Rod Registration Frame

K230989 · Nu Vasive, Incorporated · OLO · May 5, 2023 · Neurology

Device Facts

• Record ID: K230989
• Device Name: Rod Registration Frame
• Applicant: Nu Vasive, Incorporated
• Product Code: OLO · Neurology
• Decision Date: May 5, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

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 Story

Rod Registration Frame is patient reference hardware for Pulse Navigation system; used in spinal surgery. Device provides rigid anatomical reference by attaching to NuVasive pedicle screw systems via bent rod component. Surgeon inserts rod through screw system; attaches Patient Reference Array via poker chip proximal connection. Enables non-fiducial registration of patient anatomy to pre-acquired images. Used in OR by surgeons to facilitate computer-assisted navigation; improves accuracy of surgical instrument placement relative to patient anatomy. No radiographic markers present. Device is non-sterile.

Clinical Evidence

No clinical studies were conducted. Substantial equivalence is supported by non-clinical bench testing, including system-level accuracy testing, cadaver verification, design validation, tolerance analysis, and usability validation, using the same methodologies and acceptance criteria as the predicate device (K210574).

Technological Characteristics

Material: 17-4 PH Stainless Steel (ASTM A564). Form factor: Bent rod with distal fixation for pedicle screw systems and proximal poker chip connection for Patient Reference Array. Non-sterile. Non-fiducial registration only. No radiographic markers.

Indications for Use

Indicated for use with the Pulse System for computer-assisted navigation during spinal surgical procedures where stereotactic surgery is appropriate. Intended for patients undergoing spinal surgery requiring rigid anatomical reference for navigation.

Regulatory Classification

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.

Predicate Devices

• NuVasive Spinous Process Clamp (K210574)

Reference Devices

• NuVasive Hip Pin (K210574)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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Image /page/3/Picture/1 description: The image shows the Nuvasive logo. The logo consists of a stylized leaf shape in purple and gray on the left, followed by the word "NUVASIVE" in gray. The leaf shape is partially purple and partially gray, with the purple portion on the upper left and the gray portion on the lower left. The word "NUVASIVE" is in a sans-serif font and is slightly blurred.

## 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: [phone] 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

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.

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Image /page/4/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray. The leaf shape is partially purple and partially gray, with the purple portion on top and the gray portion on the bottom.

#### E. Indications for Use

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.

