The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroillac joint disruptions and degenerative sacroillitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

Device Description

The Harvester SI: Sacroiliac Fixation System (also called Harvest SI Sacroiliac Joint Fusion System and Harvester SI Fusion System) is comprised of threaded fusion implants for coupling and fusing the ilium to the sacroiliac fusion). The goal of the fusion arthrodesis is to immobilize the sacroiliac joint with two (2) or more threaded implants. The procedure may or may not be bilateral. The Harvester SI System Fusion implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F136. The Harvester SI Fusion System is offered in various diameters and lengths to accommodate patient anatomy. Instruments are provided that facilitate the insertion of the implants.

AI/ML Overview

This document describes the Harvester SI: Sacroiliac Fixation System, a medical device intended for sacroiliac joint fusion. The information provided focuses on the device's technical characteristics, indications for use, and a comparison to predicate devices, supported by non-clinical performance data.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance for the Harvester SI: Sacroiliac Fixation System. Instead, it lists the types of non-clinical tests performed and states a general conclusion:

Test Performed	Reported Device Performance
Axial pullout per ASTM F543	Sufficient for intended use, substantially equivalent to predicate devices
Torsional properties per ASTM F543	Sufficient for intended use, substantially equivalent to predicate devices
Static cantilever bending per ASTM F2193	Sufficient for intended use, substantially equivalent to predicate devices
Dynamic cantilever bending per ASTM F2193	Sufficient for intended use, substantially equivalent to predicate devices

The "acceptance criteria" are implied by the statement "sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." This suggests that the device's performance in these tests met pre-defined thresholds or demonstrated comparable performance to existing, cleared devices. Specific numerical acceptance criteria are not provided in this document.

Sample size used for the test set and the data provenance

The document describes non-clinical testing on the device itself (Harvester SI Sacroiliac Fixation System components). It does not mention any studies involving human subjects or patient data. Therefore, concepts like sample size for a "test set" in a clinical context or data provenance (country of origin, retrospective/prospective) are not applicable to the information provided. The "sample" here would refer to the number of device components tested for each mechanical property, which is not specified but is typical for mechanical testing standards like ASTM F543 and F2193.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This point is not applicable as the study described is non-clinical (mechanical testing) of a device, not a study evaluating an AI algorithm's performance against human expert consensus or a clinical ground truth.
Adjudication method for the test set

This point is not applicable as the study described is non-clinical (mechanical testing). Adjudication methods are typically relevant for clinical studies or studies where expert consensus is needed to establish a ground truth.
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

This point is not applicable. The document describes the mechanical testing of a physical medical device (sacroiliac fixation system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and effects on human readers are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This point is not applicable. The device is a physical sacroiliac fixation system, not an algorithm or software.
The type of ground truth used

For the non-clinical performance data, the "ground truth" used is the mechanical performance standards (ASTM F543 for axial pullout and torsional properties, ASTM F2193 for cantilever bending) and the performance characteristics of legally marketed predicate devices. The device's performance is compared against these engineering standards and existing devices to demonstrate substantial equivalence, rather than a clinical ground truth like pathology or outcomes data.
The sample size for the training set

This point is not applicable. The document describes mechanical testing of a physical medical device, not the development or evaluation of an AI algorithm that would require a training set.
How the ground truth for the training set was established

This point is not applicable, as there is no training set mentioned or implied for an AI algorithm.

Summary

{0}------------------------------------------------

March 23, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). 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 includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Spinus International, Inc. % Nathan Wright Engineer & Regulatory Specialist Empirical Testing Corp. 4628 Northpark Drive Colorado Springs. Colorado 80918

Re: K203780

Trade/Device Name: Harvester SI: Sacroiliac Fixation System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: January 26, 2021 Received: January 27, 2021

Dear Nathan Wright:

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 probibitions 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

{1}------------------------------------------------

801); medical device reporting (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 (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,

for

Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use	Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement on last page.
510(k) Number (if known)	K203780
Device Name	Harvester SI: Sacroiliac Fixation 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including
the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any
other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

{3}------------------------------------------------

510(K) SUMMARY

Submitter's Name:	Spinus International, Inc.
Submitter's Address:	7200 North Interstate Highway 35Building 1, Suite 101Georgetown, TX 78626
Submitter's Telephone:	254-760-4173
Contact Person:	Nathan Wright MSEmpirical Testing Corp.719-351-0248nwright@empiricaltech.com
Date Summary was Prepared:	December 23, 2020
Trade or Proprietary Name:	Harvester SI: Sacroiliac Fixation System
Common or Usual Name:	Sacroiliac Joint Fixation
Classification:	Class II per 21 CFR §888.3040
Product Code:	OUR
Classification Panel:	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

INDICATIONS FOR USE

The Harvester SI Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.

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 identical between the subject and predicates:

Indications for Use
Materials of manufacture
Structural support mechanism ●

{4}------------------------------------------------

Sizes ●
Surgical approach ●

510k Number	Trade or Proprietary or Model Name	Manufacturer	Predicate Type
K152237	Entasis™ Dual-Lead Sacroiliac Implant	CoreLink	Primary
K121148	SAMBA™ Screw System	Medical Designs LLC	Additional
K183342	SambaScrew 3D SI Fusion System	Orthofix Inc.	Additional
K201538	Life Spine SIMPACT Sacroiliac Joint Fixation System	Life Spine Inc.	Additional
K161210	Rialto™ SI Fusion System	Medtronic Sofamor Danek	Additional

Table 5-1 Predicate Devices

PERFORMANCE DATA

The Harvester SI: Sacroiliac Fixation System has been tested in the following test modes:

Axial pullout per ASTM F543 ●
Torsional properties per ASTM F543
Static cantilever bending per ASTM F2193
o Dynamic cantilever bending per ASTM F2193

The results of this non-clinical testing show that the strength of the Harvester SI: Sacroiliac Fixation 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 Harvester SI: Sacroiliac Fixation System is substantially equivalent to the predicate device.

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.