Fusion Bx

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 25, 2016 Focal Healthcare, Inc. % Mr. Georg Bauer 510(k) TPR Deputy Program Manager TUV SUD America, Inc. 1775 Old Highway 8 NW NEW BRIGHTON MN 55112-1891 Re: K153166 Trade/Device Name: Fusion Bx Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 14, 2015 Received: January 11, 2016 Dear Mr. Bauer: 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 device-related 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/Resourcesfor You/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. Michael D'Hara For 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 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. | 510(k) Number (if known) | | |--------------------------|--| |--------------------------|--| K153166 Device Name Fusion Bx #### Indications for Use (Describe) Fusion Bx is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and to record the biopsies were acquired during the procedure. 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." {3}------------------------------------------------ Focal Healthcare Inc. Fusion Bx Submitter's Name: Submitter's Address: Traditional 510(k) # 510(k) Summary [As required by 21 CFR 807.92] Focal Healthcare Inc. 10 Morrow Avenue, Unit 101 Toronto, ON M6R 2J1 Canada Ms. Maham Ansari, MS, RAC Associate Director, Regulatory Affairs & Quality +1 647 479 9603 +1 647 479 9604 maham.ansari@focalhealthcare.com Date Prepared: Contact Name: Phone Number: Fax Number: Title: Email: Device Proprietary Name: Device Common or Usual Name: Classification Name: Product Code: Regulation Number: Regulation Description: 21 August 2015 Fusion Bx™ Medical Image Processing Workstation System, Image Processing, Radiological LLZ 21 CFR 892.2050 Picture Archiving and Communications System ## Predicate Device: Substantial equivalence is claimed to the following device: | Name of Device | 3-D Imaging Workstation | |----------------|-------------------------| | Manufacturer | Eigen LLC | | 510(k) Number | K081093 | ## Device Description and Summary of Technological Characteristics Fusion Bx is designed to display the 2D live video received from commercially available ultrasound machines and use this 2D video to reconstruct a 3D ultrasound image volume. The system is designed to work with clinicians' existing ultrasound machines, transrectal ultrasound (TRUS) probes, commercially available needles, needle guides/templates and needle qun combination. Additional software features include patient data management, multi-planar reconstruction, segmentation, image measurements and 3D image registration. The device will assist clinicians in planning and performing image-guided interventional procedures such as biopsies and placing instruments in the prostate for adult men with suspected prostate cancer. Fusion Bx is comprised of a laptop-based workstation and a hardware assembly. The included hardware consists of a frame grabber, encoder converter, hardware arm (comprising of a swing arm, counterbalance, tracker and stepper), and stand. The stepper holds the ultrasound probe and measures probe position while the physician performs a normal ultrasound imaging {4}------------------------------------------------ | Focal Healthcare Inc. | |-----------------------| | Fusion Bx | procedure of the subject prostate. Encoders in the stepper and tracker send joint movement procedure of the computer workstation which tracks probe position and orientation. Control of imontation to the oomputer wonetation tem is done manually by the physician, just as it would the altrasound probo and all.recome eyer, by tracking the position and orientation of the be in the absento of Pacion and in a video image, the workstation is able to reconstruct and ultiasound probe while capturing the nace integor ... o the prostate and to display the live image position within the prostate. The computer workstation is connected to the ultrasound system via a cable and hardware The computer workstation to connected to a stream 2D ultrasound image into a format that is device that converts the rour time track can be marked up with gland readable by T dolon DX. The roometrations in ages of the patient's prostate can be Segmentation of other manch in the principle that features of the prostate can be visualized consistently with a number of imaging modalities. The physician may attach a commercially available biopsy needle guide to the TRUS probe and The privsician may uttain a sommercially at the prostate biopsy procedure. During the biopsy use the probe and blopsy noodio to personn are process visible on the Fusion Bx display. This procedure this roar time == an be marked up to record the locations where the biopsies were acquired during the procedure. As the probe and needle guide are maneuvered by the acquired duling the probe is tracked. Needle tracked. Needle trajectory is estimated by physion, the poolion and onehative to the 3D image stack. This information is provided so the physician can assess prostate abnormalities, plan and implement biopsy procedures. Supported imaging modalities include DICOM images and real-time 2D ultrasound images. Oupportou imaging modulars received through CD, USB memory stick, or over a network DICOM-compliant miages