The Cascade IOMAX™ 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 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, and stores the electrical activity of the 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.

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.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

Nerve Conduction Study (NCS): IOMAX measures, displays, records, and stores 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) or Twitch Test: IOMAX delivers a train of four pulses and measures, 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.

Device Description

The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

. Evoked potential (EP) in the form of:
- Brainstem auditory (BAEP): O
- Visual (VEP); and O
- Somatosensory (SSEP). O
Transcranial electrical motor evoked potential (TcMEP).
Electromyography (EMG). ●
Triggered EMG.
Electroencephalogram (EEG). ●
Nerve conduction studies.
Train of four (TOF). ●
SpO2 and heart rate values. ●
Threshold mode. ●
Cortical stimulation.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Cadwell IOMAX Intraoperative Monitor:

Acceptance Criteria and Reported Device Performance

The provided document describes the Cadwell IOMAX Intraoperative Monitor, an electroneurodiagnostic device. The acceptance criteria are broadly focused on the device's technical performance, safety, and compliance with various medical device standards. The document does not present specific quantitative acceptance criteria or reported performance values in a distinct table format. Instead, it states that "Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards." and "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard."

However, we can infer the categories of acceptance criteria based on the performance testing summary. The reported device performance is generally a statement of compliance.

Acceptance Criteria Category	Reported Device Performance
Biocompatibility	Accessories (SpO2 sensor) verified to be biocompatible in accordance with ISO 10993-1:2009. The core IOMAX device has no patient contact materials.
Software	Software designed and developed according to a robust software development process, rigorously verified and validated. Complies with predetermined specifications and applicable FDA guidance documents and IEC 62304:2006.
Electrical Safety	Complies with ANSI/AAMI ES60601-1:2005 and IEC 60529:1989 (and amendments/corrigenda).
Electromagnetic Compatibility	Complies with IEC 60601-1-2:2014.
Performance Testing – Bench	Complies with internal requirements and standards including IEC 60068-2-27, IEC 60068-2-64, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366, and ISO 80601-2-61.
Performance Testing – Clinical	Complies with the applicable requirements of ISO 80601-2-61:2011 for pulse oximeter equipment.

Study Details:

The provided document summarizes various tests rather than detailing a single "study" as one might expect for a clinical trial. However, it does outline the testing performed to demonstrate compliance.

Sample size used for the test set and the data provenance:
- Biocompatibility: Not explicitly stated as a "sample size" for a test set in the clinical sense. The verification was on "component materials" of accessories. Data provenance is implied to be laboratory testing of materials.
- Software, Electrical Safety, EMC, Bench Performance: Not applicable in terms of patient sample size. These involve engineering and laboratory testing of the device itself.
- Clinical Performance (SpO2): The document states "Clinical results indicate that the IOMAX complies with the applicable requirements of the standard [ISO 80601-2-61:2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment]". This standard defines requirements for pulse oximeters, which would necessitate testing on human subjects. However, the specific sample size for this clinical testing is not provided in the given text. The data provenance is clinical testing against a standard. The country of origin is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The testing described is primarily technical compliance with standards, and clinical performance for SpO2 which refers to a standard directly. There is no mention of independent expert review or ground truth establishment in the traditional sense for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided and is unlikely to be applicable for the types of compliance testing described here. Adjudication methods are typically used for medical image interpretation or diagnostic accuracy studies involving human readers.
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 MRMC comparative effectiveness study was done or mentioned. This device is an intraoperative monitor and stimulator; it is not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting cases with or without AI assistance. Therefore, no effect size of human improvement with AI assistance is applicable or provided.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The IOMAX is an electroneurodiagnostic device that acquires and displays physiological data. Its "performance" is based on the accuracy and reliability of its measurements and stimulation. The testing described (electrical safety, EMC, bench, and clinical for SpO2) assesses the device's inherent function, which is essentially "standalone performance" in the sense that the device directly performs the measurement or stimulation. It doesn't involve an "algorithm" in the AI sense, but rather the hardware and software's ability to accurately capture and present physiological signals or deliver specific stimuli.
- The clinical performance for SpO2 (compliance to ISO 80601-2-61) is a test of the device's standalone accuracy in measuring oxygen saturation and heart rate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical compliance tests (biocompatibility, software, electrical safety, EMC, bench performance), the "ground truth" is defined by the requirements of the specified industry standards (e.g., ISO 10993-1, ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 60068, IEC 60601-2-26, IEC 60601-2-40, IEC 60601-1-6, IEC 62366). The device's output is compared against the expected performance defined by these standards.
- For the clinical performance testing for SpO2, the ground truth would be established by a reference method or device as required by ISO 80601-2-61, which typically involves comparing the pulse oximeter's readings against arterial blood gas analysis results.
The sample size for the training set:
- This information is not applicable as the device is not described as an AI/machine learning device that requires a training set in the conventional sense. The "training set" for software development would be the requirements and specifications used during its creation, rather than a dataset for statistical model training.
How the ground truth for the training set was established:
- As the concept of a "training set" for an AI model is not applicable here, the establishment of ground truth for such a set is also not applicable. The software's "ground truth" during development would be its specified functional requirements.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2017

