MODEL-BASED RSA SOFTWARE

{0}------------------------------------------------ 510(k) Summary K133966 Halifax Biomedical Inc. 11493 Route 19, Mabou Nova Scotia, Canada, BOE 1X0 +1 902 945 2762 Phone Fax +1 902 945 2324 Contact: Chad Munro, CEO President Date Prepared: February 20, 2014 MAR - 6 2014 - 1. Identification of the Device: Proprietary-Trade Name: Product Code Device: Regulation Description: Regulation Medical Specialty Regulation Number Device Class Model-based RSA Software LLZ System, Image Processing, Radiological Picture archiving and communications system. Radiology 892.2050 2 - Equivalent legally marketed devices:. The Model-based RSA Software employs the software 2. cleared in K042383, the RSA-CMS. - 3. Indications for Use (intended use): Orthopaedic specialists and/or Halifax Biomedical Inc image processing labs use the Model - based RSA Software as standalone analytical software package for the evaluation of orthopaedic implant fixation, bone segment motion. Model - based RSA software measures the in - vivo 3D position and/or relative motion of metal implants, marker beads, and/or bone segments. When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment. NOT FOR MAMMOGRAPHY. - 4. Description of the Device: This is a Windows based software only product. It represents an advancement and extension of the same software cleared in K042383. Model-based RSA (Roentgen Stereophotogrammetric Analysis) is a stand-alone analytical software package for RSA digital image post-processing that runs on standard workstations running a Microsoft Windows operating system. This software is used to analyze roentgen images. It accepts digital images in the specific formats from all the major roentgen manufacturers (DICOM - CR and DX modality) as well as scanned roentgen films in bitmap (BMP) format. Generally, a pair of stereo roentgen images is taken of a patient's joint pre-operatively or postoperatively at one or more time points. Model-based RSA software is then used to measure the three dimensional (3D) relative position and/or relative motion of 3D models in the RSA images. Models may generally represent orthopaedic implants, a group of implanted markers (small tantalum beads), or bones. The 3D relative position and/or relative motion measures may provide information regarding of implants, wear of implants, and excessive or reduced motion between bones such as in spine instability and spine fusion - 5. Safety and Effectiveness, comparison to predicate device. The results of software validation, clinical evaluation, and risk analysis indicates that the new device is as safe and effective as the predicate device. - 6. Substantial Equivalence Chart, Model-based RSA Software: Please see the chart below. {1}------------------------------------------------ K133966 Page 2 of 2 | Characteristic | K042383, the RSA-CMS. | Model-based RSA Software | |---------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use: | RSA-CMS has been developed for the<br>objective and reproducible analysis on<br>digital roentgen images (DICOM CR<br>or DX) or digitised images in a PACS<br>environment. Orthopedic specialist<br>and core labs use the RSA-CMS<br>standalone analytical software<br>package In image post-processing for<br>the evaluation of new implant<br>designs, coatings and new<br>cementation techniques in clinical<br>trials. When interpreted by trained<br>physicians these parameters may be<br>useful to derive conclusions from<br>these clinical trials. | Orthopaedic specialists and/or Halifax<br>Biomedical Inc. image processing labs use<br>the Model-based RSA Software as<br>standalone analytical software package for<br>the evaluation of orthopaedic implant<br>fixation , bone segment motion. Model-<br>based RSA software measures the in-vivo<br>3D position and/or relative motion of metal<br>implants, marker beads, and/or bone<br>segments. When interpreted by trained<br>physicians these measurements may be<br>useful to derive conclusions for patient<br>treatment. NOT FOR MAMMOGRAPHY. | | Target Users | Trained physicians | SAME | | Specialty | Orthopaedic | SAME | | Image Types | DICOM, BMP, TIFF | Same | | PC Workstation | Yes | Yes | | Receive digital images<br>from various sources | Yes | Yes | | Transmit data to remote<br>viewing PACS stations<br>over a medical imaging<br>network | Yes | No | | Digital image post<br>processing | Yes | Yes | | Scaling of image facility | Yes | Yes | | Measurement<br>capabilities | Yes | Yes | | Preoperative Planning | No | Yes | | Assessment of 2D<br>migration of prostheses | Yes | Yes | | Assessment of 3D<br>migration of prostheses | Yes | Yes | - Description of non-clinical (bench) testing: Software documentation was executed according to the 7. recommendations of the FDA Guidance Document: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. This included validation and risk analysis. Validation of Model-based RSA software is done by comparing the calculated migrations with accurately applied translations and rotations using a micromanipulator in phantom experiments. - Description of clinical testing: Clinical experiments studied the accuracy and precision of migration 8. calculations using Model-based RSA. Five studies in all showed that migration calculations by the Modelbased RSA software are not biased and have high accuracy and precision. - 9. Conclusion: After analyzing software validation, bench tests, clinical data, and risk analysis, it is the conclusion of Halifax Biomedical that the Model-Based RSA Software is as safe and effective as the predicate devices, has no significant technological differences, and has no new indications for use, (In fact USING the predicate devices) thus rendering it substantially equivalent to the predicate devices. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter of the circle. The text is written in all capital letters. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 6, 2014 Halifax Biomedical, Inc. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114 Re: K133966 Trade/Device Name: Model-Based RSA Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 20, 2013 Received: December 24, 2013 Dear Mr. Kamm: 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. {3}------------------------------------------------ Page 2-Mr. Kamm . . . If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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. Sincerely yours. Smh.7) ਿੱ Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K133966 Device Name: Model-Based RSA Software Indications For Use: Orthopaedic specialists and/or Halifax Biomedical Inc image processing labs use the Model-based RSA Software as standalone analytical software package for the evaluation of orthopaedic implant fixation , bone segment motion. Model-based RSA software measures the in-vivo 3D position and/or relative motion of metal implants, marker beads, and/or bone segments. When interpreted by trained physicians these measurements may be useful to derive conclusions for patient treatment. NOT FOR MAMMOGRAPHY. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) Smh.7) (Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health > K133966 510(k) > > Page I of I