Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the 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 three faces in profile, stacked on top of each other, with a stylized wave or ribbon flowing beneath them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 10, 2017 Surge Cardiovascular % Korina Akhondzadeh Regulatory Consultant to Surge Cardiovascular KARA & Associates 6965 El Camino Real, Suite 105-428 Carlsbad, California 92009 Re: K170488 Trade/Device Name: Peak Left Ventricular Vent Cannula, 20 Fr .; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 15, 2017 Received: June 19, 2017 Dear Korina Akhondzadeh: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply {1}------------------------------------------------ with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Nicole G. Ibrahim -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K170488 ### Device Name Peak Left Ventricular Vent Cannula # Indications for Use (Describe) The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is nation of the right superior pulmonary vein with the left atrium and passing through the mitral valve. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of inomation. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for Surge Cardiovascular. The logo consists of a blue square with a white stylized "S" inside, followed by the word "SURGE" in a light gray sans-serif font. Below "SURGE" is the word "CARDIOVASCULAR" in a smaller, light gray sans-serif font. # 510(k) Summary This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92. #### l. SUBMITTER Surge Cardiovascular 2680 Walker Ave NW, Suite C Walker, MI 49544 269-629-0300 Phone: Contact at Surge Cardiovascular: Rick Shorey # Official Correspondent Korina A. Akhondzadeh KARA & Associates - Regulatory Consultant to Surge Cardiovascular 6965 El Camino Real, Suite 105-428 Carlsbad, CA 92009 760-798-9642 Phone: Fax: 760-798-9643 Date Prepared: June 15, 2017 #### ll. DEVICE | Device Name: | Peak Left Ventricular Vent Cannula | |----------------------|-------------------------------------------------------------------------------------| | Common/Usual Name: | Left Ventricular Vent | | Classification Name: | Catheter, Cannula and Tubing, Vascular,<br>Cardiopulmonary Bypass (21 CFR 870.4210) | | Product Code: | DWF | | Class: | II | #### III. PREDICATE DEVICE Primary Predicate Device Curved Left Heart Vent Catheter, K0964194 Secondary Predicate Devices DLP Left Heart Vent Catheter, K834352 Malleable Vent Catheter, K981601 This predicate devices have not been subject to a recall. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Surge Cardiovascular. The logo consists of a blue square with a white stylized "S" inside, followed by the word "SURGE" in a light gray sans-serif font. Below "SURGE" is the word "CARDIOVASCULAR" in a smaller, light gray sans-serif font. #### DEVICE DESCRIPTION IV The Peak Left Ventricular Vent Cannula is a single lumen. PVC cannula intended for use in venting the left ventricle during cardiopulmonary bypass with entrance made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. The 36cm Cannula has an open end at the distal tip and a series of side holes at the distal end of the cannula to allow for venting when inserted into the left ventricle. The device is designed with an open-ended smooth, tapered tip to minimize trauma to the tissues. The cannula body slip connector allows for connection to ¼" tubing for venting by the physician. The device is supplied with a malleable PVC Introducer which has a length of stainless steel wire enclosed within the Introducer sheath. The Introducer has a smooth rounded tip at the distal end. When the Introducer is inserted into the cannula body, the luer hub fits into the internal diameter of the slip connector. When the luer hub is seated in the cannula slip connector, the smooth rounded end of the introducer extends beyond the open tip of the Cannula. The device is provided sterile and is intended for single-use. #### V. INDICATIONS FOR USE The Peak Left Ventricular Vent Cannula is indicated for use in venting the left ventricle during cardiopulmonary bypass procedures for durations up to 6 hours. The entrance is made at the juncture of the right superior pulmonary vein with the left atrium and passing through the mitral valve. #### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Both the Peak Left Ventricular Vent Cannula and the predicate devices are tubing sets with similar inlets and outlets for connection to source containers and vials or final medication containers. Both the subject and predicate devices are based upon the same technological elements: The Peak Left Ventricular Vent Cannula and its predicate devices have similar technological characteristics: - Device materials Both subject and predicate devices have PVC cannula bodies . - . Introducer design - The subject device and the California Medical Laboratories Malleable Vent Catheter have PVC Sheath over a malleable Stainless Steel core. - . Tip design – The subject device and the California Medical Laboratories Malleable Vent Catheter have an open ended cannula with open ended tip integrated with the catheter body. - Depth markings - All devices have depth markings. - . Canula Sizes OD - Both Left Ventricular Vent Cannula and the Chase predicate device are availabel in 20 Fr The subject device and the Medtronic DLP device are avaialbe in 16 Fr and 18 Fr. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Surge Cardiovascular. The logo consists of a blue square with a white stylized "S" inside, followed by the word "SURGE" in a light gray sans-serif font. Below "SURGE" is the word "CARDIOVASCULAR" in a smaller, light gray sans-serif font. - Side Openings The subject device and predicate devices have holes at the distal end to allow for fluid flow through the cannula body. - . Cannula Length - Both the subject device and the Chase and DLP predicate devices are 15" long. - . Connector - All devices include a ¼" connector to allow for connection to a vacuum source. #### VII. PERFORMANCE DATA # Biocompatibility Testing The biocompatibility evaluation for the Peak Left Ventricular Vent Cannula device was conducted in accordance with FDA Guidance for Industry and FDA Staff - "Use of International Standard ISO 10993-1, "biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" June 16, 2016. Biocompatibility testing as required for External Communicating Devices, Circulating Blood, Limited Duration was conducted in accordance with cited guidances and standards. The battery of testing included the following tests: - Cytotoxicity - . Sensitization - Intracutaneous reactivity - . Acute systemic toxicity - Material-mediated pyrogenicity - . Hemocompatibility- Hemolysis Indirect and Hemolysis Direct - . Hemocompaiblity - Thrombogenicity - . Hemocompatiblity – Complement Activation - . Genototixicty - Reverse Mutation Assay (Ames Test) - Genotoxicity – Chromosomal Abberration # Performance Testing - Testing of Introducer Assembly of Device - . Simulated Bend/Removal of Introducer - . Flow and Simulated Use Flow Testing - . Simulated Pressure Testing - Simulated Vacuum Testing - Limit Testing for Connector Bond - Limit Testing for Introducer Bond - . Limit Testing for Kink Resistance – Empty - . Limit Testing for Kink Resistance - Full - Ink Adherence Testing - . Shipping/Disribution Studies for Packaging Integrity #### VIII. CONCLUSIONS The testing conducted supports the substantial equivalence of the Peak Left Ventricular Vent Cannula to the predicate devices and demonstrates the Peak Left Ventricular Vent {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Surge Cardiovascular. The logo consists of a blue square with a white stylized "S" inside, followed by the word "SURGE" in gray, and the word "CARDIOVASCULAR" in smaller gray letters below the word "SURGE". The logo is clean and modern, and the colors are professional and trustworthy. Cannula performs as intended. The performance testing conducted demonstrates that the Peak Left Ventricular Vent Cannula performs substantially equivalent to the predicate devices. Both the Peak Left Ventricular Vent Cannula and the predicate devices have the same intended use and technological characteristics.