The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

Device Description

The Curiteva Sacroiliac Joint Fusion System consists of screws in various diameters, lengths and thread configurations to accommodate variations in patient anatomy. The screws are designed to be implanted across the sacroiliac joint to stabilize and aid in the fusion of the sacroiliac joint. Optional washers are included to aid in the distribution of load across the bone surface directly apposing the screw head.

The Curiteva Sacroiliac Joint Fusion System implants are manufactured from medical-grade titanium alloy in accordance with ASTM F136. All system implants are intended for single use only and should not be reused under any circumstances.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Curiteva Sacroiliac Joint Fusion System. This submission focuses on establishing substantial equivalence to previously cleared devices through non-clinical performance data, primarily mechanical testing, rather than clinical studies involving AI or diagnostic performance. Therefore, many of the requested details about acceptance criteria for AI performance, clinical study design, and ground truth establishment are not applicable.

Here's an analysis based on the available information:

Assessment of Acceptance Criteria and Device Performance:

The "acceptance criteria" in this context refer to the mechanical performance standards that the device must meet to demonstrate safety and effectiveness comparable to predicate devices. The study conducted was non-clinical mechanical testing.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion (Type of Test)	Standard Followed	Reported Device Performance (Summary)	Meets Criteria?
Static four-point bending	ASTM F2193	Sufficient for intended use and substantially equivalent to predicate devices.	Yes
Dynamic four-point bending	ASTM F2193	Sufficient for intended use and substantially equivalent to predicate devices.	Yes
Static torsion	ASTM F543	Sufficient for intended use and substantially equivalent to predicate devices.	Yes
Static axial pullout	ASTM F543	Sufficient for intended use and substantially equivalent to predicate devices.	Yes

*Note: The specific numerical values for strength and performance are not provided in the summary, only the conclusion that they were "sufficient" and "substantially equivalent."*

2. Sample Size Used for the Test Set and Data Provenance:
* Sample Size: Not explicitly stated in the provided text for each mechanical test. Mechanical testing typically involves multiple samples to ensure statistical validity, but the exact number isn't quantified here.
* Data Provenance: The data is non-clinical, originating from laboratory mechanical testing. There is no patient data involved, so country of origin or retrospective/prospective status is not applicable in the typical sense.

Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable. This is a mechanical device, not a diagnostic or AI-driven system that requires expert interpretation for ground truth. The "ground truth" for mechanical testing is established by the test standards (ASTM F2193, ASTM F543) and physical measurements.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical or image interpretation studies to resolve discrepancies among experts. For mechanical testing, adherence to a standard and objective measurements are the primary methods.
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:
- Not applicable. This device is not an AI-assisted diagnostic or interpretation tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a mechanical implant, not an algorithm.
The Type of Ground Truth Used:
- The "ground truth" for this non-clinical study is defined by the objective physical properties and performance characteristics measured against established ASTM standards (ASTM F2193 for bending, ASTM F543 for torsion and pullout). The performance is then compared to predicate devices.
The Sample Size for the Training Set:
- Not applicable. This device is not an AI system that requires a "training set."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for an AI model.

Summary

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September 9, 2021

Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K210402

Trade/Device Name: Curiteva Sacroiliac Joint Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: July 30, 2021 Received: August 2, 2021

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 app roval 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/cdrl/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 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

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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 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/cdrl-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.

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal 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) K210402

Device Name

Curiteva Sacroiliac Joint Fusion System

Indications for Use (Describe)

The Curiteva Sacroillac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

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

A. Submitter Information

Submitter:	Curiteva, Inc.25127 Will McComb DriveTanner, AL 35671Phone: (256) 213-1057Fax: (256) 213-1058
Contact Person:	Eric Linderregulatory@curiteva.com
Date Prepared:	July 30, 2021

B. Device Information

Trade Name:	Curiteva Sacroiliac Joint Fusion System
Common Name:	Sacroiliac Joint Fixation / Sacroiliac Joint Fusion System
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Classification:	Class II (per 21 CFR 888.3040)
Product Code(s):	OUR
Classification Panel:	Orthopedic
Predicate Device(s):	Primary: SI-Technology SI-DESIS Screws – K151462Additional: Genesys Spine Sacroiliac Joint Fusion System - K191748Additional: Synthes 6.5mm Cannulated Screw - K021932

C. Device Description

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D. Indications for Use

The Curiteva Sacroiliac Joint Fusion System is intended for sacroiliac (SI) joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

E. Technological Characteristics

As was established in this submission, the subject Curiteva Sacroiliac Joint Fusion is substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and to have similar technological characteristics to its predicate devices through comparison in areas including design, intended use, material composition, and range of sizes.

F. Performance Data

The Curiteva Sacroiliac Joint Fusion System was mechanically tested in the following test modes:

Static four-point bending per ASTM F2193
Dynamic four-point bending per ASTM F2193 .
Static torsion per ASTM F543
Static axial pullout per ASTM F543

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

G. Conclusion

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Curiteva Sacroiliac Joint Fusion System has been shown to be substantially equivalent to legally marketed predicate devices.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.