(191 days)
OrthoView is indicated for use when a suitable licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. OrthoView provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.
OrthoView 7.2 is dedicated, digital, pre-operative planning and templating software used to create detailed pre-operative plans quickly and easily from digital x-ray images. OrthoView 7.2 is software to be used for medical purposes, performing these purposes without being part of a hardware medical device. The device provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
The provided text is a 510(k) Summary for OrthoView 7.2, a pre-operative planning and templating software. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data for acceptance criteria.
The document does not contain explicit quantitative acceptance criteria or a dedicated study section with specific performance metrics (e.g., accuracy, sensitivity, specificity) for the device's clinical use. Instead, it relies on demonstrating substantial equivalence through a comparison of technological characteristics, intended use, and a history of safe and effective use of the predicate device.
Here's an analysis based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted, the document does not present quantitative acceptance criteria or specific performance metrics as typically found in a clinical performance study. The "acceptance criteria" can be inferred as the demonstration of "substantial equivalence" to the predicate device, OrthoView 4, by proving that OrthoView 7.2 performs as intended and is safe and effective in a non-inferior manner to its predecessor.
| Category | Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device functionality (image viewing, manipulation, templating, measurements, reporting, saving) should be identical or improved compared to the predicate, within the scope of intended use. | OrthoView 7.2's core functions (Image Loading, Image Manipulation, Scaling, Analysis Methods, Landmarks, Contours, Cut Positions, Reduction, Measurements, Reporting, Saving/Commit, Image Storage) are reported as "IDENTICAL" to OrthoView 4. Some minor extensions (e.g., horizontal/vertical alignment tools, online template access, improved analysis display, Active Directory integration) are mentioned as improvements. |
| Safety | No new safety concerns should be raised compared to the predicate device. | OrthoView has been in commercial distribution since 2001, has never been subject to recall or medical device report, and has proven safe in clinical usage. Risk analysis (ISO 14971:2007) indicates the same risk profile as the predicate. |
| Effectiveness | The device should perform as intended for pre-operative planning and templating, similar to the predicate. | Each new release (including 7.2) underwent thorough testing, and clinical features were evaluated by a surgeon (within a non-clinical environment). Testing verified accuracy and performance are adequate and as intended. |
| Technical Compliance | Conformance to relevant medical device standards and guidance documents. | Device complies with ISO 14971:2012, NEMA PS 3.1 - 3.20 (2016) (DICOM), IEC 62304:2006, IEC 62336:2015, ISO-15223-1:2012, ISO 14155:2011, and FDA guidance documents for software and image management devices. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document mentions "procedure-specific images" and "a fully configured system installed on hospital representative environments," but does not specify a numerical sample size for the test images.
- Data Provenance: The document states that "All manual testing is performed... using procedure-specific images to emulate as close as possible intended use." It doesn't explicitly state the country of origin for these test images or whether they were retrospective or prospective. Given the submitter's location (UK), it's plausible the testing environment or images might be related to UK practices, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: The document states, "All new features are checked by a surgeon to verify clinical performance." For non-clinical tests, it notes, "Each release over time has experienced thorough testing and each new release has had its clinical features evaluated by a surgeon (within a non-clinical environment)." This implies at least one surgeon was involved in evaluating clinical performance.
- Qualifications of Experts: The experts are referred to simply as "a surgeon" or "a suitably licensed and qualified healthcare professional." No further details on their specific qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set:
- The document does not describe a formal adjudication method (e.g., 2+1, 3+1). The evaluation mentioned ("checked by a surgeon") appears to be a single-reader assessment for clinical performance verification.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- The document does not mention or describe a MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The focus is on demonstrating equivalence to a previous version of the software, not on quantifying human performance improvement with AI.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance):
- The performance assessment described appears to be a standalone (algorithm only) evaluation in the sense that the software's functions were tested, and its "clinical features" were verified by a surgeon in a non-clinical environment. The document confirms "OrthoView 7.2 is software to be used for medical purposes, performing these purposes without being part of a hardware medical device." However, the device's intended use is to assist a "licensed and qualified healthcare professional," implying it's designed to be used with a human in the loop for surgical planning and review. The clinical evaluation isn't comparing algorithm-only decisions to expert decisions, but rather the algorithm's functional correctness.
