(29 days)
The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab Navigation System.
The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.
The provided document is a 510(k) Premarket Notification from the FDA regarding the Virage® Navigation System. It primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about a comprehensive clinical study in the format requested.
Here's a breakdown of the information that can be extracted or inferred from the provided text, along with what is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Positional Accuracy Met | "positional accuracy...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Usability Met | "usability...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Tolerance Analysis Met | "tolerance analysis...all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays." |
| Packaging Effectiveness | "packaging...evaluated to determine no risks were introduced to the system." |
| Sterilization Effectiveness | "sterilization...evaluated to determine no risks were introduced to the system." |
| Automated Cleaning Safety | "Automated cleaning instructions were reviewed and adopted by the Virage Navigation System, but no risks were introduced to the system." |
| Biocompatibility (new arrays) | "The new reference arrays are non-patient contacting and are composed of stainless-steel (array body) and aluminum (array holder), and both materials were evaluated per ISO 10993-1. Since the device materials have neither direct nor indirect contact with the body, additional biocompatibility information is not necessary." (Implies acceptance criteria met for material safety.) |
| Risk Assessment (overall) | "A risk assessment was conducted that found risks have been reduced as far as possible and concluded that the benefits associated with spine surgery and the use of the Brainlab Navigation System with the Virage® Navigation System outweigh the risks related to polyaxial screw placement." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "verification and validation activities" but does not detail the sample sizes for these tests, nor the data provenance. These are typically included in the full 510(k) submission, but not in this summary letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document mentions "usability" but doesn't specify if experts were involved in establishing ground truth for any performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device in question is a navigation system for surgical procedures, not an AI diagnostic tool that human readers would interpret. The goal is to assist surgeons, not necessarily "improve human readers." The study described is a performance assessment of the navigation system itself.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The studies mentioned ("positional accuracy, usability, and tolerance analysis") appear to be evaluating the device performance, which is inherently a "standalone" evaluation of its mechanical and computational capabilities. However, these are not directly comparable to "algorithm only" performance for AI diagnostic tools. The device's function is to assist in surgical navigation, which implies it is always with a human in the loop during actual use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document mentions "positional accuracy." For this, the ground truth would likely be established through precise measurements using calibrated instruments or imaging techniques to determine the true position relative to the navigated object. However, the specific method of establishing this ground truth is not detailed. For "usability," the ground truth would be user feedback and observation against predefined tasks.
8. The sample size for the training set
This information is not provided in the document. The Virage® Navigation System, as described, is a mechanical and software-based navigation tool, not an AI/ML-driven diagnostic device that typically undergoes a separate "training set" for model development. The "training" for such systems would involve software development and testing rather than data-driven machine learning model training.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML model, this information is not applicable as per the provided document. If there are underlying algorithms that use data to improve, those details are not present here.
In summary:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It confirms that the device met specified acceptance criteria for various performance aspects (positional accuracy, usability, tolerance analysis, packaging, sterilization, cleaning, and material biocompatibility). However, it does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in a clinical study report for an AI/ML diagnostic device. The device itself is a surgical navigation system, not a diagnostic AI.
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April 5, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
ZimVie Spine (Zimmer Biomet Spine, Inc.) Anjanet Mort Regulatory Affairs Manager 10225 Westmoor Drive Westminster, Colorado 80021
Re: K240647
Trade/Device Name: Virage® Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: March 6, 2024 Received: March 7, 2024
Dear Anjanet Mort:
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).
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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 820.30 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali -S
Shumava 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
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Indications for Use
Submission Number (if known)
Device Name
Virage® Navigation System
Indications for Use (Describe)
The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virace Navigation instruments can be used with the Medtronic StealthStation ® S7. When used with the ZimVie reference arrays, the Virage Navigation instruments can be used with the Brainlab 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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Image /page/3/Picture/1 description: The image shows the logo for ZimVie. The logo consists of a circular icon on the left and the word "ZimVie" on the right. The circular icon is divided into four quadrants, with the top left and bottom right quadrants being light blue and the other two being dark blue. The word "ZimVie" is written in a dark blue sans-serif font.
