(203 days)
No
The description focuses on stereotactic navigation, real-time tracking, and preoperative planning using CT scans and software models, without mentioning AI or ML algorithms for image analysis, decision support, or other functions.
No.
The device is a surgical navigation system that aids in preoperative planning and intraoperative guidance for total shoulder arthroplasty, rather than directly treating a condition or restoring function.
No
This device is described as aiding surgeons during the preparation of the glenoid for total shoulder arthroplasty by providing real-time information on anatomical structures and instrumentation position, and for preoperative planning. It is a surgical navigation and planning tool, not a diagnostic device that identifies diseases or conditions.
No
The device description explicitly states that the software works with "Exactech GPS hardware trackers" and a "Exactech GPS hardware station." It also mentions the use of "disposable kit hardware" and "new surgical instruments." This indicates the device is a system that includes both software and hardware components, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for use during preoperative planning and during stereotaxic surgery to locate anatomical structures and align endoprostheses. This is a surgical navigation and planning tool, not a device used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description reinforces its role as a surgical navigation system that works with hardware trackers to provide real-time information on the position of anatomical structures and instrumentation during surgery. It also includes a preoperative planning feature using CT scans and implant models.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on specimens, or providing diagnostic information based on such analysis.
The device is a surgical planning and navigation system used to guide surgeons during a surgical procedure. This falls under the category of medical devices used for surgical assistance and guidance, not in vitro diagnostics.
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
OLO, LLZ
Device Description
The ExactechGPS Total Shoulder Application is a modification of the Exactech GPS stereotactic navigation system designed to help guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure.
Like predicate Exactech GPS system software dedicated to use with total knee arthroplasty procedures, the ExactechGPS Total Shoulder Application works with Exactech GPS hardware trackers that communicate intraoperative data to the Exactech GPS hardware station to provide surgeons with real-time information on the position of patient anatomical structures and of instrumentation used to prepare patient bone during stereotaxic surgery.
The ExactechGPS Total Shoulder Application adds a preoperative planning feature, where surgeons use CT-scan images of patient bone with software models of Exactech Equinoxe implants to preoperatively plan procedures in a virtual environment prior to surgery.
The ExactechGPS Total Shoulder Application is used with the same ExactechGPS V2 station, trackers, and disposable kit hardware as the predicate ExactechGPS. This submission includes new surgical instruments dedicated to total shoulder arthroplasty.
The ExactechGPS Total Shoulder Application with Exactech Equinoxe implants cleared in the following 510(k) submissions:
K042021 Equinoxe Shoulder System
K063569 Equinoxe Reverse Shoulder System
K093275 Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners
K093430 Equinoxe XL Keeled, XL Pegged, and Cage Glenoid
K103419 Equinoxe UHMWPE Posterior Augment Pegged Glenoids
K110708 Equinoxe Reverse Shoulder Line Extensions
K113309 Equinoxe Cage Glenoids
K121220 Equinoxe UHMWPE 16° Posterior Augment Pegged Glenoids
K131575 Equinoxe Reverse Shoulder System Superior Posterior Augmented Glenoid Baseplates
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, 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)
- 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, and that the particular requiremented through software can be consistently fulfilled
- System accuracy verification via bench testing to ensure the ExactechGPS Total Shoulder Application works with Exactech GPS hardware to display information to surgeons as intended
- System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens
- Overall system validation through simulated use via evaluation with cadaveric specimens
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 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 5, 2017
Blue Ortho Anthony Boyer President 5 Avenue Du Grand Sablon La Tronche, 38700 FR
Re: K162567
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: March 6, 2017 Received: March 10, 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 (reporting of medical devicerelated 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/ResourcesforYou/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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K162567
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)
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Image /page/3/Picture/0 description: The image is a logo for Blue Ortho, a company that specializes in augmented orthopedics. The logo features a blue square with a white "C" in the center, followed by the words "Blue Ortho" in a sans-serif font. Below the company name, the words "Augmented Orthopaedics" are written in a smaller font. The logo is simple and modern, and the blue color gives it a sense of trust and reliability.
6 Allée de Bethléem 38610 Gières France
ExactechGPS® Total Shoulder Application 510(k) Summary of Safety and Effectiveness
Submission date:
September 08, 2016
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/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a stylized letter 'C' in a rounded square shape, followed by the text "BlueOrtho" in a clean, sans-serif font. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size. The color scheme is primarily blue, giving the logo a professional and modern look.
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 #K152764 EXACTECH GPS
Manufacturer Blue Ortho
Additional Predicates
510(k) Number | Trade or Proprietary Model Name | Manufacturer |
---|---|---|
#K063408 | CTLOGICS Navigation System | Praxim |
#K151568 | OrthoVis Preoperative Plan | Arthrex |
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:
The ExactechGPS Total Shoulder Application is a modification of the Exactech GPS stereotactic navigation system designed to help guide surgeons during the preparation of the glenoid as part of a total shoulder arthroplasty procedure.
Like predicate Exactech GPS system software dedicated to use with total knee arthroplasty procedures, the ExactechGPS Total Shoulder Application works with Exactech GPS hardware trackers that communicate intraoperative data to the Exactech GPS hardware station to provide surgeons with real-time information on the position of patient anatomical structures and of instrumentation used to prepare patient bone during stereotaxic surgery.
The ExactechGPS Total Shoulder Application adds a preoperative planning feature, where surgeons use CT-scan images of patient bone with software models of Exactech Equinoxe implants to preoperatively plan procedures in a virtual environment prior to surgery.
The ExactechGPS Total Shoulder Application is used with the same ExactechGPS V2 station, trackers, and disposable kit hardware as the predicate ExactechGPS. This submission includes new surgical instruments dedicated to total shoulder arthroplasty.
The ExactechGPS Total Shoulder Application with Exactech Equinoxe implants cleared in the following 510(k) submissions:
K042021 | Equinoxe Shoulder System |
---|---|
--------- | -------------------------- |
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Image /page/5/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopaedics. The logo features a stylized letter "C" in blue, followed by the company name "BlueOrtho" in a clean, sans-serif font, also in blue. Below the company name, the words "AUGMENTED ORTHOPAEDICS" are written in smaller letters. The logo has a professional and modern look.
K063569 | Equinoxe Reverse Shoulder System |
---|---|
K093275 | Equinoxe Reverse Shoulder System 36mm Glenosphere and Humeral Liners |
K093430 | Equinoxe XL Keeled, XL Pegged, and Cage Glenoid |
K103419 | Equinoxe UHMWPE Posterior Augment Pegged Glenoids |
K110708 | Equinoxe Reverse Shoulder Line Extensions |
K113309 | Equinoxe Cage Glenoids |
K121220 | Equinoxe UHMWPE 16° Posterior Augment Pegged Glenoids |
K131575 | Equinoxe Reverse Shoulder System Superior Posterior Augmented Glenoid Baseplates |
Substantial Equivalence Conclusion:
A comparison of key features and attributes included in this submission demonstrates the proposed ExactechGPS Total Shoulder Application is substantially equivalent to the cited predicate devices. The devices share:
- Equivalent indications for use statements
- Equivalent intended use
- Equivalent technology
Testing:
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, and that the particular requiremented through software can be consistently fulfilled
- System accuracy verification via bench testing to ensure the ExactechGPS Total Shoulder Application works with Exactech GPS hardware to display information to surgeons as intended
- System accuracy verification via comparison of system outputs to CT-scan data collected during simulated use via evaluation with cadaveric specimens
- Overall system validation through simulated use via evaluation with cadaveric specimens