Who is the manufacturer of Cadwell Guardian?

Cadwell Industries, Inc. filed the 510(k) submission for Cadwell Guardian (K230415).

What is the FDA product code for Cadwell Guardian?

GWF. It is classified under 21 CFR 882.1870 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Cadwell Guardian?

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

What are the predicate devices for Cadwell Guardian?

Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor (K162199); Inomed ISIS Headboxes and Neurostimulator (K212166).

Who can help prepare an FDA 510(k) submission like Cadwell Guardian?

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.

Cadwell Guardian

K230415 · Cadwell Industries, Inc. · GWF · Aug 17, 2023 · Neurology

Device Facts

Record ID	K230415
Device Name	Cadwell Guardian
Applicant	Cadwell Industries, Inc.
Product Code	GWF · Neurology
Decision Date	Aug 17, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1870
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing.

Device Story

Multi-modality intraoperative neurophysiological monitoring system; acquires, displays, and stores physiologic data from nerves, muscles, and CNS. Inputs: spontaneous or elicited signals via electrodes/stimulators. Components: Power Comm, Base Unit, amplifiers (up to 80 channels), electrical stimulators (TCS, MCS, LCS), auditory/visual stimulators. Operation: PC-based with Cascade Surgical Studio software (v4.0). Used in OR/clinical settings by physicians/surgeons/neurologists. Provides real-time monitoring and remote review. Output: visual display of waveforms (EP, EEG, ECoG, EMG, TcMEP, NCS, TOF). Clinical decision-making: assists in assessing nervous system integrity during surgery; helps prevent iatrogenic injury.

Clinical Evidence

Bench testing only. No clinical data. Verification and validation activities confirmed compliance with internal software, system, and usability requirements. Safety and performance established via adherence to standards: ES60601-1, IEC 60601-1-6, IEC 62304, IEC 80601-2-26, IEC 60601-2-40, and IEC 60601-1-2.

Technological Characteristics

PC-based system; Windows 10/11 OS. Modular hardware: Power Comm, Base Unit, 24-channel amplifiers, ES-10 stimulators, AVX stimulator, SMX-32 EEG amplifier. Connectivity: USB, Ethernet. Stimulation: electrical (TCS, MCS, LCS), auditory, visual. Software: Cascade Surgical Studio 4.0. Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304.

Indications for Use

Indicated for patients of all ages (newborn to geriatric, weight > 2.5 kg) requiring electroneurodiagnostic monitoring of peripheral sensory/motor nerves, muscles, and the central nervous system in professional healthcare facilities for pre-operative, intraoperative, and post-operative testing.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Predicate Devices

Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor (K162199)
Inomed ISIS Headboxes and Neurostimulator (K212166)

Reference Devices

Cadwell Industries, Inc. Cadwell Zenith System (K181466)
Cadwell Industries, Inc. Sierra Summit (K162383)
Nihon Kohden Neuromaster G1 Mee2000 (K142624)

