The Innovasis Navigation Instruments are intended to be used in the preparation and placement of Innovasis 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 S7 and StealthStation System S8, 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Innovasis Navigation Instruments are reusable instruments used for the preparation and insertion of Innovasis Pedicle Screw System implants, in either open or percutaneous procedures. These instruments are designed for navigated use with the Medtronic StealthStation. The Innovasis Navigation Instruments include the Vector M-S Navigation Instruments for use with the Vector Pedicle Screw System and the Excella Navigation Instruments for use with the Excella II, Excella 3, and Excella MIS pedicle screws. The Innovasis Navigation Instruments are manufactured from medical grade stainless steels. The purpose of this 510(k) is to add the Vector M-S Navigation Instruments to the system.

AI/ML Overview

The provided text from the FDA 510(k) summary (K250182) for "Innovasis Navigation Instruments" contains information required to answer some of the questions. However, critically, this submission focuses on a medical device (navigational instruments) and not an AI/Software as a Medical Device (SaMD). Therefore, many of the typical "acceptance criteria" and "study types" associated with AI/SaMD performance evaluation (such as sensitivity, specificity, MRMC studies, ground truth establishment for algorithms, training sets, etc.) are not applicable and not detailed in this document.

The study described here is primarily an engineering analysis and geometric comparison to predicate devices, along with a validation of navigation compatibility. It does not involve AI performance evaluation or clinical outcomes in the way an AI/SaMD submission would.

Here's an attempt to answer the questions based on the provided text, while explicitly noting what information is not present or applicable.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This device is not an AI/Software as a Medical Device (SaMD). The acceptance criteria and studies described are for physical surgical navigation instruments, not for an algorithm's performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a physical instrument, the "acceptance criteria" are related to its design, materials, and compatibility, rather than performance metrics like sensitivity or specificity.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Technological Equivalence	- Principles of Operation are identical to predicate. - Indications for Use are identical to predicate. - Manufacturing and Biocompatibility are identical to predicate. - Instrument Types and Sizes are identical to predicate. - Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry) are identical to predicate. - Sterility is identical to predicate.	"The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: Principles of Operation, Indications for Use, Manufacturing and Biocompatibility, Instrument Types and Sizes, Critical Geometry (Instrument functional length, Instrument Nav Lock Connection Feature Geometry), and Sterility."
Navigation Compatibility	- Compatibility with Medtronic StealthStation™ System S7 and S8.	"A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System S7 and S8." "The results show that the subject device is substantially equivalent to cleared predicated."
Mechanical Performance	- Overall mechanical performance is equivalent to predicate devices.	"The overall technology characteristics and mechanical performance data lead to the conclusion that the Innovasis Navigation Instruments are substantially equivalent to the predicate device."

Note: The text explicitly states, "The Innovasis Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to the predicate devices." This implies that the 'performance' is largely demonstrated by meeting design specifications and showing equivalence to existing, cleared devices.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not applicable or not specified in the context of an AI/SaMD test set. The evaluation was an "engineering analysis and geometric comparison" and "validation." This suggests testing of instrument prototypes or production samples, but there is no "test set" of patient data as would be used for AI/SaMD.
Data Provenance: Not applicable in the context of patient data. The evaluation is on the manufactured instruments themselves.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth, in the AI/SaMD sense (e.g., image annotations, disease labels), is not established for this type of device submission. The "ground truth" here is the design specification and the functionality of the predicate devices.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no human interpretation or labeling of data that would require adjudication.

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

MRMC Study: No. This is not an AI/SaMD and therefore an MRMC study comparing human reader performance with and without AI assistance is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Standalone Performance: No. This is a physical medical instrument, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: For this device, the "ground truth" is primarily based on design specifications, engineering principles, and the established safety and effectiveness of the predicate devices. The "validation" would confirm that the instruments correctly interface and function with the Medtronic StealthStation System. There is no "disease ground truth" derived from expert consensus, pathology, or outcomes data in this submission.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This is not an AI/SaMD, so there is no training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set Establishment: Not applicable. As there is no training set, there is no ground truth establishment for it.

In summary, the provided FDA 510(k) pertains to physical "Innovasis Navigation Instruments" for spinal surgery, which are Class II devices. The regulatory pathway relies on demonstrating substantial equivalence to predicate devices through engineering analysis, geometric comparison, and compatibility validation, rather than the performance metrics and study designs typically associated with AI/Software as a Medical Device (SaMD) clearances.

Summary

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March 24, 2025

Innovasis, Inc. % Hannah Taggart Regulatory Associate Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K250182

Trade/Device Name: Innovasis Navigation Instruments Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: January 22, 2025 Received: January 22, 2025

Dear Hannah Taggart:

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.

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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).

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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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 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-regulatory

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assistance/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, 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

Submission Number (if known)

K250182

Device Name

Innovasis Navigation Instruments

Indications for Use (Describe)

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

Submitter's Name:	Innovasis, Inc.
Submitter's Address:	614 E 3900 SSalt Lake City, UT 84107
Submitter's Telephone:	801-261-2236
Contact Person:	Hannah Taggart, MSEmpirical Technologies719-457-1152htaggart@empiricaltech.comImage: Empirical Technologies Logo
Date Summary was Prepared:	January 22, 2025
Trade or Proprietary Name:	Innovasis Navigation Instruments
Device Classification Name:	Orthopedic Stereotaxic Instrument
Classification & Regulation #:	Class II per 21 CFR §888.4560
Product Code:	OLO
Classification Panel:	Neurology

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The Innovasis Navigation Instruments are manufactured from medical grade stainless steels. The purpose of this 510(k) is to add the Vector M-S Navigation Instruments to the system.

INDICATIONS FOR USE

TECHNOLOGICAL CHARACTERISTICS

The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Principles of Operation ●
Indications for Use
Manufacturing and Biocompatibility ●

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Instrument Types and Sizes ●
Critical Geometry
- O Instrument functional length
- Instrument Nav Lock Connection Feature Geometry O
Sterility ●

Predicate Devices

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K223511	Excella Navigation Instruments	Innovasis, Inc.	Primary
K170679/K140454	Navigated CD HORIZON® SOLERA®Screwdrivers and Taps	Medtronic Sofamor Danek, USA Inc.	Additional

Performance Data

The Innovasis Navigation Instruments have been evaluated through an engineering analysis and geometric comparison to the predicate devices. A validation was also conducted to demonstrate navigation compatibility with the Medtronic StealthStation™ System S7 and S8. The results show that the subject device is substantially equivalent to cleared predicated.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Innovasis Navigation Instruments are substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).