ProBx Software

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Harmonus Inc. Nandini Murthy Regulatory Consultant 110 Canal St 3rd Floor Lowell, Massachusetts 01852 March 2, 2018 Re: K173312 Trade/Device Name: ProBx Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: January 16, 2018 Received: January 18, 2018 Dear Nandini Murthy: 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); {1}------------------------------------------------ # Page 2 - Nandini Murthy and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Michael D. O'Hara For Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## SECTION 4 # INDICATIONS FOR USE STATEMENT A completed Indications for Use Statement follows this page. CONFIDENTIAL {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K173312 Device Name ProBx Software Indications for Use (Describe) ProBx Software is intended for use as follows: · ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices. · ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the Software displays an MRI image of the current location of the interventional instrument for positioning confirmation. · ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate. | | 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." {4}------------------------------------------------ Traditional 510(k) Premarket Notification Submission ## SECTION 5 #### 510(k) SUMMARY | Submitter Name: | Harmonus, Inc. | |----------------------------|------------------------------------------------| | Submitter Address: | 110 Canal St. Lowell, MA 01852 | | Contact Person: | Nicole Mauro, CEO | | Phone Number: | (617) 702-2271 | | Date Prepared: | 10/18/2017 | | Device Trade Name: | ProBx Software | | Device Common Name: | Image-guided, interventional planning software | | Classification Name: | System, Image Processing, Radiological, LLZ | | Classification regulation: | 21 CFR 892.2050, Product Code LLZ | | Predicate Device: | DynaCAD/Prostate Interventional, K133030 | #### Device Description: ProBx Software along with ProBx Hardware accessories is used for in-bore Magnetic Resonance Imaging (MRI) guided interventional and diagnostic procedures of the prostate. The ProBx Software is intended to be loaded onto a commercially available workstation and used as an accessory to commercially available MRI systems. The software receives pre-procedural and intra-procedural DICOM images and provides 2D and 3D visualization for treatment planning. The Software performs calculations on user-selected target locations to assist the clinician in manually utilizing the tracked accessory hardware to reach targets. The Software also provides MRI scan confirmation of positioning during the procedure. #### Indications for Use: ProBx Software is intended for use as follows: - ProBx Software is a computer-based image-guidance accessory intended for use in conjunction with commercially available Magnetic Resonance Imaging (MRI) systems and interventional devices. - ProBx Software helps physicians guide biopsy instrumentation to targets that have been defined by the physician in MRI. The Software provides the clinician with image analysis and display of pre-procedural and intra-procedural MRI images of tracked accessory hardware and the target organs, along with the projected path to the target. The Software displays an MRI image of the current location of the interventional instrument for positioning confirmation. {5}------------------------------------------------ Traditional 510(k) Premarket Notification Submission - ProBx Software is intended to be used by physicians in a clinical setting for treatment planning and guidance for clinical, interventional, and/or diagnostic procedures of the prostate. | | Submitted Device | Predicate Device #1 | Reference Device #1 | |-----------------------------------------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------|------------------------------------------| | Proprietary/Trade Name | ProBx Software | DynaCAD/Prostate<br>Interventional | SmartTarget | | 510(k) Number | n/a | K133030 | K170250 | | Product Code | LLZ | LLZ | LLZ | | Class | II | II | II | | Target Anatomy | Prostate | Prostate | Prostate | | Anatomy access | Transperineal | Transrectal | Transperineal | | Modality | MR | MR | US fusion with MR, CT | | Software | | | | | Windows OS | Yes | Yes | Yes | | Kiosk | Yes | Yes | Not known | | Medical Imaging Software | Yes | Yes | Yes | | Connectivity | | | | | DICOM Import | Yes | Yes | Yes | | Image Display | | | | | General Image 2D/3D<br>Review | Yes | Yes | Yes | | Image Processing | | | | | Registration: Fiducial-<br>tracked Instrumentation<br>in relation to patient<br>anatomy | Yes | Yes | Yes | | Required instrument<br>registration and<br>verification images prior<br>to intervention | Yes | Yes | Yes | | Planning and Navigation | | | | | Interventional<br>Hardware/Positioning<br>Device | Yes (ProBx Grid with<br>Calibrator and Patient<br>Support) | Yes (DynaTrim Needle<br>Guide and Patient<br>Support) | Yes (3rd party<br>Gridplate and Stepper) | | Add Targets | Yes | Yes | Yes | | Plan/Marks Location | Yes | Yes | Yes | | MR-guided interventional<br>planning with<br>interventional hardware | Yes | Yes | Fusion with US | ## Rationale for Substantial Equivalence: Table 5.1 Comparison of ProBx to Predicate Devices {6}------------------------------------------------ Traditional 510(k) Premarket Notification Submission The ProBx software application is substantially equivalent to the predicate device (DynaCAD, K133030) in the areas of technological characteristics such as basic design, function, method of operation, application, and intended use. Both software: - operate in Windows and function as a kiosk. - are able to import DICOM image from various sources and provide 2D and 3D image display. - are used with a positioning device and interventional hardware. - register fiducial-tracked instrumentation in relation to the patient anatomy. - provide verification images of instrumentation placement. - do not steer or in any way control the positioning of instruments used. ● - allow the procedure to be repeated based on operator judgement. - are intended for use in MR-guided procedures involving the prostate. ProBx differs slightly from the DynaCAD in the anatomy access point, fiducial placement and type of needle guide hardware. The transperineal approach using a grid in ProBx is used in reference devices (SmartTarget, K170250). The placement of fiducials is accounted for in an equivalent technique of instrumentation registration. Therefore, the new device does not raise any new potential questions related to safety or performance, and is equivalent to the existing legally marketed devices. ## Performance Data: The ProBx software proposed indications for use are supported by preclinical software verification and validation testing. Bench testing was performed using acceptable scientific methods to validate the fiducial registration technique and determine substantial equivalence to the predicate. This includes validation of the software with the ProBx Hardware in a simulated clinical use phantom study that showed our device can achieve end-to end needle placement accuracy of 1.88 mm. This result shows the ProBx Software is non-inferior to the published endto end needle placement accuracy of DynaCAD. The following are the referenced standards during design and development of the ProBx Software: - ISO 15223-1:2016, Medical devices Symbols to be used with medical device labels, labeling and information to be supplied - ISO 14971:2007, Medical Devices Application of Risk Management to Medical Devices - IEC 62304:2006, Medical Device Software Software Life Cycle Processes ## Conclusion: ProBx Software has similar indications statements as the predicate device. Both devices are used for MR-guided interventional planning with interventional hardware for procedures involving the prostate. The functionality of the ProBx Software and the predicate device is {7}------------------------------------------------ Traditional 510(k) Premarket Notification Submission identical. The results of software verification and validation testing support that ProBx Software functions as intended when used with ProBx Hardware accessories for prostate interventional procedures. Therefore, ProBx Software is substantially equivalent to the predicate device.