(158 days)
Not Found
No
The summary describes a navigation system that uses imaging modalities and digitized landmarks for surgical guidance, but there is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device components are surgical instruments used for guiding placement of screws, not directly treating a medical condition.
No
This device is described as surgical navigation instrumentation designed to assist surgeons in precisely locating anatomical structures for screw placement during spinal surgery. It provides real-time visualization and confirms hardware placement. It is an intraoperative guidance tool, not a diagnostic device that identifies or characterizes a medical condition.
No
The device description explicitly states that the Vital Navigation System is comprised of "nonsterile, reusable instruments including awls, probes, taps, and drivers," which are physical hardware components. While it is used in conjunction with a navigation system (which likely includes software), the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the instruments are used during spinal surgery to assist the surgeon in precisely locating anatomical structures and preparing for and placing screws. This is an in vivo application, meaning it's used within a living organism during a surgical procedure.
- Device Description: The description reinforces this by detailing the instruments (awls, probes, taps, drivers) used in conjunction with a navigation system during surgery.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a surgical navigation system and associated instruments, which falls under the category of surgical devices used to guide procedures within the body.
N/A
Intended Use / Indications for Use
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Product codes
OLO
Device Description
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Spinal, vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / spinal surgery
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)
To support substantial equivalence, accuracy testing of the stereotactic instruments of the subject Vital Navigation System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that the use of the proposed stereotactic instruments for the implantation of Vital and Vitality screws are safe and effective for use. Performance testing included tests per ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. In all instances, the proposed instrument system functioned as intended and demonstrated substantial equivalence to the predicate device(s).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
December 2, 2019
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is the Department of Health & Human Services logo. The right side of the logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Zimmer Biomet Spine, Inc. Alex Pawlowski Regulatory Affairs Senior Specialist 10225 Westminster Drive Westminster, Colorado 80021
Re: K191722
Trade/Device Name: Vital Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: October 31, 2019 Received: November 1, 2019
Dear Alex Pawlowski:
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, 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) K191722
Device Name Vital Navigation System
Indications for Use (Describe)
Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for 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 contains the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color.
K191722
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date | June 26, 2019 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Alex Pawlowski |
| Regulatory Affairs Senior Specialist | |
| Phone: 303-533-1062 | |
| Fax: 303-501-8444 | |
| Alternate Contact | Ted Kuhn |
| Regulatory Affairs Associate Director | |
| Phone: 720-469-5055 | |
| Fax: 303-501-8444 | |
| Trade Name | Vital Navigation System |
| Common Name | Stereotaxic Instrument |
| Device Class | Class II |
| Classification Name | OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560) |
Device Description & Technological Characteristics:
Orthopedic
The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement.
Device Panel
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Image /page/4/Picture/1 description: The image shows the logo for Zimmer Biomet. The logo consists of a blue circle with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The text is in a dark gray color, contrasting with the white background.
Intended Use / Indications for Use:
Vital Navigation System Instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation System Instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.
Summary of Technological Characteristics:
The technological characteristics of the subject Vital Navigation System components remain the same as, or similar to, the predicate Orthofix Navigated Instrument System (K172115) in regards to intended use, indications for use, design, manufacturing methods, fundamental technology, and operational principles. The purpose of this submission is to seek clearance for the release of stereotactic instruments for the implantation of Vital and Vitality screws, which utilize the existing Medtronic StealthStation system.
Summary of Performance Data:
To support substantial equivalence, accuracy testing of the stereotactic instruments of the subject Vital Navigation System were assessed and tested appropriately in accordance with ASTM standards. The assessment concluded that the use of the proposed stereotactic instruments for the implantation of Vital and Vitality screws are safe and effective for use. Performance testing included tests per ASTM F2554-18 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems. In all instances, the proposed instrument system functioned as intended and demonstrated substantial equivalence to the predicate device(s).
Predicate Devices:
Primary Predicate: Orthofix Navigated Instrument System (K172115)
Additional Predicates: Medtronic StealthStation (K140454)
Substantial Equivalence Conclusion:
The Vital Navigation System is substantially equivalent to the predicate system as a spinal fixation device in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, accuracy testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components to the Navigated Instrument System which has been cleared for stereotactic guidance during orthopedic surgery procedures. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.