(28 days)
Not Found
Unknown
The description mentions "semi-automatic segmentation" which could potentially involve AI/ML, but the document does not explicitly state the use of these technologies. The lack of mention of training/test sets or performance metrics typically associated with AI/ML further supports the "Unknown" classification.
No.
The device is an image-guided surgery system for preoperative planning and intraoperative guidance, not a device that directly treats a medical condition.
No
The device is an image-guided surgery (navigation) system and preoperative planning tool used to assist surgeons during total shoulder arthroplasty, not for diagnosing medical conditions.
No
The device description explicitly states it is an "Image Guided Surgery, or Navigation, system" and is used "during stereotaxic surgeon in locating anatomical structures and aligning the endoprosthesis". While it includes software for planning and processing, the description implies interaction with physical surgical procedures and potentially hardware components for navigation, which would not qualify it as a software-only medical device.
No, 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. They are used to provide information for diagnosis, monitoring, or screening.
- ExactechGPS Function: The ExactechGPS system is an Image Guided Surgery (Navigation) system used during surgical procedures and for preoperative planning. It uses patient CT-scan data to help surgeons locate anatomical structures and align implants. It does not analyze biological samples from the patient's body.
The device's function is focused on surgical guidance and planning based on imaging data, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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 Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.
Product codes (comma separated list FDA assigned to the subject device)
OLO, LLZ
Device Description
This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.
The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.
At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scan
Anatomical Site
Shoulder (glenoid)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Clinical setting (for preoperative planning and stereotaxic surgery)
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)
This submission includes or references the following non-clinical testing:
- Software verification testing to ensure all design outputs meet all specified requirements
- System accuracy verification via comparison of system outputs to CT-scan data collected during clinical use
- Software validation to ensure software specifications conform to user needs and intended uses
Testing demonstrates the modified ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate.
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.
Not Found
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
§ 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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym followed by the words "U.S. Food & Drug Administration" on the right. The Department of Health and Human Services logo is a stylized human figure, while the FDA text is in blue.
November 24, 2017
Blue Ortho Anthony Boyer President and CEO 6 Allee de Bethleem Gieres, 38610 France
Re: K173372
Trade/Device Name: ExactechGPS Total Shoulder Application Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: October 26, 2017 Received: October 27, 2017
Dear Anthony Boyer:
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 of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
ExactechGPS® Total Shoulder Application
Indications for Use (Describe)
The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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 Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component 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)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
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Image /page/3/Picture/1 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 similar blue color. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size.
6 Allée de Bethléem 38610 Gières France
ExactechGPS® Total Shoulder Application SPECIAL 510(k) - 510(k) Summary of Safety and Effectiveness
Submission date:
October 26, 2017
Sponsor:
BLUE ORTHO 6 Allée de Bethléem 38610 Gières France Phone: +33 (0) 4 58 00 35 25
Contact:
Anthony BOYER Phone: +33 (0) 4 76 54 95 46 Cell: +33 (0)6 30 39 50 66 anthony.boyer@blue-ortho.com
US Local Agent
Exactech, Inc. 2320 NW 66th Ct. Gainesville, FL. 32653 Phone: 352-377-1140
Trade or Proprietary or Model Name(s):
ExactechGPS® Total Shoulder Application
Common Name:
Surgical navigation system and preoperative planning tool
Classification Number 21 CFR 882.4560
Classification Name: Orthopedic Stereotaxic Instrument, Picture Archiving & Communications System
Classification Class II
Product Code OLO (21 CFR 882.4560), LLZ (21CFR 892.2050)
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Image /page/4/Picture/1 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.
6 Allée de Bethléem 38610 Gières France
Information on Devices to which Substantial Equivalence is Claimed:
Primary Predicate
| 510(k) Number | Trade or Proprietary Model Name | Manufacturer |
|---|---|---|
| #K162567 | ExactechGPS® Total Shoulder Application | Blue Ortho |
Indications for Use:
The ExactechGPS is intended for use during preoperative planning and during stereotaxic 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 Shoulder Application is specifically indicated for Total Shoulder Arthroplasty using the Equinoxe system to aid the surgeon in locating anatomical structures and aligning the glenoid component with the anatomical structures.
Device Description:
This submission proposes modifications to the ExactechGPS Total Shoulder Application cleared per #K162567.
The ExactechGPS Total Shoulder Application is an Image Guided Surgery, or Navigation, system designed to guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure. The ExactechGPS Total Shoulder Application also offers a preoperative planning feature that enables surgeons to plan a surgical intervention by evaluating implant size, type, and positioning using reconstructed patient bone models in a virtual environment. The ExactechGPS Total Shoulder Application requires patient CT-scan data to undergo segmentation prior to being imported into the software, as part of reconstructing the bone model, for both navigation and planning.
At initial release, the segmentation step was manually conducted by Blue Ortho. This submission proposes the addition of a semi-automatic segmentation option, where surgeons can elect to not send the CT exams to Blue Ortho for segmentation but employ a semiautomatic segmentation process to virtually reconstruct the bony anatomy of the patient in three dimensions. The use of semi-automatic segmentation to virtually recreate patient bone is available for planning only, and not for use during a navigated surgical procedure.
Testing:
This submission includes or references the following non-clinical testing:
- Software verification testing to ensure all design outputs meet all specified requirements
- System accuracy verification via comparison of system outputs to CT-scan data collected during clinical use
- Software validation to ensure software specifications conform to user needs and intended uses
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Image /page/5/Picture/1 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized letter "C" in blue, followed by the company name "BlueOrtho" in a similar blue color. Below the company name, the words "AUGMENTED ORTHOPAEDICS" are written in smaller font, indicating the company's focus. The logo is clean and professional, conveying a sense of innovation and expertise in the field of orthopedics.
Testing demonstrates the modified ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate.
Summary of Technological Characteristics
The rationale for substantial equivalence is based on consideration of the following characteristics:
- Intended use: the modifications do not affect device intended use. -
- -General design features and dimensions: the modifications do not affect general device features and dimensions.
- -Basic fundamental scientific technology: the modifications do not change the device computer language or other basic fundamental technologies.
- -Performance specifications: the modifications do not affect device accuracy and / or performance.
- -Hardware platform: no changes to the hardware platform or system accessories are proposed by this submission.
Substantial Equivalence Conclusion:
A comparison of specific features included in this submission demonstrates the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate. The devices share:
- Identical Indications for Use statements
- Identical intended use
- Identical technology for stereotaxic surgery
- Similar, equivalent technology for preoperative planning
The information provided by Blue Ortho in this application confirms the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the predicate cleared per #K162567.