The surgical instruments are specifically designed for use with the Pulse System, which enables computer-assisted navigation for spinal surgical procedures in which the use of stereotactic surgery may be appropriate.

When used with a Pulse Navigation system, the patient reference hardware is intended to provide a reference to a rigid anatomical structure that can be identified relative to the acquired image of the anatomy.

Device Description

The subject NuVasive Rod Registration Frame is introducing modifications based on the design of existing patient reference hardware, the Spinous Process Clamp (Pulse System K210574). The Rod Registration Frame was designed to offer surgeons more flexibility during the registration process of Pulse Navigation by providing an additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient. Despite the changes introduced to predicate Spinous Process Clamp (K210574), the subject device Rod Registration Frame is substantially equivalent to the predicate as demonstrated by verification and validation testing performed using well established and previously cleared test methods.

AI/ML Overview

The NuVasive Rod Registration Frame is a surgical instrument designed for use with the Pulse System, enabling computer-assisted navigation for spinal surgical procedures. The device provides a reference to a rigid anatomical structure that can be identified relative to an acquired image of the anatomy when used with a Pulse Navigation system. The device is a modification of an existing patient reference hardware (Spinous Process Clamp, K210574), with updated distal and proximal connection features and removal of radiographic markers (as it is used only for non-fiducial registration).

Here's an analysis of the acceptance criteria and the study proving the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes non-clinical testing to demonstrate substantial equivalence, rather than a direct table of specific numerical acceptance criteria and performance for a new, independent claim of efficacy. The core acceptance criterion is that the Rod Registration Frame performs equivalently to its predicate device (Spinous Process Clamp K210574).

Acceptance Criterion (Implicit)	Reported Device Performance
Functional Equivalence (to the predicate device in providing patient reference for navigation)	The Rod Registration Frame provides an "additional patient reference hardware design option for attaching the existing Patient Reference Array to the patient," indicating its functional role is equivalent to the predicate. It "offers surgeons more flexibility during the registration process." Performance data (listed below) was performed to demonstrate this equivalence.
Accuracy: System-level accuracy in conjunction with the Pulse System	"System Level Accuracy Testing" was performed. The results "demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices." While specific numerical accuracy values are not provided in this summary, the implication is that the accuracy is comparable and within acceptable limits for the intended use of computer-assisted spinal navigation.
Design Validation: Conformance to design specifications and adequate for intended use	"Design Validation" was performed. This likely includes tests to ensure the physical design, material properties, and mechanical integrity of the device are suitable for its application. The summary states that the results "demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices."
Tolerance Analysis: Compatibility within the system's operational tolerances	"Tolerance Analysis" was performed. This would assess how variations in manufacturing and assembly impact the device's performance within the Pulse System, ensuring consistent and reliable function. The results "demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices."
Usability: Ease of use and ergonomic suitability for surgical procedures	"Usability Validation" was performed. This evaluates the device's user interface, handling characteristics, and overall ease of integration into the surgical workflow. The results "demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices," suggesting it is as user-friendly and effective as the predicate.
Cadaver Verification: Performance in a realistic anatomical setting	"Cadaver Verification" was performed. This critically assesses the device's function and interaction with anatomical structures in a simulated surgical environment. The results "demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices," indicating successful performance in cadaveric studies.
Biocompatibility/Material Safety (implicitly covered by material comparison and previous clearance)	The subject device uses 17-4 PH Stainless Steel (conforming to ASTM A564), which is also part of the predicate device's material composition (17-4 PH Stainless Steel and 465 Stainless Steel conforming to ASTM A564 and Nitronic 60 conforming to ASTM A267). This material commonality, along with the device being non-sterile and intended for re-processing, implies that material safety criteria established for the predicate apply. The submission asserts "substantially equivalent" which infers the material safety aspect is met.

