(140 days)
Not Found
No
The summary describes an image-guided surgery system that uses hardware trackers and real-time data display for navigation, but it does not mention any AI or ML components. The modifications are stated to not change the fundamental scientific technology.
No.
The device is described as a surgical navigation system that aids the surgeon in locating anatomical structures and aligning endoprostheses during surgery, rather than directly treating a disease or condition.
No
The device is an image-guided surgery system intended to assist surgeons intraoperatively during arthroplasty by providing real-time information on the positions of anatomical structures and instrumentation, rather than diagnosing a condition.
No
The device description explicitly states that the ExactechGPS® System works with "ExactechGPS® hardware trackers" and a "ExactechGPS® hardware station," indicating it is not solely software. The performance studies also include electrical safety, EMC compatibility, photobiological safety, biocompatibility, and cleaning/sterilization validation, which are typical for hardware components.
Based on the provided information, the ExactechGPS® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning endoprostheses. This is an in vivo application, meaning it's used within a living organism during a surgical procedure.
- Device Description: The description reinforces this by stating it's an image-guided surgery or navigation system used during orthopedic surgical procedures to assist surgeons intraoperatively. It provides real-time information on the positions of patient anatomical structures and instrumentation.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The ExactechGPS® System does not perform any such analysis of biological specimens.
Therefore, the ExactechGPS® System falls under the category of a surgical navigation or guidance system, which is a type of medical device used in vivo during surgery, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
TKA Pro software application is specifically indicated for Total Knee Arthroplasty.
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.
The ExactechGPS® System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System 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 ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.
The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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® System in the intended environment of use is supported by testing that was conducted in-house and by accredited testing laboratories.
This submission includes or references the following non-clinical testing:
- General Functions tests to ensure design is fully verified and validated.
- Electrical safety testing per IEC 60601-1 determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
- EMC Compatibility testing per IEC 60601-1-2 Determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
- Photobiological safety testing per EN 62471 determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
- Biocompatibility testing per ISO 10993-1:2018 and associated standards determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
- Cleaning and sterilization validation per ISO 17664:2017, ISO 17665-1:2006, AAMI TIR12:2020 and AAMI TIR30:2011/(R) 2016 determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
May 2, 2022
Blue Ortho Matthieu Coic OA RA Director 22, Chemin du Vieux Chene Meylan, 38240 France
Re: K213877
Trade/Device Name: ExactechGPS® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 25, 2022 Received: February 1, 2022
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 (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 located 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.
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
1
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) for devices or postmarketing safety reporting (21 CFR 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/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,
For: 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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213877
Device Name ExactechGPS® System
Indications for Use (Describe)
The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
TKA Pro software application is specifically indicated for 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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, uppercase letters. The overall design is modern and professional, conveying a sense of innovation and expertise in the field of orthopedics.
22 Chemin du Vieux Chêne 38240 Meylan France
ExactechGPS® System 510(k) Summary of Safety and Effectiveness
I. SUBMISSION DATE
December 10, 2021
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
510(k) Number Trade or Proprietary Model Name Manufacturer #K193618 EXACTECH GPS Blue Ortho This predicate has not been subject to a design-related recall.
V. PROPOSED DEVICE DESCRIPTION
Trade or Proprietary or Model Name(s): ExactechGPS® System Common Name: Surgical navigation system Classification Name: Orthopedic Stereotaxic Instrument (21 CFR 882.4560, product code OLO) Classification: Class II Device Description: The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618.
The ExactechGPS® System is an image-quided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist
4
Image /page/4/Picture/0 description: The image shows the logo for BlueOrtho, a company specializing in augmented orthopedics. The logo features a blue square with a stylized "C" inside, followed by the text "BlueOrtho" in a light blue sans-serif font. Below "BlueOrtho" is the text "AUGMENTED ORTHOPAEDICS" in a smaller font size. A registered trademark symbol is located to the right of the word "Ortho".
surgeons during arthroplasty. The ExactechGPS® System 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 ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery.
The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.
VI. INDICATIONS FOR USE
The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures.
TKA Pro software application is specifically indicated for Total Knee Arthroplasty.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
This submission proposes the following hardware modifications to the ExactechGPS® system:
- A new set of ExactechGPS Trackers V2 with a different architecture, an updated electronic card and an InfraRed bandpass filter
The ExactechGPS® system cleared per 510(k) #K193618 is compatible with the Knee Clinical Applications Software suite (which includes ExactechGPS® TKA Pro and ExactechGPS® TKA Plus clinical software applications).
The proposed ExactechGPS® system that includes changes listed hereabove is compatible only with the ExactechGPS® TKA Pro clinical software application.
Based on test bench testing, the proposed changes do not alter significantly the performances of the devices and the way it is used:
- The proposed ExactechGPS Trackers V2 have the same general features and . dimensions, with the same technology and performances.
- The redesigned electronic card only resolves obsolescence issues with no . impact on user, performance and safety.
- The new InfraRed bandpass filter only improves communication reliability. ●
5
Image /page/5/Picture/0 description: The image shows the logo for BlueOrtho. The logo consists of a blue square with a stylized "C" shape inside, followed by the text "BlueOrtho" in a light blue sans-serif font. Below the text is the phrase "AUGMENTED ORTHOPAEDICS" in a smaller font.
VIII. PERFORMANCE DATA
Testing information demonstrating safety and effectiveness of the ExactechGPS® System in the intended environment of use is supported by testing that was conducted in-house and by accredited testing laboratories.
This submission includes or references the following non-clinical testing:
- General Functions tests to ensure design is fully verified and validated.
- Electrical safety testing per IEC 60601-1 determined the proposed ● ExactechGPS® System is compliant with the requirements of the standard.
- EMC Compatibility testing per IEC 60601-1-2 Determined the proposed ● ExactechGPS® System is compliant with the requirements of the standard.
- Photobiological safety testing per EN 62471 determined the proposed . ExactechGPS® System is compliant with the requirements of the standard.
- . Biocompatibility testing per ISO 10993-1:2018 and associated standards determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
- Cleaning and sterilization validation per ISO 17664:2017, ISO 17665-1:2006, . AAMI TIR12:2020 and AAMI TIR30:2011/(R) 2016 determined the proposed ExactechGPS® System is compliant with the requirements of the standard.
IX. SUBSTANTIAL EQUIVALENCE CONCLUSION
A comparison of specific features included in this submission demonstrates the proposed ExactechGPS® System is substantially equivalent to the cited predicate cleared per #K193618. The devices share identical intended use, identical general design features and basic fundamental scientific technology.