AVERT Contrast Modulation System

{0}------------------------------------------------ Image /page/0/Picture/0 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 a stylized image of three human profiles facing to the right, stacked on top of each other. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 16, 2015 Osprey Medical, Inc. Melanie Hess Vice President, Regulatory Affairs 5600 Rowland Road, Suite 250 Minnetonka, MN 55343 Re: K151300 Trade/Device Name: Avert Contrast Modulation System Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 11, 2015 Received: September 14, 2015 Dear Melanie Hess: This letter corrects our substantially equivalent letter of October 15, 2015. 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. {1}------------------------------------------------ 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 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 device-related 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" (21CFR 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 yours, # Kenneth J. Cavanaugh -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number: K151300 Device Name: AVERT™ Contrast Modulation System #### Indications for Use: The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgUml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml. Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR Over-The Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # 510(k) Summary #### 510(k) Summary As required by 21CFR 807.92(c) | 510(k) Number: __TBD_ | | |---------------------------|---------------------------------------------------------------------------------------------------------------------| | Date Prepared: | May 15, 2015 | | Submitter's Name/Address: | Osprey Medical<br>5600 Rowland Road Suite 250<br>Minnetonka, MN 55343 | | Contact Person: | Melanie Hess<br>Vice President, Regulatory Affairs<br>Tel: 952-955-8252<br>Fax: 952-955-8171<br>Mhess@ospreymed.com | #### Device Information: | Trade Name/Proprietary Name: | AVERT™ Contrast Modulation System | |------------------------------|------------------------------------------------------| | Common Name: | Injector and Syringe, Angiographic | | Classification Registration: | 21 CFR § 870.1650 | | Product Code: | DXT | | FDA Center/Branch: | CDRH/Interventional Cardiology Devices Branch (ICDB) | # Device Description: The Osprey Medical AVERT™ Contrast Modulation System provides a second fluid pathway that modifies the overall system resistance as experienced during the physician's manual injection and allows for excess (i.e. contrast that is not needed for diagnostic or therapeutic purposes) contrast media to be diverted into a reservoir and away from the patient during the manual injection of contrast media while maintaining adequate image quality. Excess contrast is typically a result of refluxed contrast within the patient's vasculature retrograde to the desired image area. The AVERT™ System allows for the modulated reduction {4}------------------------------------------------ of contrast media during manual injections in coronary or peripheral imaging procedures. The AVERT™ System is a device for physician utilization during efforts to minimize total patient contrast volumes. The AVERT™ System consists of a reusable, non-sterile apparatus (contrast modulator), which applies a force to a disposable sterile modulation reservoir with a standard, off-the-shelf 4-way stopcock and extension line. The contrast modulator utilizes an internal mechanism to apply a force to the modulation reservoir; allowing for modulated diversion of manual contrast injections. The force can be easily and quickly adjusted by moving the location of the pin as identified on the outer housing of the system, thereby increasing or decreasing the amount of force applied to the modulation reservoir. The contrast modulator is attached to a wheeled stand and is positioned near the patient, outside of the sterile field. # Intended Use: Osprey Medical AVERT™ Contrast Modulation System (AVERT System) is intended to be used for the controlled infusion of radiopaque contrast media for angiographic procedures. #### Indications for Use: The Osprey Medical AVERT™ System allows for controlled infusion and contrast volume reduction during manual injection of radiopaque contrast media. The AVERT™ System is to be used for angiographic coronary and peripheral procedures with the following agents: Iodixanol 270 or 320 mgVml, Iohexol 300 or 350 mgI/ml, and Iopamidol 300 or 370 mgI/ml. #### Predicate Device: | Trade Name/Proprietary Name: | AVERT™ Contrast Modulation System | |------------------------------|------------------------------------| | Common Name: | Injector and Syringe, Angiographic | | Classification Registration: | 21 CFR § 870.1650 | | Product Code: | DXT | | 510(k) number(s): | K140425, K150485 | ## Comparison to the Predicate Device: The AVERT Contrast Modulation System is substantially equivalent to the previously cleared AVERT Contrast Modulation System, K140425 and K150485, in that they are both designed to control the infusion of radiopaque contrast media for angiographic procedures. {5}------------------------------------------------ The AVERT™ System and predicate AVERT™ System are identical systems with the exception of the modification to the labeling in accordance with clinical trial data. The subject device is identical to the predicate in that: - . The proposed device consists of the same material and technical characteristics; and - No changes have been made to the product performance specifications, sterilization process, . manufacturing processes or risk assessment; and - . The intended use and fundamental scientific technology remains unchanged; and - . No new or different questions of safety or effectiveness are raised with the proposed modification. #### Summary of Non-Clinical Testing: Due to the identical technical characteristics, bench testing was leveraged from the predicate AVERT™ System to support the AVERT™ System. All results demonstrate the AVERT™ System meets product specification and performance requirements. The following testing was successfully completed: - . Device performance testing included flow rate, peak pressure reduction, contrast diversion, flow rate adjustability, mechanical cycle testing, image analysis and compatibility to Osprey Medical Contrast Monitoring System. All testing passed and demonstrated product performance met all prior established acceptance criteria. - Sterilization conditions have been validated in accordance with ISO 11135-1:2007, . Sterilization of health care products – Ethylene Oxide Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices to provide a Sterility Assurance Level of 106. All testing passed. - Simulated use (animal) and post-market design validation was performed and included . assessment of injection pressure, contrast diversion, image analysis. All testing passed and no new or different question of safety or effectiveness were raised. - Shelf-life, distribution and shipping testing was performed per ASTM D4169. Testing . included visual inspection, cycle testing, dye leak test, seal strength test and functional testing. All testing passed and demonstrated product performance met all prior established acceptance criteria. - . Biocompatible testing was performed in accordance with ISO 10993-1:2009 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing included cytotoxicity, sensitization, irritation (intracutaneous reactivity), systemic toxicity, hemocompatibility, {6}------------------------------------------------ genotoxicity, chemical characterization. All testing passed and meet prior established acceptance criteria. All test results demonstrate that the materials, manufacturing processes and design of the Osprey Medical AVERT™ Contrast Modulation System meet the established performance criteria and will perform as intended. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for angiographic injectors and syringes. # Clinical Testing: A prospective, randomized, multi-center clinical evaluation of the Osprey Medical AVERT System was conducted. The study control consisted of standard therapy which is peri-procedural hydration. The treatment included standard therapy plus the AVERT System. The study demonstrated a mean difference in contrast volume between the AVERT and control groups, achieving the pre-specified level of statistical significance, while maintaining adequate image quality. The use of the AVERT System across a range of manual diagnostic and PCI procedures resulted in a significant relative reduction in the volume of contrast delivered during the procedure. This reduction in contrast was achieved without device-related adverse events. ## Statement of Equivalence: The AVERT™ Contrast Modulation System has identical intended use, technological characteristics and fundamental scientific technology as the predicate device. Based on this and data collected in accordance with Osprey Medical Quality System Procedures in compliance with ISO 13485:2003 Medical Devices -Quality management systems - requirements for regulatory purposes and EN ISO 14791:2012 Risk management for medical devices, the AVERT System has been shown to be substantially equivalent under 21 CFR Part 807 subpart E.