rechargeable battery pack has been tested\npursuant to the United Nations Manual of Tests and Criteria and is packaged in a manner,to\nprevent short circuits when offered for transport or carried onboard passenger aircraft. You ask\nwhether this device is regulated as a hazardous material under the HMR.\nBased on the information provided, the Oxlife Independence Oxygen Concentrator is not currently\nsubject to the HMR because it meets the following criteria:\n1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 OC;\n2. The lithium polymer battery used to operate the device meets the requirements of the\nHMR;\n3. The portable oxygen concentrator contains no other materials subject to the HMR; and\n4. The battery pack is packaged in a manner to preclude it from creating sparks or generating\na dangerous quantity of heat (for example, by the effective insulation of exposed\nterminals).\n\n<<<PAGE 2>>>\n\nIt should also be noted that Federal Aviation Administration (FAA) approval is required before\nthese electronic devices are used by passengers on board aircraft. For W h e r assistance, you may\ncontact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch\n(AFS-220) by phone at (202)-267-3732 or email at c l : l v i ( - 1 . ~ , ~ t c y ( ( i ~ ~ ~ g ~ .\nI hope this satisfies your inquiry. If we can be of further assistance, please contact us.\n&&I/ 8yy\nSusan Gorsky\nActing Chief, Standards Development\nOffice of Hazardous Materials Standards\n\n<<<PAGE 3>>>\n\nConfidential Page 1 9/25/2008\nFormal Letter of Interpretation\nOxLife LLC.\nSeptember 25,2008\n- -\nMr. Edward T. Mauullo\nDirector, Ofice of Hazardous Materials Standard\nU.S. DOTIPHMSA (PHH-10)\n1200 New Jersey Avenue, SE East Building, 2\" Floor\nWashington, DC 20590\nWe would like to request a formal letter of interpretation that our portable oxygen\nconcentrator model Independence manufactured by OxLife LLC is exempt as hazardous\nmaterial accordiug to the rules of 49 CFR part 100-180\nThe device is a portable oxygen concentrator that is intended to supply concentrated\noxygen for adult patients requiring supplemental oxygen.\nThis product (KXINOOI) has FDA clearance on 4/16/2008 and is manufactured in\naccordance with FDA Quality System regulations and Quality Management Systems in\naccordance wi,th IS0 13485:2003 and MDD93142 Annex II.\nThe product contains less than 8 grams of lithium (small battery) and maximum internal\npressure is less than 17 psi and contains no other material subject to the HMR.\nAttached is the device description, technical information, and description of battery\nspecifications to help guide you on understanding the operation of the device.\nI look forward to answering your questions and I can be reached at:\nOxLife LLC\n141 Twin Springs Rd\nHendersonville NC 28792\nAttention: Stuart Bassine - Sr. Technical Engineer\nMargaret Poteat - Regulatory Affairs\n(828) 684-7353\noxlife@bellsouth.net\nStuart H Bassine\nPresident and Sr. Technical Engineer\nAttachments: A-General Operations (1 Page)\nB-FDA 51 0k (7 Pages),\nC-Battery Manufacture (3 Pages)\n141 T w h Sprirrgs Rd H e n d e r s o m v i l l e NC 28392\n(828)684-2353 (800) 280-261 6 Fax (828) 684-8990\n\n<<<PAGE 4>>>\n\nConfidential Page 2\nFormal Letter of Interpretation\nAttachment. A\nGENERAL OPERATIONS\nCompressor L,J\nHeat I\nI Exchange I\nExhaust\nI\nValve\nI I\nSieve\nA\nSieve\nB\nValve\nI\n\n<<<PAGE 5>>>\n\nConfidential Page 3\nFormal Letter of Interpretation\nAttachment B\nFDA 510K Clearance Letter\n6 Pages Attached PDF\n\n<<<PAGE 6>>>\n\nDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service\nFood and Drug Administration\n9200 Corporate Boulevard\nRockville MD 20850\nMs. Margaret