The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

Device Description

The Neuromonitoring Kit is designed to use stimulation to locate, identify and monitor peripheral motor nerves and spinal nerve roots during surgery. The kit contains a Probe, Guide Pin Sleeve, and cable electrodes (Guide Pin Cap, and Guide Pin Clip). The Neuromonitoring Kit can be used with the iFuse Implant System.

The design of the Probe is similar to existing stainless steel stimulating instruments. The Probe consists of a stainless steel wire with biocompatible electrical insulation applied to selected portions, and a proximal connector provided to attach the probe to a monopolar stimulator. The distal surface of the Probe is noninsulated stainless steel to provide for tissue stimulation.

The Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12. The Neuromonitoring Kit is sterile (ETO) and for single use only.

AI/ML Overview

The Neuromonitoring Kit (K161893) is a device designed for stimulation of peripheral motor nerves and spinal nerve roots during surgery for localization and identification.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (from predicate comparison)	Reported Device Performance
Principles of Operation	Monopolar nerve stimulation	Same (Monopolar nerve stimulation)
Sterilization Method	EtO Sterilization	Same (EtO Sterilization)
Usage	Single Use	Same (Single Use)
Biocompatibility	Biocompatible	Same (Biocompatible)
Biocompatible Electrical Insulation	PTFE or PVDF	PVDF
Distal Stainless Steel Patient Body Contact Surface Material	316 SS	Same (316 SS)
Proximal Stimulator Connector	DIN 42802-1 Touch-proof	Same (DIN 42802-1 Touch-proof)
IEC 60601-1 Protected Pin Design	IEC 60601-1 Protected Pin design	Same (IEC 60601-1 Protected Pin design)
Shaft Material	316 SS	Same (316 SS)
Handle Material	Acrylonitrile butadiene styrene (ABS)	Same (Acrylonitrile butadiene styrene (ABS))
Maximum Charge Density	Exhibits a range of Charge Densities depending on Probe. Maximum Charge Density is greater than the subject device (Implied acceptance for lower density)	374 μC/cm2 (This is within the acceptable range as the predicate's maximum is stated to be greater than the subject device)
Probe Length	Exhibits a range of probe lengths depending on probe. The probe length is within the range of the subject device (Implied acceptance for being within range)	225mm (This is stated to be within the range of the predicate device)
Cable/Lead Wire Length	Exhibits a range of Cable/Lead wire lengths depending on probe. The Cable/Lead Wire Length is within the range of the subject device (Implied acceptance for being within range)	2.5m (This is stated to be within the range of the predicate device)
Uncoated Conducting Surface Area	Exhibits a range of Conducting Surface Areas. Smallest Conducting Surface Area is less than the subject device (Implied acceptance for being within range)	27mm2 (This is within the acceptable range as the predicate's smallest is stated to be less than the subject device, suggesting the subject device's area is not excessively small)
Tip Diameter/Exposure	Exhibits a range of Tip Diameter/Exposures depending on probe. The Tip Diameter/Exposure is within the range of the subject device (Implied acceptance for being within range)	3.0mm (This is stated to be within the range of the predicate device)
Electrical Safety	Meets IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c)	Demonstrated that the Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12.
Electromagnetic Compatibility (EMC)	Meets IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c)	Demonstrated that the Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12.
Mechanical Performance	Performance similar to predicate (implied by substantial equivalence claim)	Mechanical performance data were provided and test results demonstrate that the subject Probe is substantially equivalent to the predicate. (Specific criteria not detailed, but overall equivalence established).

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

The document explicitly states that Electrical safety, electromagnetic compatibility and mechanical performance data were provided in support of the substantial equivalence determination. However, it does not specify the sample size used for these tests. There's no mention of a test set in the context of clinical data or patient-specific information. The testing seems to be focused on device-level performance (electrical, EMC, mechanical).

Regarding data provenance, since these are device performance tests (rather than clinical trials involving patients), the data provenance would be from laboratory or engineering testing. Neither country of origin nor retrospective/prospective nature is specified, as these terms are more applicable to patient data.

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

No information is provided regarding experts establishing ground truth. The acceptance criteria and performance data are based on engineering standards (IEC 60601 series) and comparison to a predicate device's specifications. This type of device does not involve expert interpretation or diagnostic "ground truth" in the way a medical imaging AI would.

4. Adjudication Method for the Test Set:

Not applicable. There's no mention of a test set requiring adjudication in the context of expert review or clinical outcomes. The device performance is assessed against engineering standards and specifications.

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 device is a surgical nerve stimulator/locator, not an AI-powered diagnostic or interpretive tool that assists human readers. Therefore, an MRMC study and effect size of human reader improvement with AI assistance are not relevant.

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

Not applicable. This is a physical medical device, not a standalone algorithm. Its function relies on being used by a surgeon during a procedure for nerve stimulation and localization.

