(133 days)
No
The summary describes software for image upload, display, and manual editing of pre-generated plans by users, with no mention of automated analysis, learning, or AI/ML terms.
No
This device is a software portal for image processing and preoperative planning of implant placement; it does not directly treat a patient.
No
The device is described as software for displaying/editing implant placement and surgical treatment options, facilitating the upload and review of medical images for preoperative planning, and ultimately approving a plan for production. It does not perform diagnosis of a disease or 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 hardware and software systems (CT scanner, OrthoVis Desktop Software, Arthrex Glenoid IRIS), the device itself, as described, is solely a software interface and planning tool.
Based on the provided information, the Arthrex VIP Web Portal is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Arthrex VIP Web Portal's intended use and device description clearly state it processes and displays medical images (from CT scans) and facilitates preoperative planning for surgical procedures (total shoulder joint replacement). It does not analyze biological specimens.
- The device's function is focused on surgical planning and guidance based on imaging data, not on analyzing biological samples for diagnostic purposes.
Therefore, the Arthrex VIP Web Portal falls under the category of a medical device, specifically software used for surgical planning and image processing, but it is not an IVD.
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 scamer 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 Arthrex 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 II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 Arthrex 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 preoperative plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by Arthrex technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
Mentions image processing
Image processing system
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanner such as a CT scanner.
Anatomical Site
total shoulder joint replacement components, glenoid implant lines
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons, Arthrex technicians
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 verification
Clinical Testing: Not necessary to determine substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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April 30, 2020
Arthrex Inc. Heli Chambi Infantas Sr. Regulatory Affairs Associate 1370 Creekside Blvd NAPLES, FL 34108
Re: K193523
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 Dated: March 28, 2020 Received: March 31, 2020
Dear Heli Chambi Infantas:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael C. Owens Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K193523
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 scamer 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 Arthrex 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 II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------- |
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Type of Use (Select one or both, as applicable)
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K193523
| 510(k) Summary | |
|---|---|
| 510(k) SPONSOR / MANUFACTURER: | Arthrex Inc. |
| 1370 Creekside Blvd | |
| Naples, FL 34108 | |
| CONTACT PERSON: | Heli F. Chambi Infantas |
| Sr. Regulatory Affairs Associate | |
| 1-239-598-4302, ext. 73187 | |
| Heli.Chambiinfantas@arthrex.com | |
| TRADE NAME: | ArthrexVIP Web Portal |
| DATE PREPARED: | 16-Dec-2019 |
| 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 |
Predicate Devices:
K162697: ArthrexVIP Web Portal
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 Arthrex 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 preoperative plan and either approve or modify the location and/or orientation of the joint replacement component. The approved plan is then downloaded by Arthrex technicians for production (see 510(k) K151500 and K151568) as part of the Arthrex Glenoid IRIS device.
4
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 Arthrex 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 II and Arthrex Univers Apex, Keeled or Pegged Glenoid components, the Vault Lock Glenoid Component, as well as the Univers Revers and Modular Glenoid System (MGS) Baseplate components.
Basis of Substantial Equivalence:
The modified ArthrexVIP Web Portal has the same intended use and indications for use as the predicate ArthrexVIP Web Portal (K162697) with the exception of "COS technicians" now being "Arthrex technicians" to reflect the change in manufacturer from Custom Orthopaedic Solutions (COS) to Arthrex and the addition of the Modular Glenoid System baseplate to the indicated glenoid implant lines.
The subject device is a version of the predicate device with changes to the following:
- Addition of backside seating feature
- Addition of the Univers Revers Modular Glenoid System (MGS) implant models
- Addition of the Univers Revers Universal Glenoid (UG) implant models
- Addition of the glenosphere and inlay implant models compatible with MGS and UG
- Addition of glenoid bone preparation instrument models for visualization
- Addition of the Univers Revers screw trajectory models for visualization
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 verification
Clinical Testing
Clinical testing was not necessary to determine substantial equivalence to the predicate.