NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long

Q: Who is the manufacturer of NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

Medtronic Xomed, Inc. filed the 510(k) submission for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long (K213246).

Q: What is the FDA product code for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

Q: What is the regulatory pathway for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

Nicolet Disposable Prass Probe (K873964); Xomed Monopolar Stimulator Probe (K992869).

Q: Who can help prepare an FDA 510(k) submission like NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K213246 · Medtronic Xomed, Inc. · ETN · Mar 21, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K213246
Device Name	NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long
Applicant	Medtronic Xomed, Inc.
Product Code	ETN · Ear, Nose, Throat
Decision Date	Mar 21, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators.

Device Story

NIM™ Surgeon Control Probes are single-use, sterile, handheld surgical instruments used to deliver electrical stimulation to cranial and peripheral motor nerves. Operated by surgeons in an OR setting, these probes connect to a patient interface to facilitate nerve location and identification. The device features integrated controls allowing the surgeon to adjust stimulation current and key functions directly from the surgical site. By providing controlled electrical pulses, the probe helps surgeons map nerve pathways, potentially reducing the risk of nerve damage during procedures. The device is available in Prass-tip or Ball-tip configurations.

Clinical Evidence

Bench testing only. Testing included electromechanical, dimensional, and visual design performance; sterilization validation (ISO 11135:2014); electrical safety/EMC (IEC 60601); biocompatibility (ISO 10993-1:2018); shelf-life stability; and packaging/distribution testing (ISTA 3A, ASTM D4169).

Technological Characteristics

Materials: 303 Stainless Steel with Xylamed or PTFE coating. Principle: Electrical nerve stimulation. Form factor: Handheld probe with Prass-tip or 1mm Ball-tip. Connectivity: Wired connection to patient interface/console. Sterilization: Ethylene oxide (ISO 11135:2014).

Indications for Use

Indicated for stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. Contraindicated for use with paralyzing anesthetic agents that may reduce or eliminate patient EMG response.

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

Nicolet Disposable Prass Probe (K873964)
Xomed Monopolar Stimulator Probe (K992869)

