(90 days)
Not Found
No
The summary describes a navigation system that uses tracking arrays and pre- or manual calibration with existing navigation systems (Brainlab, Medtronic StealthStation) to assist in locating anatomical structures based on acquired images or image data models. There is no mention of AI or ML being used for image analysis, data processing, or decision support. The performance studies focus on accuracy verification, instrument compatibility, and simulated use, not on the performance of an AI/ML algorithm.
No
The device is described as "Navigation Ready Instruments" and a "Universal Navigation Adaptor Set" intended to assist surgeons in locating anatomical structures during spinal procedures. It does not exert a therapeutic effect but rather aids in the precise execution of surgical interventions.
No
The device is intended to assist surgeons in locating anatomical structures and determining the correct trajectory of spinal instruments and implants during surgical procedures. It is a surgical aid, not a device used to diagnose a medical condition.
No
The device description explicitly details physical components like "reusable instruments," "Navigation Arrays," and "Navigation Rings," which are hardware. The software component is the navigation system itself (Brainlab or Medtronic StealthStation), which is a separate, third-party device that interfaces with these physical instruments.
Based on the provided text, 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, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are surgical instruments used during spinal procedures to assist the surgeon in locating anatomical structures. They interact directly with the patient's body during surgery, not with specimens taken from the body.
- Intended Use: The intended use clearly states their purpose is to assist the surgeon in locating anatomical structures in open or percutaneous procedures, specifically in surgical spinal procedures. This is an in-vivo application.
The device is a surgical navigation instrument system, which is a different category of medical device than an IVD.
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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew 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 vertebrac can be identified relative to the aquired 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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
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 (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:
- Brainlab compatible UNAS Navigation Arrays, ●
- Brainlab compatible Navigation Ring and ●
- Medtronic compatible Navigation Ring ST. ●
The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.
When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.
When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only 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
Spine, cervical, thoracic, pelvis, vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, surgical spinal 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: ●
- o Fulfillment of navigation systems instrument accuracy requirements
- Instrument Length Comparison to Predicate Device O
- Array Characteristics Comparison to Predicate Device O
- Confirmation of Array Recognition by Brainlab Navigation System о
- Implant/instrument mating conditions ●
- Navigation Connection Repeatability for Pre-Calibrated Instruments ●
- CAD Model Evaluation ●
- Simulated Use Evaluation ●
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.
SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set (K191943), Synthes Navigable Pedicle Preparation (NPP) Instruments (K122211), Brainlab Spine & Trauma Navigation (K183605)
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.
Not Found
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
September 16, 2020
Medos International, SARL % Nicole Aeschbacher Regulatory Affairs Specialist DePuy Synthes Spine Eimattstrasse 3 Oberdorf, CH-BL 4436 Switzerland
Re: K201661
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: June 17, 2020 Received: June 18, 2020
Dear Nicole Aeschbacher:
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.
1
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 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 medical devices and radiation-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, 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
2
Indications for Use
510(k) Number (if known) K201661
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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated cervical and thoracic polyaxial sorew 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 vertebrac can be identified relative to the aquired 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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navieation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
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.
3
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510(k) Summary
| A. | Submitter Information | |
|---|---|---|
| 510(k) Sponsor: | Medos International, SARL | |
| Contact Person: | Nicole Aeschbacher, Regulatory Affairs | |
| Specialist | ||
| Eimattstrasse 3 | ||
| 4436 Oberdorf | ||
| Switzerland | ||
| Telephone: | +41 61 965 61 18 | |
| Fax: | +41 61 965 66 16 | |
| Email: | naeschba@its.jnj.com | |
| B. | Date Prepared | June 17, 2020 |
| C. | Device Name | |
| Trade/Proprietary Name: | SYMPHONYTM Navigation Ready | |
| Instruments and Universal Navigation | ||
| Adaptor Set | ||
| Common/Usual Name: | Orthopedic stereotaxic instrument | |
| Device Classification and | ||
| Regulation: | Class II per 21 CFR § 882.4560 | |
| Classification Product and | ||
| Panel Code: | OLO; Orthopedic | |
| D. | Predicate Device Names | |
| Primary Predicate Device: |
SYMPHONY™ Navigation Ready Instruments and Universal Navigation Adaptor Set (K191943)
Additional Predicate Devices:
Synthes Navigable Pedicle Preparation (NPP) Instruments (K122211)
Brainlab Spine & Trauma Navigation (K183605)
5
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 (UNAS) contains reusable spine surgical instruments used to aid in determining the correct location and trajectory of spinal instruments and implants. The UNAS has an interface between third-party navigation systems and the DePuy Synthes Navigation Ready Instruments. The UNAS can only be used with Brainlab and Medtronic StealthStation® navigation systems. The UNAS includes:
- Brainlab compatible UNAS Navigation Arrays, ●
- Brainlab compatible Navigation Ring and ●
- Medtronic compatible Navigation Ring ST. ●
The Navigation Ring and Navigation Ring ST mates with compatible DePuy Synthes Navigation Ready Instruments. These instruments include drill guides, probe, taps and screwdrivers. Drills and trocar are indirectly navigable through the drill guide.
When the Brainlab compatible Navigation Ring is attached to the Navigation Ready Instrument, a UNAS Navigation Array can be attached and the instrument can be used only with the Brainlab Navigation System as either a manually calibrated or pre-calibrated instrument.
When the Navigation Ring ST is attached to the Navigation Ready Instrument, a Medtronic SureTrak® II Universal Tracker Fighter array (SureTrak II array) can be attached, and the instrument can be manually calibrated only with the Medtronic StealthStation navigation system.
F. Indications for Use
SYMPHONY Navigation Ready Instruments:
6
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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The SYMPHONY Navigation Ready Instruments can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
The SYMPHONY Navigation Ready Instruments are intended to support indicated 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 and associated tracking arrays.
These procedures include but are not limited to spinal fusion. The DePuy Synthes Navigation Ready Instrument, when used with UNAS, can be pre-calibrated and/or manually calibrated with the Brainlab Navigation System, where other navigation systems require manual calibration and tracking arrays supplied by the navigation system manufacturer.
Summary of Similarities and Differences in Technological Characteristics, G. Performance, and Intended Use
7
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 devices.
H. Materials
The subject devices are manufactured from stainless steel, titanium alloy (Ti-6Al-4V), anodized aluminum, TiN (Titanium Nitride Coating), TiAlN (Titanium Aluminum Nitride Coating), RADEL and silicone rubber.
I. Performance Data
The performance data for the subject devices consists of the following evaluations:
- Accuracy Verification: ●
- o Fulfillment of navigation systems instrument accuracy requirements
- Instrument Length Comparison to Predicate Device O
- Array Characteristics Comparison to Predicate Device O
- Confirmation of Array Recognition by Brainlab Navigation System о
- Implant/instrument mating conditions ●
- Navigation Connection Repeatability for Pre-Calibrated Instruments ●
- CAD Model Evaluation ●
- Simulated Use Evaluation ●
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 devices. The SYMPHONY Navigation Ready Instruments and Universal Navigation Adaptor Set are substantially equivalent to the predicate devices.