Related Devices

K233292 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress · Inomed Medizintechnik GmbH · Oct 27, 2023
K162199 — Cascade IOMAX Intraoperative Monitor · Cadwell Industries, Inc. · Mar 2, 2017
K212166 — ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress · Inomed Medizintechnik GmbH · Jan 7, 2022
K984052 — SYNERGY IOM SYSTEM · Oxford Instruments Medical Systems · May 17, 1999
K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) · Soterix Medical, Inc. · Mar 25, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ August 17, 2023 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Cadwell Industries, Inc. Jason Ford Regulatory Affairs Manager 909 North Kellogg Street Kennewick, Washington 99336 ### Re: K230415 Trade/Device Name: Cadwell Guardian Regulation Number: 21 CFR §882.1870 Regulation Name: Evoked response electrical stimulator Regulatory Class: Class II Product Code: GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ Dated: July 20, 2023 Received: July 21, 2023 #### Dear Jason Ford: 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 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/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). Sincerelv. -2 # Patrick Antkowiak for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) Device Name Cadwell Guardian #### Indications for Use (Describe) The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results. {3}------------------------------------------------ Type of Use (Select one or both, as applicable) 区 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, sans-serif font. To the left of the word is a circular logo containing a heartbeat symbol. A registered trademark symbol is located to the right of the word. | Submitter: | Cadwell Industries, Inc. 909 N. Kellogg Street Kennewick, Washington 99336 509-735-6481 | |------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Jason Ford Email: jasonf@cadwell.com | | Date Prepared: | February 9, 2023 | | Trade Name: | Cadwell Guardian™ | | Regulation Name: | Evoked response stimulator | | Regulation Number: | 21 CFR §882.1870 | | Regulatory Classification: | Class II | | Product Codes: | GWF, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ | | Classification Panel: | Neurology | | Primary Predicate Device: | Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor Product Code: GWF, DQA, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ 510(k) Number: K162199 | | Secondary Predicate Device: | Inomed ISIS Headboxes and Neurostimulator Product Code: GWF, GWJ, GWQ, ETN, IKN 510(k) Number: K212166 | | Reference Predicate Devices: | Cadwell Industries, Inc. Cadwell Zenith System (K181466) Cadwell Industries, Inc. Sierra Summit (K162383) Nihon Kohden Neuromaster G1 Mee2000 (K142624) | | Device | The Cadwell Guardian is a multi-modality intraoperative neurophysiological | Description: monitoring system with up to 80 channels of data acquisition. {5}------------------------------------------------ The Guardian system is designed to be flexible and scalable depending on customer and procedural requirements. All systems require a Power Comm and Guardian Base, which contains an electrical Transcranial Stimulator. The user may select up to two Omni Amplifiers, two ES-10 electrical stimulators, one AVX auditory and visual stimulator, and one SMX-32 EEG amplifier that contains a low current electrical stimulator, in order to meet specific requirements. The Guardian requires a (PC) with Windows operating system. The Guardian system uses a new version (4.0) of previously cleared Cadwell Cascade Surgical Studio software. Surgical Studio acquires, stores and reviews a wide range of intraoperative neurophysiological data, such as EMG, EEG, SSEP, BAEP, VEP, MEP and TOF, and includes Report Generation. ### Indications for Use: The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TcMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. {6}------------------------------------------------ Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results. {7}------------------------------------------------ #### Technology Comparison: | Characteristics | Proposed Device Cadwell Guardian | Predicate Device Cadwell Cascade IOMAX (K162199) | Predicate Device Inomed ISIS (K212166) | Predicate Device Cadwell Zenith (K181466) | Discussion of Major Differences | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Guardian with Cascade Surgical Studio software is an electroneurodiagnostic device that acquires, displays, and stores physiologic data from peripheral sensory and motor nerves, muscles, and the central nervous system, generated either spontaneously or elicited by stimuli. Guardian can perform somatosensory, auditory, and visual evoked potentials (EPs), electroencephalography (EEG), electrocorticography (ECoG), spontaneous and triggered electromyography (EMG), transcranial motor evoked potentials (TCMEP), direct cortical stimulation (DCS), direct nerve stimulation (TEMG, DNS), nerve conduction studies (NCS), and Train of Four (TOF) analysis. Guardian can provide remote review outside of the operating room. Guardian is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional | The Cascade IOMAXTM Intraoperative Monitor with Surgical Studio software (IOMAX) is an electroneurodiagnostic device that acquires, displays and stores physiologic data from peripheral sensory and motor nerves, muscles and the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The acquired data are necessary to perform somatosensory, auditory and visual evoked potentials (EPs), electroencephalography (EEG), electromyography (EMG), transcranial motor evoked potentials (TcMEPs), direct cortical stimulation, nerve conduction studies and Train of Four (TOF) analysis. SpO2 measures and displays oxygen saturation and heart rate information. The system also delivers direct nerve stimulation required for specific surgical procedures. Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, displays, records, and stores the electrical activity of the | ISIS Headbox 5042XX: The products are intended for intraoperative neuromonitoring; for the recording of electrophysiological signals and stimulating nerve and muscle tissues. The products are intended for use in the operating room to measure and display the electrical signals generated by muscle, peripheral nerves, and the central nervous system. The products support the clinical application of Electroencephalography (EEG), Electromyography (EMG), Somatosensory Evoked Potentials (SEP), Motor Evoked Potentials (MEP), and Auditory Evoked Potentials (AEP). The products are not intended for monitoring life- sustaining functions. ISIS Neurostimulator 504180: The ISIS Neurostimulator is intended for the provision of neurophysiological stimulation when used in surgical procedures and for diagnostics. It is suitable for | The Cadwell Zenith is an electroneurodiagnostic device that accepts, measures, displays, records, and stores electrical activity of the brain via scalp and intracranial electroencephalography (EEG) signals, and, utilizing an integrated switch matrix, relays stimulation signals to the patient. It can obtain, display and store electrophysiological data from the central nervous system, generated either spontaneously or elicited by well-defined stimuli. The data is used to perform neurodiagnostic evaluations, including EEG and direct cortical stimulation. Zenith is used with Cadwell acquisition software. Zenith is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre- operative, intraoperative | The indications for use between the proposed device and the predicates have no substantive differences. The proposed device does not include SpO2 because this measurement is not a customer requirement. The proposed device describes the use of ECoG, which was previously described in general terms under EEG in the predicate device IFU. EEG and ECoG are listed separately to differentiate between direct brain recording and scalp recording, however both are recordings obtained from 2 or more electrodes attached to the patient head, as described in the predicate device IFU. These differences in the proposed device do not raise new questions of safety or effectiveness, and is therefore considered substantially equivalent. | | Characteristics | Proposed Device Cadwell Guardian | Predicate Device Cadwell Cascade IOMAX (K162199) | Predicate Device Inomed ISIS (K212166) | Predicate Device Cadwell Zenith (K181466) | Discussion of Major Differences | | healthcare facility environment for pre-operative, intraoperative and post-operative testing. The following functions are specifically supported individually or in combination: Evoked Potentials (EPs): Guardian can provide electrical, auditory, and visual stimulation and measure, display, record, and store the electrical activity of the nervous system in response to the stimulations delivered. Electroencephalography (EEG): Guardian can measure, display, record, and store electrical activity of the brain from two or more electrodes on the scalp. Electrocorticography (ECoG): Guardian can measure, display, record, and store electrical activity directly from the brain using two or more electrodes. Free Run Electromyography (EMG): Guardian can acquire, display, record, and store EMG activity of motor nerves. Triggered Electromyography (TEMG): Guardian can electrically stimulate motor nerves, and display, record, and store the results. | nervous system in response to the stimulation. EEG: IOMAX measures, displays, records, and stores electrical activity of the brain from two or more electrodes on the head. Free Run EMG: IOMAX acquires, displays, records, and stores spontaneous EMG activity of motor nerves by continually displaying a live stream of mechanically induced myotome contractions. Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle. TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs for intraoperative assessment. Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex. Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores sensory and motor nerve conduction time (latency) by applying a stimulus to | continuous operation and can be used in the following fields: Transcranial electrical stimulation (TES) Direct cortical stimulation (DCS) Direct nerve stimulation (DNS) Transcutaneous electrical nerve stimulation (TNS) Direct muscle stimulation (DMS) | and post-operative testing on patients of all ages. | | | | Characteristics | Proposed Device Cadwell Guardian | Predicate Device Cadwell Cascade IOMAX (K162199) | Predicate Device Inomed ISIS (K212166) | Predicate Device Cadwell Zenith (K181466) | Discussion of Major Differences | | | Transcranial Motor Evoked Potentials (TcMEP): Guardian can deliver electrical transcranial stimulation, and display, record, and store the results. Direct Cortical Stimulation (DCS): Guardian can deliver electrical stimulation to various areas of the cerebral cortex, and display, record, and store the results. Direct Nerve Stimulation (DNS): Guardian can electrically stimulate cranial and peripheral nerves, and display, record, and store the results. Nerve Conduction Study (NCS): Guardian can measure, display, record, and store sensory and motor nerve conduction time (latency) by applying a stimulus to peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF): Guardian can deliver a train of four pulses, and measure, display, record, and store the results. | peripheral nerves, the spinal cord, and the central nervous system. Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, displays, records, and stores the compound muscle action potential amplitude fade for analysis. SpO2: IOMAX measures and displays oxygen saturation and heart rate information Remote Reader: IOMAX provides passive, real time remote review of intraoperative monitoring for a physician outside of the operating room. IOMAX is used by or under the direction of a licensed physician, surgeon, or neurologist in a professional healthcare facility environment for pre-operative, intraoperative and post-operative testing. | | | | | Population | Age: Newborn to geriatric Weight: > 2.5 kg | Age: Newborn to geriatric Weight: > 2.5 kg | None stated. | Patients of all ages. | No significant difference. | | Modalities | Evoked potential (EP) in the form of: • Brainstem auditory | Evoked potential (EP) in the form of: • Brainstem auditory | EEG, EMG, SEP, MEP, AEP, TES, DCS, DNS, TNS, DMS | Electroencephalogram (EEG) External cortical | Guardian does not include SpO2. These differences in the proposed device do not raise new questions of safety or | | Characteristics | Proposed Device Cadwell Guardian | Predicate Device Cadwell Cascade IOMAX (K162199) | Predicate Device Inomed ISIS (K212166) | Predicate Device Cadwell Zenith (K181466) | Discussion of Major Differences | | | Visual Somatosensory Transcranial electrical motor evoked potential (TcMEP) Electromyography (EMG) Electroencephalogram (EEG) Electrocorticography (EcoG) Nerve conduction studies (NCS) including: NCV F wave H reflex Train of four (TOF) Photic Stimulation Threshold mode Direct cortical stimulation Direct nerve stimulation | Visual Somatosensory Transcranial electrical motor evoked potential (TcMEP) Electromyography (EMG) Electroencephalogram (EEG) Nerve conduction studies in the form of: NCV F wave H reflex Train of four (TOF) SpO2 and heart rate values Threshold mode Direct cortical Stimulation | | stimulation Photic stimulation Video | effectiveness, and is therefore considered substantially equivalent. | | System Configuration | Computer based equipment with dedicated hardware peripherals/ components, and custom acquisition software. USB cable connected from base unit to computer Modules interconnected via interconnect cables (ethernet, multi-pin)…