(88 days)
No
The summary describes robotic navigation instruments that work with a robotic platform, but there is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on navigation and spatial positioning based on imaging, not on intelligent decision-making or learning algorithms.
No
The device is a set of robotic navigation instruments designed to aid in the placement of screws during spinal surgery, but it does not directly treat a disease or condition. It is a surgical tool, not a therapeutic device.
No
The device description and intended use state that the Invictus Robotic Navigation Instruments are surgical instruments designed to aid in the placement of screws during spinal surgery, specifically for navigating and/or guiding compatible surgical instruments. They do not perform any diagnostic function.
No
The device description explicitly states that the Invictus Robotic Navigation Instruments are "surgical instruments" and "reusable instruments," indicating they are physical hardware components, not software.
Based on the provided information, the Invictus Robotic Navigation Instruments are not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Invictus Robotic Navigation Instruments Function: The description clearly states that these instruments are surgical tools used during spinal surgery to facilitate the placement of screws. They are used on the patient's body, not for testing specimens taken from the body.
- Intended Use: The intended use is for guiding surgical instruments during procedures, not for diagnostic testing.
- Device Description: The description identifies them as reusable surgical instruments.
Therefore, the Invictus Robotic Navigation Instruments fall under the category of surgical instruments used in vivo (within the body) and are not IVDs.
N/A
Intended Use / Indications for Use
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or quiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
Product codes
OLO
Device Description
The Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans or fluoroscopy
Anatomical Site
Spinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons, in open or percutaneous procedures.
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
The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance.
The subject Invictus Robotic Navigation Instruments were compared to the predicate/reference devices and found to be substantially equivalent to the predicate/reference devices in terms of cleaning and reprocessing.
The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
October 6, 2023
Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Alphatec Spine, Inc. Unnati Bhuptani Sr. Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K232044
Trade/Device Name: Invictus Robotic Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 6, 2023 Received: July 10, 2023
Dear Unnati Bhuptani:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Shumaya Ali-S
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
Submission Number (if known)
Device Name
Invictus Robotic Navigation Instruments
Indications for Use (Describe)
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or quiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
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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K232044 510(k) Summary
Image /page/3/Picture/1 description: The image shows the logo for Atec. The logo is a stylized wordmark with the first letter, 'a', in green and the rest of the letters in dark blue. There is a horizontal line underneath the wordmark.
Traditional 510(k) Premarket Notification Invictus Robotic Navigation Instruments
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.
| I. | SUBMITTER: | Alphatec Spine, Inc.
1950 Camino Vida Roble
Carlsbad, CA 92008
Phone: (760) 431-9286
Fax: (760) 431-0289 |
|-----|------------------------|----------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Unnati Bhuptani
Sr. Regulatory Affairs Specialist |
| | Date Summary Prepared: | September 12, 2023 |
| II. | DEVICE | |
| Trade or Proprietary Name: | Invictus Robotic Navigation Instruments |
|---|---|
| Common Name: | Navigation Instruments |
| Classification Name: | Orthopedic Stereotaxic Instrument |
| Regulation Number: | 21 CFR 882.4560 |
| Classification: | Class II |
| Product Code: | OLO |
LEGALLY MARKETED PREDICATE DEVICES III.
Primary Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K220862 | E-GPS Navigated Instruments | July 14, 2022 |
Additional Predicate Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K171651 | EXCELSIUS GPS® | August 16, 2017 |
| K221926 | Invictus® Bone Cement, Invictus Spinal Fixation | |
| System | December 20, 2022 |
Reference Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K161363 | Arsenal Spinal Fixation System | June 10, 2016 |
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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, and the "tec" is dark blue. There is a horizontal line underneath the logo.
IV. DEVICE DESCRIPTION
The Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.
V. INDICATIONS FOR USE
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
VI. TECHNOLOGICAL COMPARISON TO PREDICATES
The subject Invictus Robotic Navigation Instruments have equivalent technological characteristics to that of the predicate devices and the minor differences do not raise any new issues of the safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates:
- Device design and dimensions
- . Indications for Use
- Materials of manufacture
- Principles of Operation ●
Identical to the predicates, the subject Invictus Robotic Navigation Instruments are also non-sterile, reusable instruments to be steam sterilized by the end user.
The technological design features of the subject instrument were compared to the predicates in intended use, indications for use, design, function and technology and it was demonstrated that they are substantially equivalent.
Clinical Information
Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data.
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Image /page/5/Picture/0 description: The image shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a trademark symbol next to the "c". A black line is underneath the logo.
VII. PERFORMANCE DATA
The Invictus Robotic Navigation Instruments have been evaluated through a dimensional analysis and geometric comparison to the predicate devices to establish the safety and effectiveness for accuracy performance.
The subject Invictus Robotic Navigation Instruments were compared to the predicate/reference devices and found to be substantially equivalent to the predicate/reference devices in terms of cleaning and reprocessing.
The results of this engineering analysis show that the subject is substantially equivalent to the cleared predicate.
VIII. CONCLUSION
Based upon the information provided in this 510(k) submission, it has been determined that the subject device is substantially equivalent to legally marketed devices in regard to indications for use, intended use, design, technology, and performance.