2. Sample size used for the test set and the data provenance:

The document states that "non-clinical testing was performed." However, it does not specify the sample size for the test sets used in System Level Accuracy Testing, Cadaver Verification, Design Validation, Tolerance Analysis, or Usability Validation.
The data provenance (e.g., country of origin, retrospective or prospective) is not explicitly stated in this summary. Given that it's non-clinical testing for a U.S. FDA submission, it's highly probable the testing was conducted in a controlled lab environment and likely within the U.S. or by a recognized testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the summary. For non-clinical performance testing of a medical device, ground truth is typically established through engineering measurements, biomechanical modeling, and cadaveric studies where anatomical landmarks might serve as a reference. The "design validation" and "cadaver verification" sections imply that expert evaluation (e.g., of surgical applicability) would have been involved, but details on their number or qualifications are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided as the testing described is non-clinical performance and validation testing, not a clinical study involving human reader assessments requiring adjudication.

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 MRMC study was done. The device (Rod Registration Frame) is a physical surgical instrument used for navigation, not an AI or imaging diagnostic tool. Therefore, a study on human reader improvement with AI assistance is not applicable. The document explicitly states: "No clinical studies were conducted."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is a physical surgical instrument, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the performance data mentioned (System Level Accuracy, Design Validation, Tolerance Analysis), the ground truth would be based on engineering specifications, physical measurements, and established performance criteria for navigation devices.
For Cadaver Verification, the ground truth would involve anatomical landmarks and verified instrument placement/registration accuracy against known anatomical points. This would likely involve precise measurement tools and potentially expert anatomical assessment.

8. The sample size for the training set:

This question is not applicable as the device is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI algorithms.

9. How the ground truth for the training set was established:

This question is not applicable for the same reason as point 8.

Summary

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May 5, 2023

NuVasive, Incorporated Leah Andre Regulatory Affairs Specialist 7475 Lusk Blvd San Diego, California 92121

Re: K230989

Trade/Device Name: Rod Registration Frame Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: April 5, 2023 Received: April 6, 2023

Dear Leah Andre:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 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,

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

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Indications for Use

510(k) Number (if known) K230989

Device Name Rod Registration Frame

Indications for Use (Describe)

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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510k Summary

In accordance with Title 21 of the Code of Federal Regulations, Part 807 and in particular 21 CFR §807.87, the following summary of information is provided:

A. Submitted by:

Leah Andre Regulatory Affairs Specialist NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Telephone: (865) 724-9780 Date Prepared: April 5, 2023

B. Device Name

Trade or Proprietary Name:	NuVasive® Rod Registration Frame
Common Name:	Stereotaxic Instrument
Classification Name:	Stereotaxic Instrument
Device Class:	Class II
Regulation Number:	21 CFR § 888.4560
Product Code:	OLO

C. Predicate Devices

The subject NuVasive Rod Registration Frame is substantially equivalent to the primary predicate device NuVasive Spinous Process Clamp cleared in K210574. Additional reference device includes NuVasive Hip Pin (K210574).

D. Device Description

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E. Indications for Use

Technological Comparison F.

The introduction of design change in patient fixation hardware introduces updated distal and proximal connection features and removal of radiographic markers (as the Rod Registration Frame is only used for non-fiducial registration).

The following table describes the summary comparison of technological characteristics of the subject device with the predicate devices:

Characteristics	Subject Device	K210574 Predicate Device	K210574 Reference Device
Indications forUse	The surgical instruments arespecifically designed for usewith the Pulse System, whichenables computer-assistednavigation for spinal surgicalprocedures in which the useof stereotactic surgery maybe appropriate.	The surgical instruments arespecifically designed for usewith the Pulse System, whichenables computer-assistednavigation for spinal surgicalprocedures in which the useof stereotactic surgery maybe appropriate.	The surgical instruments arespecifically designed for usewith the Pulse System, whichenables computer-assistednavigation for spinal surgicalprocedures in which the useof stereotactic surgery maybe appropriate.
	When used with a PulseNavigation system, the patientreference hardware is intendedto provide a reference to a rigidanatomical structure that can beidentified relative to theacquired image of the anatomy.	When used with a PulseNavigation system, the patientreference hardware is intendedto provide a reference to a rigidanatomical structure that can beidentified relative to theacquired image of the anatomy.	When used with a PulseNavigation system, the patientreference hardware is intendedto provide a reference to a rigidanatomical structure that can beidentified relative to theacquired image of the anatomy.
Product Code	OLO	OLO	OLO
21 CFRClassification	§882.4560	§882.4560	§882.4560
Material	17-4 PH Stainless Steelconforming to ASTM A564	17-4 PH Stainless Steel and 465Stainless Steel conforming toASTM A564 and Nitronic 60conforming to ASTM A267	316L SS per ASTM F138 andPPSU Radel R-5100
Principle ofOperation	Patient reference hardware thatprovides a reference to a rigidanatomical structure.	Patient reference hardware thatprovides a reference to a rigidanatomical structure.	Patient reference hardware thatprovides a reference to a rigidanatomical structure.
DeviceConstructDesign	Patient reference hardware•option for attachingPatient Reference Array topatient to acquire accuratepatient registrations	Patient reference hardware•option for attaching PatientReference Array to patientto acquire accurate patient	Patient reference hardware•option for attachingPatient Reference Array topatient to acquire accuratepatient registrations
	needed for navigatedsurgeryDistal ConnectionFeature/Patient FixationMethod: Bent Rodcomponent utilized forpatient fixation byinsertion throughNuVasive pedicle screwsystemsProximal ConnectionFeature: Poker Chipcomponent utilized forfixation to Extension Armto facilitate connection toPatient Reference ArrayNo radiographic markersdue to use of non-fiducial(Non-fiducial) registrationonly	registrations needed fornavigated surgeryDistal ConnectionFeature/Patient FixationMethod: Clampcomponent utilized forpatient fixation byactuating jaw features toclamp directly to spinousprocessProximal ConnectionFeature: PRA hubcomponent utilized forfixation to Extension Armwith Articulating Adapterto facilitate connection toPatient Reference Array.Can also be attacheddirectly to PatientReference Array.Radiographic markers usedspecifically for fiducialregistration only	needed for navigatedsurgeryDistal ConnectionFeature/Patient FixationMethod: Sharp pincomponent utilized forpatient fixation by fixationinto pelvisProximal ConnectionFeature: PRA hubcomponent utilized forfixation to Extension Armwith Articulating Adapterto facilitate connection toPatient Reference Array.Can also be attacheddirectly to PatientReference ArrayMay or may not haveradiographic markers usedspecifically for fiducialregistration only
Offered Lengths	Short and Long	Short and Long	Short and Long
OfferedDiameters	Various; compatible withNuVasive Screw Systems	N/A	N/A
RegistrationCompatibility	Non-fiducial Registration	Fiducial and Non-fiducialRegistration	Fiducial and Non-fiducialRegistration
Method ofAttachment	Inserted through NuVasivescrew systems	Clamps directly to spinousprocess	Fixated into pelvis
Region ofAnatomy	Cervical, Thoracic and Lumbarregions of the spine	Cervical, Thoracic and Lumbarregions of the spine	Lumbar and Sacral regions ofthe spine
PerformanceData/Testing/Analysis	System Level AccuracyTestingCadaver VerificationDesign ValidationTolerance AnalysisUsability Validation	System Level AccuracyTestingCadaver VerificationDesign ValidationTolerance AnalysisUsability Validation	System Level AccuracyTestingCadaver VerificationDesign ValidationTolerance AnalysisUsability Validation
AccessoryInstrumentation	Extension Arm which holdsPatient Reference Array	Extension Armwith Articulating Adapterand/or Patient Reference Array	Extension Armwith Articulating Adapterand/or Patient Reference Array
Sterilization	Non-sterile	Non-sterile	Sterile (EO)

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G. Performance Data

Non-clinical testing was performed using the same methodology and acceptance criteria as the previously cleared Spinous Process Clamp (K210574), demonstrating that the subject device's performance is substantially equivalent to the legally marketed predicate device. The following testing was performed:

. System Level Accuracy Testing

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Cadaver Verification ●
Design Validation
. Tolerance Analysis
Usability Validation ●

The results demonstrate that the subject Rod Registration Frame meets the same criteria as the predicate devices, and the subject device was therefore found to be substantially equivalent to the predicate. No clinical studies were conducted.

H. Conclusion

Results of non-clinical testing demonstrate that the subject device Rod Registration frame is substantially equivalent to the predicate device cleared in K210574.

Regulation Number and Section

§ 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).