7. Type of Ground Truth Used:
- The ground truth for the "clinical performance" verification appears to be expert consensus/opinion from a surgeon. The surgeon checks new features to verify their clinical performance, implying their judgment forms the basis of the "ground truth" for the functional correctness and clinical utility of these features. There is no mention of pathology, outcomes data, or other objective ground truth types.
8. Sample Size for the Training Set:
- The document does not specify a sample size for any training set. OrthoView 7.2 is described as pre-operative planning and templating software that primarily uses tools and templates, rather than a machine learning or AI algorithm that would typically require a training set of images with established ground truth for learning. The improvements noted are more about extended functionality and user interface rather than a new AI model.
9. How the Ground Truth for the Training Set Was Established:
- Since no training set is mentioned or implied for an AI/ML model, this information is not applicable and not provided. The software's capabilities are based on established geometric calculations, image manipulation techniques, and templating logic, rather than a learned model from data.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
Meridian Technique Ltd % Mr. Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041
Re: K171068
Trade/Device Name: OrthoView 7.2 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 9, 2017 Received: October 12, 2017
Dear Mr. Yungvirt:
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);
October 18, 2017
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Page 2 - Mr. Dave Yungvirt
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 (DICE) 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 (DICE) 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.
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
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Indications for Use
510(k) Number (if known) K171068
Device Name ORTHOVIEW 7.2
Indications for Use (Describe)
Ortho View is indicated for use when a suitable licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. OrthoView provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.
| Type of Use (Select one or both, as applicable) |
|---|
| </span> Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
Date Summary Prepared: October 16, 2017
The following section is included as required by the Safe Medical Devices Act (SMDA) of 1990 and 21CFR 807.92.
Submitter information
Table 1
| Submitter Company & Manufacturer | Meridian Technique Ltd |
|---|---|
| Establishment registration number | 3004537781 |
| Street Address | 2 Venture Road, Southampton Science Park |
| City | Southampton |
| Postal code | SO16 7NP |
| Country | UK |
| Phone number | +44(0) 2380 119663 |
| Principal Contact person | Barbara March |
| Contact title | Quality Manager |
| Contact e-mail address | Barbara.march@orthoview.com |
| Additional contact person | Andy Enefer |
| Contact title | Engineering Manager |
| Contact e-mail address | Andy.enefer@orthoview.com |
Submission information
THE DEVICE
Table 2
| The Device Which Is The Subject Of This Submission | |||
|---|---|---|---|
| Device Trade/Proprietary Name | OrthoView 7.2 | ||
| Device Classification | Class II | ||
| Device Panel | Radiology | ||
| Common Name | Image Processing System Radiological | ||
| Classification Name | Picture Archiving and Communication Systems | ||
| Primary product code | LLZ (21 CFR § 892.2050) |
| Meridian Technique Ltd | |
|---|---|
| OrthoView 7.2 - 510k Notification | |
| October 16, 2017 | |
| Total Pages | 10 |
| Page Number | 1 |
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THE PREDICATE DEVICE
The Leqally Marketed Predicate Device [807.92(a)(3)]
To demonstrate substantial equivalence of OrthoView 7.2 to a device currently cleared for marketing in the USA, Meridian Technique Ltd will utilize the following device which has not been subject to a design-related recall:
Table 3
| The Orthopaedic Predicate Device To Which Substantial Equivalence Is Claimed | |
|---|---|
| Manufacturer | Meridian Technique Ltd |
| Device Trade/Proprietary Name | OrthoView 4 |
| Device Class | Class II |
| Device Panel | Radiology |
| Common Name | Image Processing System Radiological |
| Classification Name | Picture Archiving and Communication Systems |
| Primary product code | LLZ (21 CFR § 892.2050) |
| 510(k) number | K063327 |
| Decision date | 22nd November 2006 |
THE DEVICE DESCRIPTION [807.92(a)(4)]
OrthoView 7.2 is dedicated, digital, pre-operative planning and templating software used to create detailed pre-operative plans quickly and easily from digital x-ray images. OrthoView 7.2 is software to be used for medical purposes, performing these purposes without being part of a hardware medical device.
