ArthroPlan Digital Templating Software

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 16, 2014 Arthromeda, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street, NW BUFFALO MN 55313 Re: K142944 Trade/Device Name: ArthroPlan Digital Templating Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 2, 2014 Received: December 3, 2014 Dear Mr. Job: 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. Robert A. Ochs Robert A. Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K142944 Device Name ArthroPlan Digital Templating Software ## Indications for Use (Describe) ArthroPlan™ is indicated for use by suitably licensed and qualified healthcare professionals requiring access to medical images to be used in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the size and geometry of the prosthetic/fixation device when planning a potential hip arthroplasty surgical procedure. Templating is done without alteration of the original image, using scaling and measurement tools in a digital environment, in conjunction with manufacturers' templates available via the ArthroPlan library of digital templates for prosthetic and fixation devices. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | # 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 ## Arthromeda's ArthroPlan™ Digital Templating Software Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared: Arthromeda®, Inc. Phone: 513-236-0857 Facsimile: 513-898-2106 Contact Person: Elsa Abruzzo Date Prepared: August 29, 2014 #### Name/Address of Sponsor: Arthromeda, Inc. 172 Middle Street, Suite 207 Lowell, Massachusetts 01852 USA | Trade Name:<br>(ArthroPlan) | ArthroPlan™ Digital Templating Software | |------------------------------|-------------------------------------------------------| | Common or Usual Name: | System, Image Processing, Radiological | | Classification Name: | Picture Archiving and Communications System<br>(PACS) | | Classification: | Class II | | Product Code and Regulation: | LLZ, CFR 892.2050 | | Classification Panel: | Radiology | ## Predicate Devices: - Predicate devices for the ArthroPlan™ Digital Templating Software, include the: Meridian Technique, Ltd., Orthoview™ (K063327) - Agfa Healthcare Corporation Orthopedic Software For IMPAX Workstations (K071972) ## Intended Use / Indications for Use ArthroPlan™ is indicated for use by suitably licensed and qualified healthcare professionals requiring access to medical images to be used in conjunction with templates for prosthetic and fixation devices, for the purposes of choosing the size and geometry of the prosthetic/fixation device when planning a potential hip arthroplasty surgical procedure. Templating is done without alteration of the original image, using scaling and measurement tools in a digital environment, in conjunction with {4}------------------------------------------------ manufacturers' templates available via the ArthroPlan library of digital templates for prosthetic and fixation devices. ## Device Description ArthroPlan™ is software designed and developed for preoperative planning, a.k.a. digital templating, for orthopedic operations. It includes tools for performing common measurements and drawings in combination with orthopedic implant manufacturer's electronic templates (provided in the ArthroPlan Template Library, which is part of the software). The measurements and scaling tools enable the user performing preoperative planning for orthopedic procedures. - The software allows the user to capture the radiographic image, import it to the software, accurately scale the degree of maqnification of the image, and overlay and manipulated (size, angle, rotate, invert, etc.) the desired electronic template(s) on the image facilitating the election of the appropriate size of prosthetic/fixing. ## Technological Characteristics The ArthroPlan is software that can be downloaded from Arthromeda's website via the Internet, installed on a personal computer, laptop, or workstation and unlocked using an Arthromeda, Inc. provided key. The key is single use, permitting only one installation of the software on one personal computer, laptop, or workstation and preventing any unauthorized use of the software. The device consists of a standalone Microsoft Windows compatible software installed on a personal computer, laptop, or workstation. - Access to the software is controlled through existing security measures on the computer, laptop, or workstation. Radiographic images are captured from normal viewing programs (such as PACS) available to the user and copied into the software for processing off-line. ArthroPlan does not provide access to these viewing programs. Patient confidentiality and patient identification is determined by the user on the off-line saved file. Image integrity is maintained during processing. ArthroPlan Software imports images at a 1 to 1 ratio using the bitmap format. During the saving of images, there is a potential loss of data. Saving of images using the APL or BMP format are recommended. Any other format potentially causes loss of data. The captured, imported, and saved image may be retrieved and processed with the following functionality: - י Scaling of the radiographic image based on known size image marker within software program (original image is not altered) - -Selection of desired prosthetic and fixing device