(204 days)
No
The document describes a navigated instrument system that relies on external navigation systems (Medtronic StealthStation) and imaging modalities (CT, MR, fluoroscopy) for guidance. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The focus is on the accuracy and precision of the instruments in conjunction with the navigation system.
No.
The device is an instrument system used to assist a surgeon in precisely locating anatomical structures during spinal surgery, rather than directly treating a medical condition or disease.
No.
The device is a navigated instrument system used for precise surgical navigation during spinal surgery, which is an interventional/treatment purpose, not a diagnostic one. It assists the surgeon in locating anatomical structures, but does not provide a diagnosis.
No
The device description explicitly states that the Zavation Navigation instruments are "non-sterile, reusable instruments" manufactured from stainless steel. This indicates a physical hardware component, not a software-only device.
Based on the provided information, 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 Zavation Navigated Instrument System is a surgical navigation tool used during surgery to assist the surgeon in precisely locating anatomical structures and placing implants. It does not analyze biological samples.
- Intended Use: The intended use clearly states it's for assisting in surgical procedures, not for diagnostic testing of samples.
- Device Description: The description details reusable surgical instruments made of stainless steel, not components for analyzing biological samples.
Therefore, the Zavation Navigated Instrument System falls under the category of a surgical navigation system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are 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. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.
Product codes
OLO
Device Description
The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT or MR based model, fluoroscopy images
Anatomical Site
Vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical care setting
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 following testing was performed:
- Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
- Mating Interface Assessments
- CMM Inspection
- Instrument Verification
Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/0 description: The image contains 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 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.
July 12, 2023
Zavation Medical Products, LLC Katie Motley Design Engineer 3670 Flowood Drive Flowood, Mississippi 39232
Re: K223808
Trade/Device Name: Zavation Navigation Instrument System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: June 9, 2023 Received: June 9, 2023
Dear Katie Motley:
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-S
Shumaya Ali, MPH 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) K223808
Device Name Zavation Navigated Instrument System
Indications for Use (Describe)
Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are 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. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkec System.
Please refer to the following Instructions for Use (IFU) and Surgical Techniques for complete system guides, descriptions, indications and warnings:
- Zavation Spinal System .
- Zavation Z-Linkpc System ●
- 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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K223808 510K Summary
| Date: | July 12, 2023 |
|---|---|
| Submitter: | Zavation Medical Products, LLC |
| 3670 Flowood Drive | |
| Flowood, MS 39232 | |
| Phone: 601-919-1119 | |
| Fax: 800-447-1302 | |
| Contact person: | Katie Motley |
| Type of 510(k) submission: | Traditional |
| Trade name: | Zavation Navigation Instrument System |
| Common name: | Orthopedic Sterotaxic Instrumentation |
| Classification regulation: | 21 CFR 882.4560 Stereotaxic Instrument |
| Device classification: | Class II |
| Classification Panel: | Orthopedic |
| Product code: | OLO |
| Basis for submission | New Submittal |
Device Description:
The Zavation Navigation instruments non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899
Indications for Use:
Zavation Navigated Instrument System are indicated for use during the placement of Zavation Spine screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Zavation Navigated Instruments are reusable and are specifically designed for use with the Medtronic Navigation StealthStation System which are 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. Use of Zavation Navigated Instrument System is limited to use only with Zavation Spinal System and Zavation Z-Linkse System.
Please refer to the following Instructions for Use (IFU) and Surgical Techniques for complete system guides, descriptions, indications and warnings:
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- Zavation Spinal System
- Zavation Z-Link Posterior Cervical System
- . Medtronic StealthStation Navigation System
Materials:
This submission seeks clearance of just the Zavation Navigation Instrument System. Instruments are made from Stainless Steel according to F899. This is the same material used in the predicate devices.
List of Instruments:
Zavation Navigated Instrument System consists of taps, probes, and screwdrivers both canulated and non-canulated indicated to be used with Zavation Spinal System; Zavation Navigation System also includes taps, probes, & a screwdriver indicated to be used with Zavation Z-Link Posterior Cervical System.
Predicate Device:
Primary - K170679 MEDTRONIC NAVIGATED INSTRUMENTS FOR USE WITH STEALTHSTATION® AND IPC® POWEREASE SYSTEMS
Additional - K153603 Alphatec Navigation Instruments; Alphatec Spine, Inc.
Reference - K211113 Zavation Spinal System; Zavation Medical Products, LLC.
Reference – K211993 Zavation Z-Linkec System; Zavation Medical Products, LLC.
Technological Characteristics:
The Zavation Navigated Instrument System are non-sterile, reusable instruments that can be operated manually. These instruments are intended to be used with the Medtronic StealthStation® System to aid in implantation of associated Zavation screw implants. The instruments are manufactured from stainless steel per ASTM F899.
Performance Data:
The following testing was performed:
- . Accuracy and Precision Testing of Navigation System per ASTM F2554-10 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical System
- Mating Interface Assessments
- CMM Inspection
Instrument Verification
Validation testing includes 1:1 accuracy and performance testing of the subject and predicate device in a simulated surgical navigation use environment.
Substantial Equivalence Conclusion:
The overall technological characteristics of the Zavation Navigated Instrument System, including working length, material, and intended use are very similar to the predicate systems. The nonclinical tests conducted also lead to the conclusion that the Zavation Navigated Instrument System is substantially equivalent to the predicate Medtronic navigation instruments when used with the StealthStation™ System and NavLock Tracker.