K. Poteat\nGeneral Manager1 Management Representative\nOxLife LLC\n141 Twin Springs Road\nHendersonville, North Carolina 28792\nRe: KO80082\nTrademevice Name: Oxlife Independence Oxygen Concentrator\nRegulation Number: 2 1 CFR 868.5440\nRegulation Name: Portable Oxygen Generator\nRegulatory Class: I1\nProduct Code: CAW\nDated: June 2 1,2007\nReceived: January 17,2008\nDear Ms. Poteat:\nWe have reviewed your Section 510(k) premarket notification of intent to market the device\nreferenced above and have determined the device is substantially equivalent (for the\nindications for use stated in the enclosure) to legally marketed predicate devices marketed in\ninterstate commerce prior to May 28, 1976, the enactment date of the Medical Device\nAmendments, or to devices that have been reclassified in accordance with the provisions of\nthe Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket\napproval application (PMA). You may, therefore, market the device, subject to the general\ncontrols provisions of the Act. The general controls provisions of the Act include\nrequirements for annual registration, listing of devices, good manufacturing practice,\nlabeling, and prohibitions against misbranding and adulteration.\nIf your device is classified (see above) into either class II (Special Controls) or class Ill\n(PMA), it may be subject to such additional controls. Existing major regulations affecfing\nyour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In\naddition, FDA may publish further announcements concerning your device in the Federal\nRegister.\n\n<<<PAGE 7>>>\n\nDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service\nPage 2 - Ms. Poteat Food and Drug Administration\n9200 Corporate Boulevard\nRockville MD 20850\nPlease be advised that FDA's issuance of a substantial equivalence determination does no1\nmean that FDA has made a determination that your device complies with other requirements\nof the Act or any Federal statutes and regulations administered by other Federal agencies.\nYou must comply with all the Act's requirements, including, but not limited to: registration\nand listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice\nrequirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if\napplicable, the electronic product radiation control provisions (Sections 53 1-542 of the Act);\n21 CFR 1000-1050.\nThis letter will allow you to begin marketing your device as described in your Section 510(k)\npremarket notification. The FDA finding of substantial equivalence of your device to a\nlegally marketed predicate device results in a classification for yow device and thus, permits\nyour device to proceed to the market.\nIf you desire specific advice for your device on our labeling regulation (21 CFR Part 801),\nplease contact the Office of. Compliance at (240) 276-01 15. Also, please note the regulation\nentitled, \"Misbranding by reference to premarket notification\" (21CFR Part 807.97). You\nmay obtain other general information on your responsibilities under the Act from the\nDivision of Small Manufacturers, International and Consumer Assistance at its toll-free\nnumber (800) 638-2041 or (301) 443-6597 or at its Internet address\nhttu://www.fda.~ov/cdrhlindust~/su~uort/index.html.\nSincerely yours, .f--'\"--\\\nChiu Lin, Ph.D.\nDirector\nDivision of Anesthesiology, General Hospital,\nInfection Control and Dental Devices\nOffice of Device Evaluation\nCenter for Devices and\nRadiological Health\nEnclosure\n\n<<<PAGE 8>>>\n\nOXLIFE LLC APPLICATION FOR SPECIAL 51 0(k) \"The Independence\"\n01/21/08 updated on 4/8/2008 Page 12\n10.0 51 0(k) Summary bgo op7.