Biopsy Forceps

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains text around the perimeter. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". In the center of the seal is an image of three faces in profile, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 2, 2017 Fehling Instruments GmbH & Co. KG % Arne Briest CEO VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe Germany Re: K170726 Trade/Device Name: Biopsy Forceps Regulation Number: 21 CFR 870.4075 Regulation Name: Endomyocardial Biopsy Device Regulatory Class: Class II Product Code: DWZ Dated: March 6, 2017 Received: March 9, 2017 Dear Mr. Briest: 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 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, M.A. Hillebrand for for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K170726 Device Name Biopsy Forceps Indications for Use (Describe) FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ # 510(k) Summary #### 1. Submission Sponsor and Application Correspondent # A. Submission Sponsor Fehling Instruments GmbH & Co. KG Hanauer Landstr. 7A D-63791 Karlstein Germany | Phone: | + 49 6188 9574 - 0 | |----------|---------------------| | Fax: | + 49 6188 9574 - 46 | | Contact: | Mrs. Ulrike Lindner | FDA Establishment Registration #: 9615005 # B. Application Correspondent - VISAMED GmbH Kastellstr. 8 D-76227 Karlsruhe Germany | Phone: | +49-721-476-4847 | |----------|------------------| | Fax: | +49-721-476-4849 | | Contact: | Mr. Arne Briest | #### 2. Date Prepared Date Prepared: May 15, 2017 #### 3. Device Identification Trade/Proprietary Name: Biopsy Forceps Device: Device, Biopsy, Endomyocardial Regulation Description: Endomyocardial biopsy device Classification Regulation 21 CFR 870.4075 Product Code: DWZ Device Class: Class 2 Classification Panel Cardiovascular {4}------------------------------------------------ # 4. Legally Marketed Predicate Devices ### Primary Predicate: K973818 - Boston Scientific Corporation Northwest Technology Center, Inc.; T-REX ™- Biopsy foreceps, cleared December 16, 1997 ### Additional Predicate: K881412 - Fehling Medizintechnik GmbH, Myocard Biopsy Forcep, cleared September 8, 1988 ### 5. Device Description The Biopsy Forceps are designed to allow percutaneous access to the right or left ventricles of the heart to obtain diagnostic tissue samples. The forceps consist of three main components: - an actuating handle ergonomically designed for comfortable use, 1. - 2. a flexible shaft, - and surgical stainless steel cutting jaws. 3. At the distal end of the forceps is a pair of stainless steel jaws used to obtain the tissue samples. At the proximately end of the forceps is the actuation handle used to activate the jaws and steer the device. The product is provided single for use and sterile. #### 6. Indications for Use FEHLING biopsy forceps are used to obtain endomyocardial biopsy specimens from the right and left ventricle via percutaneous arterial or venous approach. #### 7. Substantial Equivalence Discussion The Biopsy Forceps have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices. The Biopsy Forceps are identical in design, material and intended to the previously cleared Biopsy Forceps by Fehling. | | Biopsy Forceps<br>(subject device) | MYOCARD BIOPSY<br>FORCEP | T-REX™ Biopsy | Substantial<br>Equivalence | |---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | 510k Reference | (subject device) | K881412 | K973818 | - | | Product Code | DWZ | DWZ | DWZ | Identical | | Regulation # | 870.4075 | 870.4075 | 870.4075 | Identical | | Class | II | II | II | Identical | | | Biopsy Forceps<br>Bioptome (subject<br>device) | MYOCARD BIOPSY<br>FORCEP | T-REX™ Biopsy | Substantial<br>Equivalence | | Manufacturer | FEHLING<br>INSTRUMENTS<br>GmbH & Co. KG | FEHLING<br>INSTRUMENTS<br>GmbH & Co. KG | Boston Scientific<br>Corporation Northwest<br>Technology Center,<br>Inc. | | | Indication for<br>Use | FEHLING biopsy<br>forceps are used to<br>obtain<br>endomyocardial<br>biopsy specimens<br>from the right and left<br>ventricle via<br>percutaneous arterial<br>or venous approach. | The Fehling<br>Myocardial Biopsy<br>Forceps are intended<br>for use in ventricular<br>endomyocardial biopsy | The T-REX biopsy<br>forceps is used to<br>obtain endomyocardial<br>biopsy specimens from<br>the right and left<br>ventricle via<br>percutaneous arterial<br>or venous approach. | Similar | | Sterility | Sterile | Sterile | Sterile | Identical | | Sterilization | ETO, SAL 10-6 | ETO, SAL 10-6 | ETO, SAL 10-6 | Identical | | Utility | Single Use | Single Use | Single Use | Identical | | | End-Effector and Jaw Assembly | | | | | Jaws | Proprietary<br>sharpening method | Proprietary sharpening<br>method | Proprietary sharpening<br>method | Identical | | Actuator links | Hardened stainless<br>steel | Hardened stainless<br>steel | Hardened stainless<br>steel | Identical | | Actuator/ pull<br>wire<br>connection | Laser Welded | Laser Welded | Laser Welded | Identical | | Housing | Slotted jacket | Slotted jacket | Laser welded housing<br>halves | Similar | | Housing to<br>outer Jacket<br>Connection | Laser Welded | Laser Welded | Laser welded | Identical | | Crank length /<br>lever angle | 1.6mm jaws;<br>1.8mm jaws;<br>2.2mm jaws; | 1.6mm jaws;<br>1.8mm jaws;<br>2.2mm jaws; | 1.8mm jaws;<br>2.2mm jaws;<br>15° | Similar | | Length of<br>Shaft | 510 mm<br>800 mm<br>1000 mm<br>1200 mm | 510 mm<br>800 