The device provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images.
Conditions of Use
- OrthoView 7.2 is either a standalone device or is provided for use specifically with third . party PACS equipment.
- OrthoView 7.2 may be installed on each workstation or deployed onto a workstation from ● a central server.
- The OrthoView 7.2 software has no direct or indirect patient-contacting components and ● makes no intentional contact with the patient or any other persons.
- . The OrthoView 7.2 software may communicate with a third party source of digital X Ray images and may therefore be connected to a proprietary network.
- Some optional features require Internet access but OrthoView 7.2 can be used without such access.
Service and Maintenance Technicians will be required to:
- Install initial software and software enhancements. ●
- Maintain access codes and rights. ●
- Install Templates and Licenses. ●
The scope for contact is the same as for the Operator.
| Meridian Technique LtdOrthoView 7.2 - 510k Notification | Total Pages | Page Number |
|---|---|---|
| October 16, 2017 | 10 | 2 |
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Table 4
| Minimum Operating System Requirements | |
|---|---|
| Computer | PC or MAC compatible computer |
| Operating System MAC OS | OS X 10.12 or higher |
| Operating System Windows | Windows 7, 8, 8.1 or 10 |
| Processor | 1 GHz CPU |
| Memory | 2GB RAM |
| Free Hard Disc Space | 2GB free disk space |
| Graphics/Display | 1280 x 1024 colour graphics display |
| (Optional) Intranet Connection to PACS. | 100MBit/Sec |
| (Optional) Internet Connection (required forcase management, auto template updateand anonymous stat collection featuresonly). | 2MBit/Sec. |
Note -this is a minimum requirement for OrthoView 7.2 and NOT for the associated PACS system with which it is operating. It is expected that the associated PACS system will exceed this specification.
INTENDED USE & INDICATIONS FOR USE:
The subject of this submission - OrthoView 7.2
Orthoview is indicated for use when a suitable licensed and qualified healthcare professional requires access to medical images with the intention of using such images to plan or review a surgical procedure. OrthoView provides a set of tools and templates (representing prosthetic and fixation devices) to assist the healthcare professional in planning their surgery. The device is not to be used for mammography.
| Meridian Technique LtdOrthoView 7.2 - 510k NotificationOctober 16, 2017 | Total Pages | Page Number |
|---|---|---|
| 10 | 3 |
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| Feature | OrthoView 7.2 | Predicate Device - OrthoView 4 |
|---|---|---|
| Device for premarket notification | FDA marketing clearance K063327following 510(k) submission November 2006 | |
| Indications for Use | The Intended use of OrthoView 7.2 is when a suitablylicensed and qualified healthcare professional requiresaccess to medical images with the intention of using suchimages for pre-operative planning of a potential surgicalprocedure. | OrthoView 4 has the identical intended use anduses identical software and algorithms to achievethis purpose |
| OrthoView 7.2 is indicated for use when a suitably licensedand qualified healthcare professional requires access tomedical images with the intention of using such images toplan or review a surgical procedure. OrthoView 7.2 providesa set of tools and templates (representing prosthetic andfixation devices) to assist the healthcare professional inplanning their surgery.The device is not to be used for mammography | OrthoView 4 is indicated for use when a suitablylicensed and qualified healthcare professionalrequires access to medical images with theintention of using such images, in conjunction withtemplates for prosthetic and fixation devices, for thepurposes of choosing the nature and characteristicsof the prosthetic/fixation device to be used whenplanning a potential surgical procedure. In addition,Trauma and Osteotomy modules and TraumaTemplates are provided to extend the range offunctionality available to the healthcareprofessional. |
Table 5 – Comparison and Explanation of the Instructions For Use Differences [807.92(a)(5)]
| Meridian Technique Ltd | Total Pages | Page Number |
|---|---|---|
| OrthoView 7.2 - 510k Notification | 10 | 4 |
| October 16, 2017 |
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Table 5 – Comparison and Explanation of the Instructions For Use Differences [807.92(a)(5)]
| Feature | OrthoView 7.2 | Predicate Device - OrthoView 4 |
|---|---|---|
| Device for premarket notification | FDA marketing clearance K063327following 510(k) submission November 2006 | |
