Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a surgical instrument (Rod Registration Frame) used with a computer-assisted navigation system. While the system itself might utilize advanced algorithms, the description of the specific device being cleared focuses on its mechanical function as patient reference hardware and its substantial equivalence to a predicate device, with no mention of AI or ML in its design or function.

Therapeutic

No.
The device is a surgical instrument and patient reference hardware designed for use with a computer-assisted navigation system to aid in spinal surgical procedures, providing a reference to anatomical structures rather than directly treating a disease or condition.

Diagnostic

No

The device is a surgical instrument and patient reference hardware for computer-assisted navigation during spinal surgical procedures. Its function is to provide a reference to an anatomical structure for navigation, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is "patient reference hardware" and describes physical components ("Rod Registration Frame") designed to attach to the patient. It also mentions "verification and validation testing performed using well established and previously cleared test methods" which are typical for hardware devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for use with a computer-assisted navigation system for spinal surgical procedures. This is an in-vivo application, meaning it's used directly on or within a living patient during surgery.
Device Description: The description reinforces its use as patient reference hardware for attaching a reference array to the patient during surgery.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information for diagnosis, monitoring, or treatment.

IVD devices are specifically designed to perform tests on samples taken from the human body in vitro (outside the body). This device is a surgical instrument used in vivo (within the body) to aid in navigation during surgery.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

OLO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cervical, Thoracic and Lumbar regions of the spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

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
Cadaver Verification
Design Validation
Tolerance Analysis
Usability Validation

No clinical studies were conducted.

Key Metrics

Not Found

Predicate Device(s)

K210574

Reference Device(s)

K210574

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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)

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)
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/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: (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

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