7. The Type of Ground Truth Used:

The "ground truth" for this device's performance appears to be based on:

Compliance with international electrical safety and electromagnetic compatibility standards (IEC 60601-1:2012 and IEC 60601-1-2:2007).
Engineering specifications and characteristics that are compared to a legally marketed predicate device (Rhythmlink International Monopolar Stimulating Instrument K072736) to establish substantial equivalence.

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

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

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 18, 2016

SI-BONE, Inc. Roxanne Dubois VP, Regulatory Affairs and Quality Assurance 3055 Olin Ave, Suite 2200 San Jose, California 95128

Re: K161893

Trade/Device Name: Neuromonitoring Kit Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: PDQ Dated: September 15, 2016 Received: September 16, 2016

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161893

Device Name Neuromonitoring Kit

Indications for Use (Describe)

The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

Type of Use (Select one or both, as applicable)

☑ Research Use (Per 21 CFR 201.128 Subject to Review)
☐ Same Therapeutic Use (Per 21 CFR 201.128)

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image displays the logo for the SI-BONE iFuse Implant System. The logo is divided into two parts, with "SI-BONE" on the left and "iFuse Implant System" on the right. Below "iFuse Implant System" is the text "Minimally Invasive Sacroiliac Joint Surgery", indicating the system's purpose.

510(k) SUMMARY - K161893 Neuromonitoring Kit

I. SUBMITTER

SI-BONE, Inc. 3055 Olin Avenue, Suite 2200, San Jose, CA 95128 Phone: 408-207-0700 Fax: 408-557-8312

Contact Person: Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. rdubois@si-bone.com Email: Mobile: 408-828-5019 408-207-0700 x2236 Office: Date Prepared: October 14, 2016

II. DEVICE

Name of Device:	Neuromonitoring Kit
Common or Usual Name:	Neuromonitoring Kit
Classification Name:	Surgical nerve stimulator/locator (21 CFR 874.1820)
Regulatory Class:	II
Product Code:	PDQ

III. PREDICATE DEVICE

Rhythmlink International Monopolar Stimulating Instrument (K072736). No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The Neuromonitoring Kit meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12. The Neuromonitoring Kit is sterile (ETO) and for single use only.

V. INDICATIONS FOR USE

The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The design of the Probe is similar to the design of the predicate device. Both the Probe and the predicate device consists of a stainless steel wire with biocompatible electrical insulation applied to selected portions, and a proximal connector provided to attach the Probe to a monopolar stimulator. For both, the distal surface of the Probe is non-insulated stainless steel to provide for implant and tissue stimulation. In addition, the subject device and predicate device are manufactured the same way and at the same facility.

The following is a comparison of the technological characteristics of the Neuromonitoring Kit where compared to the predicate device.

Characteristic	ProposedNeuromonitoring Kit	Rhythmlink International Monopolar StimulatingInstrument Predicate Device
510k number	K161893	K072736
Principles of Operation	Same	Monopolar nerve stimulation
Sterile (EtO)	Same	EtO Sterilization
Single Use	Same	Single Use
Biocompatible	Same	Biocompatible
Biocompatible Electricalinsulation	PVDF	PTFE or PVDF
Distal stainless steel patientcontact surface	Same	316 SS
Proximal stimulatorconnector	Same	DIN 42802-1 Touch-proof
IEC 60601 - 1 Protected Pindesign	Same	IEC 60601 - 1 Protected Pin design
Shaft Material	Same	316 SS
Handle Material	Same	Acrylonitrile butadiene styrene (ABS)
Maximum Charge Densitywhich will be generated bythe probe	374 μC/cm2	Exhibits a range of Charge Densities dependingon Probe.Maximum Charge Density is greater than thesubject device
Probe Length	225mm	Exhibits a range of probe lengths depending onprobe.The probe length is within the range of thesubject device
Cable/ Lead Wire Length	2.5m	Exhibits a range of Cable/Lead wire lengthsdepending on probe.The Cable/Lead Wire Length is within the rangeof the subject device.
Uncoated Conducting SurfaceArea	27mm2	Exhibits a range of Conducting Surface Areas.Smallest Conducting Surface Area is less thanthe subject device .
Tip Diameter/ Exposure	3.0mm	Exhibits a range of Tip Diameter/Exposuresdepending on probe.The Tip Diameter/Exposure is within the rangeof the subject device.

Table 1 – Substantial Equivalence Comparison Table

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There are no changes to the technological characteristics of the Probe.

VII. PERFORMANCE DATA

Electrical safety, electromagnetic compatibility and mechanical performance data were provided in support of the substantial equivalence determination.

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the Neuromonitoring Kit and demonstrated that the Neuromonitoring Kit, including the Probe within the kit, meets the requirements of IEC 60601-1:2012 reprint and IEC 60601-1-2:2007 Clause 56.3(c) per 21 CFR 898.12.

Electrical safety, electromagnetic compatibility and mechanical performance test results demonstrate that the subject Probe is substantially equivalent to the predicate.

VIII. CONCLUSIONS

The Neuromonitoring Kit that is the subject of this 510(k) is substantially equivalent to the predicate device.

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Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.