(117 days)
The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ 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.
The CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.
The provided FDA Clearance Letter and 510(k) Summary for the CORUS™ Navigation System-GX (K251060) do not contain detailed information about specific acceptance criteria, study methodologies (like sample sizes for test/training sets, data provenance, ground truth establishment, or expert involvement), or the results of a multi-reader multi-case (MRMC) comparative effectiveness study.
The document states that the device was evaluated through "an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance." It also mentions "a functional assessment was conducted to evaluate compatibility and simulated use testing." However, it does not provide the quantitative acceptance criteria or the specific performance metrics achieved in these evaluations.
Therefore, based solely on the provided text, I cannot complete many sections of your request. I will indicate where the information is not present.
Here's a breakdown of the available information:
Acceptance Criteria and Device Performance
Due to the lack of quantitative performance data in the provided document, I cannot create a table of acceptance criteria and reported device performance. The document states:
- "The CORUS™ Navigation System-GX instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance."
- "A functional assessment was conducted to evaluate compatibility and simulated use testing."
- "The results of these engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate."
This language indicates that the device met the necessary performance for clearance by demonstrating substantial equivalence, but it does not disclose the specific numerical thresholds or achieved performance metrics.
Study Information Based on Provided Text:
1. A table of acceptance criteria and the reported device performance
Not Available in the Provided Text. The document generally states that "engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate," implying that performance criteria were met, but does not list specific criteria or results.
2. Sample sizes used for the test set and the data provenance
Not Available in the Provided Text for "accuracy performance" or "functional assessment" studies. The document mentions "engineering analysis and geometric comparison" and "functional assessment" and "simulated use testing," but it does not specify sample sizes or data provenance (e.g., retrospective/prospective, country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not Applicable/Not Available. The device is a "Stereotaxic Instrument" intended to assist surgeons in locating anatomical structures. The described evaluations ("engineering analysis," "geometric comparison," "functional assessment," and "simulated use testing") suggest a focus on mechanical accuracy, compatibility, and functionality rather than diagnostic interpretation requiring human expert ground truth. Therefore, the concept of "experts establishing ground truth for a test set" in the context of image interpretation is not directly applicable here. The ground truth might be defined by engineering specifications or physical measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Available. Given the nature of the device and the described evaluations, an adjudication method for image interpretation or diagnosis is not relevant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was performed. This device is a navigation system instrument, not an AI-assisted diagnostic tool that would typically undergo such a study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Partially Applicable / Inferred. The evaluations described ("engineering analysis and geometric comparison," "functional assessment," "simulated use testing") would inherently involve testing the device's performance in a standalone or controlled environment, ensuring its mechanical and functional specifications are met, independent of a specific surgical procedure on a live patient. The device "does not include its own navigation platform" but works with the Globus Medical ExcelsiusGPS™. The testing would focus on the navigation instruments' accuracy and compatibility with this platform.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Inferred to be Engineering/Physical Specifications. For a stereotaxic instrument, the ground truth for "accuracy performance" would typically be derived from engineering specifications, physical measurements using highly precise measurement tools, or established anatomical models/phantoms. It is not expert consensus on images, pathology, or outcomes data.
8. The sample size for the training set
Not Applicable / Not Available. The document describes "engineering analysis and geometric comparison" and "functional assessment," and "simulated use testing." This type of evaluation is typically for mechanical devices and does not describe a machine learning algorithm that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not Applicable. See point 8.
U.S. Food & Drug Administration FDA Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 30, 2025
Providence Medical Technology, Inc.
℅ Hannah Taggart
Engineer & Regulatory Specialist
Empirical Technology
4628 Northpark Drive
Colorado Springs, Colorado 80918
Re: K251060
Trade/Device Name: CORUS™ Navigation System-GX
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: July 1, 2025
Received: July 1, 2025
Dear Hannah Taggart:
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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K251060 - Hannah Taggart
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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-
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K251060 - Hannah Taggart
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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
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Page 4
Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251060 |
|---|---|
| Please provide the device trade name(s). | |
| CORUS™ Navigation System-GX |
| Please provide your Indications for Use below. |
|---|
| The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ 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. |
| Please select the types of uses (select one or both, as applicable). | ☒ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|
CORUS™ Navigation System-GX
Page 8 of 29
Page 5
K251060 510(K) SUMMARY
510(k) Owner: Providence Medical Technology, Inc.
4234 Hacienda Drive, Suite 150
Pleasanton CA, 94588
Company Contact Person: Edward Liou; Providence Medical Technology, Inc.
415-754-8593; ed@providencemt.com
Contact Person: Hannah Taggart, MS; Empirical Technologies
719- 457-1152; htaggart@empiricaltech.com
Date Summary was Prepared: July 29, 2025
Trade or Proprietary Name: CORUS™ Navigation System-GX
Device Classification Name: Orthopedic Stereotaxis Instruments
Classification & Regulation #: Class II per 21 CFR §882.4560
Product Code: OLO
Classification Panel: Orthopedic – Restorative, Repair and Trauma Devices (DHT6C)
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The CORUS™ Navigation System-GX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel-G and Navigation Chisel Rasp-G are specifically designed for use with Globus Medical ExcelsiusGPS™ for navigation of the instruments to the facet joint. The instrument set provides access to the posterior spinal facet joint and decortication for bone preparation.
INDICATIONS FOR USE
The CORUS™ Navigation System-GX for use with the CORUS™ Spinal System is intended to be used during spinal surgery to assist the surgeon in locating and preparing facet joints in either open, or minimally invasive procedures. The CORUS™ Navigation System-GX is specifically designed for use with the Globus Medical ExcelsiusGPS™ 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.
TECHNOLOGICAL CHARACTERISTICS
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are the same between the subject and predicates:
- Indications for Use
- Materials of manufacture
- Critical Geometry
- Principles of Operation
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Predicate Devices
| 510k # | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K191100 | ExcelsiusGPS Spine 1.1 Interbody Module | Globus Medical Inc. | OLO | Primary |
| K212636 | CORUS Spinal System-X | Providence Medical Technologies, Inc. | HRX | Additional |
| K240625 | CORUS™ Navigation Access System | Providence Medical Technologies, Inc. | OLO | Additional |
The Globus ExcelsiusGPS system includes the navigation platform software and hardware while the subject instruments are used in conjunction with the predicate navigation platform software and hardware the same as the predicate instrument in place of the Globus instruments. The subject does not include its own navigation platform.
PERFORMANCE DATA
The CORUS™ Navigation System-GX instruments have been evaluated through an engineering analysis and geometric comparison to predicate devices to establish the safety and efficacy for accuracy performance. A functional assessment was conducted to evaluate compatibility and simulated use testing. The biocompatibility evaluation of the instruments leveraged equivalence in materials and manufacturing to previously cleared instruments (K180876). The results of these engineering analysis and evaluations show that the subject is substantially equivalent to the cleared predicate.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the CORUS™ Navigation System-GX is substantially equivalent to the predicate device.
2 | Page
§ 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).