MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD

{0}------------------------------------------------ MAY 2 6 1998 Model 6416 Bipolar Temporary Transvenous Pa 510(k) Summary ## 510(k) Summary | 1. SUBMITTER'S NAME<br>& ADDRESS | Susan Noddin, Product Regulation Manager<br>Medtronic, Inc.<br>7000 Central Avenue NE<br>Minneapolis, MN 55432<br>Phone: (612) 514-6191<br>Fax: (612) 514-6424 | | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | 2. TRADE NAME: | Bipolar transvenous temporary pacing lead, Model 6416 | | | Common Name: | Temporary Pacing Lead | | | Classification Name: | Temporary Pacemaker Electrode | | | Classification | This device has been classified by the Circulatory Systems Device<br>Panel into Class II, (21 CFR 870.3680(a)). | | | 3. SUBSTANTIALLY<br>EQUIVALENT DEVICE(S) | Temporary Transvenous Pacing Lead, Medtronic Model 6704,<br>marketed via K772103, K790261<br>Medtronic Vector X Guiding Catheter, marketed via K950179 | | | 4. DEVICE DESCRIPTION | The Model 6416 lead consists of a small distal active fixation helix, tip<br>and ring electrodes, an insulated coaxial conductor, and two staggered<br>pin, low-profile bifurcation connectors. The Model 6416 system also<br>includes a guiding catheter which is used for percutaneous lead<br>introduction and placement in the heart. After implantation of the lead,<br>the catheter is removed, and the lead's connectors are attached to an<br>external pulse generator for a contemplated implant duration of up to 7<br>days. After completion of therapy, the lead is removed by counter-<br>rotation and gentle traction. No part of the device remains in the body. | | | 5. INDICATIONS FOR USE | The Medtronic Model 6416 Temporary, Transvenous Pacing Lead<br>System features an active fixation, bipolar lead and a soft-tipped<br>lubricated guide catheter. The system is designed for temporary<br>intracardiac pacing and/or EGM recording. The system is disposable,<br>for temporary single patient use with a contemplated implant duration of<br>7 days or less. The lead and accessories are supplied sterile. The lead<br>is introduced transvenously using the guide catheter. Once within the<br>appropriate chamber, the helical tip electrode of the lead is actively fixed<br>into the endocardium. After lead placement, the guide catheter is<br>removed by sliding it over the lead's bifurcated connector. | | | 6. TECHNOLOGICAL<br>CHARACTERISTIC<br>COMPARISONS | The bipolar transvenous temporary pacing lead system, Model 6416 is<br>substantially equivalent to the following products:<br>Bipolar temporary transvenous pacing lead, Medtronic Temptron Model<br>6704 (K772103, K790261).<br>Medtronic Vector X Guiding Catheter (K950179).<br>The table that follows contains a comparison of the similarities and<br>differences of the Model 6416 to the predicate devices to which it is<br>substantially equivalent. Similarities between the Model 6416 and the<br>comparison devices are noted. | | | Feature | Model 6416 Lead | Model 6704 Lead | | Lead Type | Temporary, single-use | Same | | Intended use (including anatomical<br>site) | Transvenous atrial and ventricular<br>bipolar pacing | Transvenous ventricular bipolar<br>pacing | | Lead Introduction Method | Percutaneous, assisted by<br>disposable guiding catheter | Percutaneous, assisted by<br>disposable introducer | | (Minimum) Device Compatability | Medtronic external cardiac<br>stimulators and cable accessories | Same | | Distal configuration | Straight with fixation helix | Straight, no fixation | | Lead Body | 3.5 French coaxial wire<br>16-wire braid with 3 inner<br>conductors | 4 French coaxial wire<br>16-wire braid with 3 inner<br>conductors | | Ring and Tip Electrodes | 316L stainless steel | 316 / 304 stainless steel | | Electrode surface area | Tip: 4.3 mm²<br>Ring: 17 mm² | Tip: 12 ± 1 mm²<br>Ring: 20 ± 2 mm² | | Electrode ring:tip ratio | 4:1 | 1.6:1 | | Electrode spacing | 1 centimeter | Same | | Outer Insulation material | Polyethylene | Same | | Inner insulation material | FEP | Nylon | | Lead length | 100, 140, & 200 cm | 110 cm | | Connector type | Staggered pin, low profile<br>bifurcation | In-line