#### 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 for<br>Use | The surgical instruments are<br>specifically designed for use<br>with the Pulse System, which<br>enables computer-assisted<br>navigation for spinal surgical<br>procedures in which the use<br>of stereotactic surgery may<br>be appropriate. | The surgical instruments are<br>specifically designed for use<br>with the Pulse System, which<br>enables computer-assisted<br>navigation for spinal surgical<br>procedures in which the use<br>of stereotactic surgery may<br>be appropriate. | The surgical instruments are<br>specifically designed for use<br>with the Pulse System, which<br>enables computer-assisted<br>navigation for spinal surgical<br>procedures in which the use<br>of stereotactic surgery may<br>be appropriate. |
| | When used with a Pulse<br>Navigation system, the patient<br>reference hardware is intended<br>to provide a reference to a rigid<br>anatomical structure that can be<br>identified relative to the<br>acquired image of the anatomy. | When used with a Pulse<br>Navigation system, the patient<br>reference hardware is intended<br>to provide a reference to a rigid<br>anatomical structure that can be<br>identified relative to the<br>acquired image of the anatomy. | When used with a Pulse<br>Navigation system, the patient<br>reference hardware is intended<br>to provide a reference to a rigid<br>anatomical structure that can be<br>identified relative to the<br>acquired image of the anatomy. |
| Product Code | OLO | OLO | OLO |
| 21 CFR<br>Classification | §882.4560 | §882.4560 | §882.4560 |
| Material | 17-4 PH Stainless Steel<br>conforming to ASTM A564 | 17-4 PH Stainless Steel and 465<br>Stainless Steel conforming to<br>ASTM A564 and Nitronic 60<br>conforming to ASTM A267 | 316L SS per ASTM F138 and<br>PPSU Radel R-5100 |
| Principle of<br>Operation | Patient reference hardware that<br>provides a reference to a rigid<br>anatomical structure. | Patient reference hardware that<br>provides a reference to a rigid<br>anatomical structure. | Patient reference hardware that<br>provides a reference to a rigid<br>anatomical structure. |
| Device<br>Construct<br>Design | Patient reference hardware<br>•<br>option for attaching<br>Patient Reference Array to<br>patient to acquire accurate<br>patient registrations | Patient reference hardware<br>•<br>option for attaching Patient<br>Reference Array to patient<br>to acquire accurate patient | Patient reference hardware<br>•<br>option for attaching<br>Patient Reference Array to<br>patient to acquire accurate<br>patient registrations |
| | needed for navigated<br>surgery<br>Distal Connection<br>Feature/Patient Fixation<br>Method: Bent Rod<br>component utilized for<br>patient fixation by<br>insertion through<br>NuVasive pedicle screw<br>systems<br>Proximal Connection<br>Feature: Poker Chip<br>component utilized for<br>fixation to Extension Arm<br>to facilitate connection to<br>Patient Reference Array<br>No radiographic markers<br>due to use of non-fiducial<br>(Non-fiducial) registration<br>only | registrations needed for<br>navigated surgery<br>Distal Connection<br>Feature/Patient Fixation<br>Method: Clamp<br>component utilized for<br>patient fixation by<br>actuating jaw features to<br>clamp directly to spinous<br>process<br>Proximal Connection<br>Feature: PRA hub<br>component utilized for<br>fixation to Extension Arm<br>with Articulating Adapter<br>to facilitate connection to<br>Patient Reference Array.<br>Can also be attached<br>directly to Patient<br>Reference Array.<br>Radiographic markers used<br>specifically for fiducial<br>registration only | needed for navigated<br>surgery<br>Distal Connection<br>Feature/Patient Fixation<br>Method: Sharp pin<br>component utilized for<br>patient fixation by fixation<br>into pelvis<br>Proximal Connection<br>Feature: PRA hub<br>component utilized for<br>fixation to Extension Arm<br>with Articulating Adapter<br>to facilitate connection to<br>Patient Reference Array.<br>Can also be attached<br>directly to Patient<br>Reference Array<br>May or may not have<br>radiographic markers used<br>specifically for fiducial<br>registration only |
| Offered Lengths | Short and Long | Short and Long | Short and Long |
| Offered<br>Diameters | Various; compatible with<br>NuVasive Screw Systems | N/A | N/A |
| Registration<br>Compatibility | Non-fiducial Registration | Fiducial and Non-fiducial<br>Registration | Fiducial and Non-fiducial<br>Registration |
| Method of<br>Attachment | Inserted through NuVasive<br>screw systems | Clamps directly to spinous<br>process | Fixated into pelvis |
| Region of<br>Anatomy | Cervical, Thoracic and Lumbar<br>regions of the spine | Cervical, Thoracic and Lumbar<br>regions of the spine | Lumbar and Sacral regions of<br>the spine |
| Performance<br>Data/<br>Testing/Analysis | System Level Accuracy<br>Testing<br>Cadaver Verification<br>Design Validation<br>Tolerance Analysis<br>Usability Validation | System Level Accuracy<br>Testing<br>Cadaver Verification<br>Design Validation<br>Tolerance Analysis<br>Usability Validation | System Level Accuracy<br>Testing<br>Cadaver Verification<br>Design Validation<br>Tolerance Analysis<br>Usability Validation |
| Accessory<br>Instrumentation | Extension Arm which holds<br>Patient Reference Array | Extension Arm<br>with Articulating Adapter<br>and/or Patient Reference Array | Extension Arm<br>with Articulating Adapter<br>and/or Patient Reference Array |
| Sterilization | Non-sterile | Non-sterile | Sterile (EO) |

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Image /page/5/Picture/1 description: The image shows the logo for Nuvasive. The logo consists of a stylized leaf shape on the left, with the word "NUVASIVE" in gray letters to the right of the leaf. The leaf is split into two colors, with the top half being a dark purple and the bottom half being a light gray.

#### 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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Image /page/6/Picture/0 description: The image contains the logo for Nuvasive. The logo consists of a stylized leaf shape in purple and gray, followed by the word "NUVASIVE" in gray sans-serif font. The leaf shape is on the left side of the logo, and the word "NUVASIVE" is on the right.

- 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.