(59 days)
No
The summary describes surgical instruments used with a robotic navigation platform, but does not mention any AI or ML capabilities within the instruments themselves or the platform's core function as described. The focus is on navigation and guidance based on imaging.
No.
Explanation: The device is a surgical instrument intended to aid in the placement of screws during spinal surgery, rather than directly treating or diagnosing a medical condition itself.
No
The device is described as surgical instruments used for guiding the placement of screws during spinal surgery, not for diagnosing medical conditions.
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 IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Invictus Robotic Navigation Instruments are surgical instruments used during spinal surgery to facilitate the placement of screws. They are used in vivo (within the living body) as part of a surgical procedure, not to analyze samples in vitro (outside the living body).
- Intended Use: The intended use is to aid surgeons in navigating and guiding surgical instruments during a procedure, not to diagnose or provide information based on analyzing bodily samples.
Therefore, the Invictus Robotic Navigation Instruments fall under the category of surgical instruments or devices used in surgical procedures, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System 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 spationing 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.
Product codes (comma separated list FDA assigned to the subject device)
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
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)
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 Invictus Robotic Navigation Instruments were compared to the predicate devices and found to be substantially equivalent 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 (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.
K161363, K203742, K083416, K111449, K124058
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/2 description: The image shows the logo for the U.S. Food & 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.
June 6, 2024
Alphatec Spine, Inc. Alanna Joshi Regulatory Affairs Specialist 1950 Camino Vida Roble Carlsbad, California 92008
Re: K240951
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: April 5, 2024 Received: April 8, 2024
Dear Alanna Joshi:
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 (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/cdrb/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).
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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 820.70) 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 mediation-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,
Shumava 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 Ouality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K240951
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 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 spationing 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.
| 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 shows the logo for "atec". The "a" is green, while the "tec" is dark blue. There is a trademark symbol to the right of the "c". There is a black line underneath the logo.
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: | Alanna Joshi
Regulatory Affairs Specialist |
| | Date Summary Prepared: | April 5, 2024 |
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 |
III. LEGALLY MARKETED PREDICATE DEVICES
Primary Predicate Device:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K232044 | Invictus Robotic Navigation Instruments | October 6, 2023 |
Additional Predicate Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K232275 | Invictus Spinal Fixation System | September 27, 2023 |
| K171651 | EXCELSIUS GPS® | August 16, 2017 |
Reference Devices:
| 510(k) | Product Name | Clearance Date |
|---|---|---|
| K161363 | Arsenal Spinal Fixation System | June 10, 2016 |
| K203742 | IdentiTi ALIF Standalone Interbody System | March 18, 2021 |
| K083416 | Revolve Stabilization System | January 9, 2009 |
| K111449 | Revolve Stabilization System | August 17, 2011 |
| K124058 | CREO Stabilization System | May 13, 2023 |
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Image /page/4/Picture/0 description: The image shows the logo for "atec". The "a" is green, while 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 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 safety and effectiveness. Specifically, the following characteristics are similar between the subject and predicates: device design and dimensions, indications for use, materials of manufacture, and 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.
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.
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Image /page/5/Picture/0 description: The image shows the logo for a company called "atec". The "a" is green and stylized, while the "tec" is dark blue. There is a trademark symbol next to the "c". A black line is underneath the logo.
The Invictus Robotic Navigation Instruments were compared to the predicate devices and found to be substantially equivalent 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.