OxLife LLC — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Ave.. SE Wash~ngton. DC 20590 Mr. Stuart H. Bassine President and Senior Technical Engineer OxLife LLC 14 1 Twin Springs Rd. Hendersonville, NC 28792 Ref. No. 08-0237 Dear Mr. Bassine: This is in response to your September 25, 2008 letter regarding the applicability of the Hazardous Materials Regulations (HMR; 49 CFR Parts 100- 180) to a device your company calls the Oxlife Independence Oxygen Concentrator. You state in your letter, supporting documentation, and a subsequent conversation with a member of my staff that the device is a portable oxygen concentrator intended to supply concentrated oxygen for adult patients requiring supplemental oxygen. This device consists of a lightweight, portable oxygen concentrator with an integrated oxygen delivery valve for continuous flow or pulse delivery. The process by which oxygen is provided is called molecular sieve absorption technology. The maximum pressure of the oxygen exerted within the device is less than 17 psia during normal operation at a range from -10" C to 131° C. The device can be powered by multiple power sources, including AC, DC or rechargeable battery power. The battery pack consists of 7 cells with 1.14 grams of lithium content each, or a total of 7.98 total equivalent lithium content, and no other hazardous materials. The lithium polymer rechargeable battery pack has been tested pursuant to the United Nations Manual of Tests and Criteria and is packaged in a manner,to prevent short circuits when offered for transport or carried onboard passenger aircraft. You ask whether this device is regulated as a hazardous material under the HMR. Based on the information provided, the Oxlife Independence Oxygen Concentrator is not currently subject to the HMR because it meets the following criteria: 1. The pressure of the oxygen in the device does not exceed 40.6 psia at 20 OC; 2. The lithium polymer battery used to operate the device meets the requirements of the HMR; 3. The portable oxygen concentrator contains no other materials subject to the HMR; and 4. The battery pack is packaged in a manner to preclude it from creating sparks or generating a dangerous quantity of heat (for example, by the effective insulation of exposed terminals).#

Page 2It should also be noted that Federal Aviation Administration (FAA) approval is required before these electronic devices are used by passengers on board aircraft. For W h e r assistance, you may contact Mr. Dave Catey, Aviation Safety Inspector for the FAA Air Carrier Operations Branch (AFS-220) by phone at (202)-267-3732 or email at c l : l v i ( - 1 . ~ , ~ t c y ( ( i ~ ~ ~ g ~ . I hope this satisfies your inquiry. If we can be of further assistance, please contact us. &&I/ 8yy Susan Gorsky Acting Chief, Standards Development Office of Hazardous Materials Standards#

Page 3Confidential Page 1 9/25/2008 Formal Letter of Interpretation OxLife LLC. September 25,2008 - - Mr. Edward T. Mauullo Director, Ofice of Hazardous Materials Standard U.S. DOTIPHMSA (PHH-10) 1200 New Jersey Avenue, SE East Building, 2" Floor Washington, DC 20590 We would like to request a formal letter of interpretation that our portable oxygen concentrator model Independence manufactured by OxLife LLC is exempt as hazardous material accordiug to the rules of 49 CFR part 100-180 The device is a portable oxygen concentrator that is intended to supply concentrated oxygen for adult patients requiring supplemental oxygen. This product (KXINOOI) has FDA clearance on 4/16/2008 and is manufactured in accordance with FDA Quality System regulations and Quality Management Systems in accordance wi,th IS0 13485:2003 and MDD93142 Annex II. The product contains less than 8 grams of lithium (small battery) and maximum internal pressure is less than 17 psi and contains no other material subject to the HMR. Attached is the device description, technical information, and description of battery specifications to help guide you on understanding the operation of the device. I look forward to answering your questions and I can be reached at: OxLife LLC 141 Twin Springs Rd Hendersonville NC 28792 Attention: Stuart Bassine - Sr. Technical Engineer Margaret Poteat - Regulatory Affairs (828) 684-7353 oxlife@bellsouth.net Stuart H Bassine President and Sr. Technical Engineer Attachments: A-General Operations (1 Page) B-FDA 51 0k (7 Pages), C-Battery Manufacture (3 Pages) 141 T w h Sprirrgs Rd H e n d e r s o m v i l l e NC 28392 (828)684-2353 (800) 280-261 6 Fax (828) 684-8990#