Related Devices

K231580 — NIM 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) · Medtronic Xomed, Inc. · Aug 30, 2023
K062549 — XLTEK STIMULATOR PROBES, MODELS 105233, 105234, 105235, 105236, 105237 AND 105238 · Excel Tech. , Ltd. · Oct 4, 2006
K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT · Rhythmlink International, LLC · Sep 22, 2011
K133348 — STIM PROBE · Spes Medica Srl · Nov 21, 2014
K103128 — CADWELL DISPOSABLE MONOPOLAR / BIPOLAR / CONCENTRIC / FLUSH TIP /BALL TIP PEDICLE SCREW STIMULATOR PROBE, · Cadwell Lab, Inc. · Feb 23, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. March 21, 2022 Medtronic Xomed, Inc. Alexandra Oliver Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville. Florida 32216 Re: K213246 Trade/Device Name: NIM™ Surgeon Control Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: February 23, 2022 Received: February 25, 2022 ### Dear Alexandra Oliver: 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 {1}------------------------------------------------ 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/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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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 Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213246 Device Name NIM™ Surgeon Control Probes Indications for Use (Describe) The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X 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." {3}------------------------------------------------ # 510(k) Summary | I. SUBMITTER | | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | Company (submitter): | Medtronic Xomed, Inc. 6743 Southpoint Drive North Jacksonville, Florida 32216 USA Telephone Number: (904) 296-9600 | | Date Prepared: | March 15, 2022 | | Contact Person: | Alexandra Oliver Senior Regulatory Affairs Specialist Telephone: (904) 332-8936 Email Address: Alexandra.j.oliver@medtronic.com | ## II. DEVICE | Proprietary (Trade) Name: | NIM™ Surgeon Control Probes | |---------------------------|-----------------------------------| | Common Name: | Stimulator, nerve | | Regulation Name: | Surgical nerve stimulator/locator | | Regulation Number: | 21 CFR 874.1820 | | Product Code: | ETN | | Classification: | II | | Panel: | 77 (Ear, Nose, & Throat) | #### III. PREDICATE DEVICE(s) The NIM™ Surgeon Control Probes are substantially equivalent in intended use and technological characteristics to the following predicate devices: | 510(k) Number | 510(k) / Device Name | 510(k) Clearance Date | |---------------|-------------------------------------|-----------------------| | K873964 | Nicolet Disposable Prass Probe | November 20, 1987 | | K992869 | Xomed Monopolar Stimulator Probe | October 07, 1999 | {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION #### Device Description The NIMTM surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices. #### Intended Use The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators. #### V. INDICATIONS FOR USE #### Indications for Use The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots. #### VI. SUBSTANTIAL EQUIVALENCE #### Substantial Equivalence/Device Comparison (Subject Device(s) to Predicate Devices) | Feature/Attribute | Surgeon Control Probes (Subject Device(s)) | Nicolet Disposable Prass Probe / K873964 (Predicate Device) | Xomed Monopolar Stimulator Probe / K992869 (Predicate Device) | |-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | ETN | ETN | ETN | | Regulation Number | 21 CFR 874.1820 | 21 CFR 874.1820 | 21 CFR 874.1820 | | Regulation Description | Surgical nerve stimulator/locator | Surgical nerve stimulator/locator | Surgical nerve stimulator/locator | | Classification | Class II | Class II | Class II | | Common Name | Nerve Stimulator | Nerve Stimulator | Nerve Stimulator | | Device Description | The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices. | The Prass Probes carry stimulation current from the console, via the Patient Interface, to the patient [...] The incrementing prass probes provide the surgeon with the means to adjust the stimulation current at the surgical site. | The Monopolar Ball-Tip Stimulating Probes carry stimulation current from the console, via the Patient Interface, to the patient [...] The incrementing probes provide the surgeon with the means to adjust the stimulation current at the surgical site. | | Intended Use | The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators | This device is intended for use as an intraoperative motor nerve stimulator with the Nerve Integrity Monitor (NIM™) | To stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | | Indications for Use | The NIM™ surgeon control probes are intended to stimulate | This device is indicated for intraoperative motor nerve monitoring | The Ball-Tip Monopolar Stimulating Probe is intended to stimulate | | Feature/Attribute | Surgeon Control Probes (Subject Device(s)) | Nicolet Disposable Prass Probe / K873964 (Predicate Device) | Xomed Monopolar Stimulator Probe / K992869 (Predicate Device) | | | cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | | Contraindications | The NIM™ surgeon control probes are contraindicated for use with paralyzing anesthetic agents when monitoring a motor nerve as these may reduce or eliminate the patient's EMG response. | The NIM 3.0 is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate, EMG responses to direct or passive nerve stimulation. | The NIM 3.0 is contraindicated for use with paralyzing anesthetic agents that will significantly reduce, if not completely eliminate. EMG responses to direct or passive nerve stimulation. | | Operating Principle | Electrical stimulation | Electrical stimulation | Electrical stimulation | | Design | Offered in Prass-tip or Ball-tip configurations | Prass-tip configuration | Ball-tip configuration | | Probe tip (exposed area) tissue contact surface geometry | Probe Prass Tip: Flat • Probe Ball Tip: • 1mm ball | Flat (Prass) | 1mm ball | | Probe working length | Probe Prass: 3.76" • [9.6cm] Probe Ball: 3.76" • [9.6cm] | 3.76" [9.6cm] | 3.76" [9.6cm] | | Patient-contacting Materials | 303 Stainless Steel with Xylamed coating insulation or Teflon Polytetrafluoroethylene (PTFE) coating insulation | 303 Stainless Steel with Xylamed coating insulation | 303 Stainless Steel with Teflon Polytetrafluoroethylene (PTFE) coating insulation | | Patient contact | Direct | Direct | Direct | | Biocompatible | Yes | Not available | Yes | | Sterile | Yes | Yes | Yes | | Single-Use Disposable | Yes | Yes | Yes | | Duration of Use | Limited (<24 hours) | Limited (<24 hours) | Limited (≤24 hours) | {5}------------------------------------------------ #### Substantial Equivalence Discussion A comparison of technological characteristics was provided in the submission to establish substantial equivalence. Both the subject device(s) and the predicate device(s) share similar characteristics (design, materials, operating principle, energy source, and performance). The similar characteristics do not raise different questions of safety and effectiveness. {6}------------------------------------------------ #### VII. PERFORMANCE DATA #### Performance Testing Discussion Design performance testing was completed to ensure the functionality and intended use of the NIM™ Surgeon Control Probes was met in accordance with external standards, and device specifications via pre-defined acceptance criteria. Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data. The testing included in this submission provides objective evidence through passing results that key technological characteristics such as the ones listed below are proven to be safe and effective. This performance testing was used to support substantial equivalence, proving the subject device(s) are as safe and effective as their predicate devices. - . Electromechanical, dimensional, and visual design performance - Sterilization validation to ISO 11135:2014 - Electrical safety & EMC testing to IEC 60601 - Biocompatibility testing and risk analysis to ISO 10993-1:2018 - Stability testing of proposed shelf life ● - Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169 ### VIII. CONCLUSION ### Conclusion Utilizing FDA's Guidance for Industry and Food and Drug Administration Staff, "Format for Traditional and Abbreviated 510(k)s" issued on September 13, 2019, a comparison of key performance characteristics demonstrates that the subject device(s), the NIM™ Surgeon Control Probes do not raise different questions of safety and effectiveness compared to the predicate device(s). The NIM™ Surgeon Control Probes are proven to be as safe and effective as their legally marketed predicate devices. The design performance testing has also demonstrated that the NIM™ Surgeon Control Probes perform as well as the predicates.