(120 days)
No
The summary describes software for image transfer and pre-operative planning, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is a software portal for preoperative planning and image transfer, not a therapeutic device. It aids in surgical planning but does not directly treat a condition.
No
The document states the device is intended for use as a "software interface and for the transfer of imaging information from a medical scanner" and as "pre-operative software for simulating implant placement and surgical treatment options". While it uses medical images, its purpose is planning and simulation, not diagnosis.
Yes
The device description explicitly states "The OrthoVis Web Portal is composed of software intended for use...". While it interacts with other systems (medical scanners, instrument systems, implant systems), the core device being described and submitted for 510(k) appears to be the software portal itself. The performance studies focus on software verification and validation and a simulated use comparison of the software process.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for:
- Software interface and transfer of imaging information.
- Pre-operative simulation of implant placement and surgical treatment options.
- Use with specific surgical instrument systems and implant systems.
- Device Description: The description focuses on software for uploading images, preoperative planning, and plan approval related to surgical procedures.
- Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not involve the analysis of biological specimens.
The device is a medical device software used for surgical planning and guidance, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The OrthoVis Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as pre-operative software for simulating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below.
- · Arthrex Univers Apex
- · Arthrex Univers II
- · Arthrex Univers Revers
- · DePuy Global AP
- DePuy Global StepTech
- · DePuy Delta Xtend Reverse
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.
Product codes
LLZ, KWS, PHX
Device Description
The OrthoVis Web Portal is composed of software intended for use to facilitate upload of medical images and preoperative planning and plan approval of placement and orientation of Arthrex and DePuy total shoulder replacement systems. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K13367 and K151568). The user is then able to login to the OrthoVis Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the shoulder replacement component and then approved plan is then available to download by COS technicians for further preoperative planning production (see 510(k) K123122 and K142072) and for download by the user/surgeon.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner
Anatomical Site
Glenoid, shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Simulated Use Comparison between OrthoVis Web Portal Process and CD Mailer/Go-To-Meeting/Email Process: Surgeons with experience in using the OrthoVis Preoperative Plan via the CD Mailer/Go-To-Meeting/Email process were asked to compare that experience with the OrthoVis Web Portal Process and fill out a survey based on the two experiences.
Non-clinical testing:
The first part consisted of automated unit tests.
The second part used an automatic integration-testing tool to test the Web Portal user interface.
The third part manually tested remaining errors.
Automated testing framework created test cases according to constraint rules for correct results and to violate rules to verify constraints and error messages.
WebDriver testing tool (W3C standard) used to drive the user interface in a large number of scenarios. Automated tests made from prepared data to test each requirement.
Manual code inspection verified error handlers. Manual testing executed during each testing phase.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing:
- Software verification and validation
- Dimensional validation
- Simulated Use Comparison between OrthoVis Web Portal Process and CD Mailer/Go-To-Meeting/Email Process
Key results: Software verification and validation established substantial equivalence. Dimensional validation confirmed the same code responsible for reading and display of CT scans is used in both cleared OrthoVis Shoulder software and OrthoVis Web Portal software. Simulated use comparison was performed. The non-clinical testing proved that the device is as safe and effective as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K13367, K151568, K123122, K142072
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked on top of each other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Custom Orthopaedics Solutions, Incorporated Mr. Keith Grafmeyer Product Engineer 10000 Cedar Avenue Cleveland, Ohio 44106
October 2, 2015
Re: K151501
Trade/Device Name: OrthoVis Web Portal Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ, KWS, PHX Dated: May 26, 2015 Received: June 4, 2015
Dear Mr. Grafmeyer:
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
1
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.
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" (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 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151501
Device Name OrthoVis Web Portal
Indications for Use (Describe)
The OrthoVis Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as pre-operative software for simulating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below.
- · Arthrex Univers Apex
- · Arthrex Univers II
- · Arthrex Univers Revers
- · DePuy Global AP
- DePuy Global StepTech
- · DePuy Delta Xtend Reverse
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.
| 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) |
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510(k)
Summary
| 510(k) SPONSOR / MANUFACTURER: | Custom Orthopaedic Solutions, Inc.