Cadwell Industries, Inc. Melissa Kirkup Ionm Product Manager 909 North Kellogg Street Kennewick, Washington 99336

Re: K162199

Trade/Device Name: Cascade IOMAX Intraoperative Monitor Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, DQA, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT Dated: February 27, 2017 Received: February 28, 2017

Dear Ms. Kirkup:

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 -S

Carlos L. Peña. PhD. MS for 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) K162199/S002

Device Name Cascade IOMAX Intraoperative Monitor

Indications for Use (Describe)

Evoked Potentials (EPs): IOMAX provides electrical, auditory or visual stimulation and measures, and stores the electrical activity of the 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.

Train of Four (TOF) or Twitch Test: IOMAX delivers a train of four pulses and measures, and stores the compound muscle action potential amplitude fade for analysis.

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.

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Submission Date:	01 March 2017
Submitter:	Cadwell Industries, Inc.909 North Kellogg StreetKennewick, WA 99336
Submitter andApplicationCorrespondent	Ms. Melissa Kirkup, Au.D. CNIMPhone: +1 (509) 735-6481, extension 226Email: melissak@cadwell.com
Manufacturing Site:	Cadwell Industries, Inc.909 North Kellogg StreetKennewick, WA 99336
Trade Name:	Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor
Common andClassificationName:	Evoked response stimulator and intraoperative monitor
ClassificationRegulation:	21 CFR §882.1870, 21 CFR §870.2700; 21 CFR §874.1820,21 CFR 882.1890, 21 CFR §882.1900, 21 CFR §882.1400,21 CFR §882.1540, 21 CFR §890.1375, 21 CFR §882.1550
Product Code:	GWF, DQA, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT
SubstantiallyEquivalent Devices:		Predicate510(k) Number	PredicateManufacturer / Model
	Predicate Device:	K142624	Nihon Kohden Corporation/ Neuromaster G1Mee2000
	Reference Devices:	K971214	Cadwell Laboratories, Inc. / Kilowin
		K020400 K040358	MEPS, LLC / DigitimerD185 Multipulse CorticalStimulatorExcel Tech Ltd. / XltekProtektor Stimulator,Models 10247 & 10248
SubstantiallyEquivalent Devices(cont):	New Cadwell Model	Predicate510(k) Number	PredicateManufacturer / Model
		K051357	Digitimer Ltd. / DS7AConstant Current HighVoltage Stimulator, ModelDS7A; DS7AH ConstantCurrent High VoltageStimulator, Model DS7AH
		K072964	Cardinal Health, Inc. /Nicolet Cortical Stimulator
		K083124	Medtronic Xomed, Inc. /NIM 3.0
		K093304	Natus Medical, Inc. /Protektor 32
		K112718	NuVasive, Inc. / NuVasiveNVM5 System
		K120979	CareFusion 209, Inc. /CareFusion Nicolet EDX
		K141105	Hunan Accurate Bio-medical Technology Co.,Ltd. / Pulse Oximeter
		K143641	NuVasive, Inc., / NuVasiveNVM5 System
		K152563	Beijing Choice ElectronicTechnology Co., Ltd. /Pulse Oximeter(MD300M/MD300K2)

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Device Description: The IOMAX is a multimodality intraoperative neuromonitoring (IONM) system. It consists of Cadwell custom hardware, a standard laptop or desktop personal computer (PC) running a standard off-the-shelf (OTS) operating system (OS), and Cadwell custom software.

The modalities recorded, measured and displayed by the IOMAX are:

. Evoked potential (EP) in the form of:
- Brainstem auditory (BAEP): O
- Visual (VEP); and O
- Somatosensory (SSEP). O
Transcranial electrical motor evoked potential (TcMEP).
Electromyography (EMG). ●
Triggered EMG.
Electroencephalogram (EEG). ●
Nerve conduction studies.
Train of four (TOF). ●
SpO2 and heart rate values. ●
Threshold mode. ●
Cortical stimulation.

Indications for Use:

The Cascade IOMAX™ 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 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.

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Indications for Use: TcMEP: IOMAX delivers transcranial stimulation via dedicated outputs (continued) for intraoperative assessment.

