(58 days)
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.
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.
Here's an analysis of the provided text to extract information about the device's acceptance criteria and the supporting study, focusing on the requested categories:
Device Name: NEXXT SPINE NAVIGATION System
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated Goal) | Reported Device Performance (as per study) |
|---|---|
| Dimensional Analysis | Demonstrated substantial equivalence to predicate device. |
| Positional Accuracy | Demonstrated substantial equivalence to predicate device. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set.
The provenance of the data is that it was generated through side-by-side testing of the NEXXT SPINE NAVIGATION System and the predicate device. The text does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number or qualifications of experts used to establish ground truth. The study appears to be a technical performance test rather than involving clinical experts for ground truth assessment.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The study outlined is a technical performance study comparing the device to a predicate, not a study evaluating human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Yes, a standalone performance study was conducted. The "Navigation dimensional analysis and positional accuracy validations" were performed on the device itself, comparing its technical performance to a predicate device, without the involvement of human operators or a human-in-the-loop scenario.
7. Type of Ground Truth Used:
The ground truth for the performance tests appears to be established by technical measurements and standards as per ASTM F2554. This standard likely defines acceptable dimensional and positional accuracy, which served as the "ground truth" against which the device's performance was measured. It is not expert consensus, pathology, or outcomes data.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. This is expected given that the device is an instrumentation system with navigation capabilities, not an AI or machine learning algorithm that typically requires a training set. The performance data focuses on inherent accuracy and dimensional properties.
9. How the Ground Truth for the Training Set Was Established:
As there is no mention of a training set, the establishment of ground truth for a training set is not applicable.
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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
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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 whichincludes taps and a probe, an awl and an inserter. The devices are used inconjunction with the Medtronic® StealthStation Navigation System to assist withplacement of the Nexxt Spine INERTIA® Systems (INERTIA® Pedicle Screw andINERTIA® Pedicle Screw and Deformity Correxxion System) pedicle screws. Theinstruments are sold non-sterile and are reusable. |
| Intended Use: | The NEXXT SPINE NAVIGATION System is an instrumentation system intendedto be used during preparation and placement of Nexxt Spine's INERTIA® Systemspedicle screws during spinal surgery to assist the surgeon in precisely locatinganatomical structures in either open or minimally invasive procedures. Theseinstruments are designed for use with the Medtronic StealthStation® System,which is indicated for any medical condition in which the use of stereotacticsurgery 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 fromstainless steels as described by ASTM F899. |
| Primary Predicate: | Navigated CD Horizon® Solera® Screwdrivers and Taps (Medtronic SofamorDanek, 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 SPINENAVIGATION System and predicate device. The test results demonstrate that theNEXXT SPINE NAVIGATION System performance is substantially equivalent tothe predicate. |
| TechnologicalCharacteristics: | The NEXXT SPINE NAVIGATION System has the same technologicalcharacteristics as the predicate device. Therefore the fundamental scientifictechnology of the NEXXT SPINE NAVIGATION System is the same as previouslycleared devices. |
| Conclusion: | The NEXXT SPINE NAVIGATION System possesses the same intended use andtechnological characteristics as the predicate devices. Therefore the NEXXTSPINE NAVIGATION System is substantially equivalent for its intended use. |
§ 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).