(99 days)
No reference devices were used in this submission.
No
The summary describes a device that uses electrical stimulation for nerve localization and monitoring. There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on electrical and mechanical performance and safety standards.
No
The device is used for localization, identification, and monitoring of nerves during surgery, which is a diagnostic or procedural aid function, not a therapeutic treatment.
Yes
The device is designed to "locate, identify and monitor peripheral motor nerves and spinal nerve roots during surgery" by using stimulation. This is a diagnostic function because it provides information about the state or location of anatomical structures.
No
The device description explicitly details physical hardware components (Probe, Guide Pin Sleeve, cable electrodes) and mentions electrical safety, electromagnetic compatibility, and mechanical performance testing, indicating it is a hardware device with associated software/firmware for stimulation control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery." This is a direct interaction with the patient's body for a surgical procedure.
- Device Description: The device is a "Neuromonitoring Kit" containing a probe and electrodes designed for electrical stimulation of nerves. This is an active medical device used in vivo (within the living body).
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This device does not perform tests on samples.
The device is clearly designed for direct surgical use on the patient's nervous system, which falls under the category of an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Neuromonitoring Kit is indicated for stimulation of peripheral motor nerves, including spinal nerve roots, for localization and identification during surgery.
Product codes (comma separated list FDA assigned to the subject device)
PDQ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral motor nerves, spinal nerve roots
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
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 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
Neuromonitoring Kit | Rhythmlink International Monopolar Stimulating
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
insulation | PVDF | PTFE or PVDF |
| Distal stainless steel patient
contact surface | Same | 316 SS |
| Proximal stimulator
connector | Same | DIN 42802-1 Touch-proof |
| IEC 60601 - 1 Protected Pin
design | Same | IEC 60601 - 1 Protected Pin design |
| Shaft Material | Same | 316 SS |
| Handle Material | Same | Acrylonitrile butadiene styrene (ABS) |
| Maximum Charge Density
which will be generated by
the probe | 374 μC/cm2 | Exhibits a range of Charge Densities depending
on Probe.
Maximum Charge Density is greater than the
subject device |
| Probe Length | 225mm | Exhibits a range of probe lengths depending on
probe.
The probe length is within the range of the
subject device |
| Cable/ Lead Wire Length | 2.5m | Exhibits a range of Cable/Lead wire lengths
depending on probe.
The Cable/Lead Wire Length is within the range
of the subject device. |
| Uncoated Conducting Surface
Area | 27mm2 | Exhibits a range of Conducting Surface Areas.
Smallest Conducting Surface Area is less than
the subject device . |
| Tip Diameter/ Exposure | 3.0mm | Exhibits a range of Tip Diameter/Exposures
depending on probe.
The Tip Diameter/Exposure is within the range
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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