(51 days)
No
The summary describes software for creating a preoperative plan based on CT scans and segmentation tools, but there is no mention of AI or ML in the device description, intended use, or specific sections for AI/ML mentions. The performance studies focus on software verification/validation and user comparisons, not AI/ML performance metrics.
No
The device is a preoperative planning tool that creates a document based on patient CT scans to assist in surgical planning, which is not a therapeutic intervention itself.
No.
The device is a preoperative planning tool that assists in surgical placement of components, rather than diagnosing a disease or condition.
Yes
The device description explicitly states it is a "preoperative plan document that is created in the OrthoVis software," and the intended use is a "preoperative plan created via the OrthoVis software," indicating the device itself is the software-generated plan, not a physical component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Arthrex OrthoVis Preoperative Plan uses a patient's CT scan (an image) to create a surgical plan. It does not analyze blood, tissue, urine, or any other biological specimen.
- The intended use is for surgical planning. The purpose of this device is to assist a surgeon in planning the placement of a glenoid component during total shoulder replacement surgery. This is a surgical planning tool, not a diagnostic test performed on a biological sample.
- The input is a CT scan. CT scans are medical images, not biological specimens.
Therefore, the Arthrex OrthoVis Preoperative Plan falls under the category of a medical device used for surgical planning, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.
The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
Product codes
LLZ
Device Description
The Arthrex OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.
This 510(k) submission is identical to the OrthoVis Preoperative Plan (K133367) submission and clearance with the exception of the following modifications:
- -The intended use of the OrthoVis Preoperative Plan for the K133367 clearance was for the Depuy family of glenoid components (Global APG, Global StepTech, and Delta Xtend). These components have now been replaced in the OrthoVis software with the Arthrex family of glenoid components which include:
- O Univers™ II and Univers™ Apex Keeled Glenoid.
- o Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.
Ortho Vis can produce a preoperative plan document (.pdf file) that contains text, images. and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan is provided to the ordering surgeon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
glenoid, scapula, humerus (shoulder)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ordering surgeon
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
- Inter and Intra User Surgical Planning Comparison Study
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).
0
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three human profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 31, 2015
Custom Orthopaedic Solutions, Inc. % Mr. Peter O'Neill President 10000 Cedar Avenue CLEVELAND OH 44106
Re: K151568
Trade/Device Name: Arthrex OrthoVis Preoperative Plan Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 1, 2015 Received: July 8, 2015
Dear Mr. O'Neill:
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 Ochs. Ph.D. Acting 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) K151568
Device Name Arthrex OrthoVis Preoperative Plan
Indications for Use (Describe)
The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.
The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
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.
A subsidiary of Cleveland Clinic
10000 Cedar Avenue
Cleveland, Ohio 44106 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Peter O'Neill
President
10000 Cedar Ave
Cleveland, OH 44106
Tele: (216) 406-6149
Email: poneill@customorthopaedics.com |
| DATE PREPARED: | 1-June-2015 |
TRADE NAME: Arthrex OrthoVis Preoperative Plan
COMMON NAMES:
Preoperative Planning tool
| Product | Product Code | Regulation and
Classification
Name | Device Class |
|---------------------------------------|--------------|-----------------------------------------------------------------------|--------------|
| Arthrex OrthoVis
Preoperative Plan | LLZ | 21 CFR 892.2050
Picture Archiving
&
Communications
System | II |
PREDICATE DEVICES:
Custom Orthopaedic Solutions OrthoVis Preoperative Plan (K133367)
DEVICE DESCRIPTION:
The Arthrex OrthoVis Preoperative Plan is a preoperative plan document that is created in the OrthoVis software. A patient CT scan is loaded into the OrthoVis software and the desired bony anatomy can be separated and segmented with OrthoVis tools, allowing extracted and segmented bones (e.g., scapula, humerus) to be virtually implanted with shoulder replacement implants.
This 510(k) submission is identical to the OrthoVis Preoperative Plan (K133367) submission and clearance with the exception of the following modifications:
4
- -The intended use of the OrthoVis Preoperative Plan for the K133367 clearance was for the Depuy family of glenoid components (Global APG, Global StepTech, and Delta Xtend). These components have now been replaced in the OrthoVis software with the Arthrex family of glenoid components which include:
- O Univers™ II and Univers™ Apex Keeled Glenoid.
- o Univers™ II and Univers™ Apex Pegged Glenoid,
- o Univers Revers™ Baseplate.
Ortho Vis can produce a preoperative plan document (.pdf file) that contains text, images. and in electronic format, a rotatable 3D model(s) of the implanted component and bone. This preoperative plan document is labeled, via a watermark, as unapproved until the ordering surgeon approves the plan, at which point such labeling is removed and the final plan is provided to the ordering surgeon.
INTENDED USE AND INDICATIONS:
The Arthrex OrthoVis Preoperative Plan is a preoperative plan created via the OrthoVis software that facilitates accurate preoperative planning and intraoperative placement of the glenoid component in total shoulder replacement.
The Arthrex Preoperative Plan is indicated for use in planning the central glenoid guide pin for the Arthrex Univers™ II and Univers™ Apex Keeled glenoid component, Univers™ II and Univers™ Apex Pegged glenoid component, and the Univers Revers™ Baseplate.
The indications for use of the Arthrex shoulder systems with which the Arthex OrthoVis Preoperative Plan is intended to be used are the same as those described in the labeling for these shoulder systems.
BASIS OF SUBSTANTIAL EQUIVALENCE:
The Arthrex OrthoVis Preoperative Plan is substantially equivalent to 510(k) K133367 because the indications for use and intended use are identical with the exception of replacing the Depuy family of glenoid components with the Arthrex family of glenoid components in the OrthoVis software. Both the Depuy and Arthrex shoulder implant systems use a central guide pin to guide the subsequent preparation of the glenoid surface prior to implant placement. Both the subject device and predicate device aim to improve central guide pin placement accuracy by providing a surgeon with a preoperative plan in the form of a PDF document.
Non-Clinical Testing
The following testing was performed to demonstrate substantial equivalency of the Arthrex OrthoVis Preoperative Plan to the predicate device.
- . Software verification and validation
- Inter and Intra User Surgical Planning Comparison Study .