connector with separate<br>bifurcation assembly | | Connector polarity markings | Long (-) & short (+) wires | Molded (+) and (-) on connectors | | Included accessories | Catheter, hemostasis valve/ cap,<br>torque tool | Bifurcation assy/ introducer set | | Sterilization Method | 100% EtO | Same | | Packaging | 5 sterile packages per carton | Same | | Feature | Model 6416 Guiding Catheter | Vector X Guiding Catheter | | Guiding Catheter | Radiopaque marker bands | No marker bands | | All other features | Same | Same | | 7. SUMMARY OF STUDIES | Medtronic, Inc. performed device integrity testing to support the Model<br>6416 is substantially equivalent to the predicate devices.<br>Device integrity testing included: | | | | Visual verification | Dimensional verification | | | Electrical verification<br>Flex life verification | Pull strength verification | | | All test results for the device met specified requirements. | | | 8. CONCLUSION (STATEMENT<br>OF EQUIVALENCE) | Through the data and information provided in this submission,<br>numerous similarities support a substantial equivalence determination,<br>and, therefore, clearance of the 510(k) notification for the Model 6416. | | Image /page/0/Picture/4 description: The image contains a black arrow pointing to the left, enclosed within a black rectangular border. The arrow is simple in design, with a straight shaft and a pointed head. The arrow and border are the only elements present in the image, set against a white background. Table of Contents నే → {1}------------------------------------------------ Image /page/1/Picture/2 description: The image contains a simple black arrow pointing to the left. The arrow is composed of a horizontal line with an angled line forming the arrowhead. The arrow is positioned above a horizontal line, which may be part of a box or frame. ﺔ 3 {2}------------------------------------------------ Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol that resembles a stylized human figure or a flame-like design, composed of curved lines. MAY 26 1998 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Susan Noddin Product Regulation Manager Medtronic, Inc. 7000 Central Avenue, N.E. Minneapolis, MN 55432-3576 Re : K973360 Trade Name: Medtronic Model 6416 Transvenous Bipolar Temporary Pacing Lead System Requlatory Class: II Product Code: LDF Dated: March 19, 1998 Received: March 20, 1998 Dear Ms. Noddin: 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 Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 {3}------------------------------------------------ Page 2 - Ms. Susan Noddin 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) 594-4618. 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, Thomas J. Callahon Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use The Medtronic Model 6416 Temporary. Transvenous Pacing Lead System features an active fixation, bipolar lead and a soft-tipped lubricated guide catheter. The system is designed for temporary intracardiac pacing and/or EGM recording. The system is disposable, for temporary single patient use with a contemplated implant duration of 7 days or less. The lead and accessories are supplied sterile. The lead is introduced transvenously using the guide catheter. Once within the appropriate chamber, the helical tip electrode of the lead is actively fixed into the endocardium. After lead placement, the guide catheter is removed by sliding it over the lead's bifurcated connector. (Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)  | (Division Sign-Off) | | |------------------------------------------|---------| | Division of Cardiovascular, Respiratory, | | | and Neurological Devices | | | 510(k) Number | K973360 | | Prescription Use | <div> / </div> | |----------------------|---------------------| | (Per 21 CFR 801.109) | | OR | Over-The-Counter Use | |--------------------------| | (Optional Format 1-2-96) | Image /page/4/Picture/8 description: The image shows a simple black arrow pointing to the left. The arrow is contained within a rectangular box. The arrow appears to be centered within the box, with equal spacing on the top and bottom.