\n10.1 Submitters Name: OxLife LLC\n10.2 Submitters Address: 141 Twin Springs Rd Hendersonville NC\n28792\n10.3 Submitters Phone & Fax: 828-684-7353 ph. 828-684-8990 fx.\n10.4 Contact Person: Margaret K. Poteat\nGeneral ManagerIManagement\n' Representative\n10.5 Date Summary Prepared: January 7,2008\n10.6 TradeIProprietaw Name: OxLife IndependenceTM Oxygen\nConcentrators\n10.7 Common/Usual Name: Oxygen Concentrator\n10.8 Classifcation Name: Portable Oxygen Concentrator\n1 0.9 Comparison to Currently Marketed Devices:\nThe 0x1-ife lndependence Oxygen\nConcentrator is substantially equivalent to the\nSeQual Eclipse Model 1000 KO13931\n10.10 Device Description:\n'The Oxlife lndependence Oxygen Concen,trator is used on a prescriptive\nbasis by patients requirirlg supplemental oxygen. Patients may include but\nare not restricted to those with chronic obstructive pulmonary disease\n(COPD). The device is not intended to be life sustaining or to be life\nsupporting. It is used with a nasal cannula to channel oxygen from the\ndevice to the patient. The concentrator and the nasal cannula are non-\nsterile.\nThe Oxlife lndependence Oxygen Concentrator provides approximately\n90% oxygen to the patient on contir~uous to 3 and on a conserver flow basis\nat an 'equivalentn rate of 1.0 liters per min~~te to 6.0 liters to minute.\nThe Oxlife lndependence Oxygen Concentrator is capable of continuous\nuse in a home, institution, vehicles and various mobile environments.\nPower options include 110-220 VAC;l2-14 VDC or rechargeable batteries.\nThe Oxlife lndependence Oxygen Concentrator uses molecular sieve\nadsorption technology. Ambient air is drawn *thru particle filters by a\ncompressor and forced thnr molecular sieve beds, which adsorb nitrogen\nand allow oxygen to pass. The airflow is then changed and nitrogen is\ndesorbed from molecular sieve, allowing it to adsorb again during next\nSmall Business Decision Number SBD088145 EIN # 41-2095576\n\n<<<PAGE 9>>>\n\nOXLIFE LLC APPLICATION FOR SPECIAL 510(k) \"The Independence\"\n01 /21/08 updated on 4/8/2008 Page 13\ncycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is\nexhausted back into the room. A series.of sieve beds, a valve, and timers\nare used to make the system function.\nOxygen is delivered to the patient on a continuous flow basis in precise\namounts during 'the inhalation part of ,the breathing cycle. 'This consewer\ntechnology eliminates waste of unused oxygen at other times in the\nbreathing cycle when it is not needed. Oxlife lndependence Oxygen\nConcentrator senses the beginning of the inhalation cycle and releases a\nspecified dose of oxygen enriched gas from the accumulator reservoir, thru\na final filter, into the connected nasal cannula and onto the patient.\nThe design of the Oxlife lndependence Oxygen Concentrator has focused\non maximizing efficiencies and miniaturizing components to enable\ncontinuous duty use and to provide minimal weight and battery operation\nfor mobile use.\n'The basic technology of the Oxlife lndependence Oxygen Concen,trator is\nequivalent to other approved oxygen concentrators. 'The principles of\noperation are equivalent to the predicate device noted in the submission.\n10.1 1 lndications for Use:\nlndications For Use: The OxLife Oxygen Concentrators are indicated for the\nadministration for supplemental oxygen.\n10.12 Technological Characteristics:\nThe Oxlife lndependence Oxygen Concentrator utilizes well\nestablished technologies. Molecular sievelpressure swing adsorption\ntechnology has been used for many years to produce oxygen. Demand\nflow delivery systems have been in use on portable oxygen sources for\nmany years. The capability of AC,DC or rechargeable battery power\nhas also been in use.