The Curiteva Navigation System is intended to be used during the preparation and placement of Curiteva screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The Curiteva Navigation System is 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 vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy.

Device Description

The Curiteva Navigation System instruments are reusable surgical instruments for use with the Medtronic® StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) to assist surgeons in precisely locating anatomical structures in open or minimally invasive procedures for preparation and placement of Curiteva screws.

The Curiteva Navigation System includes awls, probes, taps, drills, and drivers. The Curiteva Navigation System instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System, as specified.

All instruments are made of stainless steel per ASTM F899. The Curiteva Navigation System instruments are not compatible with implants from other manufacturers and are designed for use only with Medtronic StealthStation Navigation System hardware and software.

AI/ML Overview

This FDA 510(k) summary (K223200) describes a device that is an accessory to a navigation system, not a standalone AI/software device. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (like MRMC studies, training set details, or ground truth establishment by experts for algorithmic performance) are not applicable to this submission.

The Curiteva Navigation System consists of physical surgical instruments (awls, probes, taps, drills, and drivers) intended for use with an existing, cleared navigation system (Medtronic StealthStation). The performance evaluation focuses on the physical accuracy and compatibility of these instruments, not on an AI algorithm's diagnostic or predictive capabilities.

Based on the provided document, here's an analysis of the acceptance criteria and performance study:

Understanding the Device and its Evaluation

Device Category: Orthopedic Stereotaxic Instrument (accessory to a Computer Assisted Surgical System).
Purpose: To assist surgeons in precisely locating anatomical structures during spinal surgery when used with a Medtronic StealthStation Navigation System.
Nature of Device: Reusable surgical instruments (physical, non-AI).

Acceptance Criteria and Performance Study Summary

Given the nature of the device as surgical instruments, the "acceptance criteria" here refer to testing that demonstrates the instruments' physical accuracy and suitability for their intended use when integrated with the specified predicate navigation system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion (Test Performed)	Reported Device Performance/Conclusion
Positional Accuracy	The Curiteva Navigation System instruments were tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems." The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use. This implies that the positional accuracy, as measured by the standard, met predefined acceptance thresholds (though specific numerical thresholds and results are not provided in this summary).
Dimensional Comparison to Predicate Devices	Dimensional comparisons were made between the subject and predicate devices. While specific results are not detailed, this testing would ensure that the new instruments are dimensionally compatible and comparable to existing cleared instruments used with similar navigation systems, without introducing new safety or performance concerns. The conclusion of substantial equivalence implies these comparisons were favorable.
Material Compatibility/Safety	All instruments are made of stainless steel per ASTM F899. This ensures the material meets established standards for medical devices, contributing to patient safety (e.g., biocompatibility, corrosion resistance, durability for sterilization).
Compatibility with Medtronic StealthStation	The instruments are designed for use only with Medtronic StealthStation® Navigation System S7 v2.1.0 and S8 v1.2.0 (1.2.0-20) hardware and software. The testing would validate this compatibility. The summary implicitly concludes successful compatibility as it deems the device suitable for its intended use with this system.
Compatibility with Curiteva Implant Systems	The instruments are to be used with the Curiteva Pedicle Screw System or the Curiteva Sacroiliac Joint Fusion System. This implies testing or design validation to ensure proper fit and function with these specific implant systems during surgical procedures.
Substantial Equivalence to Predicate Device	Conclusion: "The overall technology characteristics and mechanical performance data lead to the conclusion that the Curiteva Navigation System is substantially equivalent to the predicate device [Medtronic Navigated Instruments (K161210)]." This is the overarching acceptance criterion for 510(k) clearance, relying on all the above performance demonstrations.

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

Sample Size: The document does not specify a specific "sample size" in terms of patient data. For the positional accuracy testing (ASTM F2554-18), the sample would be the physical instruments themselves or specific test fixtures designed to simulate use. The standard typically involves repetitive measurements to establish accuracy and precision. No human patient test set is described, as this is laboratory testing of the instruments.
Data Provenance: The testing is non-clinical (i.e., laboratory-based, bench testing). No patient data (e.g., from specific countries, retrospective/prospective studies) is mentioned, as it is not relevant for this type of device and performance evaluation.

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

Not Applicable. For this type of mechanical/physical device accessory, "ground truth" is established by a standardized measurement method (e.g., a calibrated measurement system validating positional accuracy against a known reference). Experts (e.g., radiologists) are not involved in establishing this specific type of "ground truth." The ground truth for positional accuracy is derived from metrology principles and measurement standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies involving interpretation of medical images or patient outcomes, especially with AI algorithms. This device's testing is purely technical/mechanical.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. An MRMC study is relevant for AI or diagnostic devices where human readers' performance (with or without AI assistance) is being evaluated. This is a set of physical surgical instruments, not an AI algorithm.

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

No. This device is a set of physical instruments, not a software algorithm, so "standalone" algorithm performance is not applicable. Its performance is always "human-in-the-loop" in the ultimate clinical use (surgeon using the instrument). The ASTM F2554-18 test can be considered a "standalone" test of the physical instruments' accuracy when used with the specified navigation system, but it's measuring physical precision, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of these physical instruments is based on quantifiable, objective measurements derived from engineering and metrology standards. Specifically, for positional accuracy, it's defined by the reference measurements and tolerances within the ASTM F2554-18 standard. It is not based on expert consensus, pathology, or clinical outcomes data in this context.

8. The Sample Size for the Training Set

Not Applicable. This is not an AI/ML device, so there is no training set for an algorithm.

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

Not Applicable. There is no training set mentioned or implied for this device.

Summary

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January 6, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Curiteva, Inc. Eric Linder Chief Technology Officer 25127 Will McComb Drive Tanner, Alabama 35671

Re: K223200

Trade/Device Name: Curiteva Navigation System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: September 30, 2022 Received: October 13, 2022

Dear Eric Linder:

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, 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) K223200

Device Name Curiteva Navigation System

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 - K223200

Submitter's Name:	Curiteva, Inc.
Submitter's Address:	25127 Will McComb Dr.Tanner, Alabama 35671
Submitter's Telephone:	(256) 213-1057
Contact Person:	Eric Linderregulatory@curiteva.com
Date Summary was Prepared:	January 5, 2023
Trade or Proprietary Name:	Curiteva Navigation System
Common or Usual Name:	Orthopedic Stereotaxic Instrument
Classification:	Class II per 21 CFR §882.4620
Product Code:	OLO
Classification Panel:	Division of Orthopedic Devices

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

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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.

TECHNOLOGICAL CHARACTERISTICS

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 similar between the subject, predicate, and reference devices:

Indications for use
. Materials of manufacture
Principles of operation
. Design

Table 1 - Predicate Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	ProductCode
K161210(PRIMARY) /K143628 /K143375 /K140454	Medtronic NavigatedInstruments	Medtronic SofamoreDanek USA, Inc.	OLO

Table 2 - Reference Devices

510k Number	Trade or Proprietary orModel Name	Manufacturer	ProductCode
K191810	Curiteva Pedicle ScrewSystem	Curiteva, Inc.	NKB, KWP
K210402	Curiteva Sacroiliac JointFusion System	Curiteva, Inc.	OUR

PERFORMANCE DATA

The Curiteva Navigation System instruments have been tested per ASTM F2554-18, "Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems". Dimensional comparisons were also made between the subject and predicate devices.

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The results of this non-clinical testing show that the performance of the Curiteva Navigation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the Curiteva Navigation System is 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).