Terumo Heart, Inc. — Hazardous Materials Safety Interpretation

Page 1U.S. Department of Transportation Pipeline and Hazardous Materials Safety Administration 1200 New Jersey Avenue, SE Washington, D.C. 20590 JUL 2 2 2008 Mr. Keith Proctor Terumo Heart Inc. 6 180 Jackson Road Ann Arbor, MI 48 103 Ref. No.: 08-0075 Dear Mr. Proctor: This is in response to your February 26, 2008 letter concerning requirements under the Hazardous Materials Regulations (HMR; 49 CFR Parts 171 -1 80) for design-type testing of lithium-ion batteries. As described in your letter, your company manufactures a medical device powered by a lithium-ion battery pack. The previous design (the S2) has been tested (both the individual cells and the battery pack) in accordance with the UN Manual of Tests and Criteria (tests TI - T8 contained in section 38.3). Your company is planning on replacing the S2 battery with a new battery (the S3). The S3 cells have successfully passed the UN T1 - T8 tests; however, the battery pack made with S3 cells has not been tested. You ask if you must perform the UN T1 - T8 tests on the battery pack made with the S3 cells. In your letter you state that the new battery pack will have an increase of equivalent lithium content of 0.144 gram. In accordance with section 38.2 of the UN Manual of Test and Criteria, a change of more than 0.1 gram or 20 percent by mass, whichever is greater, to the cathode, to the anode, or to the electrolyte is considered a new battery. Therefore, the new battery pack described in your letter is subject to the UN T1 - T8 tests. You should also be aware that your batteries as described in your letter are considered "small lithium batteries" under the HMR, and as such are not subject to the UN TI - T8 testing for domestic transportation until October 1,2009 (see enclosed Docket HM 224C and HM 224E, published August 9,2007 (72 FR 44929)). I hope this information is helphl. If you have W h e r questions, please do not hesitate to contact this office. Hattie L. Mitchell Chief, Regulatory Review and Reinvention Office of Hazardous Materials Standards Enclosure#

Page 2Page 1 of 2 Drakeford, Carolyn <PHMSA> From: Shelton, Paul <PHMSA> Sent: Monday, March 17, 2008 3:39 PM To: Drakeford, Carolyn <PHMSA> Cc: Singh, Harpreet <PHMSA> Subject: FW: UN T I - T8 test requirements From: Proctor Keith Sent: Tuesday, February 26, 2008 5:28 PM To: 'approvals@dot.govl Subject: FW: LIN T1 - T8 test requirements To Whom It May Concern, Terumo Heart, Inc. is a U.S. subsidiary of Terumo Corporation with headquarters and manufacturing facilities in Ann Arbor, Michigan. The company's focus is the innovation and introduction of products to improve the quality of healthcare for heart failure patients. Specifically, Terumo Heart has developed a Left Ventricular Assist Device to provide mechanical circulatory support for patients that have end stage left ventricular failure. A key component of this system is the rechargeable Lithium ion battery packs that are provided to power the implantable pump. The current product uses a lithium ion cell produced by LG Chemical identified as S2, this cell is being replaced by a similar cell from LG Chemical identified as S3. A copy of the MSDS sheets for both of these battery cells is attached. The current battery pack utilizes 8 S2 cells arranged in a 2P4S (two parallel four series) configuration. The S3 replacement cells are direct replacements for the S2 cells. There are no changes required for the configuration, protection circuit, housing, or cabling. The S2 and S3 cells have passed the UN tests T1 - T8 at the cell level. Terumo Heart has also conducted the UN tests T1 - T8 of the S2 battery pack. Our question is whether the UN tests T1 - T8 are required for the S3 battery packs. The following table provides the Lithium content of the cell and pack for the two configurations. Lithium content Lithium content There is a 0.144 gram increase in the equivalent lithium content of the S3 battery pack as compared to the S2 battery pack. Please contact for any additional information requirements.#

Page 3Page 2 of 2 Sincerely, Keith Proctor Director Regulatory Affairs and Quality Systems Terumo Heart Inc 6 1 80 Jackson Road Ann Arbor MI 48 103 734 741 -6360 direct 978 394-0222 cell keith.proctor@terumomedica1.com CONFIDENTIALITY NOTICE: This email contains information from the sender that may be confidential, legally privileged, proprietary or otherwise protected from disclosure. This email is intended for use only by the person or entity to whom it is addressed. If you are not the intended recipient, any use, disclosure, copying, distribution, printing, or any action taken in reliance on the contents of this email, is strictly prohibited. If you received this email in error, please contact the sending party by replying in an email to the sender, delete the email from your computer system and destroy any paper copies of the printed email.#