MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD

{0}------------------------------------------------ MEDTRONIC CONFIDENTIAL AUG 1 4 2001 Special 510(k) Premarke Model 6500 Unipolar Temporary Myocardial Pacing Lead loder 6500 Unipolar Teliffordi y Myobatantial Equivalence KOL2452 # 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}------------------------------------------------ ## Predicate Devices The predicate device for the Model 6500 Unipolar Temporary Myocardial Pacing Parties of the Model 6500 Unicolar Temporary The predicate device for the Model 6500 Unipslar Temporary Myocardial Pacing Lead. ## Device Description The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an The Model 0500 Unipolar Temperary They conductor which are crimped together. electrode and an insulated multi-inament concession of the lead is attached to the A blue monomanent proximally ocheardumatic myocardial curved needle. A t electrode and terminates distally in an atraumatic myocardial in museum electrode and terminates distanty in an active the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire tissue. An alraumatic chest neceite at the probably of oremove the pacing lead, permits exiting the pacing icad through the enains in the body, except the silicone rubber disc in case of atrial application. ## Packaging The sterile packaging for the Model 6500 Unipolar Temporary Myocardial Pacing I he sterife packaging for the Model Coop Configuration. The inner pouch (or package liner) Lead consists of a dodoic pouch connigation. Tyvek - polyester/polyethylene laminate. The pouches are heat-sealed. ## Intended Use The is designed for temporary atrial and ventricular pacing and sensing for a The is designed for temporary attrails release. The device is supplied sterile and intended for single use only. ## Technological Characteristics The technology used with the Model 6500 Unipolar Temporary Myocardial The technology asoc with the Moderial characteristics as the predicate device. ## Summary of Studies Medtronic, Inc. performed system compatibility testing to support that the Model 6500 Unipolar Temporary Myocardial Pacing Lead is equivalent to the predicate device. Device testing included: - Environmental Conditioning {2}------------------------------------------------ Special 510 Model 6500 Unipolar Temporary Myocardia loder 6500 Umpolar Temporary ikyo ostantial Equivalence - Visual Verification . - Dimensional Testing . - Electrical Testing . - Mechanical Testing . All system compatibility tests performed have demonstrated that the modified Model 6500 heartwire meets the specified requirements. # Sterilization Validation The Model 6500 Unipolar Temporary Myocardial Pacing Lead is sterilized using a The Model 0300 Oxide (ETO) sterilization process. Processes appropriate for sterilizing the devices were validated. ## Conclusion Through data and information presented, numerous similarities support a I hrough data and micrination proseence, and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. Market clearance of the Model 6500 Unipolar Temporary Myocardial Pacing Lead is supported through this Special 510(k) Premarket Notification. 31 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 1 4 2001 Ms. Tina L. Benoit Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576 Re: K012452 Trade Name: Model 6500 Unipolar 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 predicate 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, please 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, Dore K. Miller James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # INDICATIONS FOR USE 510(k) Number (if known): KO12452 NA Device Name: Medtronic® Model 6500 Unipolar Temporary-Myocardial Pacing Lead Indications For Use: The Model 6500 Unipolar Temporary Myocardial Pacing I he Model 0500 Omporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. schsing for a concemplated in 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) 1 Over-The-Counter Use__ OR Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Deak Teth **Division of Cardiovascular & Respiratory Devices** 510(k) Number K012452 4