\nTechnologies utilized by the Oxlife Independence Oxygen\nConcentrator brings forth no new questions of safety and effectiveness.\nThese technologies are also currently being used in the identified\npredicate device.\nSmall Business Decision Number SBD088145 EIN # 41-2095576\n\n<<<PAGE 10>>>\n\nOXLIFE LLC APPLICATION FOR SPECIAL 51 0(k) \"The Independencen\n01/21/08 updated on 4/8/2008 Page 14\nBench top perFormance testing has demonstrated that the Oxlife\nlndependence Oxygen Concentrator is equivalent to the SeQual\nEclipse Model 1000 KO13931\n10.1 3 PerFormance Data:\nThe results of the oxygen concentration testing confirm that the oxygen\noutput of the modified devices meets specifications and is substantially\nequivalent to the predicate device. Also, the inverter.provides adequate\npower to run the devices from a 12 Volt DC power source.\n10.1 4 Conclusion:\nBased on 'the design, performance specifications and testing and\nintended use, the Oxlife lndependence Oxygen Concentrator are\nsubstantially equivalent to the currently marketed devices.\nSmall Business Decision Number SBD088145 EIN # 41-2095576\n\n<<<PAGE 11>>>\n\nAttachment 2\n8.0 Statement of Indications for Use\nlndications for Use\n51 0 (k) Number: KO80082\nDevice Name: Oxlife Independence Oxygen Concentrator\nIndications For Use: The OxLife Oxygen Concentrators are indicated for the\nadministration for supplemental oxygen.\nPrescription Use X AND/OR - Over-The-Counter Use\n(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)\n, /.I. l&\n(Division Sign-Off)\nDivision of ~nestheslolo~~, General Hosphl\nInfection Control, Dental ~evices\n510(k) Number: 1\\04 004 1\n\n<<<PAGE 12>>>\n\nConfidential Page 4\nFormal Letter of Interpretation\nATTACHMENT C\nLETTERS FROM BATTERY MANUFACTURE\n2 Pages Attached PDF\n\n<<<PAGE 13>>>\n\nH E R S Precise Products lnc.\nAddress: No.10, Alley 9, Lane 170, Sec. 1, Shenlin Rd.,\nDaya Township, Taichung County 428, Taiwan\nTel: 886-4-2568-1353 Fax: 886-4-2565-4689 E-Mail:samuel.nebox@rnsa.hinet.net -\nSpecification of Lithium Polymer Rechargeable Battery Pack\nDate: Sept. 22,2008\nModel No: HP-8030A\nNote:\nB(+) means \"Positive\" of battery, and Ch(+) indicates \"Positive' of charger.\nMarketing Vice President\nHERS Precise Products Inc.\n\n<<<PAGE 14>>>\n\nH E R S Precise P r o d u c t s l n c .\nAddress: No.10, Alley 9, Lane 170, Sec. 1, Shenlin Rd.,\nDaya Township, Taichung County 428, Taiwan\nTel: 886-4-2568-1353 - Fax: 886-4-2565-4689 E-~ail:samuel.-nebox@msa.hinet.net -\nCompliance Declaration of\nLithium Polymer Rechargeable Battery Pack\nDate: Sept. 22, 2008\nAccording to the 48th Edition of the IATA Dangerous Goods Regulations effective\nJanuary 2007, all lithium ion andlor lithium polymer cells and batteries must be tested in\naccordance with the \"UN Manual of Tests and Criteria, Part Ill, Subsection 38.3 (Test\nT I -T8), November I, 2006\".\nHereafter we, HERS Precise Products Inc., certify that the model@) listed in this\ndocument is complied with the requirements from test T I through test T8, specified on\n\"UN Manual of Tests and Criteria, Part Ill, Subsection 38.3\".\nLithium Polymer Rechargeable Battery\nManufacturer:\nLithium Polymer Rechargeable Battery\nModel@):\nHERS Precise Products Inc.\nHP-8030A\nNo.\nT I\nT2\nT3\nT4\nT5\nT6\nT7\nT8\nTest Items\nAltitude Simulation\nThermal Test\nVibration\nShock\nExternal Short Circuit\nImpact\n(For cell only)\nOvercharge\n(For battery only)\nForced Discharge\n(For cell only)\nResults\nYes Pass\nYes Pass\nYes Pass\nYes Pass\nYes Pass\n--------\n~ F a i l\noFail\noFail\noFail\noFail\n--------\nYes Pass\n~ F a i l\n--------\n--------\nMarketing Vlce President\nHERS Precise Products Inc.","truncated":false,"body_characters":16035}