MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD

{0}------------------------------------------------ K012460 p. 1/3 MEDTRONIC CONFIDENTIAL Special 510(k) Premarket Notification Model 6495 Bipolar Temporary Myocardial Pacing Lead Attachment D: 510(k) Summary of Substantial Equivalence AUG 1 4 2001 ## ATTACHMENT D 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE ### Submitter Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432 Contact: Tina Benoit, Associate Product Regulation Manager Telephone: (763) 514-4112 Fax: (763) 514-6424 E-Mail: tina.benoit@medtronic.com Date Prepared: July 31, 2001 ### Name of Device Trade Name: Temporary Pacemaker Electrode, 74 LDF Common Name: Temporary Pacing Lead Classification: Class II {1}------------------------------------------------ K012460 p. 2/3 MEDTRONIC CONFIDENTIAL Special 510(k) Premarket Notification Model 6495 Bipolar Temporary Myocardial Pacing Lead Model 6495 Dipolar \ Summary of Substantial Equivalence ### Predicate Devices The predicate device for the Model 6495 Bipolar Temporary Myocardial Pacing The production and the currently market released Model 6495 Bipolar Temporary Myocardial Pacing Lead. ### Device Description The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi-filament lead, which contains a distal, discrete, ring electrode, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. Terminated on the back of the chest needle are two breakaway connector pins. To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body. ### Packaging The sterile packaging for the Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of a double pouch configuration. The inner pouch (or package liner) and outer pouch materials are transparent Tyvek - polyester/polyethylene laminate. The pouches are heat-sealed. #### Intended Use The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The device is supplied sterile and intended for single use only. ### Technological Characteristics The technology used with the Model 6495 Bipolar Temporary Myocardial Pacing Lead is the same technological characteristics as the predicate device. {2}------------------------------------------------ K012460 p.3/3 MEDTRONIC CONFIDENTIAL Special 510(k) Premarket Notification Model 6495 Bipolar Temporary Myocardial Pacing Lead Model 0435 Dipolar > Substantial Equivalence ### Summary of Studies Medtronic, Inc. performed system compatibility testing to support that the Model Mcdirolie, the perfective syocardial Pacing lead is equivalent to the predicate device. Device testing included: - Environmental Conditioning . - Visual Verification . - Dimensional Testing . - Electrical Testing . - Mechanical Testing . All system compatibility tests performed have demonstrated that the modified Model 6495 heartwire meets the specified requirements. #### Sterilization Validation The Model 6495 Bipolar Temporary Myocardial Pacing Lead is sterilized using a The Model 6495 Dipolar Tomporilization process. Processes appropriate for sterilizing the devices were validated. ### Conclusion Through data and information presented, numerous similarities support a I hrough data and information pivalence and show the device modifications do not determination of bactuation equive or alter the fundamental scientific technology of the device. Market clearance of the Model 6495 Bipolar Temporary Myocardial Pacing Lead is supported through this Special 510(k) Premarket Notification. {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Image /page/3/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of an eagle with its wings spread. AUG 1 4 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Tina L. Benoit Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576 Re: K012460 Trade Name: Model 6495 Bipolar Temporary Myocardial Pacing Lead Regulation Number: 21 CFR 870.3680 Regulatory Class: Class II (two) Product Code: 74 LDF Dated: July 31, 2001 Received: August 1, 2001 Dear Ms. Benoit: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this {4}------------------------------------------------ #### Page 2 - Ms. Tina L. Benoit response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nredicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, (1) be se contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Oakteh James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Special 510(k) Premarket Notification Model 6495 Bipolar Temporary Myocardial Pacing Lead Indications for Use # INDICATIONS FOR USE NA KO 12460 510(k) Number (if known): Device Name: Medtronic® Model 6495 Bipolar Temporary Myocardial Pacing Lead Indications For Use: The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Division of Cardiovascular & Respiratory Devices 510(k) Number K012460 (Optional Format 1-2-96)