The NIM™ Surgeon Control Probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Medtronic Xomed, Inc. NIM™ Surgeon Control Probes. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance testing. However, it does not contain information about an AI/ML-based medical device study.

The document details safety and effectiveness testing for a physical medical device (nerve stimulator probes), not a software algorithm that performs diagnostic or prognostic tasks. Therefore, many of the requested elements (like "AI vs without AI assistance," "ground truth," "training set," "multi reader multi case study," etc.) are not applicable to the information contained in this FDA clearance letter.

Based on the provided text, here's what can be extracted and what information is missing/not applicable:

1. A table of acceptance criteria and the reported device performance:

The document states that "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." It then lists the types of tests performed. It does not present a specific table with quantitative acceptance criteria and corresponding performance results. It generally states that the tests yielded "passing results."

Acceptance Criteria	Reported Device Performance
Functionality and intended use met in accordance with external standards and device specifications (pre-defined acceptance criteria)	Demonstrated "passing results" for all performance testing.
Compliance with ISO 11135:2014 for sterilization validation	Achieved sterilization validation.
Compliance with IEC 60601 for electrical safety & EMC testing	Achieved electrical safety & EMC compliance.
Compliance with ISO 10993-1:2018 for biocompatibility testing and risk analysis	Achieved biocompatibility and risk analysis compliance.
Stability testing for proposed shelf life	Stability confirmed for proposed shelf life.
Packaging performance to ISTA 3A and ASTM D4169	Packaging performance validated for environmental conditioning and distribution simulation.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: The document mentions "Bench engineering test samples" but does not specify the sample size for any of the performance tests.
Data Provenance: Not applicable in the context of this device's testing. The testing appears to be primarily lab-based engineering performance testing of physical prototypes, not data collection from patients or medical images. It's not a retrospective or prospective study on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualification of those experts:

Not applicable. This device is hardware for stimulating nerves, not an AI system requiring expert consensus for a "ground truth" diagnosis or image interpretation. The "ground truth" for this device's performance would be engineering specifications and standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This study is not evaluating expert interpretation of medical data. Performance is evaluated against objective 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:

No, this study was not conducted. The device is a surgical tool, not an AI software designed to assist human readers (e.g., radiologists) in interpreting cases.

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

Not applicable. This is a physical device, not an algorithm. Its performance is inherent to its design and manufacturing.

7. The type of ground truth used:

The "ground truth" for this type of device is compliance with established engineering and safety standards (e.g., IEC, ISO, ASTM) and the manufacturer's own pre-defined device specifications. It's not clinical diagnosis or outcomes data in the context of an AI study.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable. Because no AI/ML model training set is involved, this question is irrelevant to the provided document.

In summary: The provided FDA clearance letter is for a traditional hardware medical device (nerve stimulator probes) and describes its performance testing against engineering and safety standards to demonstrate substantial equivalence to predicate devices. It does not contain information related to the development or validation of an AI/ML-based medical device.

Summary

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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

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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

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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)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

I. SUBMITTER
Company (submitter):	Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216 USATelephone Number: (904) 296-9600
Date Prepared:	March 15, 2022
Contact Person:	Alexandra OliverSenior Regulatory Affairs SpecialistTelephone: (904) 332-8936Email 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 DisposablePrass Probe	November 20, 1987
K992869	Xomed MonopolarStimulator Probe	October 07, 1999

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IV. DEVICE DESCRIPTION

Device Description

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 ControlProbes(Subject Device(s))	Nicolet Disposable PrassProbe / K873964(Predicate Device)	Xomed MonopolarStimulator Probe /K992869(Predicate Device)
Product Code	ETN	ETN	ETN
RegulationNumber	21 CFR 874.1820	21 CFR 874.1820	21 CFR 874.1820
RegulationDescription	Surgical nervestimulator/locator	Surgical nervestimulator/locator	Surgical nervestimulator/locator
Classification	Class II	Class II	Class II
Common Name	Nerve Stimulator	Nerve Stimulator	Nerve Stimulator
Device Description	The NIM™ surgeoncontrol probes carrystimulation current fromthe patient interface tothe patient. It alsoenables the user to adjuststimulation current andkey functions from thesurgical site. All probesare single use devices.	The Prass Probes carrystimulation current fromthe console, via thePatient Interface, to thepatient [...] Theincrementing prass probesprovide the surgeon withthe means to adjust thestimulation current at thesurgical site.	The Monopolar Ball-TipStimulating Probescarry stimulation currentfrom the console, via thePatient Interface, to thepatient [...] Theincrementing probesprovide the surgeonwith the means to adjustthe stimulation currentat the surgical site.
Intended Use	The NIM™ surgeoncontrol probes areintended for use asintraoperative nervestimulators	This device is intendedfor use as anintraoperative motornerve stimulator with theNerve Integrity Monitor(NIM™)	To stimulate cranial andperipheral motor nervesfor location andidentification duringsurgery, including spinalnerve roots
Indications for Use	The NIM™ surgeoncontrol probes areintended to stimulate	This device is indicatedfor intraoperative motornerve monitoring	The Ball-Tip MonopolarStimulating Probe isintended to stimulate
Feature/Attribute	Surgeon ControlProbes(Subject Device(s))	Nicolet Disposable PrassProbe / K873964(Predicate Device)	Xomed MonopolarStimulator Probe /K992869(Predicate Device)
	cranial and peripheralmotor nerves for locationand identification duringsurgery, including spinalnerve roots	cranial and peripheralmotor nerves for locationand identification duringsurgery, including spinalnerve roots	cranial and peripheralmotor nerves forlocation andidentification duringsurgery, including spinalnerve roots
Contraindications	The NIM™ surgeoncontrol probes arecontraindicated for usewith paralyzinganesthetic agents whenmonitoring a motornerve as these mayreduce or eliminate thepatient's EMG response.	The NIM 3.0 iscontraindicated for usewith paralyzing anestheticagents that willsignificantly reduce, ifnot completely eliminate,EMG responses to director passive nervestimulation.	The NIM 3.0 iscontraindicated for usewith paralyzinganesthetic agents thatwill significantlyreduce, if notcompletely eliminate.EMG responses to director passive nervestimulation.
OperatingPrinciple	Electrical stimulation	Electrical stimulation	Electrical stimulation
Design	Offered in Prass-tip orBall-tip configurations	Prass-tip configuration	Ball-tip configuration
Probe tip (exposedarea) tissuecontact surfacegeometry	Probe Prass Tip: Flat•Probe Ball Tip:•1mm ball	Flat (Prass)	1mm ball
Probe workinglength	Probe Prass: 3.76"•[9.6cm]Probe Ball: 3.76"•[9.6cm]	3.76" [9.6cm]	3.76" [9.6cm]
Patient-contactingMaterials	303 Stainless Steel withXylamed coatinginsulation or TeflonPolytetrafluoroethylene(PTFE) coatinginsulation	303 Stainless Steel withXylamed coatinginsulation	303 Stainless Steel withTeflonPolytetrafluoroethylene(PTFE) coatinginsulation
Patient contact	Direct	Direct	Direct
Biocompatible	Yes	Not available	Yes
Sterile	Yes	Yes	Yes
Single-UseDisposable	Yes	Yes	Yes
Duration of Use	Limited (<24 hours)	Limited (<24 hours)	Limited (≤24 hours)

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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.

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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.

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.