are roomed throught be processed. This includes images that have connection. Images that are oompressed in hossless, such as JPEG2000, compression been compressed adming roosy, cash an encessed to perform volume estimations of the methous. The UD integoriation of interest (ROIs). Length measurements are also available. Data, notes and images are stored in the patient file for later retrieval. Images are stored as Data, notes and intaged are stored in are stored in DICOM format with the same image size unchanged onginals: mago mark ups are in place to place to protect against data loss. and onemallon as the transfer where data loss is evaluated upon receipt and/or reading of data. In summary, Fusion Bx offers the physician additional 3D information for assessing prostate n summally, I dolon DX onero the procedures. The additional image processing abliomalities, prairing and implomenting are of probe-based procedures, and leatures are generated with minimal onanges to the live prostate assessment or the prysician always had adoooo to the existing workflow by connecting to standard ultrasound equipment. This system will not prevent the clinician from using the standard ultrasound equipment. {5}------------------------------------------------ # Intended Use/Indications for Use Fusion Bx is intended for use by physicians for enhanced visualization of ultrasound imaging of the prostate in clinic and hospital settings. It provides 2D and 3D image visualization including review, manipulation, and analysis tools. Additional features include patient data management, image measurement, multiplanar reconstruction, 3D image registration, segmentation, image annotation, and recording of the locations where the biopsies were acquired during the procedure. ## Substantial Equivalence The product's technical features are substantially equivalent to the Eigen 3-D Imaging Workstation (K081093). Both are software applications that provide 2D and 3D medical image viewing and acquisition to aid visualization of the prostate gland. Both devices provide additional features which include patient data management, multi-planar reconstruction, prostate segmentation, image measurement and annotation, 3D surface/image registration, and recording the locations where biopsies were acquired during a procedure. In addition, both devices are composed of a mechanical assembly, and a computer-based workstation. The mechanical assembly holds the ultrasound probe and tracks probe position while the physician performs a normal ultrasound imaging procedure of the subject's prostate. Ultrasound system operation and transrectal probe movement all remain under manual control of the physician. The differences between the two devices can be characterized as the minor addition or removal of features that have no impact on the overall safety or workflow of the device. These include: - Minor differences in the mechanical assembly designed to achieve the same purpose, � i.e. to track the position and orientation of the ultrasound probe while capturing the ultrasound video image. - Pay-per-use functionality of the Fusion Bx system. � - Fusion Bx does not allow recording of video sequences. � - The predicate device only supports an end-fire probe, whereas Fusion Bx supports both e a side-fire probe and a bi-plane probe (side- and end-fire). The reconstruction requires the probe to be in the side-fire mode, while biopsy navigation supports both side-fire and end-fire modes of operation. These differences do not raise any safety or effectiveness concerns. # Testing and Performance Data The Fusion Bx has been designed to comply with the following standards: - ISO 14971: 2007 [2012] ו - IEC 62304: 2006 l - AAMI/ANSI ES 60601-1: 2005/(R)2005 + A1: 2012 (E) 1 - IEC 60601-1-2: Edition 3: 2007 = - -IEC 62366-1: Edition 1.0: 2015 - NEMA PS 3.1 3.20: 2011 Digital Imaging and Communications in Medicine (DICOM) 【 {6}------------------------------------------------ | Focal Healthcare Inc. | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------| | Fusion Bx | Section 5: 510(k) Summary | Traditional 510(k) | | Стрования в продавления в могу в при всемей «Автории» (со своем в как всемента в как своем в как полника в композительно в политика в композительно по можности в можности в м | | | All product and engineering specifications were verified and validated. Test phantoms incorporating simulated prostates were used to verify system performance through verification, validation and benchmarking. Compatibility with the BK ultrasound and the 8088 and 8188 probes was confirmed. Through careful measurements, the measured error in the positioning system was determined to be acceptable at less than 2.5 mm and less than 0.176° at the tip of the probe, and the geometric error in the ultrasound reconstruction was determined to be acceptable at less than 3% volume difference and less than a 2.5 mm error in distance measurements. ## Conclusion The results of comparing the intended use, function, technological characteristics, mode of operation and specifications of Fusion Bx with those of the predicate device demonstrate that Fusion Bx is substantially equivalent to the existing product in the market today. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------