Corvocet Biopsy System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "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, forming a single, unified shape. The profiles are depicted in a simple, abstract manner. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 25, 2016 Merit Medical Systems, Inc. Ms. Ileana Davis Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095 Re: K153337 Trade/Device Name: Corvocet Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: February 25, 2016 Received: February 26, 2016 Dear Ms. Davis: 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 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 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. {1}------------------------------------------------ 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, # Jennifer R. Stevenson -A For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K153337 Device Name Corvocet Biopsy System Indications for Use (Describe) The disposable Corvocet Biopsy System is intended for use in obtaining core biopsy samples from soft tissues such as liver, kidney, prostate, spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not intended for use in bone. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------|---------------------------------------------------------------------------| | <div> <span>☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span>☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </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}------------------------------------------------ # 5.0 510(k) Summary | General<br>Provisions | Submitter Name: | Merit Medical Systems, Inc. | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | | Address: | 1600 West Merit Parkway<br>South Jordan, UT 84095 | | | Telephone Number: | (801) 208-4187 | | | Fax Number: | (801) 316-4065 | | | Contact Person: | Ileana Davis, Regulatory Affairs Specialist | | | Date Prepared: | 18 November 2015 | | | Registration Number: | 1721504 | | Subject Device | Trade Name: | Corvocet Biopsy System | | | Common/Usual Name: | Biopsy System | | | Classification Name: | Instrument, Biopsy | | | Device Class: | II | | | Product Code: | KNW | | | Classification Regulation: | CFR 876.1075 | | Predicate<br>Device | Trade Name: | Max-Core® Disposable Core Biopsy<br>Instrument | | | Classification Name: | Instrument, Biopsy | | | Premarket Notification: | K133948 | | | Manufacturer: | Bard Peripheral Vascular, Inc. | | Device<br>Description | Merit's Corvocet Biopsy System is a core needle biopsy device intended<br>to obtain core biopsy samples from soft tissues. It is an automatic device<br>that uses a spring coupled to a cutting needle to obtain full core soft<br>tissue specimens. It has an echo-enhanced tip to aid with visibility under<br>ultrasound, fully adjustable throw length (10-25mm) and depth markings<br>on the needle. The device also features a light weight design, ergonomic<br>grip, dual firing triggers, a ready indicator, and an optional safety<br>interlock.<br><br>The Corvocet Biopsy System is available in several needle gauge sizes<br>and lengths to accommodate soft tissue biopsy needs. The top and rear<br>firing triggers are color coded according to the various gauge sizes (e.g.<br>yellow = 20G, pink = 18G, purple = 16G, and green = 14G). The biopsy<br>system will be offered as stand-alone as well as paired with the<br>Corvocet™ Coaxial Introducer.<br><br>The Merit Corvocet Biopsy System is supplied sterile and is intended for<br>single use only. | | | Indications for<br>Use | The disposable Corvocet Biopsy System is intended for use in obtaining<br>core biopsy samples from soft tissues such as liver, kidney, prostate | | | intended for use in bone. | | | | The Indications for Use statement for the Corvocet Biopsy System is not<br>identical to the predicate device; however, the differences do not alter<br>the intended therapeutic use of the device nor do they affect the safety<br>and effectiveness of the device relative to the predicate. Both the subject<br>and predicate devices have the same intended use of obtaining core<br>biopsy samples from soft tissues. | | | | The technological characteristics of the subject Corvocet Biopsy System<br>are substantially equivalent to those of the predicate Max-Core®<br>Disposable Core Biopsy Instrument. | | | | Comparison to<br>Predicate<br>Device | At a high level, the subject and predicate devices are based on the<br>following same elements:<br>• Clinical use<br>• Labeling<br>• Basic design<br>• Principle of operation<br>• Performance<br>• Needle gauges | | | | The following differences exist between the subject and predicate<br>devices:<br>• Soft tissues<br>• Materials<br>• Adjustable throw length | | | Performance<br>Data | FDA guidance and recognized performance standards have been<br>established for biopsy instrument under Section 514 of the Food, Drug<br>and Cosmetic Act. A battery of tests was performed based on the<br>requirements of the below recognized performance standards and<br>guidance, as well as biocompatibility, sterilization, and labeling standards<br>and guidance. Conformity to these standards demonstrates that the<br>proposed Corvocet Biopsy System met the standards' established<br>acceptance criteria applicable to the safety and efficacy of the device.<br>Performance testing was conducted based on the risk analysis and<br>based on the requirements of the following documents: | | | | • Guidance for the Content of Premarket Notifications for Biopsy<br>Devices Used in Gastroenterology and Urology<br>• ISO 7864:1993 – Sterile hypodermic needles for single use<br>• ISO 7864-2:1993 – Sterile hypodermic syringes and needles –<br>Part 2: Specification for sterile hypodermic needles for single use<br>• ISO 9626:1991 Amendment 1:2001- Stainless steel needle<br>tubing for manufacture of medical devices<br>• ISO 6009:1992 – Hypodermic needles for single use – Color<br>coding for identification | | {4}------------------------------------------------ spleen, breast, lung, lymph nodes and various soft tissue tumors. It is not {5}------------------------------------------------ - ISO 11607-1:2006 Packaging for terminally sterilized medical . devices - Part 1: Requirements for materials, sterile barrier systems, and packaging systems - ASTM D4169-09 Standard Practice for Performance Testing of ● Shipping Containers and Systems - ISO 2233:2001 Packaging Complete, filled transport ● packages and unit loads - Conditioning for testing - . ASTM F1980-11 - Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices - . ISO 11135:2014 - Sterilization of health care products - Ethylene oxide - Requirements for development, validation and routine control of a sterilization process for medical devices - ISO 10993-1:2009 - Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009 Biological evaluation of medical devices -. Part 5: Tests for in vitro cytotoxicity - ISO 10993-7:2008 Biological evaluation of medical devices -● Part 7: Ethylene oxide sterilization residuals - ISO 10993-10:2010 Biological evaluation of medical devices -. Part 10: Tests for irritation and skin sensitization - ISO 10993-11:2006 Biological evaluation of medical devices -● Part 11: Tests for systemic toxicity - . United States Pharmacopoeia 37, National Formulary 32 <151> Pyrogen Test, 2014. The following performance data were provided in support of the substantial equivalence determination: ### Performance Testing - Bench - Dimensional verification ● - Tensile of joints ● - Adjustable throw accuracy ● - Multiple Samples ● - Cycle/Fatigue - Device Visibility ● - Ink adherence ● - Simulated Use . The Corvocet Biopsy System met the acceptance criteria for all performance testing. ## Biocompatibility testing The biocompatibility evaluation for the Corvocet Biopsy System was conducted in accordance with the FDA Blue Book Memorandum #G95-1 Use of International Standard ISO 10993 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing" May 1, 1995, and the International Standard ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process as recognized by FDA. The battery of testing included the following tests: {6}------------------------------------------------ | Cytotoxicity Sensitization Irritation Acute Systemic Toxicity Pyrogenicity Chemical Characterization | | |------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Substantial Equivalence | Based on the indications for use, design, safety and performance testing the subject Corvocet Biopsy System meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Max-Core® Disposable Core Biopsy Instrument, K133948. |