(233 days)
No
The summary does not mention AI or ML, and the device description focuses on mechanical adaptors for navigation systems.
No.
This system is an accessory used for navigation during spinal surgery to assist in precisely locating anatomical structures and facilitating screw insertion, rather than directly treating a disease or condition.
No
Explanation: The device is described as a surgical navigation system that assists surgeons in precisely locating anatomical structures and preparing for screw insertion during spinal surgery. It is a tool for surgical assistance, not for diagnosing medical conditions.
No
The device description explicitly states that the system "includes Universal Adaptors" and is used with "instrumentation" from other systems, indicating the presence of hardware components. The validation activities also focus on "instruments" and "Universal Navigation System Instruments," further confirming it is not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Zimmer Biomet Universal Navigation System is a surgical navigation system used during surgery to assist the surgeon in precisely locating anatomical structures and guiding the insertion of screws. It interacts directly with the patient's anatomy during a surgical procedure, not with samples taken from the body.
- Intended Use: The intended use clearly describes its role in assisting surgical procedures, not in analyzing biological samples.
- Device Description: The description focuses on the instruments and their use in conjunction with other surgical systems.
- Input: The input is imaging data (CT, MR, fluoroscopy, digitized landmarks) of the patient's anatomy, not biological samples.
Therefore, the Zimmer Biomet Universal Navigation System falls under the category of a surgical navigation system, which is a type of medical device used in vivo (within the living body), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors 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 skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Product codes
OLO
Device Description
The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Anatomical Site
rigid anatomical structure, such as a skull, a long bone or vertebra (from Indications for Use from Cover Letter)
pelvis or vertebra (from Indications for Use from 510(k) Summary)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Validation activities are used to confirm the instruments meet performance requirements, providing assurance of device performance for their intended use, similar to predicate systems. Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance with ASTM F24554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Clinical data was not needed for the Zimmer Biomet Universal Navigation System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K132884, K151974, K171907, K172275
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
October 24, 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: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The logo is simple and professional, reflecting the agency's role in protecting public health.
Zimmer Biomet Spine, Inc. Alex Pawlowski Regulatory Affairs Senior Specialist 10225 Westmoor Drive Westminster, Colorado 80021
Re: K190556
Trade/Device Name: Zimmer Biomet Universal Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: July 26, 2019 Received: July 29, 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/cfpmp/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 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
1
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 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,
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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Indications for Use
510(k) Number (if known) K190556
Device Name Zimmer Biomet Universal Navigation System
Indications for Use (Describe)
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These adaptors 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 skull, a long bone or vertebra can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of 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 shows the logo for Zimmer Biomet. The logo consists of a circular icon with a stylized "Z" inside, followed by the text "ZIMMER BIOMET" in a sans-serif font. The icon and text are in a matching color, which appears to be a shade of blue.
K190556
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 | July 26, 2019 |
|---|---|
| Applicant/Sponsor | Zimmer Biomet Spine, Inc. |
| 10225 Westmoor Dr. | |
| Westminster, CO 80021 | |
| Contact Person | Alex Pawlowski |
| Regulatory Affairs Senior Specialist | |
| Phone: 303-553-1062 |
Ted Kuhn
Regulatory Affairs Associate Director
Phone: 303-501-8549 |
| Trade Name | Zimmer Biomet Universal Navigation System |
| Common Name | Stereotaxic Instrument |
| Device Class | Class II |
| Classification Name | OLO - Orthopedic Stereotaxic Instrument (21 CFR 882.4560) |
| Device Panel | Orthopedic |
| Primary Predicate | K122211 Synthes Navigable Pedicle Preparation Instruments |
| Secondary Predicate | K133444 Medtronic StealthStation |
| Reference Devices | K132884 Pathfinder NXT Spine System
K151974 Polaris Spinal Fixation System
K171907 Vitality Spinal Fixation System
K172275 Vitality+ Power Instrument System, Vitality Spinal Fixation
System |
4
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 words "ZIMMER BIOMET" in a simple, sans-serif font. The text is in a dark gray or black color, providing a clear contrast against a white background.
Device Description & Technological Characteristics:
The Zimmer Biomet Universal Navigation System includes Universal Adaptors that are intended to be used with instrumentation from Vitality Spinal Fixation System (including Vital Power Instrument System), Pathfinder NXT Minimally Invasive Pedicle Screw System, and Polaris Spinal Fixation System (including Cypher MIS Screw System) to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Intended Use / Indications for Use:
The Zimmer Biomet Universal Navigation System is indicated for use during the preparation and insertion of Zimmer Biomet screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The universal adaptors 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 pelvis or vertebra, can be identified relative to an acquired image: CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
Summary of Technological Characteristics:
The technological characteristics of the subject Zimmer Biomet Universal Navigation System components remain the same as, or similar to, the predicates in regards to intended use, indications for use, design, manufacturing methods, materials, and operational principles. The purpose of this submission is to seek clearance to introduce new adaptors designed to interface with the already-Cleared surgical navigation system, Medtronic StealthStation System using the Medtronic SureTrak II instruments and already-Cleared pedicle screw preparation and insertion instruments to facilitate preparation and insertion of Zimmer Biomet screws using navigation.
Summary of Performance Data:
Validation activities are used to confirm the instruments meet performance requirements, providing assurance of device performance for their intended use, similar to predicate systems. Accuracy testing of the Zimmer Biomet Universal Navigation System Instruments was performed in accordance with ASTM F24554-18 Standard Practice For Measurement of Positional Accuracy of Computer Assisted Surgical Systems. Clinical data was not needed for the Zimmer Biomet Universal Navigation System.
Substantial Equivalence Conclusion:
The Zimmer Biomet Universal Navigation System is substantially equivalent to the predicate system in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, materials and operational principles. Furthermore, validation testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject components. Based on this information, the subject device does not raise any new issues regarding the safety or efficacy when compared to its predicates.