10000 Cedar Avenue
Cleveland, Ohio
44106 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Keith Grafmeyer
Product Engineer
Custom Orthopaedic Solutions
10000 Cedar Ave.
Cleveland, OH 44106
Tele: (216) 445 -3403
Email: kgrafmeyer@customorthopaedics.com |
| TRADE NAME: | OrthoVis Web Portal |
| DATE PREPARED: | 26-May -2015 |
| DATE REVISED: | 08-Aug-2015 |
| COMMON NAMES: | -Image processing system and preoperative software for
simulating / evaluating implant placement and surgical
treatment options
-Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer
Cemented
-Shoulder Prosthesis, Reverse Configuration |
| Product | Product Code | Regulation and Classification Name | Device Class |
|---|---|---|---|
| OrthoVis Web Portal | LLZ | 21 CFR 892.2050 | |
| Picture Archiving and | |||
| Communications System | II | ||
| Secondary Product Names and Codes | |||
| OrthoVis Web Portal - | |||
| Accesory to Glenoid IRIS | KWS | 21 CFR 888.3660 | II |
| OrthoVis Web Portal - | |||
| Accesory to Glenoid IRIS | PHX | 21 CFR 888.3660 | II |
4
Predicate Devices:
K133367: OrthoVis Preoperative Plan
K142072: Glenoid Intelligent Reusable Instrument System (Glenoid IRIS)
DEVICE DESCRIPTION
The OrthoVis Web Portal is composed of software intended for use to facilitate upload of medical images and preoperative planning and plan approval of placement and orientation of Arthrex and DePuy total shoulder replacement systems. Each surgeon user's uploaded images are grouped into cases and associated with that user's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K13367 and K151568). The user is then able to login to the OrthoVis Web Portal to review the preoperative plan and either approve or modify the location and/or orientation of the shoulder replacement component and then approved plan is then available to download by COS technicians for further preoperative planning production (see 510(k) K123122 and K142072) and for download by the user/surgeon.
INTENDED USE AND INDICATIONS FOR USE
The OrthoVis Web Portal is intended for use as a software interface and for the transfer of imaging information from a medical scanner such as a CT scanner. It is also intended as pre-operative software for simulating / evaluating implant placement and surgical treatment options. The OrthoVis Web Portal is intended for use with the Glenoid Intelligent Reusable Instrument system and with the OrthoVis Preoperative Plan. It is also intended for use with the Arthrex and DePuy shoulder replacement implant systems listed below.
- Arthrex Univers Apex
- · Arthrex Univers II
- Arthrex Univers Revers
- DePuy Global AP
- DePuy Global StepTech
- DePuy Delta Xtend Reverse
The Glenoid Intelligent Reusable Instrument System ("Glenoid IRIS") is a patient specific manual instrument system intended for use to facilitate preoperative planning and intraoperative placement of the central glenoid guide pin used in the preparation of the glenoid in total shoulder systems that utilize a central guide pin for preparing the glenoid to receive the glenoid implant.
BASIS OF SUBSTANTIAL EQUIVALENCE
The OrthoVis Web Portal has nearly the same intended use and indications for use as the OrthoVis Preoperative Plan (K133367) and the Glenoid Intelligent Reusable Instrument System (Glenoid IRIS) (K142072). The main difference between the original OrthoVis software and the OrthoVis Web Portal is that the Web Portal facilitates the communication between the COS planning technician and surgeon.
Technological Comparison to Predicate
The device described here is intended to collect images and preferences from a surgeon relative to a case, move those images to an in-house workstation for processing, and to allow those plans to be displayed for a surgeon to either request adjustments to the plan or approve the plan, followed by distribution of the final plan materials.
These functions were previously done by a largely manual process involving secure email and physical mail. This table compares the new technology to the old process, describing the use of the web portal, SFTP transfer, and email to do these functions.