mm<br>1000 mm<br>1200 mm | - | Identical<br>(additional<br>1200 mm<br>length<br>offering for<br>2.2 mm jaws) | | Attachment of<br>actuator/<br>actuator links<br>and<br>jaws/housing | Captured by slotted<br>jacket | Captured by slotted<br>jacket | Captured by laser<br>welded housing halves | Similar | | Body | | | | | | Pull Wire | Solid Stainless Steel<br>Wire | Solid Stainless Steel<br>Wire | Solid Stainless Steel<br>Wire | Identical | | Shape | Flexible | Flexible | Flexible and pre-<br>curved | Similar | | Liner | --- | --- | Liner between outer<br>jacket and pull wire | Identical | | Jacket sheath | Jacket sheath<br>covering the outer<br>jacket | Jacket sheath covering<br>the outer jacket | Jacket sheath covering<br>the outer jacket | Similar | | Handle Assembly | | | | | | Handle<br>transition to<br>outer jacket | Crimped joint with<br>internal rope | Crimped joint with<br>internal rope | Crimped joint with<br>integral strain relief | Similar | | Handle<br>transition to<br>handle body | Plastic handle<br>transition press fit into<br>tapered handle body | Plastic handle<br>transition press fit into<br>tapered handle body | Stainless steel handle<br>transition press fit into<br>tapered handle body | Similar | | Finger Grip /<br>Handle body | Pusher for holding<br>jaws open during<br>specimen | Pusher for holding<br>jaws open during<br>specimen | Locking feature for<br>holding jaws open<br>during specimen<br>removal | Similar | | Finger grip<br>insert for<br>attachment of<br>pull wire | Plastic (POM) | Plastic (POM) | Aluminum / Press fit | Similar | | Handle Spring | 20mm coil spring | 20mm coil spring | 12,7 mm Spring coil | Similar | | Package | | | | | | Configuration | Single Barrier | Single Barrier | Single Barrier | Similar | | Product<br>Holder | Blister Package | Blister Package | Coil or Card | Similar | | Similar basic design and shape, fitting the indication, dimensions are adjusted accordingly | | | | | {5}------------------------------------------------ {6}------------------------------------------------ # 8. Non-Clinical Performance Data #### Biocompatibility Biocompatibility testing on the Fehling-Biopsy Forceps was conducted and evaluated per ISO 10993-1. #### Cytotoxicity The full strength EMEM10 test article showed no cytotoxic potential to L-929 mouse fibroblast cells. #### Chemical Characterization The Biopsy Forceps, were exhaustively extracted in Purified Water, Ethanol, and Hexane. The resulting extracts were analyzed by Fourier Transform Infrared Spectroscopy (FTIR) and Gas Chromatography (GC-MS). The ethanol and hexane test extracts were analyzed by Ultra Performance Liquid Chromatography - Mass Spectroscopy (UPLC-MS). The purified water test extract was analyzed by Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) and lon Chromatography. # Conclusion: The biological risk assessment performed was supported by information on the Biopsy Forceps materials of construction, gathered toxicological data on these materials, available chemical characterization and biological data on Biopsy Forceps. This information and related analysis provides the evidence required to conclude that additional biocompatibility testing is not needed. The Biopsy Forceps therefore meets the requirements of ISO 10993-1 and 2016 FDA Guidance for {7}------------------------------------------------ externally communicating devices with limited contact (<24 hours) with circulating blood and can be considered biocompatible for use. ### Non-Clinical Performance Testing No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. #### Dimensional Verification Tests Dimensional verification testing was performed to evaluate the Biopsy Forceps. All samples passed the test and met the acceptance criteria. #### Tensile Tests Tensile Tests on critical joints were performed on the Biopsy Forceps to evaluate the mechanical stability of the product. All samples passed the test and met the acceptance criteria. #### Simulation Test - Insertion and Taking of Tissue Samples The purpose of the test was to evaluate the introduction of the device to a worst case anatomical structure and to harvest tissue samples using fresh porcine heart specimens. The process was repeated 10 times per device. All samples passed the test and met the acceptance criteria. #### Shelf Life Testing and Transport Simulation Shelf Life Testing and Transport Simulation testing was performed to support the shelf life of 5 years and the safe transport of the Biopsy Forceps. All samples passed the test and met the acceptance criteria. The Biopsy Forceps have a shelf life of 5 years. #### 9. Clinical Performance Data There was no clinical testing required to support the medical device. #### 10. Statement of Substantial Equivalence The information presented in this 510(k) submission demonstrates that the differences between the Biopsy Forceps and the predicate devices do not raise any questions regarding safety and effectiveness. Performance testing and compliance with voluntary standards demonstrate that the Fehling- Biopsy {8}------------------------------------------------ Forceps are substantially equivalent to the relevant aspects of the predicate devices in terms of design, components, materials, principals of operation, biocompatibility, performance characteristics, and intended use. The Biopsy Forceps are determined to be substantially equivalent to the referenced predicate devices.