| Discussion | The indications for use have been changed to reflect accurately the usage of the device and the predicate. Thewording has been slightly changed to reflect that surgeons can plan surgery using either device without actuallyusing a prosthetic or fixation device. Either device allows the healthcare professional to use a set of wizards tomake measurements and angles between anatomical landmarks. While these measurements and angles are oftenused to choose the nature and characteristics of a prosthetic/fixation device they are sometimes sufficient outputin themselves for the surgical plan and so a surgeon may use the device without applying templates/fixationdevices. Several procedures within the predicate and new device do not require templates/fixation devices to beused. Review has also been added since a healthcare professional may use OrthoView 7.2 or the predicatedevice to review the plan or surgery of another surgeon by viewing it within the device. The indications for usehave therefore been modified to provide a more accurate usage statement allowing for situations whereby the fullfeature set is not required in order to produce a viable plan for some procedures. In addition, the sentence addedin the predicate device submission has been removed. This is because the additional features mentioned arealready completely covered in the rest of the indications for use (they were originally added to the predicate deviceto highlight the extension of functionality in OrthoView 4 added since its previous 510K).Despite the change of wording the new device is substantially equivalent to the predicate device in that there is nochange in usage but a clarification of possible and permissible current usage. |
| Meridian Technique Ltd | Total Pages | Page Number |
|---|---|---|
| OrthoView 7.2 - 510k Notification | 10 | 5 |
| October 16, 2017 |
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The Application Of The Device And The Intended Patient Population [807,92(a)(5)]
The anatomical site selected and the corresponding image presented by the device are decided and chosen by the physician.
It is evident that the decision regarding whether a patient is included in the target population for either application resides with the patient's physician only and hence, neither application of the device has any direct influence on the target patient population. It is therefore beyond the scope of OrthoView 7.2 to specify an anatomical site or target population other than 'any'.
Technological Characteristics [807.92(a)(6)1
OrthoView 7.2 is medical device software that permits the pre-planning of surgical procedures by permitting image viewing and manipulation within a PACS computer or standalone environment. It is designed to integrate into a third-party provided PACS hardware and software environment. This implies the provision of a computer specification appropriate to a PACS environment. OrthoView 7.2 can be configured to be launched from within a networked environment or as a standalone application. The device is intentionally non-patient contacting patient and does not deliver medication or therapeutic treatment. Energy used or delivered to the user is associated with the related workstation only and not the device.
Performance Data:
Conformance Standards & Guidances
The device complies with the following international and FDA-recognized consensus standards and FDA quidance documents:
- ISO 14971:2012 & ISO14971:2007 Medical devices Application of risk management ● to medical devices
- NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communication in Medicine (DICOM)
- . IEC 62304:2006 Medical device software - Software life cycle processes
- IEC 62336:2015. Medical devices Application of usability engineering to medical ● devices
- . ISO-15223-1:2012-Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling And Information, Part 1 General Requirements
- . ISO 14155:2011 - Clinical Investigation of Medical Devices for Human Subjects. Good Clinical Practice
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Guidance for the Submission of Premarket Notifications for Medical Image Management Devices
- . Applying Human Factors and Usability Engineering to Medical Devices
Testing
A full test report is provided for each completed test. The test report includes the objective of the test, description of the test methods and procedures, study endpoint(s), predefined pass/fail criteria, results summary and conclusions.
The feature tests of the predicate device now form the regression tests of the subject device verifying that OrthoView 7.2 includes the same functionality as the predicate device.
Non-clinical tests [807.92(b)(1)]
Each release over time has experienced thorough testing and each new release has had its clinical features evaluated by a surgeon (within a non-clinical environment).
| Meridian Technique Ltd | Total Pages | Page Number |
|---|---|---|
| OrthoView 7.2 - 510k NotificationOctober 16, 2017 | 10 | 6 |
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Non-clinical testing was performed to determine substantial equivalence. This non-clinical testing included the regression tests associated with the predicate device. Testing verified that the accuracy and performance of the system is adequate and performs as intended. This software has been extensively verified via code reviews, automated and manual testing.