Cortical Stimulation: IOMAX delivers Low Current Stimulation (LCS) during surgical procedures to map various areas of the cortex.

Triggered EMG (TEMG): IOMAX electrically stimulates the motor nerves, and displays, records, and stores the resulting compound muscle action potentials in the innervated muscle.

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.

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Technology Comparison:

The IOMAX employs the same technological characteristics as the predicate device.

Characteristic	Predicate Device	Proposed Device
Modalities	Evoked potential (EP) in the formof:• Brainstem auditory• Visual• SomatosensoryTranscranial electrical motor evokedpotential (TcMEP)Electromyography (EMG)Electroencephalogram (EEG)Nerve conduction velocity in theform of:• NCV• F wave• H reflexTrain of four (TOF)SpO2 analysesEtCO2 analysesThreshold mode	Evoked potential (EP) in the formof:• Brainstem auditory• Visual• SomatosensoryTranscranial electrical motor evokedpotential (TcMEP)Electromyography (EMG)Electroencephalogram (EEG)Nerve conduction studies in theform of:• NCV• F wave• H reflexTrain of four (TOF)SpO2 and heart rate valuesThreshold mode
SystemConfiguration	Computer based equipment withdedicated hardwareperipherals/components	Same
Input Boxes(Breakout Boxes)	1, 2, 3, or 4	One (1) Cortical ModuleUp to four (4) Limb Modules
Stimulation Pods	1, 2, 3, or 4 within low-level	High: Up to four (4) Limb ModulesLow: One (1) Cortical Module
Number ofAmplifierChannels	32	Up to 48
TcMEP ControlBox	1	One (1) Cortical Module
Footswitch	Available	Not available.
Vital Signs	Temperature, SpO2, EtCO2	SpO2 and heart rate (HR)
Output Type	1 for high or low output, 1 forTcMEP output	High: 1Low: 1TcMEP: 1
Output Modes	Constant current or voltage	High: Constant currentLow: Constant currentTcMEP: Constant current or voltage

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Summary of Performance Testing:

Biocompatibility The IOMAX has no patient contact materials, and therefore this section does not apply to them.

The SpO2 sensor and accessories for use with the IOMAX have patient contact materials and are made from medical grade biocompatible materials.

The appropriate component materials for these accessories were verified to be biocompatible in accordance with the following standard:

ISO 10993-1: 2009, Biological evaluation of medical devices Part . 1: Evaluation and testing within a risk management process.
Verification results indicate that the appropriate component materials comply with the standard.

The Cadwell Surgical Studio software contains MODERATE level of Software concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents:

FDA guidance: The content of premarket submissions for software ● contained in medical devices, 11 May 05.
FDA guidance: Off-the-shelf software use in medical devices, 09 Sep ● 99.
FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02.
FDA guidance: Content of premarket submissions for management of . cybersecurity in medical devices, 02 Oct 14.
· IEC 62304: 2006, Medical device software Software life cycle processes

Test results indicate that the Cadwell Surgical Studio software complies with its predetermined specifications and the applicable guidance documents.

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Electrical Safety	The IOMAX was tested for performance in accordance with the following standard:ANSI/AAMI ES60601-1: 2005/(R)2012, C1:2009/(R)2012, A2:2010/(R)2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. IEC 60529: 1989, Am1: 1999, Am2: 2013, Cor2: 2015, Degrees of protection provided by enclosures (IP 67). Test results indicate that the IOMAX complies with the applicable standards.
ElectromagneticCompatibility	The IOMAX was tested for performance in accordance with the following standard:IEC 60601-1-2: 2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests. Test results indicate that the IOMAX complies with the applicable standards.
PerformanceTesting – Bench	The IOMAX was tested for performance in accordance with internal requirements and the following standards: IEC 60068-2-27: 2008, Environmental testing – Part 2-27: Tests – Test Ea and guidance: Shock IEC 60068-2-64: 2008, Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs IEC 60601-2-40: 1998, Medical electrical equipment – Part 2-40: Particular requirements for the safety of electromyographs and evoked response equipment IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices. ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment Test results indicate that the IOMAX complies with its predetermined specifications and the applicable standards.
Performance Testing – Clinical:	The IOMAX was tested for clinical performance in accordance with the following standard:• ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipmentClinical results indicate that the IOMAX complies with the applicable requirements of the standard.
Conclusion	Verification and validation activities were conducted to establish the performance and safety characteristics of the IOMAX. The results of these activities demonstrate that the IOMAX is as safe, as effective, and performs as well as or better than the predicate devices.Therefore, the IOMAX is considered substantially equivalent to the predicate devices.

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Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
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.(b)
Classification. Class II (performance standards).