(141 days)
Not Found
No. The device description and intended use do not mention AI, DNN, or ML. The summary of performance studies also only indicates dimensional analysis and compatibility testing, not performance related to AI models.
No.
The device is a set of surgical instruments used with a robotic navigation platform to facilitate screw placement during spinal surgery; it does not directly treat a disease or condition itself.
No
The device is a surgical instrument intended for use during the placement of screws in spinal surgery. It is designed to navigate and guide other surgical instruments, not to diagnose medical conditions.
No
The Salvo® Robotic Navigation Instruments are described as "surgical instruments," "reusable," and "offered as non-sterile, to be cleaned and steam sterilized by the end user." This clearly indicates they are physical hardware components, not software. While they interact with a robotic navigation platform (ExcelsiusGPS®), they themselves are instruments.
No.
The device is a surgical instrument used to aid in the physical placement of screws during spinal surgery, not to perform in vitro diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® 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.
Product codes
OLO
Device Description
The Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as 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 / Not explicitly stated, inferred as surgical setting
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 Salvo® 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. Validation testing was also conducted to demonstrate compatibility of the subject device with the built-in safety feature of the ExcelsiusGPS end effector.
Clinical testing is not applicable.
The overall technology characteristics and engineering analysis lead to the conclusion that the Salvo® Robotic Navigation Instruments are substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
FDA 510(k) Clearance Letter - Salvo® Robotic Navigation Instruments
Page 1
April 3, 2025
Spine Wave, Inc.
Ronald Smith
Executive Vice President, Quality, Regulatory & Clinical Affairs
Three Enterprise Drive
Suite 210
Shelton, Connecticut 06484
Re: K243514
Trade/Device Name: Salvo® Robotic Navigation Instruments
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: February 28, 2025
Received: February 28, 2025
Dear Ronald Smith:
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.
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K243514 - Ronald Smith Page 2
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).
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 QS 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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243514 - Ronald Smith Page 3
assistance/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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K243514
Device Name
Salvo® Robotic Navigation Instruments
Indications for Use (Describe)
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® 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.
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:
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Page 5
510(k) Summary
510(k) #: K243514
Prepared on: 2025-03-31
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | Spine Wave, Inc. |
| Applicant Address | Three Enterprise Drive Suite 210 Shelton CT 06484 United States |
| Applicant Contact Telephone | 203-712-1846 |
| Applicant Contact | Mr. Ronald Smith |
| Applicant Contact Email | rsmith@spinewave.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | Salvo® Robotic Navigation Instruments |
| Common Name | Stereotaxic instrument |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Regulation Number | 882.4560 |
| Product Code(s) | OLO |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K220862 | E-GPS Navigated Instruments | OLO |
| K171651 | ExcelsiusGPS® | OLO |
Device Description Summary
21 CFR 807.92(a)(4)
The Salvo® Robotic Navigation Instruments are surgical instruments that are designed to be used with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. These instruments are intended to facilitate the placement of screws during spinal surgery. The instruments are reusable and offered as non-sterile, to be cleaned and steam sterilized by the end user.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Salvo® Robotic Navigation Instruments are indicated for use during the preparation and placement of Salvo® Spine System screws in open or minimally invasive procedures. The Salvo® Robotic Navigation Instruments are specifically designed for use with Globus Medical's ExcelsiusGPS® 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.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The subject Salvo® Robotic Navigation Instruments has the same intended use as the primary predicate. Specifically, the devices are used during the preparation and placement of screws in open or minimally invasive spinal procedures with Globus Medical's ExcelsiusGPS® Robotic Navigation Platform. Therefore, the subject Salvo® Robotic Navigation Instruments is substantially equivalent to
Page 6
its predicate in intended use, and no new issues of safety and effectiveness are raised.
Technological Comparison
21 CFR 807.92(a)(6)
The subject Salvo® 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, materials of manufacture, and principles of operation. Identical to the predicates, the subject Salvo® Robotic Navigation Instruments are also non-sterile, reusable instruments to be steam sterilized by the end user.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The Salvo® 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. Validation testing was also conducted to demonstrate compatibility of the subject device with the built-in safety feature of the ExcelsiusGPS end effector.
Clinical testing is not applicable.
The overall technology characteristics and engineering analysis lead to the conclusion that the Salvo® Robotic Navigation Instruments are substantially equivalent to the predicate device.