Accuryn Monitoring System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized depiction of three human profiles merging into a single form, often interpreted as representing health, humans, and services. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the emblem. Re: Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 15, 2016 Potrero Medical, Inc. Devyani Nanduri Director of Clinical and Regulatory Affairs 101 Mississippi St. San Francisco, CA 94107 > K153655 Trade/Device Name: Accuryn Monitoring System Regulation Number: 21 CFR 876.5130 Regulation Name: Urological Catheter and Accessories Regulatory Class: Class II Product Code: EZL, EXY, PHU Dated: March 11, 2016 Received: March 14, 2016 Dear Devyani Nanduri, 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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 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 yours, # Herbert P. Lerner -S Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological 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) K153655 Device Name Accuryn Monitoring System ### Indications for Use (Describe) The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days). | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | <div> <span> <b> </b> </span> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## 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 information. 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." {3}------------------------------------------------ II. ��� # 510(k) Summary # Accuryn Monitoring System #### Submitter Information 1. | 510(k) Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 CFR 807.92 | |-----------------------|----------------------------------------------------------------------------------------------------------------------------------------| | Submission Sponsor | Potrero Medical, Inc. | | | 101 Mississippi St. | | | San Francisco, CA 94107 | | Contact Person | Contact Person: Devyani Nanduri, PhD | | | Phone: (415) 926-8618 | | | Fax: (415) 800-7086 | | Date Prepared | December 18, 2015 | | I. Device | | | Name of Device | Accuryn™ Monitoring System | | | Accuryn™ Sensing Urinary Catheter, Accuryn™ Monitor | | Common or Usual | Temperature-sensing Foley catheter, Intra-abdominal pressure | | Name | monitoring device | | Classification Name | Catheter, Retention Type, Balloon (21 CFR 876.5130) | | | Intra-Abdominal Pressure Monitoring Device (Unclassified) | | Regulatory Class | II | | Product Code(s) | EZL, PHU, EXY | | II. Predicate Devices | Bardex Latex-Free Temperature Sensing Foley Catheter (K070582)<br>Bard Intra-abdominal Pressure Monitoring Device (K070201) | #### IV. Device Description The Accuryn Monitoring System consists of the three components, the Accuryn Sensing Urinary Catheter, Accuryn Urine Collection Set, and the Accuryn Monitor. The Accuryn Sensing Urinary Catheter is a single use, sterile, MR conditional, disposable 16 French, twoway silicone urinary bladder catheter with two opposing drainage eyes and 4 lumens. The first lumen of the Urinary Catheter is for urine drainage and is packaged pre-connected to the Accuryn Urine Collection Set. The Accuryn Urine Collection Set function with the Accuryn Monitor to measure and display urine output and is considered a 510(k) exempt device per 21 CFR 876.1800 (urine flow or volume measuring system, product code EXY). The second lumen is for the 5cc retention balloon, which serves to keep the catheter in place. Inflation of the retention balloon is provided by connecting a barrel tip syringe filled with sterile water to the catheter by means of a two-way valve. Sterile water is conveyed through the retention balloon lumen to inflate the retention balloon; water is contained within the balloon to maintain retention; the water is removed by reopening the valve to deflate the balloon prior to removing the catheter from the bladder. The third lumen contains a thermistor wire for monitoring a patient's core body temperature in degrees Fahrenheit and degrees Celsius when connected to the Accuryn Monitor. The fourth lumen consists of a closed air column that connects to a pressure transducer inside the Accuryn Monitor. Intra-abdominal pressure is measured via this lumen and displayed on the Monitor screen. {4}------------------------------------------------ #### V. Indications for Use The Accuryn Monitoring System is intended for use in the drainage and/or collection of urine, and in the monitoring of urine output and core body temperature, in degrees Fahrenheit and degrees Celsius. The Accuryn Monitoring System is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The Accuryn Sensing Urinary Catheter is a single use device intended for short-term use (less than 30 days). #### VI. Substantial Equivalence The Accuryn Monitoring System utilizes substantially equivalent performance attributes as the predicate devices. Similarities to the predicate device include the following: - Provided Sterile - Single Use - Materials used - Performance standard ASTM F623-99(2006) - Urinary catheter properties (shaft color, shaft diameter, retention balloon size) - Temperature measurement functionality - . Pressure measurement functionality Differences in technological characteristics between the Accuryn Monitoring System and the predicate devices do not raise different questions of safety and effectiveness. Accepted scientific methods exist for assessing the effect of these different characteristics, such as bench and biocompatibility testing. #### VII. Performance Data Biocompatibility testing was conducted in accordance with ISO 10993-1:2009/(R)2013, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and FDA Draft Guidance, Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices Part 1: Evaluation of Testing." Performance bench testing was performed per ASTM F623-99 (2006), Standard Performance Specification for Foley Catheter and Coefficient of Friction testing. MR compatibility testing was conducted in accordance with ASTM F2052-14, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, ASTM F2213-06 (R2011), Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment, ASTM F2182-11a, Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging, and ASTM F2119-07 (R2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants. Software-related documentation provided in accordance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005) for Moderate Level of Concern device. The Accuryn Monitoring System meets the requirements of basic safety and essential performance as defined by the IEC 60601-1 2005 300 Edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance and complies with IEC 60601-1-2 2007, Medical Electrical Equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests. ## VIII. Conclusions Results from the bench tests for design verification and validation have proven acceptable performance on all tests to indicate that the device is suitable for its intended use and is as safe and effective as the predicate devices to support a determination of substantial equivalence.