Mammotome revolve Dual Vacuum Assist Biopsy System

{0}------------------------------------------------ Image /page/0/Picture/1 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, with flowing lines extending from the bottom profile. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 25, 2016 Devicor Medical Products, Inc. Ms. Shawna Rose Director, Regulatory Affairs 300 E-Business Way, Fifth Floor Cincinnati, Ohio 45241 Re: K152989 Trade/Device Name: Mammotome Revolve Dual Vacuum Assist Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: November 25, 2015 Received: November 27, 2015 Dear Ms. Rose: 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 -S 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) K152989 Device Name Device Name: Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System Indications for Use (Describe) The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. • The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 The following information is provided as required by 21 CFR § 807.92 for the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990 the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based. ## Company: Devicor® Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Establishment Registration Number: 3008492462 #### Contact: Shawna Rose Director, Regulatory Affairs Devicor Medical Products, Inc. 300 E-Business Way, Fifth Floor Cincinnati, OH 45241 Ph: 513-864-9178 Fax: 513-864-9011 E-mail: srose@mammotome.com Date of Submission: November 24, 2015 Proprietary Name: Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System Common Name: Biopsy System Regulation: 21 CFR 876.1075 Regulatory Class: II Product Codes: KNW Classification Name: Biopsy Instrument - Predicate Devices: Mammotome® Biopsy System, K033700 Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System, K123259 {4}------------------------------------------------ Device Description: The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination. The Mammotome revolve® Dual VAB System is comprised of three primary subsystems: - 1) a sterile, single-use probe - 2) a reusable holster, and - 3) a reusable control unit. Intended Use: The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities. - . The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. - The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality. The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. ## Technological Characteristics: The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System facilitates the diagnostic removal of tissue through a combination of vacuum and rotational/translational cutting functions. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System utilizes the same primary subsystems as identified in the predicate devices to achieve its intended use: {5}------------------------------------------------ - 1) a sterile single use probe containing a trocar tipped biopsy needle, rotating cutter specimen, collection chambers and vacuum tubing/valving; - 2) a reusable holster, containing the drive motors, gear trains and user activation switches; and - 3) a reusable control unit, containing the vacuum pump, power supply, valve actuators, user interface touchscreen, control electronics, and software. In addition, several optional accessories are available including remote keypad and footswitch controls, a transport cart, and probe guides for various stereotactic (ST) tables. The Mammotome revolve® Dual VAB System has been updated to integrate the Ultrasound modality as well as improvements on the performance reliability of the stereotactic functionality, while maintaining the basic technology, functionality and clinical outcomes of the predicate systems. Consistent with the configuration of the currently marketed systems, the Mammotome revolve® VAB System is configured for use in multiple imaging modalities, including Stereotactic and Ultrasound. The system relies on software to operate many of its functions including utilization of closed loop control on cutter position. In both predicate software systems, the focus of the software is to aid in system set-up and facilitate biopsy functions. The Mammotome revolve® Dual VAB System software has been updated to include the Ultrasound functionality, as well as to provide improved GUI screen functionality and address market feedback. A side-by-side comparison of the marketed and proposed devices is provided below. {6}------------------------------------------------ ## Side-by-Side Comparison to Legally Marketed Device ## Table 1a: Capital Equipment Side-by-Side Comparison of Mammotome revolve® Holster and Control Module to previous generation Mammotome® VAB Holster and Control Modules | Device<br>Characteristics:<br>Holster / Control<br>Module | Marketed Device:<br>Mammotome® ST<br>System (K033700) | Marketed Device:<br>Mammotome® EX<br>System (K033700) | Marketed Device:<br>Mammotome revolve®<br>(ST) Biopsy System<br>(K123259) | Proposed Device:<br>Mammotome revolve®<br>(ST and U/S) Biopsy<br>System | |-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | Indications for Use | Breast Biopsy/complete,<br>partial removal of imaged<br>abnormality/ partial<br>removal of palpated<br>abnormality | Breast Biopsy/complete,<br>partial removal of imaged<br>abnormality/ partial<br>removal of palpated<br>abnormality | Breast Biopsy / complete,<br>partial removal of imaged<br>abnormality /partial<br>removal of palpated<br>abnormality | Breast Biopsy / complete,<br>partial removal of imaged<br>abnormality /partial<br>removal of palpated<br>abnormality | | User interface<br>Mechanisms | Buttons on Remote Keypad,<br>Pedals