MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD

{0}------------------------------------------------ K01 2458 p. 1/3 AUG 1 4 2001 MEDTRONIC CONFIDENTIA Special 510(k) Premarket Notification Model 6492 Unipolar Temporary Atrial Pacing Lead Attachment D: 510(k) Summary of Substantial Equivalence # 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}------------------------------------------------ 01 2458 p.2/3 MEDTRONIC CONFIDENTIAL Special 510(k) Premarket Notification Model 6492 Unipolar Temporary Atrial Pacing Lead Attachment D: 510(k) Summary of Substantial Equivalence #### Predicate Devices The predicate device for the Model 6492 Unipolar Temporary Atrial Pacing Lead is the currently market released Model 6492 Unipolar Temporary Atrial Pacing Lead. ### Device Description The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally 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. 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 6492 Unipolar Temporary Atrial 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 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial 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 6492 Unipolar Temporary Atrial Pacing Lead has is the same technological characteristics as the predicate device. {2}------------------------------------------------ K012458 p.3/3 MEDTRONIC CONFIDENTIAL #### Special 510(k) Premarket Notification Special Temporary Atrial Pacing Lead # Summary of Studies Medtronic, Inc. performed system compatibility testing to support that the Model Medironic, Inc. Performed system ocing Lead is equivalent to the predicate device. Device testing included: - Environmental Conditioning . - Visual Verification . - Electrical Testing . - Mechanical Testing . All system compatibility tests performed have demonstrated that the modified Model 6492 heartwire meets the specified requirements. #### Sterilization Validation The Model 6492 Unipolar Temporary Atrial Pacing Lead is sterilized using a 100% Ethylene Oxide (ETO) sterilization process. Processes appropriate for sterilizing the devices were validated. ## Conclusion Through data and information presented, numerous similarities support a I firough data of substantial equivalence 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 6492 Unipolar Temporary Atrial Pacing Lead is supported through this Special 510(k) Premarket Notification. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. Public Health Service 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: K012458 RoT2150 Trade Name: Model 6492 Unipolar Temporary Atrial 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 we have teviewed your becaon b r (x) xe is substantially equivalent (for the indications for use above and we nave determined an arketed predicate devices marketed in interstate commerce stated in the enclosation to legally manage of the Medical Device Amendments, or to devices that phor to May 20, 1978, and exardance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Free. "The general smanufacturing 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 (1 remancer ripproval), 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 mspoctions, the Four and 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 I his lotter will and n your ding of substantial equivalence of your device to a legally marketed nouticate 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 11 you don't open 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, (301) 59 + 10 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 mormation on your responsive this 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, Don't Tell Lee James E. Dillard III James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ MEDTRONIC CONFIDENTIAL Special 510(k) Premarket Notification Model 6492 Unipolar Temporary Atrial Pacing Lead Indications for Use # INDICATIONS FOR USE K012458 510(k) Number (if known): Device Name: Medtronic® Model 6492 Unipolar Temporary Atrial Pacing Lead Indications For Use: The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial 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 K012453 (Optional Format 1-2-96)