The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. 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 iFuse Implant System® consists of cannulated triangular, titanium (iFuse implants: Ti 6Al 4V ELI, ASTM F136/F1580 and iFuse-3D implants: Ti 6Al 4V ELI, ASTM F3001) implants with a porous surface and an instrument system. The principle of operation is that the triangular implant shape and porous surface are designed to prevent and minimize motion/micromotion of the sacroiliac (SI) joint, and thereby stabilize the joint. The mechanism of action is that the interference fit allows fixation, stabilization and fusion. The delivery system uses guide pins for accurate permanent surgical placement. The implants are available in varying lengths and diameters and are provided sterile (gamma sterilization).

AI/ML Overview

This document is a 510(k) summary for the iFuse Implant System®, which is seeking clearance for a modified labeling of an existing device. Therefore, it specifically states that no new performance testing was required to support this 510(k). This means there is no study described within this document that "proves the device meets the acceptance criteria" under this specific submission.

The document is a clearance for a medical device (iFuse Implant System) based on substantial equivalence to a predicate device (iFuse Implant System, K162733). The clearance is for an expanded indication for use.

Here's a breakdown of the requested information based on what is available (or explicitly stated as not applicable) in the provided text:

1. A table of acceptance criteria and the reported device performance

The document explicitly states: "No performance testing was required to support the modified labeling that is the subject of this 510(k)." and "The intended use, indications for use and the technological characteristics are unchanged compared to the predicate device and support that the proposal contained within this 510(k) is substantially equivalent to the predicate device."

This means that for this particular submission (K182983), no new acceptance criteria or new device performance data were generated or reported. The device is cleared based on the substantial equivalence to a previously cleared version of the same device, which would have had its own acceptance criteria and performance data. This document does not provide those original criteria or data.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no new performance testing was conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no new performance testing and thus no new ground truth establishment were conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no new performance testing was conducted for this 510(k) submission.

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

Not applicable. This is a physical implantable device, not an AI or imaging diagnostic tool, so an MRMC study is irrelevant.

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

Not applicable. This is a physical implantable device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no new performance testing was conducted for this 510(k) submission.

8. The sample size for the training set

Not applicable, as this is a physical implantable device and does not involve a "training set" in the context of machine learning or algorithms.

9. How the ground truth for the training set was established

Not applicable, as this is a physical implantable device and does not involve a "training set" in the context of machine learning or algorithms.

In summary: The provided document is an FDA clearance letter and 510(k) summary for an expanded indication for use of an existing medical device. It explicitly states that no new performance testing was required for this submission because the device's technological characteristics are unchanged from its predicate, and thus, it did not need to generate new acceptance criteria or performance data for this clearance.

Summary

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November 27, 2018

SI-BONE, Inc. Roxanne J. Dubois Vice President, Regulatory Affairs 471 El Camino Real, Suite 101 Santa Clara, California 95050

Re: K182983

Trade/Device Name: iFuse Implant System® Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: October 26, 2018 Received: October 29, 2018

Dear Ms. Dubois:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Ronald P. Jean -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K182983

Device Name iFuse Implant System®

Indications for Use (Describe)

The iFuse Implant System is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption 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.

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 - iFuse Implant System®

I. SUBMITTER

SI-BONE, Inc. 471 El Camino Real, Suite 101, Santa Clara, CA 95050 Phone: 408-207-0700; Fax: 408-557-8312

Contact Person: Roxanne J. Dubois, VP, Regulatory Affairs, SI-BONE, Inc. Email: rdubois@si-bone.com Phone: 408-828-5019; Fax: 408-557-8312 Date Prepared: October 26, 2018

II. DEVICE

Trade Name of Device:	iFuse Implant System ®
Common or Usual Name:	Sacroiliac Joint Fixation
Regulation Number:	21 CFR 888.3040, Smooth or threaded metallic bone fastener
Product Code:	OUR

III. PREDICATE AND REFERENCE DEVICES

Predicate:	iFuse Implant System® by SI-BONE, Inc., K162733
Reference Device:	VIPER® Systems (Pedicle Screw Spinal System), K121020

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE VI.

The iFuse Implant System® consists of manual instruments and a series of triangular titanium implants intended for surgical implantation to provide immediate SI joint stabilization and allow long-term fusion. There are no changes to the technological characteristics of the device that is the subject of this 510(k).

VII. PERFORMANCE DATA

No performance testing was required to support the modified labeling that is the subject of this 510(k).

VIII. CONCLUSIONS

The intended use, indications for use and the technological characteristics are unchanged compared to the predicate device and support that the proposal contained within this 510(k) 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.