Neuromonitoring Kit

K161893 · SI-BONE, Inc. · PDQ · Oct 18, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161893
• Device Name: Neuromonitoring Kit
• Applicant: SI-BONE, Inc.
• Product Code: PDQ · Ear, Nose, Throat
• Decision Date: Oct 18, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

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

Device Story

Neuromonitoring Kit facilitates localization and identification of peripheral motor nerves and spinal nerve roots during surgery. Kit components include probe, guide pin sleeve, and cable electrodes (guide pin cap and clip). Device functions as monopolar stimulator; stainless steel probe tip delivers electrical stimulation to tissue. Used in surgical settings; operated by surgeons. Output provides nerve stimulation to assist in identifying nerve proximity; aids clinical decision-making regarding surgical navigation and avoidance of nerve injury. Benefits patient by reducing risk of iatrogenic nerve damage during procedures, such as those involving iFuse Implant System.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety, electromagnetic compatibility (EMC), and mechanical performance verification per IEC 60601-1:2012 and IEC 60601-1-2:2007 standards.

Technological Characteristics

Stainless steel probe with PVDF electrical insulation; proximal connector for monopolar stimulator. Sterile (EtO), single-use. Dimensions: 225mm length, 3.0mm tip diameter, 27mm2 uncoated surface area. Max charge density 374 μC/cm2. Complies with IEC 60601-1 and IEC 60601-1-2.

Indications for Use

Indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.

Regulatory Classification

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.

Predicate Devices

• Rhythmlink International Monopolar Stimulating Instrument (K072736)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <span style="font-size: 10px;">☑ Research Use (Per 21 CFR 201.128 Subject to Review)</span> |
|---------------------------------------------------------------------------------------------|
| <span style="font-size: 10px;">☐ Same Therapeutic Use (Per 21 CFR 201.128)</span> |

> 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: [phone] Fax: [phone]

Contact Person: Roxanne Dubois, VP, Regulatory and Quality, SI-BONE, Inc. [e-mail] Email: Mobile: [phone] 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 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.

### 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 | Proposed<br>Neuromonitoring Kit | Rhythmlink International Monopolar Stimulating<br>Instrument 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 Electrical<br>insulation | PVDF | PTFE or PVDF |
| Distal stainless steel patient<br>contact surface | Same | 316 SS |
| Proximal stimulator<br>connector | Same | DIN 42802-1 Touch-proof |
| IEC 60601 - 1 Protected Pin<br>design | Same | IEC 60601 - 1 Protected Pin design |
| Shaft Material | Same | 316 SS |
| Handle Material | Same | Acrylonitrile butadiene styrene (ABS) |
| Maximum Charge Density<br>which will be generated by<br>the probe | 374 μC/cm2 | Exhibits a range of Charge Densities depending<br>on Probe.<br>Maximum Charge Density is greater than the<br>subject device |
| Probe Length | 225mm | Exhibits a range of probe lengths depending on<br>probe.<br>The probe length is within the range of the<br>subject device |
| Cable/ Lead Wire Length | 2.5m | Exhibits a range of Cable/Lead wire lengths<br>depending on probe.<br>The Cable/Lead Wire Length is within the range<br>of the subject device. |
| Uncoated Conducting Surface<br>Area | 27mm2 | Exhibits a range of Conducting Surface Areas.<br>Smallest Conducting Surface Area is less than<br>the subject device . |
| Tip Diameter/ Exposure | 3.0mm | Exhibits a range of Tip Diameter/Exposures<br>depending on probe.<br>The Tip Diameter/Exposure is within the range<br>of 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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