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(Note that email is only used for indication of status change, and does not ever contain PHI.)
| Function | Predicates | Subject |
|---|---|---|
| Surgeon authentication | Phone conversation. | Secure portal login with hashed |
| password. | ||
| Confidential communication | Postal mail, phone call, or secure email. | 1. HTTPS/SSH network |
| communication for all web portal and | ||
| surgeon upload/downloads |
- STFP for local office
uploads/downloads. - Email for status change notification
(e.g. plan ready, etc.) |
| Create case | Phone conversation, file on local
computer. | Web portal case creation page. |
| Store case | Local files | Encrypted database on server |
| Submit images | CD/DVD in postal mail, files put on
local server | 1. Files uploaded via HTTP web portal
upload page to protected directory. - Local office is notified that files are
uploaded via case status change. - Files are then downloaded via SFTP
secure protocol from network server
to local server. |
| Create surgical plan | Planning software on local
workstation. | Planning software on local
workstation. |
| Preview surgical plan with surgeon | Surgeon uses commercial screen
sharing software (i.e. PC Anywhere) to
view local workstation screen during
phone conversation. | 1. Files uploaded by office to web
portal protected directory via SFTP
secure protocol. - Web portal software imports plan
information into web database, and
imports images into web image store. - Web portal notifies surgeon of plan
availability via case status change
email. - Surgeon logs into portal.
- Surgeon views plan interactively in
3D on plan view page. |
| Surgeon requests adjustments to plan | During phone conversation, surgeon
verbally requests adjustments and sees
changes on shared screen. | 1. Surgeon uses web controls to change
3D image on plan view page. - Surgeon indicates on plan view page
via web controls that changes are
requested. - Local office is notified via email of
status change. |
| Surgeon approves plan | During phone conversation or secure
email, surgeon verbally approves plan. | 1. Surgeon views plan on plan view
page. - Surgeon indicates on plan via web
controls that the plan is approved. - Local office is notified via email of
status change. |
| Function | Predicates | Subject |
| Surgeon gets final copy of approved
plan | The Approved Preoperative Plan is
created in OrthoVis and sent in a PDF
file via secure email. | 1. Local office prepares PDF file on
OrthoVis and uploads via STFP secure
protocol. - Surgeon is notified via email of
status change. - Surgeon logs into web portal.
- Surgeon downloads PDF containing
final approved plan. |
| Surgeon is reminded of plan | Reminder phone call. | Periodic generation of reminder emails
about status change until download
occurs. |
6
NON-CLINICAL TESTING
The following testing was performed to demonstrate substantial equivalency of the OrthoVis Web Portal to the predicate device
- Software verification and validation
- Dimensional validation
- Simulated Use Comparison between OrthoVis Web Portal Process and CD Mailer/Go-To-Meeting/Email Process
Software Verification and Validation
Software Verification and Validation was performed in order to establish substantial equivalence to the predicate device.
Dimensional Validation
Dimensional validation of the OrthoVis system was performed (see Exhibit A). The same code responsible for reading and display of CT scans is used in the cleared OrthoVis Shoulder software (K123122, and K133367) as is used in the OrthoVis Web Portal software.
Simulated Use Comparison between OrthoVis Web Portal Process and CD Mailer/Go-To-Meeting/Email Process
Surgeons with experience in using the OrthoVis Preoperative Plan via the CD Mailer/Go-To-Meeting/Email process were asked to compare that experience with the OrthoVis Web Portal Process and fill out a survey based on the two experiences.
CLINICAL TESTING
Clinical testing was not necessary to determine substantial equivalence between the OrthoVis Web Portal and the predicate device.
NON-CLINICAL TESTING SUMMARY AND CONCLUSION
The testing done for the web portal consisted of three parts:
- The first part consisted of automated unit tests. -
- -The second part used an automatic integration-testing tool to test the Web Portal user interface.
- -The third part manually tested remaining errors.
The sum of our automated and manual tests described below provide comprehensive coverage of the application requirements, and proved that our device is as safe and effective as the predicate device.
We tested each constraint and protection using an automated testing framework that created test cases that followed the constraint rules to verify correct results, and by creating test cases that violate these
7
rules to verify that the constraints and error messages were working correctly.
Operational behavior of the user interface (those part of the requirements that could be observed by a user of the application) was tested using the WebDriver testing tool (which is now a W3C standard) to drive the user interface in a large number of scenarios. By "robotically" operating the user interface, the application was tested exactly as if a user (using Chrome or Firefox) was executing a series of tests. Automated tests were made from prepared data to test each requirement. By using rigorous automation, tests can be repeated many times when moving to each specific environment, to test servers or to run regression tests when features are added.
Since some errors are difficult to mitigate with automated testing, we verified, by manual code inspection, that error handlers are in place and operational. We completed manual testing that was executed as usual during each testing phase.