Cascade IOMAX Intraoperative Monitor

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is an image of three human profiles facing to the right, with the profiles overlapping each other. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K162199/S002 Device Name Cascade IOMAX Intraoperative Monitor #### Indications for Use (Describe) 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. 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. {3}------------------------------------------------ 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}------------------------------------------------ | Submission Date: | 01 March 2017 | | | |------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter: | Cadwell Industries, Inc.<br>909 North Kellogg Street<br>Kennewick, WA 99336 | | | | Submitter and<br>Application<br>Correspondent | Ms. Melissa Kirkup, Au.D. CNIM<br>Phone: +1 (509) 735-6481, extension 226<br>Email: melissak@cadwell.com | | | | Manufacturing Site: | Cadwell Industries, Inc.<br>909 North Kellogg Street<br>Kennewick, WA 99336 | | | | Trade Name: | Cadwell Industries, Inc. Cascade IOMAX™ Intraoperative Monitor | | | | Common and<br>Classification<br>Name: | Evoked response stimulator and intraoperative monitor | | | | Classification<br>Regulation: | 21 CFR §882.1870, 21 CFR §870.2700; 21 CFR §874.1820,<br>21 CFR 882.1890, 21 CFR §882.1900, 21 CFR §882.1400,<br>21 CFR §882.1540, 21 CFR §890.1375, 21 CFR §882.1550 | | | | Product Code: | GWF, DQA, ETN, GWE, GWJ, GWQ, GZO, IKN, JXE, OLT | | | | Substantially<br>Equivalent Devices: | | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model | | | Predicate Device: | K142624 | Nihon Kohden Corporation<br>/ Neuromaster G1<br>Mee2000 | | | Reference Devices: | K971214 | Cadwell Laboratories, Inc. / Kilowin | | | | K020400<br>K040358 | MEPS, LLC / Digitimer<br>D185 Multipulse Cortical<br>Stimulator<br>Excel Tech Ltd. / Xltek<br>Protektor Stimulator,<br>Models 10247 & 10248 | | Substantially<br>Equivalent Devices<br>(cont): | New Cadwell Model | Predicate<br>510(k) Number | Predicate<br>Manufacturer / Model | | | | K051357 | Digitimer Ltd. / DS7A<br>Constant Current High<br>Voltage Stimulator, Model<br>DS7A; DS7AH Constant<br>Current High Voltage<br>Stimulator, Model DS7AH | | | | K072964 | Cardinal Health, Inc. /<br>Nicolet Cortical Stimulator | | | | K083124 | Medtronic Xomed, Inc. /<br>NIM 3.0 | | | | K093304 | Natus Medical, Inc. /<br>Protektor 32 | | | | K112718 | NuVasive, Inc. / NuVasive<br>NVM5 System | | | | K120979 | CareFusion 209, Inc. /<br>CareFusion Nicolet EDX | | | | K141105 | Hunan Accurate Bio-<br>medical Technology Co.,<br>Ltd. / Pulse Oximeter | | | | K143641 | NuVasive, Inc., / NuVasive<br>NVM5 System | | | | K152563 | Beijing Choice Electronic<br>Technology Co., Ltd. /<br>Pulse Oximeter<br>(MD300M/MD300K2) | {5}------------------------------------------------ {6}------------------------------------------------ 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. {7}------------------------------------------------ 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. 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, 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. {8}------------------------------------------------ ### Technology Comparison: ### The IOMAX employs the same technological characteristics as the predicate device. | Characteristic | Predicate Device | Proposed Device | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Modalities | Evoked potential (EP) in the form<br>of:<br>• Brainstem auditory<br>• Visual<br>• Somatosensory<br>Transcranial electrical motor evoked<br>potential (TcMEP)<br>Electromyography (EMG)<br>Electroencephalogram (EEG)<br>Nerve conduction velocity in the<br>form of:<br>• NCV<br>• F wave<br>• H reflex<br>Train of four (TOF)<br>SpO2 analyses<br>EtCO2 analyses<br>Threshold mode | Evoked potential (EP) in the form<br>of:<br>• Brainstem auditory<br>• Visual<br>• Somatosensory<br>Transcranial electrical motor evoked<br>potential (TcMEP)<br>Electromyography (EMG)<br>Electroencephalogram (EEG)<br>Nerve conduction studies in the<br>form of:<br>• NCV<br>• F wave<br>• H reflex<br>Train of four (TOF)<br>SpO2 and heart rate values<br>Threshold mode | | System<br>Configuration | Computer based equipment with<br>dedicated hardware<br>peripherals/components | Same | | Input Boxes<br>(Breakout Boxes) | 1, 2, 3, or 4 | One (1) Cortical Module<br>Up to four (4) Limb Modules | | Stimulation Pods | 1, 2, 3, or 4 within low-level | High: Up to four (4) Limb Modules<br>Low: One (1) Cortical Module | | Number of<br>Amplifier<br>Channels | 32 | Up to 48 | | TcMEP Control<br>Box | 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 for<br>TcMEP output | High: 1<br>Low: 1<br>TcMEP: 1 | | Output Modes | Constant current or voltage | High: Constant current<br>Low: Constant current<br>TcMEP: Constant current or voltage | {9}------------------------------------------------ ### 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. {10}------------------------------------------------ | Electrical Safety | The IOMAX was tested for performance in accordance with the following standard:<br>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. | |----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Electromagnetic<br>Compatibility | The IOMAX was tested for performance in accordance with the following standard:<br>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. | | Performance<br>Testing – 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:<br>• ISO 80601-2-61: 2011, Medical electrical equipment – Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment<br>Clinical 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.<br>Therefore, the IOMAX is considered substantially equivalent to the predicate devices. | {11}------------------------------------------------