Page 4Confidential Page 2 Formal Letter of Interpretation Attachment. A GENERAL OPERATIONS Compressor L,J Heat I I Exchange I Exhaust I Valve I I Sieve A Sieve B Valve I#

Page 5Confidential Page 3 Formal Letter of Interpretation Attachment B FDA 510K Clearance Letter 6 Pages Attached PDF#

Page 6DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Margaret K. Poteat General Manager1 Management Representative OxLife LLC 141 Twin Springs Road Hendersonville, North Carolina 28792 Re: KO80082 Trademevice Name: Oxlife Independence Oxygen Concentrator Regulation Number: 2 1 CFR 868.5440 Regulation Name: Portable Oxygen Generator Regulatory Class: I1 Product Code: CAW Dated: June 2 1,2007 Received: January 17,2008 Dear Ms. Poteat: 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 Ill (PMA), it may be subject to such additional controls. Existing major regulations affecfing 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.#

Page 7DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Page 2 - Ms. Poteat Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Please be advised that FDA's issuance of a substantial equivalence determination does no1 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 53 1-542 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 yow 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) 276-01 15. 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 httu://www.fda.~ov/cdrhlindust~/su~uort/index.html. Sincerely yours, .f--'"--\ 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#

Page 8OXLIFE LLC APPLICATION FOR SPECIAL 51 0(k) "The Independence" 01/21/08 updated on 4/8/2008 Page 12 10.0 51 0(k) Summary bgo op7. 10.1 Submitters Name: OxLife LLC 10.2 Submitters Address: 141 Twin Springs Rd Hendersonville NC 28792 10.3 Submitters Phone & Fax: 828-684-7353 ph. 828-684-8990 fx. 10.4 Contact Person: Margaret K. Poteat General ManagerIManagement ' Representative 10.5 Date Summary Prepared: January 7,2008 10.6 TradeIProprietaw Name: OxLife IndependenceTM Oxygen Concentrators 10.7 Common/Usual Name: Oxygen Concentrator 10.8 Classifcation Name: Portable Oxygen Concentrator 1 0.9 Comparison to Currently Marketed Devices: The 0x1-ife lndependence Oxygen Concentrator is substantially equivalent to the SeQual Eclipse Model 1000 KO13931 10.10 Device Description: 'The Oxlife lndependence Oxygen Concen,trator is used on a prescriptive basis by patients requirirlg supplemental oxygen. Patients may include but are not restricted to those with chronic obstructive pulmonary disease (COPD). The device is not intended to be life sustaining or to be life supporting. It is used with a nasal cannula to channel oxygen from the device to the patient. The concentrator and the nasal cannula are non- sterile. The Oxlife lndependence Oxygen Concentrator provides approximately 90% oxygen to the patient on contir~uous to 3 and on a conserver flow basis at an 'equivalentn rate of 1.0 liters per min~~te to 6.0 liters to minute. The Oxlife lndependence Oxygen Concentrator is capable of continuous use in a home, institution, vehicles and various mobile environments. Power options include 110-220 VAC;l2-14 VDC or rechargeable batteries. The Oxlife lndependence Oxygen Concentrator uses molecular sieve adsorption technology. Ambient air is drawn *thru particle filters by a compressor and forced thnr molecular sieve beds, which adsorb nitrogen and allow oxygen to pass. The airflow is then changed and nitrogen is desorbed from molecular sieve, allowing it to adsorb again during next Small Business Decision Number SBD088145 EIN # 41-2095576#

Page 9OXLIFE LLC APPLICATION FOR SPECIAL 510(k) "The Independence" 01 /21/08 updated on 4/8/2008 Page 13 cycle. Oxygen is collected in an accumulator reservoir. Waste nitrogen is exhausted back into the room. A series.of sieve beds, a valve, and timers are used to make the system function. Oxygen is delivered to the patient on a continuous flow basis in precise amounts during 'the inhalation part of ,the breathing cycle. 'This consewer technology eliminates waste of unused oxygen at other times in the breathing cycle when it is not needed. Oxlife lndependence Oxygen Concentrator senses the beginning of the inhalation cycle and releases a specified dose of oxygen enriched gas from the accumulator reservoir, thru a final filter, into the connected nasal cannula and onto the patient. The design of the Oxlife lndependence Oxygen Concentrator has focused on maximizing efficiencies and miniaturizing components to enable continuous duty use and to provide minimal weight and battery operation for mobile use. 'The basic technology of the Oxlife lndependence Oxygen Concen,trator is equivalent to other approved oxygen concentrators. 'The principles of operation are equivalent to the predicate device noted in the submission. 10.1 1 lndications for Use: lndications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen. 10.12 Technological Characteristics: The Oxlife lndependence Oxygen Concentrator utilizes well established technologies. Molecular sievelpressure swing adsorption technology has been used for many years to produce oxygen. Demand flow delivery systems have been in use on portable oxygen sources for many years. The capability of AC,DC or rechargeable battery power has also been in use. Technologies utilized by the Oxlife Independence Oxygen Concentrator brings forth no new questions of safety and effectiveness. These technologies are also currently being used in the identified predicate device. Small Business Decision Number SBD088145 EIN # 41-2095576#

