Beacon Fine Needle Fiducial System

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 30, 2015 Covidien LLC % Rachel Silva Senior Regulatory Affairs Specialist 15 Hampshire Street MANSFIELD, MA 02048 Re: K152586 Trade/Device Name: Beacon Fine Needle Fiducial System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable Clip Regulatory Class: Class II Product Code: NEU, FCG Dated: September 8, 2015 Received: September 10, 2015 Dear Ms. Silva: 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 (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, Robert Oals Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health 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) K152586 152586 Device Name Beacon Fine Needle Fiducial System #### Indications for Use (Describe) The Beacon Fine Needle Fiducial System is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The needle is designed with a passive (i.e. automatic) safety shielding feature to aid in the prevention of needle stick injury. Type of Use (Select one or both, as applicable) [X] 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 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." FORM FDA 3881 (8/14) PSC Poolisions Setsices (301) 443-674) EF Expiration Date: January 31, 2017 See PRA Statement below. Form Approved: OMB No. 0910-0120 {3}------------------------------------------------ ## 5.0 510(k) Summary Submitter's Name and Address Covidien Ilc 15 Hampshire Street Mansfield. MA 02048 ## Contact Person Rachel Silva Senior Regulatory Affairs Specialist 540 Oakmead Parkway Sunnyvale, CA 94085 Phone & Fax: (408) 328-7359 Date Prepared: December 18, 2015 ## Name of Device Proprietary Name: Beacon™ Fine Needle Fiducial System Common/Usual Name: Implantable clip and Gastroenterology-urology biopsy instrument Classification Panel: General & Plastic Surgery Device Regulation: Class II, 21 CFR 878.4300; 21 CFR 876.1075 Product Code: NEU (Marker, Radiographic, Implantable), FCG (Kit, Needle, Biopsy) ## Establishment Registration Number, Owner/Operator Number Establishment Registration Number: 3004904811 Owner/Operator Number: 1282497 ### Predicate Device(s) BNX Fine Needle Aspiration (FNA) System (cleared under K150891 on 5/1/15) ### Device Description The Beacon™ Fine Needle Fiducial System is a sterile, single-use, endoscopic ultrasound device which consists of the Beacon™ Endoscopic Ultrasound (EUS) Delivery System and a Beacon™ Fine Needle Fiducial (FNF) Needle preloaded with fiducial markers. The Beacon™ EUS Delivery System with Beacon™ FNF Needle is inserted through the accessory channel of an ultrasound endoscope. The Beacon™ FNF Needle houses two fiducial markers and a fiducial spacer enclosed with bone wax. A blunt stylet contained within the Beacon™ FNF Needle allows for manual deployment of the fiducial markers to the intended location. Once the fiducial markers have been implanted, the Beacon™ FNF Needle may be removed from the Beacon™ EUS Delivery System and replaced with a new Beacon™ FNF Needle for placing additional fiducial markers. The Beacon™ Fine Needle Fiducial System has an integrated needle protection shield that automatically encloses the distal end of the needle during removal to cover the needle sharp. The needle tip is covered to help protect against inadvertent needle sticks. {4}------------------------------------------------ # Indications for Use The device is intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. The needle is designed with a passive (i.e. automatic) safety shielding feature to aid in the prevention of needle stick injury. # Technological Characteristics of the Device Compared to Predicate Device The Beacon™ Fine Needle Fiducial System is identical to the legally marketed BNX Fine Needle Aspiration (FNA) System (K150891) in terms of principle of operation, anatomical location, and fundamental scientific technology. Both systems use a delivery system and needle sub-assembly to manually initiate delivery of fiducial markers, as well as exchange needles. In addition, the Beacon™ FNF System indications for use are the same when compared to the predicate BNX Fine Needle Aspiration (FNA) System (K150891); with respect to fiducial delivery and prevention of needle stick injury. Although the predicate BNX FNA System is compatible for use with fiducial markers and bone wax, the materials are not provided with the system. The Beacon™ FNF System includes the components preloaded into the needle sub-assembly for the user. This premarket notification discusses the inclusion of such materials into the Beacon™ Fine Needle Fiducial Needle subassembly and the design modifications that assist placement of preloaded fiducial markers. Design changes to the Beacon™ FNF System from the predicate BNX FNA System include the following: - . Modification to the distal end of the needle stylet - Inclusion of two gold seed fiducial markers - Inclusion of bone wax - . Addition of a fiducial spacer - Addition of a deployment indicator ● # Non-Clinical Test Summary Bench testing was performed for attributes affected by the modifications made to the subject device. Bench testing evaluated such characteristics as fiducial deployment force, fiducial echogenic performance, bond strengths, and deployment indicator functionality. Performance testing for the Beacon™ Fine Needle Fiducial System also consisted of user validation testing, biocompatibility assessment, sterilization validation, packaging validation, shelf life testing, Image Guided Radiotherapy Compatibility, and Magnetic Resonance testing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during device testing. # Conclusion Covidien IIc considers the Beacon™ Fine Needle Fiducial System to be substantially equivalent to legally marketed predicate device BNX Fine Needle Aspiration System (K150891) based on the indications for use, technological characteristics, and safety and performance testing. Testing performed demonstrated that the Beacon™ Fine Needle Fiducial System met the required specifications for its intended use.