INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten word that appears to be "KANITS". The letters are written in a simple, slightly stylized font, with some of the strokes being thicker than others. The overall impression is that of a casual, handwritten note. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Submitted By: | Cardiac Control Systems, Inc.<br>3 Commerce Boulevard<br>Palm Coast, FL. 32164<br>Telephone: (904) 445-5450<br>Fax: (904) 445-7226 | | Date Prepared: May 9, 1997<br><br>DEC 2 9 1997 | | | |-------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|------------------------------------------------|--|--| | Contact Person: | Terry C. McMahon<br>Vice President, Regulatory Affairs/<br>Quality Assurance | | | | | | Device Name: | * | Temporary Cardiac Pacing Catheter<br>(common name); | | | | | | * | Temporary Pacemaker Electrode<br>- 74LDF (classification name); | | | | | | * | INTERIM™ AV Shaped Temporary Pacing Catheter; Model INT-AV610 | | | | | Predicate Device: | * | Telectronics (formerly Cordis) Temporary Pervenous with Remote Anode<br>Market cleared by 510(k) K770214 (03/28/77) | | | | ## Indication for Use and Description of Subject Device: The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter. The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting. Feasibility studies were conducted using a catheter with a similar electrode configuration to that of the subject device. These studies were used to determine the optimal location for the atrial electrodes with regard to atrial sensing potential. Clinical studies using the actual design of the subject device were not performed. {1}------------------------------------------------ Image /page/1/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, rendered in black. The symbol is stylized with flowing lines to suggest movement and represents the department's mission related to health and human welfare. DEC 28 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Terry C. McMahon Vice President, Regulatory Affairs .and Quality Assurance Cardiac Control Systems, Inc. 3 Commerce Boulevard Palm Coast, FL 32164 Re : K971775 INTERIM™ AV Model INT-AV610 Temporary Pacing Catheter Regulatory Class: II (two) Product Code: LDF September 30, 1997 Dated: Received: October 1, 1997 Dear Mr. McMahon: 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 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 Requlation (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 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 requlations. {2}------------------------------------------------ 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.qov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callehan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a handwritten word that appears to be "KANITS". The letters are written in a simple, slightly stylized font, with some of the strokes being thicker than others. The overall impression is that of a casual, handwritten note. ## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | Submitted By: | Cardiac Control Systems, Inc.<br>3 Commerce Boulevard<br>Palm Coast, FL. 32164<br>Telephone: (904) 445-5450<br>Fax: (904) 445-7226 | | Date Prepared: May 9, 1997<br>DEC 29 1997 | | | | |-------------------|------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|--|--| | Contact Person: | | Terry C. McMahon<br>Vice President, Regulatory Affairs/<br>Quality Assurance | | | | | | Device Name: | * | Temporary Cardiac Pacing Catheter<br>(common name); | | | | | | | * | Temporary Pacemaker Electrode<br>- 74LDF (classification name); | | | | | | | * | INTERIM TM AV Shaped Temporary Pacing Catheter; Model INT-AV610 | | | | | | Predicate Device: | * | Telectronics (formerly Cordis) Temporary Pervenous with Remote Anode<br>Market cleared by 510(k) K770214 (03/28/77) | | | | | ## Indication for Use and Description of Subject Device: The subject device is indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chamber. The catheter consists of radiopaque polymer (PEBAX) tubing encapsulating a braided wire core for optimum torque response. All electrodes, the two atrial ring electrodes and one ventricular ring electrode and a terminal contact tip electrode, are platinum-indium for maximum conductivity. The electrodes terminate at the proximal end of the catheter with 2 mm goldplated pin connectors for connection with the temporary external pacemaker. The INTERIMIM AV Shaped Temporary Pacing Catheter has a Cournand curve at the ventricular tip and a second curve (offset from the Cournand curve by 90°) in the region from 112 mm to 187 mm from the distal tip electrode. This curve or atrial lobe is 20 mm in amplitude and 75 mm wide. The atrial lobe is centered around the atrial ring-electrode pair to conform with the shape of the atrium endocardium. The atrial lobe and the Cournand curve are permanently set by the same manufacturing process which relies only on the PEBAX insulation to maintain the curved shape. No internal stiffening wires are used. The curve is intended to permit positioning of the atrial electrodes in contact or close proximity to the atrial wall for atrial sensing. The Model INT-AV610 is a 6F diameter catheter. The materials use in the INTERIM™ AV Shaped Temporary Pacing Catheter are: PEBAX® (polyether block amide) thermoplastic insulation, platinum-iridium electrodes, braided stainless steel conductive wire and gold plated pin connectors. Only the PEBAX® insulation and the platinum-iridium electrodes are patient contacting. Feasibility studies were conducted using a catheter with a similar electrode configuration to that of the subject device. These studies were used to determine the optimal location for the atrial electrodes with regard to atrial sensing potential. Clinical studies using the actual design of the subject device were not performed. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with flowing lines, suggesting movement and progress. DEC 28 1997 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Terry C. McMahon Vice President, Regulatory Affairs .and Quality Assurance Cardiac Control Systems, Inc. 3 Commerce Boulevard Palm Coast, FL 32164 Re : K971775 INTERIM™ AV Model INT-AV610 Temporary Pacing Catheter Regulatory Class: II (two) Product Code: LDF September 30, 1997 Dated: Received: October 1, 1997 Dear Mr. McMahon: 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 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 Requlation (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 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 requlations. {5}------------------------------------------------ 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.qov/cdrh/dsmamain.html". Sincerely yours, Thomas J. Callehan Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {6}------------------------------------------------ K971775 510(k) Number (if known): Device Name: INTERIMIN AV Shaped Temporary_Pacing Catheter Indications For Use: INTERIM™ AV Temporary Pacing Catheters are indicated for temporary use in ventricular intracardiac pacing and intracardiac sensing in either the atrial or ventricular chambers. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Clitshmith (Division Sign-Off) (Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)