CROSSNAV Navigation Enabled Instruments

K233255 · DePuy Synthes · OLO · Jun 17, 2024 · Neurology

Device Facts

• Record ID: K233255
• Device Name: CROSSNAV Navigation Enabled Instruments
• Applicant: DePuy Synthes
• Product Code: OLO · Neurology
• Decision Date: Jun 17, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which: • the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated, - · the use of stereotactic surgery may be appropriate, and · reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy. These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System. The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Device Story

Reusable orthopedic instruments (drills, taps, screwdrivers) used in spinal surgery; facilitate preparation and placement of DePuy Synthes screws. Operated manually or via power systems (DePuy Synthes or Medtronic IPC POWEREASE). Instruments feature tracking arrays for use with VELYS Spine System or Medtronic StealthStation navigation. Surgeon uses navigation system to track instrument position relative to patient anatomy (CT/MR/fluoroscopy) to assist in precise screw placement. CROSSNAV Adaptor enables compatibility with VELYS Spine System. Benefits include improved surgical accuracy in open or percutaneous spinal procedures.

Clinical Evidence

No clinical data. Performance evaluated via bench testing: accuracy verification, fulfillment of navigation system instrument accuracy requirements, CAD model evaluation, and simulated use evaluation.

Technological Characteristics

Reusable instruments made of stainless steel and titanium alloys (Ti-6Al-4V). Coatings include AlTiN, TiN, and Tungsten Carbide. Includes drills, taps, and screwdrivers. Compatible with VELYS Spine System and Medtronic StealthStation via tracking arrays. Manual or power-driven operation.

Indications for Use

Indicated for patients undergoing spinal surgery (e.g., spinal fusion) requiring preparation and placement of DePuy Synthes screws where stereotactic surgery is appropriate and anatomical structures can be referenced to imaging (CT, MR, 2D/3D fluoroscopy) or anatomical models. Compatible with specific DePuy Synthes systems (EXPEDIUM, VIPER, SYMPHONY OCT, TriALTIS) and navigation platforms (VELYS Spine System, Medtronic StealthStation).

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

• Navigation Enabled Instruments (K200791)
• TriALTIS Navigation Enabled Instruments (K231527)

Submission Summary (Full Text)

{0}------------------------------------------------

June 14, 2024

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right is the FDA (U.S. Food & Drug Administration) logo, with the letters "FDA" in a blue square and the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text to the right of the square.

Depuy Synthes Daniel Meyer Regulatory Affairs Manager Eimattstrasse 3 Oberdorf, 4436 Switzerland

## Re: K233255

Trade/Device Name: CROSSNAV Navigation Enabled Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 12, 2023 Received: June 10, 2024

## Dear Daniel Meyer:

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.

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).

{1}------------------------------------------------

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 820.70) 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 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-reportingcombination-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.

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-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,

Image /page/1/Picture/6 description: The image shows a digital signature. The signature is from Jesse Muir. The date of the signature is 2024.06.17 and the time is 10:48:44 -04'00'.

For 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

{2}------------------------------------------------

## Indications for Use

Submission Number (if known)

K233255

Device Name

CROSSNAV Navigation Enabled Instruments

Indications for Use (Describe)

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

• the use of EXPEDIUM, VIPER, SYMPHONY OCT and the TriALTIS Spine System is indicated,

- · the use of stereotactic surgery may be appropriate, and
· reference to a rigid anatomical structure, such as the pelvis or a vertebra can be identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

Type of Use (Select one or both, as applicable)

