(293 days)
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.
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 provided document describes the EXACTECH GPS, a stereotaxic instrument intended for use during total knee arthroplasty to locate anatomical structures and align endoprostheses. The product is a submission for changes to the original EXACTECH GPS (K100742), specifically regarding sterile battery sterilization packaging and the introduction of Revision Total Knee Application software.
The document includes a summary of Safety and Effectiveness for the EXACTECH GPS, outlining testing related to the new Revision Total Knee Application software. This testing includes Design Verification (including accuracy testing) and Design Validation (including cadaveric sessions) to demonstrate substantial equivalence to the predicate device.
However, the document does not explicitly provide a detailed table of specific acceptance criteria and reported device performance metrics for the software's accuracy, nor does it detail the specific study methodology or results proving the device meets these criteria. The text only broadly states that "performance specifications: the proposed modifications do not affect device accuracy and/or performance."
Therefore, based on the provided text, I cannot complete points 1 through 9 with specific quantitative data. The information is not detailed enough to extract those specifics.
The document states:
- Testing: "Revision Total Knee Application software: - Design Verification (including accuracy testing) - Design Validation (including cadaveric sessions)"
- 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."
This implies that some form of accuracy testing was performed during Design Verification and usability/effectiveness testing in cadaveric sessions during Design Validation. However, the specific metrics, thresholds, sample sizes, and expert details for these studies are not disclosed in this summary.
In summary, while the document confirms that accuracy and cadaveric studies were performed to support the device's substantial equivalence, it does not provide the detailed information required to fill out the requested table and answer the specific questions about acceptance criteria, study design, and performance metrics.
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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
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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 ORTHO5 avenue du Grand Sablon38700 La TroncheFrancePhone: +33 (0) 4 76 54 95 46 |
| Contact | Anthony BOYERPhone: +33 (0) 4 76 54 95 46Cell: +33 (0)6 30 39 50 66anthony.boyer@blue-ortho.com |
| U.S.Headquarters | Exactech, Inc.2320 NW 66th Ct.Gainesville, FL. 32653Phone: 352-377-1140 |
| Trade Name | EXACTECH GPS |
| Common Name | Stereotaxic Instruments |
| ClassificationName | Stereotaxic Instrument (21 CFR 882.4560, Product Code OLO Class II) |
| Information ondevices to whichsubstantialequivalence isclaimed: | 510(k) Number: K100742Trade or Property Model Name: Exactech GPSManufacturer: BLUE ORTHO |
| Indications forUse: | The EXACTECH GPS is intended for use during stereotaxic surgery to aid thesurgeon in locating anatomical structures and aligning the endoprostheses withthe anatomical structures.It is specifically indicated for primary and revision Total Knee Arthroplasty. |
| DeviceDescription: | The EXACTECH GPS is an Image Guided Surgery, or Navigation, system fororthopedic surgical procedures intended to be used to intraoperatively assistsurgeons during total knee arthroplasty. The EXACTECH GPS enables surgeons toacquire intraoperative data by computing and displaying information such asdistances, angles, and placement of prosthetic components in order to identifyand characterize bone cuts necessary to achieve surgical goals.The predicate device is the EXACTECH GPS cleared in K100742. Both predicateand proposed device have the same intended use, general design features, andbasic fundamental scientific technology. |
| Compare to the predicate device cleared in K100742, this submission proposeschanges 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 validationRevision Total Knee Application software:- Design Verification (including accuracy testing)- Design Validation (including cadaveric sessions) |
| Summary ofTechnologicalCharacteristics | The rationale for substantial equivalence is based on consideration of thefollowing characteristics:- Intended Use: the proposed modifications do not affect device intendeduse.- General Design Features and Dimensions: the proposed modifications donot affect key device features and dimensions.- Shelf life of the sterile components: proposed and predicate devices havethe same shelf life.- Basic fundamental scientific technology: the proposed modifications do notchange the device computer language and / or localization technology.- Performance Specifications: the proposed modifications do not affectdevice accuracy and / or performance. |
| SubstantialEquivalenceConclusion | Proposed device was tested during engineering studies and testing ensuresResults of engineering studies and cadaveric sessions referenced in this 510(k)submission demonstrate the proposed EXACTECH GPS is substantially equivalentto 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
§ 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).