All manual testing is performed on a fully configured system installed on hospital representative environments using procedure-specific images to emulate as close as possible intended use. All new features are checked by a surgeon to verify clinical performance.
Feature additions since the OrthoView 4 have been verified as being within the scope of the intended use of the predicate. In this way, data generated from each test supports the finding of substantial equivalence.
Substantial Equivalence
The characersitics of the device and the predicate device allow the healthcare professional to use a set of wizards to make measurements and angles between anatomical landmarks. These measurements and angles may be used to choose the nature and characteristics of a prosthetic/fixation device and they are also sufficient output for a surgical plan. Ortho/iew 7.2 and the predicate device also allow the healthcare professional to review the plan of another surgeon by viewing it within the device.
Functional Comparison
| TECHNOLOGICAL COMPARISON | |
|---|---|
| Physical Properties | |
| OrthoView 7.2 (this submission) | OrthoView 4 (Predicate Device) |
| System Requirements- IDENTICALWindows 7, 8.1, 8 or 10, MAC OS X 10.12+2GB RAM2GB Free Disk Space1280 x 1024 Colour Graphics Display | Windows XP or Windows 2000512MB RAM (1GB Recommended)100Mb Free disk Space1024x768 Colour Graphics Display |
| Although the System requirements havechanged they are aligned with the improvedhardware available in hospitals sincerelease of the predicate device. The currentoperating environment is identical in that itreflects the availability of Desktop devicesto the clinicians in the intended use.Although MAC is a new Operating Systemit is in keeping with meeting the needs ofthe clinicians using the device. | |
| Installation - IDENTICALThere is no change to the deliveryinstallation, licensing and integrations ofOrthoView. | To be downloaded from the Internet, installedand unlocked using a license provided byMeridian Technique Ltd |
| Launch - IDENTICALThe means of launching OrthoView 7.2 areidentical to the predicate device. | Can be configured to be launched from withina PACs workstation environment or as astandalone application. |
| Login - IDENTICALAccess/Login rights are identical but nowinclude the capability to use Hospitalenforced access rights through ActiveDirectory. | Grant access rights only to authorized users(via PC password system). |
Table 6
| Meridian Technique LtdOrthoView 7.2 - 510k NotificationOctober 16, 2017 | Total Pages10 | Page Number7 |
|---|---|---|
| --------------------------------------------------------------------------------- | ------------------- | ------------------ |
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| TECHNOLOGICAL COMPARISONPhysical Properties | |
|---|---|
| OrthoView 7.2 (this submission)Image Loading - IDENTICALThe Image loading is identical and theexpected modalities are also unchanged. | OrthoView 4 (Predicate Device)Receive X-Ray images in a digital formatfrom third party X-Ray machines/ X-Raydigitisers or PACS systems. Orthoview 4provides the means of recording, storing andretrieving the templating process stepsperformed by the licensed medicalprofessional when assessing the optimumprosthetic device for a particular patient. |
| Image Manipulation - IDENTICALImage manipulation functionality such asWindow/level/flip etc is identical. Thefunction of the existing 90 degree rotationtools has been extended to horizontal andvertical alignment.Templates may now be obtained throughan online server. | Orthoview 4 permits to pre-plan surgicalprocedures by permitting image viewing andmanipulation and prosthetic template overlaywithin a PACS workstation or standaloneenvironment.Orthoview 4 processes such images securelywith respect to patient confidentiality, patientidentification and image integrity and allowsthe image to be retrieved for processing asfollows:Scaling of the image.Selection of appropriate prosthetic and fixingdevice manufacturer and size rangetemplates.Overlaying the template on the image andpermitting selection of appropriate size ofprosthetic/fixing.Provide additional functionality in the form ofTrauma Wizards, Pediatrics WizardsOsteotomy Wizards, Fracture ReductionTools and Trauma TemplatesPrint and archive appropriate reports.Receive and store templates for prosthesesand fixations supplied by Meridian forparticular manufacturers' range of products.Provide traceability of operator, date and pre-operative plans. |