Page 10OXLIFE LLC APPLICATION FOR SPECIAL 51 0(k) "The Independencen 01/21/08 updated on 4/8/2008 Page 14 Bench top perFormance testing has demonstrated that the Oxlife lndependence Oxygen Concentrator is equivalent to the SeQual Eclipse Model 1000 KO13931 10.1 3 PerFormance Data: The results of the oxygen concentration testing confirm that the oxygen output of the modified devices meets specifications and is substantially equivalent to the predicate device. Also, the inverter.provides adequate power to run the devices from a 12 Volt DC power source. 10.1 4 Conclusion: Based on 'the design, performance specifications and testing and intended use, the Oxlife lndependence Oxygen Concentrator are substantially equivalent to the currently marketed devices. Small Business Decision Number SBD088145 EIN # 41-2095576#

Page 11Attachment 2 8.0 Statement of Indications for Use lndications for Use 51 0 (k) Number: KO80082 Device Name: Oxlife Independence Oxygen Concentrator Indications For Use: The OxLife Oxygen Concentrators are indicated for the administration for supplemental oxygen. Prescription Use X AND/OR - Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) , /.I. l& (Division Sign-Off) Division of ~nestheslolo~~, General Hosphl Infection Control, Dental ~evices 510(k) Number: 1\04 004 1#

Page 12Confidential Page 4 Formal Letter of Interpretation ATTACHMENT C LETTERS FROM BATTERY MANUFACTURE 2 Pages Attached PDF#

Page 13H E R S Precise Products lnc. Address: No.10, Alley 9, Lane 170, Sec. 1, Shenlin Rd., Daya Township, Taichung County 428, Taiwan Tel: 886-4-2568-1353 Fax: 886-4-2565-4689 E-Mail:samuel.nebox@rnsa.hinet.net - Specification of Lithium Polymer Rechargeable Battery Pack Date: Sept. 22,2008 Model No: HP-8030A Note: B(+) means "Positive" of battery, and Ch(+) indicates "Positive' of charger. Marketing Vice President HERS Precise Products Inc.#

Page 14H E R S Precise P r o d u c t s l n c . Address: No.10, Alley 9, Lane 170, Sec. 1, Shenlin Rd., Daya Township, Taichung County 428, Taiwan Tel: 886-4-2568-1353 - Fax: 886-4-2565-4689 E-~ail:samuel.-nebox@msa.hinet.net - Compliance Declaration of Lithium Polymer Rechargeable Battery Pack Date: Sept. 22, 2008 According to the 48th Edition of the IATA Dangerous Goods Regulations effective January 2007, all lithium ion andlor lithium polymer cells and batteries must be tested in accordance with the "UN Manual of Tests and Criteria, Part Ill, Subsection 38.3 (Test T I -T8), November I, 2006". Hereafter we, HERS Precise Products Inc., certify that the model@) listed in this document is complied with the requirements from test T I through test T8, specified on "UN Manual of Tests and Criteria, Part Ill, Subsection 38.3". Lithium Polymer Rechargeable Battery Manufacturer: Lithium Polymer Rechargeable Battery Model@): HERS Precise Products Inc. HP-8030A No. T I T2 T3 T4 T5 T6 T7 T8 Test Items Altitude Simulation Thermal Test Vibration Shock External Short Circuit Impact (For cell only) Overcharge (For battery only) Forced Discharge (For cell only) Results Yes Pass Yes Pass Yes Pass Yes Pass Yes Pass -------- ~ F a i l oFail oFail oFail oFail -------- Yes Pass ~ F a i l -------- -------- Marketing Vlce President HERS Precise Products Inc.#