(88 days)
No
The summary describes a navigation system that uses tracking arrays and manual calibration with a navigation system (Medtronic StealthStation) to assist in locating anatomical structures based on pre-acquired images. There is no mention of AI or ML being used for image analysis, navigation, or any other function. The system relies on traditional navigation principles and manual calibration.
No
This device is intended to assist the surgeon during spinal procedures by providing navigation capabilities for instrument placement. It does not directly treat a disease or condition.
No.
The device is intended to assist surgeons in locating anatomical structures and guiding surgical instruments during spinal procedures by providing navigation capabilities relative to images. It does not perform diagnostic functions such as identifying or analyzing diseases or conditions.
No
The device description explicitly states that the SYMPHONY Navigation Ready Instruments are reusable instruments (hardware) and the Universal Navigation Adaptor Set contains a Navigation Ring ST (hardware). The system relies on the physical interaction of these hardware components with a navigation system and tracking arrays.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are surgical instruments designed to assist surgeons in locating anatomical structures and preparing for and inserting spinal implants during surgical procedures. They are used on the patient's body during surgery, not for testing samples outside the body.
- Intended Use: The intended use clearly states their purpose is to assist in surgical spinal procedures by providing navigation capabilities based on imaging data.
- Device Description: The description details the physical instruments (drills, trocar, probe, taps, screwdriver) and the adaptor set used to interface with a navigation system. This aligns with surgical tools, not diagnostic tests.
Therefore, this device falls under the category of surgical instruments or navigation systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SYMPHONY Navigation Ready Instruments:
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.
Product codes (comma separated list FDA assigned to the subject device)
OLO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, 2D fluoroscopic image or 3D fluoroscopic image reconstruction
Anatomical Site
Spinal, vertebrae, cervical and thoracic spine, pelvis
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical spinal procedures, open or percutaneous procedures
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data for the subject devices consists of the following evaluations:
- Accuracy Verification:
- Toggle Analysis (positional and angular deviation)
- Length Comparison to Reference Device
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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 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.
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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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:
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.
F. Indications for Use
SYMPHONY Navigation Ready Instruments:
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.
5
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.
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
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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.