manufacturer, model, and size template for overlay and manipulation on image - -Overlay and manipulation (size, angle, rotate, inverting, etc.) of the selected electronic template on the image {5}------------------------------------------------ - Combine compatible prosthetic/fixing implant templates from different manufacturers - -Display, print, and archive reports (final images with template overlay including manufacturer name, model, size, measurements, etc.) - Receive and store templates for prosthesis and fixation supplied by -Arthromeda, Inc. for particular manufacturers' ranges of products - -Provide traceability of operator, date, and decision made ## Performance Data Performance testing including a non-clinical user validation was conducted on the ArthroPlan software. Testing was conducted in compliance to the applicable guidances and standards including: | FDA Guidance (January<br>11, 2002) | General Principles of Software Validation; Final Guidance for Industry and FDA<br>Staff | |------------------------------------|------------------------------------------------------------------------------------------------| | FDA Guidance<br>(May 11, 2005) | Guidance for the Content of Premarket Submissions for Software Contained in<br>Medical Devices | | ISO 62304 | Medical Device Software - Software life cycle processes | | ISO 62366 | Medical Devices -Application of usability engineering to medical devices. | | IEC/ISO 10918-1 | Digital compression and coding of continuous-tone still images: Compliance<br>testing | | NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) Set | | ANSI/AAMI HE75 | Human Factors engineering - Design of medical devices | # Table 1: Applicable Standards and Guidances In all instances, the ArthroPlan functioned as intended and all results of the user and software validations observed was as expected. Risk analysis indicates that ArthroPlan is identical to the predicate devices in the patient environment. ArthroPlan uses similar materials and constructional principles to the predicate device. ArthroPlan processes data in the form of images collected (captured) in the patient environment after the event of actual collection. This non-patient contact processing is described exactly in terms of its software functions and associated templates. For these reasons the non-clinical user validation conducted is sufficient to verify the functionality of the ArthroPlan. {6}------------------------------------------------ Performance testing of the ArthroPlan Digital Templating Software indicates that it meets is specifications and performs as intended. I In particular, the following functions have been tested and confirmed as operating according to specified requirements and being substantially equivalent to the predicates: - -Patient and procedure selection - -Image collection (capture) and scaling - -Procedure planning - Templating - - -Committing and saving operating session data - -Compilation and printing of associated reports ## Substantial Equivalence The ArthroPlan Digital Templating Software is as safe and effective as the Meridian Technique. Ltd., Orthoview™ (K063327) and Agfa Healthcare Corporation Orthopedic Software For IMPAX Workstations (K071972) predicate devices. The ArthroPlan has the intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the ArthroPlan and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the ArthroPlan software is as safe and effective as above cited predicates. Thus, the ArthroPlan is substantially equivalent. | Comparison of Technological Characteristics | | | |-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | Characteristic | ArthroPlan | Predicate Devices | | Device Type | Standalone Software for Digital Templating | Same | | Computer Environment | Personal Computer, laptop, workstation/server | Same | | Clinical Use Case | Used for planning orthopedic procedures using templates in the areas of prosthetic placement. | Same | | Principle of Operation | On captured radiographic image, the user identifies physiological landmarks and software calculates commonly used measurements based on those landmarks. The software also allows the user to overlay electronic templates of orthopedic implants provided by implantable device manufacturers. | Same | | Means of radiographic image collection | Obtained from pre-obtained digital images via PACS system | Same | | Processing of Data | Processes data to provide prosthetic and fixing template overlay and placement | Same | | Templating Features | Scaling, measurement, template manipulation (sizing, moving, rotation, inverting, angling, etc.) | Same | | Templates | Library of manufacturer electronic templates available in software | Same | | Patient Contact | No patient contact | Same | | Human Intervention for Interpretation of Images | Requires physician to use and interpret data. Decision on implant selection is up to the physician | Same | ## Table 2: Comparison of Technological Characteristics {7}------------------------------------------------ # Conclusions The ArthroPlan Digital Templating Software is substantially equivalent to the predicate devices in intended use and technology. Performance incompliance to the applicable guidances and standards demonstrates that the ArthroPlan software devices is as safe, as effective, and performs equivalently to the predicate devices.