(90 days)
No
The summary describes an image-guided surgery system that uses CT scan data for segmentation and bone model reconstruction, but it does not mention the use of AI or ML algorithms for these processes or any other function.
No.
The device is a surgical navigation system intended to aid surgeons in locating anatomical structures and aligning components during total ankle arthroplasty, not to provide therapy itself.
No
The device is described as an "Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure." Its purpose is to aid surgeons in "locating anatomical structures and aligning the endoprosthesis," rather than diagnosing a condition.
No
The device description explicitly states that the ExactechGPS Total Ankle Navigation works on the Blue Ortho ExactechGPS System, which is composed of hardware components including ExactechGPS Trackers, ExactechGPS Station, and ExactechGPS camera. While the submission focuses on the software application, the overall system includes hardware.
Based on the provided information, this device 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- ExactechGPS Function: The ExactechGPS system is a surgical navigation system used during orthopedic surgery (Total Ankle Arthroplasty). It uses pre-operative CT scans and real-time tracking to help the surgeon locate anatomical structures and align implants.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is based on image processing (CT scans) and spatial tracking during the surgical procedure.
Therefore, the ExactechGPS Total Ankle Application falls under the category of a surgical guidance or navigation system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the requred anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
The ExactechGPS Total Ankle Navigation is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.
Product codes
OLO, LLZ
Device Description
The ExactechGPS Total Ankle Application proposed by Blue Ortho in this submission is new clinical software application.
The ExactechGPS Total Ankle Application (TAA) system is intended to be used during stereotaxic surqical procedures to aid the surgeons in locating anatomical structures and aligning the endoprosthesis with the patient bony anatomy provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Ankle Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure. The ExactechGPS Total Ankle Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model.
It encompasses two software applications:
- The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
- -The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.
The ExactechGPS Total Ankle Navigation is working on the Blue Ortho ExactechGPS System cleared per 510(k) #K213877. The system is composed of ExactechGPS Trackers, which are rigidly fixed to the patient bony anatomy, and other components (ExactechGPS Station and ExactechGPS camera) that are not in contact with the patient.
In the predicate device, a planning application is provided and indicated for preoperative planning of surgical procedure. This submission does not propose planning pre-operative planning application. The others main principles of operation and technological principles between the predicate and the proposed device are similar.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Ankle, tibia, talar bones
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Orthopedic 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)
Testing information demonstrating safety and effectiveness of the ExactechGPS Total Ankle Application is supported by testing that was conducted in-house.
This submission includes or references the following non-clinical testing:
- Software verification testing to ensure all design outputs meet all specified requirements
- Software validation to ensure software specifications conform to user needs and intended uses
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
November 16, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Blue Ortho Matthieu Coic QA RA Director 22 Chemin du Vieux Chene Meylan, 38240 France
Re: K232521
Trade/Device Name: ExactechGPS® Total Ankle Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: August 18, 2023 Received: August 18, 2023
Dear Matthieu Coic:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232521
Device Name ExactechGPS® Total Ankle Application
Indications for Use (Describe)
The ExactechGPS is intended for use during preoperative planning and during orthopedic surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the requred anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
The ExactechGPS Total Ankle Navigation is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.
| 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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Image /page/3/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized blue "C" shape on the left, followed by the text "BlueOrtho" in a clean, sans-serif font. Below "BlueOrtho" is the tagline "AUGMENTED ORTHOPAEDICS" in smaller, lighter font, indicating the company's focus on advanced orthopedic solutions.
ExactechGPS® Total Ankle Application 510(k) Summary of Safety and Effectiveness
I. SUBMISSION DATE
August 18, 2023
II. SUBMITTER
BLUE ORTHO 22 Chemin du Vieux Chêne 38240 Meylan France Phone: +33 (0)4 58 00 35 25 Contact person: Matthieu COIC - Mail: matthieu.coic@blue-ortho.com
III. US LOCAL AGENT
Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL. 32653 Phone: 352-377-1140
IV. INFORMATION ON DEVICES TO WHICH SUBSTANTIAL EQUIVALENCE IS CLAIMED
Primary Predicate
510(k) Number Trade or Proprietary Model Name ExactechGPS Total Shoulder Application #K213546 This predicate has not been subject to a design-related recall.