| Scaling - IDENTICALThe workflow and practice of scalingremains unchanged. | A marker (not included) is a radio-opaqueobject of known size which is placed on thepatient in the same plane as the joint beingimaged. Using markers is a more accuratemethod to confirm oversize but a rudimentaryruler scaling tool is also available to establishpixel spacing on the x-ray, in the event thatthis information is not present on the image. |
| Analysis Methods - IDENTICALDifferent methods of analysing data for thepre-operative plan are now available to theuser. The mechanism for selecting theanalysis methods and wizards are thesame, only the presentation of the relevantwizards has been improved. | The analysis or report summary is generatedby the Report Wizard available from the GUIwhich offers the options of printing and orsaving the analysis of the pre-operative plan. |
| Meridian Technique LtdOrthoView 7.2 - 510k NotificationOctober 16, 2017 | Total Pages10 | Page Number8 |
|---|---|---|
| --------------------------------------------------------------------------------- | ------------------- | ------------------ |
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| TECHNOLOGICAL COMPARISON | ||
|---|---|---|
| Physical Properties | ||
| OrthoView 7.2 (this submission)Landmarks - IDENTICALThe mechanism for identifying landmarkson an x-ray is identical. The clinicalrelevance of these points is the same | OrthoView 4 (Predicate Device)Various Wizards are available to identify therelevant anatomical points or landmarksaccording to the clinical procedure beingplanned. | |
| Contours - IDENTICALContours are identical to the wizards usedin the predicate device to define cut areasin Limb Deformity etc. | Various wizards are available forassessment, planning and reduction forcentre of rotation and angulation in planninglimb deforinty correction | |
| Cut Positions - IDENTICALCut positioning functionality is identical tothe wizards used in the predicate device forosteotomies etc. | The Osteotomy wizard defines the positionand angle of cut required when straighteninga shaft. | |
| Reduction - IDENTICALNo change to this functionality. | Various Reduction tools and wizards areavailable for manipulating image fragmentsand specialized animators for limb deformityprocedures | |
| Measurements - IDENTICALThe Measurement technology and functionis identical to the predicate device. There isno difference to the importance or likelihoodof error from these measurements. | The many joint specific wizards rely onmeasurements in order to correctly pre-plansurgery | |
| Reporting - IDENTICALThe reporting function is identical with theadded improvement of an analysis specificdisplay. | Orthoview 4 provides the means ofrecording, storing and retrieving thetemplating process steps performed by thelicensed medical professional whenassessing the optimum prosthetic device fora particular patient. | |
| Saving/Commit - IDENTICALThe Save & Commit functions are identical. | An OrthoView 4 planning session can be'Saved' or 'Committed'. 'Saving' a sessionallows it to be re-opened for review.'Committing' creates a permanent, read-onlyrecord. | |
| Image Storage - IDENTICALImages are still stored permanently inPACS Systems and may be storedtemporarily in files. OrthoView 7.2 allowsthose temporary plans to be stored as fileswithin a Case Management System ifdesired. | Images are permanently stored within PACSsystems within the Hospital. Interim plansmay be stored and transported as files. |
Risk Analysis
A Risk Analysis has been completed for the device in accordance with ISO14971:2007 and risk control measures have been implemented to mitigate identified hazards, including those resulting from intentional or inadvertent misuse of the device. Any risks posed by the design, manufacture and use of OrthoView 7.2 have been evaluated. The risk analysis indicates that the subject device has the same risk profile in the patient environment, using the same materials and construction principles as the predicate device. Accordingly, it is believed that no further clinical work is required.
| Meridian Technique Ltd | Total Pages | Page Number |
|---|---|---|
| OrthoView 7.2 - 510k NotificationOctober 16, 2017 | 10 | 9 |
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Safety and Effectiveness
OrthoView has been in commercial distribution since 2001, has never been the subject of a recall or medical device report and has proven to be safe and effective in clinical usage. Each release has been thoroughly tested and the clinical features have been evaluated by a surgeon (within a non-clinical environment).
Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics, performance testing and technological comparison, OrthoView 7.2 raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.
| Meridian Technique Ltd | Total Pages | Page Number |
|---|---|---|
| OrthoView 7.2 - 510k Notification | 10 | 10 |
| October 16, 2017 |
N/A