X 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary

| A. | Submitter Information | |
|----|--------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| | 510(k) Sponsor: | Medos International, SARL |
| | Contact Person: | Daniel Meyer<br>Regulatory Affairs Manager<br>Eimattstrasse 3<br>4436 Oberdorf BL<br>Switzerland |
| | Telephone: | [phone] |
| | Email: | [e-mail] |
| B. | Date Prepared | 12 October 2023 |
| C. | Device Name | |
| | Trade/Proprietary Name: | CROSSNAV Navigation Enabled Instruments |
| | Common/Usual Name: | Orthopedic Stereotaxic Instrument |
| | Device Classification and<br>Regulation: | Class II<br>OLO – 21 CFR §882.4560 |
| | Classification Product and<br>Panel Code | OLO – Neurology |
| D. | Predicate Device Names | |
| | Primary Predicate Device: | |
| | Navigation Enabled Instruments (K200791) – OLO | |
| | Additional Predicate Device: | |
| | TriALTIS Navigation Enabled Instruments (K231527) -OLO | |

{4}------------------------------------------------

#### E. Device Description

Navigation Enabled Instruments are reusable instruments used for the preparation and placement of DePuy Synthes EXPEDIUM™, VIPER™, SYMPHONY™ OCT and TriALTISTM screws, in either open or percutaneous procedures. The Navigation Enabled Instruments include drills, taps and screwdrivers and can be operated manually or under power. These instruments are designed for navigated and non-navigated use. Navigation Enabled Instruments also include the CROSSNAV™ Adaptor to facilitate navigation of the Navigation Enabled Instruments with the VELYS Spine System. Navigation of these instruments is achieved using the VELYS Robotic-Assisted Solution for Spine as well as the Medtronic StealthStation navigation system and associated tracking arrays.

#### Indications for Use F.

Navigation Enabled Instruments are reusable instruments indicated to be used during the preparation and placement of DePuy Synthes screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or percutaneous procedures. The Navigation Enabled Instruments are designed for use with only the specific DePuy Synthes implant system(s) for which they are indicated; and with the VELYS Spine System as well as the with the Medtronic StealthStation® System. The Navigation Enabled Instruments are indicated for use in surgical spinal procedures, in which:

- the use of EXPEDIUM™, VIPER™, SYMPHONY™ OCT and the TriALTISTM Spine . System is indicated,
- . the use of stereotactic surgery may be appropriate, and
- reference to a rigid anatomical structure, such as the pelvis or a vertebra can be . identified relative to the acquired image (CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction) and/or an image data based model of the anatomy.

These procedures include but are not limited to spinal fusion. The Navigation Enabled Instruments are also compatible with DePuy Synthes Power Systems and the Medtronic IPC® POWEREASE System.

The Navigation Enabled Instruments used in conjunction with the SYMPHONY OCT System are intended to support indicated cervical and thoracic polyaxial screw placement only.

### Summary of Similarities and Differences in Technological Characteristics, G. Performance, and Intended Use

The technological characteristics, including design, material and performance as well as intended use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices.

{5}------------------------------------------------

Compared to the predicate devices, the subject devices expand the scope of the Navigation Enabled Instruments for compatibility with an additional Navigation System, the VELYS Spine System. Similarly to predicate devices, CROSSNAV Navigation Enabled Instruments include drills, taps and screwdrivers and are indicated for use when implanting DePuy Synthes screws. This does not raise new questions of safety and effectiveness based on application of recognized consensus standards and design controls.

#### H. Materials

The subject devices are manufactured from stainless steel alloys and titanium alloys (Ti-6Al-4V). Several of the devices have coatings including AlTiN (Aluminum Titanium Nitride Coating), TiN (Titanium Nitride Coating) and Tungsten Carbide coating.

#### I. Performance Data

The performance data for the subject devices consists of the following evaluations:

- . Accuracy Verification through engineering analysis,
- Fulfillment of navigation systems instrument accuracy requirements as stated by . the navigation manufacturer,
- . CAD Model Evaluation,
- . Simulated Use Evaluation.

#### J. Conclusion

The indications for use of the CROSSNAV Navigation Enabled Instruments are consistent with those of the predicate devices. The technological characteristics of the CROSSNAV Navigation Enabled Instruments in terms of design, materials and performance are consistent with those of the predicate devices. The CROSSNAV Navigation Enabled Instruments are substantially equivalent to the predicate devices.