Manufacturer Blue Ortho
V. PROPOSED DEVICE DESCRIPTION
Trade or Proprietary or Model Name(s): ExactechGPS® Total Ankle Application Common Name: Surgical navigation system
Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560, product code OLO); Medical Image Communications Device (21 CFR 892.2020, product code LMD)
Classification: Class II
Device Description:
The ExactechGPS Total Ankle Application proposed by Blue Ortho in this submission is new clinical software application.
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Image /page/4/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized blue "C" shape on the left, followed by the text "BlueOrtho" in a clean, sans-serif font. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size.
The ExactechGPS Total Ankle Application (TAA) system is intended to be used during stereotaxic surqical procedures to aid the surgeons in locating anatomical structures and aligning the endoprosthesis with the patient bony anatomy provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Ankle Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the tibia and talar bones as part of a total ankle arthroplasty procedure. The ExactechGPS Total Ankle Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model.
It encompasses two software applications:
- The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
- -The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating anatomical structures and aligning the tibial and talar components with the anatomical structures.
The ExactechGPS Total Ankle Navigation is working on the Blue Ortho ExactechGPS System cleared per 510(k) #K213877. The system is composed of ExactechGPS Trackers, which are rigidly fixed to the patient bony anatomy, and other components (ExactechGPS Station and ExactechGPS camera) that are not in contact with the patient.
In the predicate device, a planning application is provided and indicated for preoperative planning of surgical procedure. This submission does not propose planning pre-operative planning application. The others main principles of operation and technological principles between the predicate and the proposed device are similar.
VI. INDICATIONS FOR USE
The ExactechGPS is intended for use during preoperative planning and during orthopedic surgery to aid the surgeon in locating anatomical structures and aligning the endoprosthesis with the anatomical structures provided that the required anatomical landmarks can be identified on the patient's preoperative CT scan.
The ExactechGPS Total Ankle Case Manager Application is specifically indicated for creating Total Ankle Navigation cases, uploading CT scans for reconstruction, download the reconstruction and export the reconstructed case to the Total Ankle Navigation Application.
The ExactechGPS Total Ankle Navigation Application is specifically indicated for Total Ankle Arthroplasty using the Vantage ankle system to aid the surgeon in locating
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Image /page/5/Picture/0 description: The image shows the logo for BlueOrtho Augmented Orthopaedics. The logo features a blue square with a stylized "C" shape inside it. To the right of the square is the text "BlueOrtho" in a matching blue color. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size.
anatomical structures and aligning the tibial and talar components with the anatomical structures.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
This proposed submission proposes the following differences compare to the ExactechGPS Total Shoulder Application predicate device:
- Different Indications for Use, as the patient joint treated during the surgical ● procedure in the proposed device is the ankle, and is the shoulder in the predicate device.
- In the predicate device, a planning application is provided and indicated for preoperative planning of surgical procedure. This submission does not propose planning pre-operative planning application, but only a software application to manage surgical cases created by the user.
- Integration in the ExactechGPS Total Ankle Navigation Application of the Exactech total ankle systems, including Vantage Fixed Bearing or Mobile Bearing, Vantage 3D and Vantage 3D+, cleared in the following 510(k) submissions:
| K152217 | Vantage Total Ankle System |
|---|---|
| K183343 | Vantage Total Ankle Flat Cut Talar Components |
| K230717 | Vantage 3D/3D+ |
At a high level, the subject and predicate devices are based on the following same technological elements:
- The proposed device do not affect general device features and dimensions.
- The proposed device do not change the device computer language or other . basic fundamental technologies.
- No changes to the hardware platform and localization system are proposed by ● this submission.
VIII. PERFORMANCE DATA
Testing information demonstrating safety and effectiveness of the ExactechGPS Total Ankle Application is supported by testing that was conducted in-house.
This submission includes or references the following non-clinical testing:
- Software verification testing to ensure all design outputs meet all specified ● requirements
- Software validation to ensure software specifications conform to user needs and intended uses
IX. SUBSTANTIAL EQUIVALENCE CONCLUSION
A comparison of specific features included in this submission demonstrates the proposed ExactechGPS Total Ankle Application is substantially equivalent to the cited predicate cleared per # K213546. The devices share identical intended use, identical general design features and basic fundamental scientific technology.