The SYMPHONY Navigation Ready Instruments when used with the compatible Universal Navigation Adaptor Set are intended to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of SYMPHONY OCT System is indicated.

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set (UNAS) is intended for use with the compatible DePuy Synthes Navigation Ready Instruments to assist the surgeon in locating anatomical structures in either open or percutaneous procedures. These are indicated for use in surgical spinal procedures, in which:

· the use of stereotactic surgery may be appropriate, and

· reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer. These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.

Device Description

SYMPHONY Navigation Ready Instruments:

The SYMPHONY Navigation Ready Instruments are reusable instruments used for the preparation for and insertion of SYMPHONY OCT screws, in either open or percutaneous procedures. These instruments are designed for navigated and nonnavigated use. Navigation of these instruments is achieved using the DePuy Synthes Universal Navigation Adaptor Set (UNAS). For further details on UNAS, refer to the UNAS labeling.

Universal Navigation Adaptor Set:

The Universal Navigation Adaptor Set contains the Navigation Ring ST used to aid in determining the correct location and trajectory of spinal instruments and implants. The Navigation Ring ST has an interface between the Medtronic StealthStation® navigation system and the DePuy Synthes Navigation Ready Instruments.

The Navigation Ready Instruments include drills, trocar, probe, taps and screwdriver. When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Passive Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated with the Medtronic StealthStation navigation system.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set. The key aspects regarding acceptance criteria and supporting studies are extracted below.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Measure)	Reported Device Performance (Summary)
Accuracy Verification
Toggle Analysis (Positional Deviation)	Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence.
Toggle Analysis (Angular Deviation)	Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence.
Length Comparison to Reference Device	Not explicitly stated in quantitative terms but implied to meet performance for substantial equivalence.
Implant/Instrument Mating Conditions	Found to be acceptable.
Simulated Use Evaluation	Successful preparation of holes and screw insertion in sawbones model; final screw position compared favorably with post-operative scan and sawbones model.

Note: The document does not provide specific quantitative acceptance criteria or detailed numerical results for the performance tests. The conclusion of substantial equivalence implies that the device met the necessary performance standards to be considered safe and effective as its predicate.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of instruments, number of measurements) for the accuracy verification tests or the simulated use evaluation.
The data provenance for the test set (e.g., country of origin, retrospective/prospective) is not explicitly stated. However, given it's a pre-market notification for a medical device seeking FDA clearance, the testing would typically be conducted under controlled laboratory conditions rather than using patient data. The simulated use evaluation used "sawbones models," which are synthetic bone models, indicating a prospective, lab-based study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for the test set. The accuracy verification likely relied on engineering measurements against known specifications, and the simulated use evaluation would have been assessed by engineering and potentially clinical staff involved in the study.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication for establishing ground truth is not mentioned as part of the performance data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. The document describes a technical and simulated use evaluation rather than a clinical study involving human readers or a comparison of human performance with and without AI assistance. The device is a surgical instrument set, not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The "performance data" sections (Accuracy Verification, Implant/instrument mating, Simulated Use Evaluation) represent the standalone performance of the device (instruments and adaptor set) in conjunction with a navigation system. It's not an algorithm in the AI sense, but rather the functional performance of the hardware. The simulated use evaluation specifically describes the device, when manually calibrated with the Medtronic StealthStation navigation system, being used to prepare holes and insert screws, and the final screw position was compared to a post-operative scan and sawbones model. This assesses the system's ability to guide the surgeon accurately.

7. The Type of Ground Truth Used

Accuracy Verification: The ground truth for accuracy (positional, angular, length) would likely be based on engineering specifications, calibrated measurement devices, or a statistically reliable "true" value derived from multiple precise measurements.
Simulated Use Evaluation: The ground truth for the simulated use was based on:
- The "final screw position in the software" (from the Medtronic StealthStation navigation system).
- Comparison with a "post-operative scan" of the sawbones model.
- Comparison with the "sawbones model" itself.
  This implies a comparison against the intended surgical plan or ideal placement within the physical model.

8. The Sample Size for the Training Set

Not applicable. This device is a set of physical surgical instruments and an adaptor, not an AI or machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

Summary

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October 18, 2019

Medos International, SARL % Daria Bochenek Senior Regulatory Affairs Specialist DePuy Synthes Spine Eimattstrasse 3 Oberdorf, 4436 CH

Re: K191943

Trade/Device Name: SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 19, 2019 Received: July 22, 2019

Dear Daria Bochenek:

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,

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191943

Device Name

SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set

Indications for Use (Describe)

SYMPHONY Navigation Ready Instruments:

· the use of SYMPHONY OCT System is indicated.

· the use of stereotactic surgery may be appropriate, and

These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

· the use of stereotactic surgery may be appropriate, and

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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K191943 510(k)Summary

Submitter Information A. Medos International, SARL 510(k) Sponsor: Daria Bochenek, Senior Regulatory Affairs Contact Person: Specialist Eimattstrasse 3 4436 Oberdorf Switzerland Telephone: +41 61 965 61 54 Fax: +41 61 965 66 16 Email: dbochene@its.jnj.com B. Date Prepared July 19, 2019 C. Device Name SYMPHONYTM Navigation Ready Trade/Proprietary Name: Instruments and Universal Navigation Adaptor Set Common/Usual Name: Orthopedic stereotaxic instrument Device Classification and Class II per 21 CFR § 882.4560 Regulation: Classification Product and OLO; Orthopedic Panel Code: D. Predicate Device Names Primary Predicate Device: Synthes Navigable Pedicle Preparation (NPP) Instruments (K122211) Reference Device:

Medtronic StealthStation® System (K133444)

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E. Device Description

SYMPHONY Navigation Ready Instruments:

Universal Navigation Adaptor Set:

F. Indications for Use

SYMPHONY Navigation Ready Instruments:

the use of SYMPHONY OCT System is indicated, ●
the use of stereotactic surgery may be appropriate, and .
reference to a rigid anatomical structure, such as a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

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These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments require manual calibration with the Medtronic StealthStation navigation system.

The SYMPHONY Navigation Ready Instruments are intended to support cervical and thoracic polyaxial screw placement.

Universal Navigation Adaptor Set:

the use of stereotactic surgery may be appropriate, and ●
. reference to a rigid anatomical structure, such as the pelvis or a vertebrae 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 using a navigation system which includes tracking arrays supplied by the navigation system manufacturer.

These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, requires manual calibration with the Medtronic StealthStation navigation system.

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

The technological characteristics, including material, design and performance as well as intended use of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are consistent with those of the predicate device.

H. Materials

The subject devices are manufactured from stainless steel, anodized aluminum and silicone rubber.

I. Performance Data

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

. Accuracy Verification:
- o Toggle Analysis (positional and angular deviation)
- o Length Comparison to Reference Device

K191943

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Implant/instrument mating conditions ●
. Simulated Use Evaluation. SYMPHONY Navigation Ready Instruments were assembled with UNAS and with the Medtronic tracking arrays, manually calibrated and navigated. As a result, holes in pedicles and lateral masses of cervical and thoracic spine were prepared and SYMPHONY screws were inserted in a sawbones model. Final screw position in the software was compared with post-operative scan and sawbones model.

J. Conclusion

The indications for use of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are consistent with those of the predicate devices. The technological characteristics of the SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set in terms of design, materials and performance are consistent with those of the predicate device. The SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are substantially equivalent to the predicate device.

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).