(58 days)
Not Found
No
The document describes a surgical navigation system that uses existing imaging modalities (CT, MR, fluoroscopy) and a predicate navigation system (Medtronic StealthStation) to assist with screw placement. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The focus is on the instrumentation's compatibility and accuracy with the established navigation system.
No.
The device is an instrumentation system used to assist a surgeon in precisely locating anatomical structures during spinal surgery for the placement of pedicle screws; it does not directly treat a disease or condition.
No
The device is an instrumentation system intended to assist surgeons in precisely locating anatomical structures for precise placement of pedicle screws during spinal surgery. It is not used for diagnosis.
No
The device description explicitly states that the system includes physical instruments such as taps, a probe, an awl, and an inserter, which are hardware components.
Based on the provided information, the NEXXT SPINE NAVIGATION System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is an "instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures". This describes a surgical navigation system used during a surgical procedure, not a device used to perform tests on samples taken from the body to diagnose or monitor a condition.
- Device Description: The description lists surgical instruments like taps, a probe, an awl, and an inserter. These are tools used in surgery, not for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The NEXXT SPINE NAVIGATION System's function is to aid in the physical placement of surgical implants during a procedure.
N/A
Intended Use / Indications for Use
The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 of the anatomy.
Product codes
OLO
Device Description
The NEXXT SPINE NAVIGATION System is an instrumentation system which includes taps and a probe, an awl and an inserter. The devices are used in conjunction with the Medtronic® StealthStation Navigation System to assist with placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The instruments are sold non-sterile and are reusable.
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
Vertebra
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, clinical 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Navigation dimensional analysis and positional accuracy (per ASTM F2554) validations were performed in side-by-side testing of the NEXXT SPINE NAVIGATION System and predicate device. The test results demonstrate that the NEXXT SPINE NAVIGATION System performance is substantially equivalent to the predicate.
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).
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Image /page/0/Picture/0 description: The image shows the date March 31, 2022. The text is in a simple, sans-serif font and is horizontally aligned. The date is written out in full, with the month, day, and year clearly indicated.
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Nexxt Spine LLC % Karen E. Warden President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K220291
Trade/Device Name: NEXXT SPINE NAVIGATION System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 31, 2022 Received: February 1, 2022
Dear Karen Warden:
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
1
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 (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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name NEXXT SPINE NAVIGATION System
Indications for Use (Describe)
The NEXXT SPINE NAVIGATION System is an instrumentation system intended to be used during preparation and placement of Nexxt Spine's INERTIA® Systems pedicle screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. These instruments are 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 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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510(k) Summary
| Date: | 28 March 2022 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | NEXXT SPINE NAVIGATION System |
| Common Name: | Spinal navigation system |
| Regulatory Class: | Class II |
| Regulation Name, Regulation Number, Product Code: | Stereotaxic instrument, 882.4560, OLO |
| Device Description: | The NEXXT SPINE NAVIGATION System is an instrumentation system which |
| includes taps and a probe, an awl and an inserter. The devices are used in | |
| conjunction with the Medtronic® StealthStation Navigation System to assist with | |
| placement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw and | |
| INERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. The | |
| instruments are sold non-sterile and are reusable. | |
| Intended Use: | The NEXXT SPINE NAVIGATION System is an instrumentation system intended |
| to be used during preparation and placement of Nexxt Spine's INERTIA® Systems | |
| pedicle screws during spinal surgery to assist the surgeon in precisely locating | |
| anatomical structures in either open or minimally invasive procedures. These | |
| instruments are 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 of the anatomy. | |
| Materials: | The NEXXT SPINE NAVIGATION System components are manufactured from |
| stainless steels as described by ASTM F899. | |
| Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic Sofamor |
| Danek, USA Inc. – K140454) | |
| Performance Data: | Navigation dimensional analysis and positional accuracy (per ASTM F2554) |
| validations were performed in side-by-side testing of the NEXXT SPINE | |
| NAVIGATION System and predicate device. The test results demonstrate that the | |
| NEXXT SPINE NAVIGATION System performance is substantially equivalent to | |
| the predicate. | |
| Technological | |
| Characteristics: | The NEXXT SPINE NAVIGATION System has the same technological |
| characteristics as the predicate device. Therefore the fundamental scientific | |
| technology of the NEXXT SPINE NAVIGATION System is the same as previously | |
| cleared devices. | |
| Conclusion: | The NEXXT SPINE NAVIGATION System possesses the same intended use and |
| technological characteristics as the predicate devices. Therefore the NEXXT | |
| SPINE NAVIGATION System is substantially equivalent for its intended use. |