3/6/2024
510(k) Summary
Sponsor Information
| Name | Zimmer Biomet Spine, Inc. (d/b/a ZimVie Spine) | |
|---|---|---|
| Address | 10225 Westmoor Dr.Westminster, CO 80021 | |
| Establishment Registration | 3012447612 | |
| Primary Contact Person(s) | Regan ReamRegulatory Affairs Associate | Phone: (720) 227-2187Email : Regan.Ream@zimvie.com |
| Anjanet MortRegulatory Affairs Manager | Phone: (720) 839-7926Email: Anjanet.Mort2@zimvie.com |
| Device Information | |
|---|---|
| Proprietary Name | Virage® Navigation System |
| Common Name | Stereotaxic Instruments |
| Device Class | Class II |
| Device Panel | Orthopedic Panel (87) |
| Regulation Number | 21 CFR § 882.4560 |
| Classification Name-Product Code(s) | Orthopedic Stereotaxic Instrument (OLO) |
| Predicate Devices | Primary Predicate: Virage® Navigation System(K212023) |
| Reference Devices | Reference Device #1Medtronic StealthStation S7(K133444) |
| Reference Device #2Brainlab Navigation System(K212245) |
Device Description
The Virage® Navigation System is comprised of nonsterile, reusable instruments including drills, taps, and drivers that can be operated manually and/or under a power surgical technique to prepare for and insert Virage OCT polyaxial screws. The Virage Navigation System instruments are designed for use with either the Medtronic StealthStation S7 or the Brainlab Spine & Trauma Navigation software (version 2.0 and higher). The ZimVie reference arrays can only be used with the Brainlab Spine & Trauma Navigation System. The Virage Navigation System is also compatible with the Zimmer Biomet Universal Power System.
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Image /page/4/Picture/1 description: The image shows the logo for ZimVie. The logo consists of a circular icon on the left and the word "ZimVie" on the right. The icon is a circle divided into four sections, with two sections in a light blue color and two sections in a dark blue color. The word "ZimVie" is written in a dark blue, sans-serif font.
Intended Use / Indications for Use
The Virage Navigation System instruments are to be used during the preparation and placement of Virage® OCT polyaxial screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in open procedures. When used with the Medtronic NavLock arrays, the Virage Navigation instruments can be used with the Medtronic StealthStation® S7. When used with the ZimVie reference arravs, the Virage Navigation instruments can be used with the Brainlab Navigation System.
Substantial Equivalence Assessment
The technological characteristics (the intended use, scientific technology and design, performance assessment, and operational principles) of the subject Virage® Navigation System components remain the same as, or similar to, the predicate Virage® Navigation System (K212023) or the reference Brainlab Navigation Systems (K212245).
The only modification to the indications for use was to add the option of using the Brainlab Navigation System with the Virage® Navigation System instruments through the newly developed reference arrays. The subject of the submission introduced new arrays to support the Brainlab Navigation System. introducing a new material (7075-T6 aluminum), but the device remains biocompatible and within the risk profile of the Virage® Navigation System. The submission also details the adoption of automated cleaning instructions, but the automated cleaning instructions do not introduce any new risks to the Virage® Navigation System.
Performance Testing Conclusion
The following verification and validation activities were performed: positional accuracy, usability, and tolerance analysis, which all met the acceptance criteria when the Virage Navigation instruments were attached to the ZimVie reference arrays. Additionally, packaging and sterilization were evaluated to determine no risks were introduced to the system. Automated cleaning instructions were reviewed and adopted by the Virage Navigation System, but no risks were introduced to the system. The new reference arrays are non-patient contacting and are composed of stainless-steel (array body) and aluminum (array holder), and both materials were evaluated per ISO 10993-1. Since the device materials have neither direct nor indirect contact with the body, additional biocompatibility information is not necessary.
A risk assessment was conducted that found risks have been reduced as far as possible and concluded that the benefits associated with spine surgery and the use of the Brainlab Navigation System with the Virage® Navigation System outweigh the risks related to polyaxial screw placement.
§ 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).