on Footswitch,<br>Touchscreen | Buttons on Holster,<br>Buttons on Remote<br>Keypad, Pedals on<br>Footswitch, Touchscreen | Buttons on Holster, Buttons<br>on Remote Keypad, Pedals<br>on Footswitch, Touchscreen | Buttons on Holster, Buttons<br>on Remote Keypad, Pedals<br>on Footswitch, Touchscreen | | Microprocessor and<br>upgradeable software | Yes | Yes | Yes | Yes | | Display | Yes, LCD display | Yes, LCD display | Yes, LCD display | Yes, LCD display | | Translational Cutter<br>Movement | Automatic or Semi<br>Automatic | Automatic or Semi<br>Automatic | Automatic | Automatic | | Rotational Cutter<br>Movement | Automatic with cutter<br>advancement | Automatic with cutter<br>advancement | Automatic with cutter<br>advancement | Automatic with cutter<br>advancement | | Rotational and<br>Translation Speed<br>control | Yes; Closed-loop control | Yes; Closed-loop control | Yes, Closed loop control | Yes, Closed loop control | | Drive Train Type | Flexible Mechanical Drive<br>Cable | On board Motor and Gear<br>Train | On board Motor and Gear<br>Train | On board Motor and Gear<br>Train | | Independent Lateral<br>and Axial Vacuum<br>System | Yes | Yes | Yes | Yes | | Remote Footswitch /<br>Keypad Capability | Yes | Yes | Yes | Yes | {7}------------------------------------------------ #### 510(k) Premarket Notification Mammotome revolve® Dual Vacuum Assisted Biopsy System #### Disposables Side-by-Side Comparison of Mammotome revolve® Probes to Table 1b: previous generation Mammotome® VAB Probes | Device Characteristics:<br>Probes | Marketed Device:<br>Mammotome® ST System<br>(K033700) | Marketed Device:<br>Mammotome® EX System<br>(K033700) | Marketed Device:<br>Mammotome revolve® (ST)<br>Biopsy System (K123259) | Proposed Device:<br>Mammotome revolve®<br>ST and U/S Biopsy System | | | |-------------------------------------------|-------------------------------------------------------|-------------------------------------------------------|------------------------------------------------------------------------|--------------------------------------------------------------------|--|--| | Needle Assembly | | | | | | | | Needle Insertion<br>Method | Fired or Manual | Manual | Fired or Manual | Fired or Manual | | | | Tip Type | Bladed trocar | Bladed trocar | Bladed trocar | Bladed trocar | | | | Tip Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | | | Needle Configuration | Dual lumen | Dual lumen | Dual lumen | Dual lumen | | | | Needle Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | | | Needle Diameter Sizes | 8G, 11G, and 14G | 8G, 11G, and 14G | 8G and 10G | 8G and 10G | | | | Probe Housing | | | | | | | | Vacuum Port<br>Attachment | Yes, tethered to control<br>module | Yes, tethered to control<br>module | Yes, tethered to Control<br>Module | Yes, tethered to Control<br>Module | | | | Specimen Retrieval /<br>Collection Method | Manual | Manual | Automatic | Automatic | | | | Housing Material | Plastic | Plastic | Plastic | Plastic | | | | Probe Cutter Subassembly | | | | | | | | Cutting Method | Rotation and translation of<br>inner cutter | Rotation and translation of<br>inner cutter | Rotation and translation of<br>inner cutter | Rotation and translation of<br>inner cutter | | | | Tissue Transport<br>Method | Mechanical and Vacuum | Mechanical and Vacuum | Vacuum | Vacuum | | | | Cutter Material | Stainless steel | Stainless steel | Stainless steel | Stainless steel | | | | Packaging | | | | | | | | Type | C-film with Tyvek Cover | C-film with Tyvek Cover | PETG with Tyvek Cover | PETG with Tyvek Cover | | | | Sterilization | | | | | | | | Method | Cobalt 60 Irradiation | Cobalt 60 Irradiation | Cobalt 60 Irradiation | Cobalt 60 Irradiation | | | {8}------------------------------------------------ #### Performance testing: To demonstrate substantial equivalence of the proposed device to the predicate devices, sideby-side comparison of tissue sample collection, using an in vivo porcine model, was performed. This model has historically been used to evaluate the ability of Mammotome® biopsy devices to collect tissue samples. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate devices were each used to obtain tissue samples. Each sample was evaluated against the following criteria: - Sample weight - Sampling reliability - Sample quality Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System would retrieve a tissue sample comparable to that of the predicate device. Additional testing was performed as well for integration of Ultrasound functionality and system enhancements. The Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System and the predicate device were each used to obtain test functionality and obtain tissue samples. Each sample was evaluated against the following criteria: - . Sample weight - . Sampling reliability - Sample quality - . Holster to Probe recognition - . Holster/Control Module communication Testing results confirmed that the Mammotome revolve® Vacuum Assisted Biopsy (VAB) System Ultrasound functionality and system enhancements was comparable to that of the predicate device. ## Conclusion: Side-by-side comparison of the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System to the predicate systems was performed on the technical characteristics of design, product components, materials of construction, system functionality, and clinical application (specifically, tissue sample characteristics). The test results of the Mammotome revolve® Dual Vacuum Assisted Biopsy (VAB) System demonstrated that it performed comparable to the safety and effectiveness of the predicate devices, and thus can be considered substantially equivalent.