(293 days)
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No
The summary describes a traditional image-guided surgery system focused on navigation and measurement, with no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is an image-guided surgery system that assists surgeons in locating anatomical structures and aligning endoprostheses during total knee arthroplasty by providing intraoperative data; it does not directly treat or prevent a disease or condition.
No
Explanation: The device is an Image Guided Surgery system designed to assist surgeons during total knee arthroplasty by providing intraoperative data on distances, angles, and placement of prosthetic components to achieve surgical goals. It is a surgical navigation system, not a diagnostic device.
No
The device description explicitly states it is an "Image Guided Surgery, or Navigation, system" and mentions "acquiring intraoperative data" and "computing and displaying information". This strongly implies the use of hardware components (like cameras, sensors, or tracking systems) to acquire the data necessary for navigation, which is not consistent with a software-only device. The performance studies also mention "Sterile battery", further suggesting hardware components.
Based on the provided information, the EXACTECH GPS is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures" during surgery. This is an in vivo application, meaning it's used directly on or within a living patient during a surgical procedure.
- Device Description: The description reinforces this by stating it's an "Image Guided Surgery, or Navigation, system for orthopedic surgical procedures intended to be used to intraoperatively assist surgeons." Again, this points to use during surgery on a living patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. The EXACTECH GPS does not perform any such tests on biological samples.
Therefore, the EXACTECH GPS falls under the category of a surgical navigation system used during a procedure on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for primary and revision Total Knee Arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
HAW
Device Description
The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for orthopedic surgical procedures intended to be used to intraoperatively assist surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals.
The predicate device is the EXACTECH GPS cleared in K100742. Both predicate and proposed device have the same intended use, general design features, and basic fundamental scientific technology.
Compare to the predicate device cleared in K100742, this submission proposes changes to:
- Sterile battery sterilization packaging
- Introduction of the Revision Total Knee Application software
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterile battery:
- Process qualifications related to packaging and sterilization
- Shelf life validation
Revision Total Knee Application software:
- Design Verification (including accuracy testing)
- Design Validation (including cadaveric sessions)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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 features a stylized representation of a human figure in profile, with three overlapping faces suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure, emphasizing the department's role and national scope.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 13, 2016
BLUE ORTHO Mr. Anthony Boyer President 5 avenue du Grand Sablon La Tronche, 38700 FRANCE
Re: K152764
Trade/Device Name: EXACTECH GPS Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: HAW Dated: June 9, 2016 Received: June 13, 2016
Dear Mr. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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" (21CFR 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,
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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Indications for Use
510(k) Number (if known) K152764
Device Name
EXACTECH GPS
Indications for Use (Describe)
The EXACTECH GPS is intended for use during stereotaxic surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
It is specifically indicated for primary and revision Total Knee Arthroplasty.
| Type of Use (Select one or both, as applicable) | ☑ 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 BlueOrtho, a company that specializes in augmented orthopedics. The logo features a blue square with a white "C" inside of it. To the right of the square is the company name, "BlueOrtho", in a sans-serif font. Below the company name is the tagline, "AUGMENTED ORTHOPAEDICS", in a smaller font.
5 Avenue du Grand Sablon 38700 La Tronche France
BLUE NAVIGATION SYSTEM TRADITIONAL 510(k) – 510(k) Summary of Safety and Effectiveness
| Submission date: | June 09, 2016 |
|---|---|
| Sponsor | BLUE ORTHO |
| 5 avenue du Grand Sablon | |
| 38700 La Tronche | |
| France | |
| Phone: +33 (0) 4 76 54 95 46 | |
| Contact | Anthony BOYER |
| Phone: +33 (0) 4 76 54 95 46 | |
| Cell: +33 (0)6 30 39 50 66 | |
| anthony.boyer@blue-ortho.com | |
| U.S. | |
| Headquarters | Exactech, Inc. |
| 2320 NW 66th Ct. | |
| Gainesville, FL. 32653 | |
| Phone: 352-377-1140 | |
| Trade Name | EXACTECH GPS |
| Common Name | Stereotaxic Instruments |
| Classification | |
| Name | Stereotaxic Instrument (21 CFR 882.4560, Product Code OLO Class II) |
| Information on | |
| devices to which | |
| substantial | |
| equivalence is | |
| claimed: | 510(k) Number: K100742 |
| Trade or Property Model Name: Exactech GPS | |
| Manufacturer: BLUE ORTHO | |
| Indications for | |
| Use: | The EXACTECH GPS is intended for use during stereotaxic surgery to aid the |
| surgeon in locating anatomical structures and aligning the endoprostheses with | |
| the anatomical structures. | |
| It is specifically indicated for primary and revision Total Knee Arthroplasty. | |
| Device | |
| Description: | The EXACTECH GPS is an Image Guided Surgery, or Navigation, system for |
| orthopedic surgical procedures intended to be used to intraoperatively assist | |
| surgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons to | |
| acquire intraoperative data by computing and displaying information such as | |
| distances, angles, and placement of prosthetic components in order to identify | |
| and characterize bone cuts necessary to achieve surgical goals. |
The predicate device is the EXACTECH GPS cleared in K100742. Both predicate
and proposed device have the same intended use, general design features, and
basic fundamental scientific technology. |
| | Compare to the predicate device cleared in K100742, this submission proposes
changes to:
- Sterile battery sterilization packaging
- Introduction of the Revision Total Knee Application software |
| Testing | Sterile battery: - Process qualifications related to packaging and sterilization
- Shelf life validation
Revision Total Knee Application software:
- Design Verification (including accuracy testing)
- Design Validation (including cadaveric sessions) |
| Summary of
Technological
Characteristics | The rationale for substantial equivalence is based on consideration of the
following characteristics: - Intended Use: the proposed modifications do not affect device intended
use. - General Design Features and Dimensions: the proposed modifications do
not affect key device features and dimensions. - Shelf life of the sterile components: proposed and predicate devices have
the same shelf life. - Basic fundamental scientific technology: the proposed modifications do not
change the device computer language and / or localization technology. - Performance Specifications: the proposed modifications do not affect
device accuracy and / or performance. |
| Substantial
Equivalence
Conclusion | Proposed device was tested during engineering studies and testing ensures
Results of engineering studies and cadaveric sessions referenced in this 510(k)
submission demonstrate the proposed EXACTECH GPS is substantially equivalent
to the predicate. |
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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.
5 Avenue du Grand Sablon 38700 La Tronche France