NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 30, 2023 Medtronic Xomed, Inc. Alexandra Oliver Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216 Re: K231580 Trade/Device Name: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 30, 2023 Received: May 31, 2023 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 app roval 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 801): medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 (OS) 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 medical devices and radiation-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/cdrl-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. Shuchen Peng -S 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231580 Device Name NIM™ 35cm long Surgeon Control Probe Indications for Use (Describe) The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------|----------------------------------------------------------------| | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 - K231580 #### I. SUBMITTER | Company (submitter): | Medtronic Xomed, Inc.<br>6743 Southpoint Drive North<br>Jacksonville, Florida 32216 USA<br>Telephone Number: (904) 296-9600 | |----------------------|------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | May 19, 2023 | 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™ 35cm long Surgeon Control Probe | |---------------------------|--------------------------------------| | 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 35cm long NIM™ Surgeon Control Probe is substantially equivalent in intended use and technological characteristics to the following predicate device: | 510(k) Number | 510(k) / Device<br>Name | 510(k) Clearance<br>Date | |---------------|---------------------------------|--------------------------| | K213246 | NIMTM Surgeon<br>Control Probes | March 21, 2022 | {4}------------------------------------------------ ### IV. DEVICE DESCRIPTION #### 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. ### Intended Use The NIMTM 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 via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA. ### VI. SUBSTANTIAL EQUIVALENCE #### Substantial Equivalence/Device Comparison (Subject Device(s) to Predicate Devices) | Feature/Attribute | 35cm long Surgeon Control Probe<br>(Subject Device(s)) | Surgeon Control Probes, K213246<br>(Predicate Device) | Comparison | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | ETN | ETN | SAME | | Regulation Number | 21 CFR 874.1820 | 21 CFR 874.1820 | SAME | | Regulation Description | Surgical nerve stimulator/locator | Surgical nerve stimulator/locator | SAME | | Classification | Class II | Class II | SAME | | Common Name | Nerve Stimulator | Nerve Stimulator | SAME | | 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 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. | SAME | | Intended Use | The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators | The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators | All probes are intended for the SAME use, as an intraoperative nerve stimulator. | | Indications for Use | The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including | The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots | The subject device's extended length is to accommodate TOETVA as a minimally invasive approach. The | | Feature/Attribute | 35cm long Surgeon Control Probe<br>(Subject Device(s)) | Surgeon Control Probes, K213246<br>(Predicate Device) | Comparison | | | spinal nerve roots via<br>minimally invasive Transoral<br>endoscopic thyroidectomy via<br>vestibular approach -<br>TOETVA | | usability study on the<br>NIM 35cm long probe<br>shows this probe<br>length is suitable for<br>use in a TOETVA<br>approach. | | Contraindications | The NIM™ surgeon control<br>probes are contraindicated for<br>use with paralyzing anesthetic<br>agents when monitoring a<br>motor nerve as these may<br>reduce or eliminate the<br>patient's EMG response. | The NIM™ surgeon control<br>probes are contraindicated for<br>use with paralyzing anesthetic<br>agents when monitoring a<br>motor nerve as these may<br>reduce or eliminate the<br>patient's EMG response. | SAME | | Operating<br>Principle | Electrical stimulation | Electrical stimulation | SAME | | Design | Offered in a ball-tip<br>configuration with insulated<br>shaft and permanently molded<br>incrementing (stim) handle for<br>use in the sterile field | Offered in prass-tip or ball-tip<br>configurations; both with<br>insulated shaft and<br>permanently molded<br>incrementing (stim) handle for<br>use in the sterile field | SAME | | Probe tip (exposed<br>area) tissue<br>contact surface<br>geometry | 1mm ball | 1mm ball | SAME (for ball-tip<br>geometries<br>respectively) | | Probe working<br>length | 13.78" [35.0 cm] | 3.76" [9.6cm] | The 35 cm Ball Tip<br>probe has a longer<br>length for extended<br>reach. The patient<br>contacting surfaces<br>and stimulation<br>performance is<br>unaffected by this<br>modification to the<br>length. | | Patient-contacting<br>Materials | 303 Stainless Steel with Teflon<br>Polytetrafluoroethylene<br>(PTFE) coating insulation | 303 Stainless Steel with<br>Xylamed coating insulation or<br>Teflon Polytetrafluoroethylene<br>(PTFE) coating insulation | SAME (for ball-tip<br>materials respectively) | | Patient contact | Direct | Direct | SAME | | Biocompatible | Yes | Yes | SAME | | Sterile | Yes | Yes | SAME | | Single-Use<br>Disposable | Yes | Yes | SAME | | Duration of Use | Limited (<24 hours) | Limited (<24 hours) | SAME | {5}------------------------------------------------ # Substantial Equivalence Discussion A comparison of technological characteristics was provided in the submission to establish substantial equivalence. Both the subject device and the predicate device(s) share the same design, {6}------------------------------------------------ materials, operating principle, energy source, and performance characteristics, in addition to identical intended use to stimulate cranial and peripheral motor nerves for location and identification during surgery. Furthermore, NIM™ surgeon control probes ball-tip geometry and biocompatibility mirror the predicate device(s). The subject device differs from the predicate device to accommodate TOETVA as a minimally invasive approach. The subject device probe working length is 35cm (vs 9.6cm for the predicate), and the indications for use explicitly provide for TOETVA. Usability testing performed on the 35cm long probe demonstrated that the subject device is suitable for its intended use and does not compromise the safety or performance of the subject device relative to the predicate. Therefore, the NIM™ 35cm long Surgeon Control Probe is substantially equivalent to its legally marketed predicate device. # VII. PERFORMANCE DATA # Performance Testing Discussion Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe 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 is as safe and effective as its predicate device. - 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 - Usability testing to IEC 62366-1:2015 ● # 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, the 35cm long NIM™ Surgeon Control Probe is substantially equivalent to the predicate device(s). The 35cm long NIM™ Surgeon Control Probe has been proven to be as safe and effective as its legally marketed predicate device. The design performance testing has demonstrated that the NIM 35cm long Surgeon Control {7}------------------------------------------------ Probe is equivalent to the predicate for delivering current for nerve stimulation. The usability study on the NIM 35cm long probe shows this probe length is suitable for use in a TOETVA approach.