(89 days)
No
The summary describes a web portal for image upload, preoperative planning review, and plan approval. It mentions image processing but does not mention AI, ML, or related terms, nor does it describe any training or test sets typically associated with AI/ML development. The functionality described is consistent with traditional software for medical image viewing and manipulation.
No.
A therapeutic device directly treats a medical condition or disease. This device is a software portal used for preoperative planning of shoulder joint replacement components, not for direct treatment.
No
The device is intended for software interface of imaging information, displaying/editing implant placement and surgical treatment options, and preoperative planning. It does not state that it is used to diagnose a medical condition.
Yes
The device description explicitly states it is "composed of software" and its function is to facilitate image upload, preoperative planning review, and plan approval. While it interacts with other devices (scanners, desktop software, and the IRIS system), the described device itself is solely a software interface and planning review tool.
Based on the provided information, the Arthrex VIP Web Portal is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Arthrex VIP Web Portal's Function: The Arthrex VIP Web Portal is a software interface that processes and displays medical imaging data (from CT scans) and facilitates preoperative planning for surgical procedures (shoulder joint replacement). It does not analyze biological samples.
- Intended Use: The intended use clearly states its purpose is for managing imaging information, displaying/editing implant placement, and working with surgical planning systems. This is related to surgical planning and execution, not diagnostic testing of biological samples.
Therefore, the Arthrex VIP Web Portal falls under the category of medical device software used for surgical planning and image management, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
Product codes
LLZ, KWS, PHX
Device Description
The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner
Anatomical Site
Shoulder joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained COS technicians, Surgeon user
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Software verification and validation
- Regression Testing
- Unit Testing
- Code reviews and checks
- Integration Testing
- Dimensional Validation (performed on predicate device and code has not changed for the subject device)
Clinical testing was not necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2016
Custom Orthopaedic Solutions, Incorporated Mr. Keith Grafmever Project Manager 10000 Cedar Avenue Cleveland, Ohio 44106
Re: K153612
Trade/Device Name: ArthrexVIP 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: December 7, 2015 Received: December 17, 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 Parts 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/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 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,
Lori A. Wiggins -S
for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) NA K153612
Device Name ArthrexVIP Web Portal
Indications for Use (Describe)
The Arthrex VIP Web Portal is intended for use as a software interface of imaging information from a medical scanner such as a CT scanner. It is also intended as software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The Arthrex VIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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
Project Manager
Custom Orthopaedic Solutions
10000 Cedar Ave.
Cleveland, OH 44106
Tele: (216) 445 -3403
Email: kgrafmeyer@customorthopaedics.com |
| TRADE NAME: | ArthrexVIP Web Portal |
| DATE PREPARED: | 07-Dec-2015 |
| COMMON NAMES: | Image processing system and preoperative software for
simulating / evaluating implant placement and surgical
treatment options |
| Product | Product Code | Regulation and
Classification Name | Device
Class |
|-----------------------|--------------|------------------------------------------------------------------------------------------|-----------------|
| ArthrexVIP Web Portal | LLZ | 21 CFR 892.2050
Picture Archiving and
Communications System | II |
| ArthrexVIP Web Portal | KWS | 21 CFR 888.3660
Prosthesis, Shoulder, Semi-
Constrained, Metal/Polymer
Cemented | II |
| ArthrexVIP Web Portal | PHX | 21 CFR 888.3660
Shoulder Prosthesis, Reverse
Configuration | II |
Predicate Devices:
K151501: OrthoVis Web Portal K151568: Arthrex OrthoVis Preoperative Plan K151500: Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS)
Device Description:
The ArthrexVIP Web Portal is composed of software intended for use to facilitate upload of medical
4
images, preoperative planning, and plan approval of placement and orientation of total shoulder joint replacement components. Each surgeon user's uploaded images are associated with specific cases and associated with that surgeon's profile. Uploaded images can be downloaded from the portal by COS technicians and used to create preoperative plans (see 510(k) K151568) in the OrthoVis Desktop Software. The surgeon user is then able to login to the ArthrexVIP Web Portal to review the plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by COS technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
Intended Use and Indications:
The ArthrexVIP 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 software for displaying/editing implant placement and surgical treatment options that were generated in the OrthoVis Desktop Software by trained COS technicians. The ArthrexVIP Web Portal is intended for use with the Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) and with the Arthrex OrthoVis Preoperative Plan. It is indicated for use with the following glenoid implant lines: Arthrex Univers Apex, Arthrex Univers II, and Arthrex Univers Revers.
Basis of Substantial Equivalence:
The ArthrexVIP Web Portal has the same intended use and indications for use as the OrthoVis Web Portal (K151501), with the exception of ArthrexVIP being indicated for use solely with the Arthrex line of shoulder arthroplasty implants.
The subject device is a version of the predicate device with changes to the following:
- Measurement Features
- Viewer Controls
- Implant Controls and Options
- Organization of information
- User Interface (UI)
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the ArthrexVIP Web Portal to the OrthoVis Web Portal:
- Software verification and validation
- Regression Testing
- Unit Testing
- Code reviews and checks
- Integration Testing
- Dimensional Validation (performed on predicate device and code has not changed for the subject device)
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence between to the predicate.