Cadwell Sierra Summit, Cadwell Sierra Ascent by CADWELL INDUSTRIES, INC.

Cadwell Sierra Summit is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), Evoked Potentials (EP), and Autonomic Reponses (RR Interval Variability). The Cadwell Sierra Summit is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for acquisition, display, storage, transmission, analysis, and reporting of electrophysiological and environmental data including Electromyography (EMG), Nerve Conduction Studies (NCS), and Somatosensory Evoked Potentials (SEP). The Cadwell Sierra Ascent is used to detect the physiologic function of the nervous system, and to support the diagnosis of neuromuscular diseases or conditions.

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Device Description

The Cadwell Sierra Summit and Ascent systems are designed for the acquisition, display, analysis, storage, and reporting of electrophysiologic information from the human nervous and muscular systems. The systems are designed to perform nerve conduction studies (NCS), needle electromyography (EMG) studies and evoked potential (EP) studies. The Sierra Summit is the full featured version and also includes autonomic (RR Interval) studies and an interface to allow display and control of non-invasive third-party imaging modalities.. Hereafter, the Sierra Summit is described as the full featured variant. The Summary of Technical Characteristics table below details the differences between the Summit and Ascent systems.

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

Sierra Summit console base unit with integrated control panel ●
Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
Display monitor ●
Summit software

The Sierra Summit has the following optional accessories/components:

Remote Head Box (for 3-12 channel amplifier) ●
StimTroller (Hand Held Electrical Stimulator)
Electrical Stimulator Switch Box ●
Footswitch (single) ●
Visual Stimulators (LED Goggles, LCD Checks)
VEP Calibration Sensor
Headphones or other auditory transducers
Reflex Hammer
Temperature Probe ●
Cart
Isolation Transformer or Medical Grade Power Strip
Printer

AI/ML Overview

The provided text is a 510(k) Summary for the Cadwell Sierra Summit and Cadwell Sierra Ascent devices. It details the device descriptions, indications for use, and a summary of technical characteristics compared to predicate devices, along with performance testing. However, it does not include specific acceptance criteria for performance metrics (such as sensitivity, specificity, accuracy) or detailed results from studies designed to prove the device meets such criteria.

The "Performance Testing - Bench" section mentions conformance to various standards and internal requirements, concluding that "Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards." This is a general statement of compliance, not a presentation of performance data against specific acceptance criteria.

Therefore, most of the information requested in the prompt cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated from the document:

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

This information is not provided in the document. The document states compliance with "predetermined specifications and applicable standards" for various tests (biocompatibility, software, electrical safety, EMC, and bench performance), but it does not list specific numerical acceptance criteria or quantitative performance results for the device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The document describes "Performance Testing - Bench" and "Verification and validation activities," but it does not specify sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. The document refers to the device being used by "qualified medical practitioners" for diagnosis but clarifies that the device "does not provide any diagnostic conclusion about the patient's condition to the user." There is no mention of experts establishing ground truth for any test sets related to diagnostic performance.

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

This information is not provided in the document. There is no mention of an adjudication method.

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:

This information is not provided in the document. The device is a diagnostic electromyograph for measuring electrophysiological data and supporting the diagnosis of neuromuscular diseases. It is not described as an AI-assisted device for interpretation or diagnosis to be used "with AI vs without AI assistance" by human readers in the context of improving effectiveness. The document states, "This device does not provide any diagnostic conclusion about the patient's condition to the user."

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

This information is not provided in the document. Given the nature of the device (electromyograph for data acquisition and analysis, not providing diagnostic conclusions), it typically functions as a tool for a human practitioner, rather than as a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided in the document. As no specific performance studies against a diagnostic "ground truth" are detailed, the type of ground truth is not mentioned.

8. The sample size for the training set:

This information is not provided in the document. No training data or training set sample size is mentioned, as the device is not an AI/machine learning model in the sense of requiring a training set for diagnostic outcome prediction.

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

This information is not provided in the document. As no training set is mentioned, the method for establishing its ground truth is also not.

Summary

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

March 1, 2017

Cadwell Industries, Inc. Christopher Bolkan QA/RA Engineer 909 North Kellogg Street Kennewick, Washington 99336

Re: K162383

Trade/Device Name: Cadwell Sierra Summit, Cadwell Sierra Ascent Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN, GWF, JXE, GWJ, GWE, GZP Dated: January 19, 2017 Received: January 23, 2017

Dear Christopher Bolkan:

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

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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) K162383

Device Name Cadwell Sierra Summit, Cadwell Sierra Ascent

Indications for Use (Describe)

Cadwell Sierra Summit:

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Cadwell Sierra Ascent:

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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510(k) Summary Cadwell Sierra Summit and Ascent

[A summary of 510(k) safety and effectiveness information in accordance with 21 CFR 807.92]

1. Submitter / 510(k) Holder:

Name	Cadwell Industries, Inc.
Address	909 N. Kellogg Street, Kennewick, Washington 99336
Establishment Reg No.	3020018
Contact person	Mr. Chris Bolkan
Phone number	509-735-6481
Fax number	509-783-6503
Email	ChrisB@Cadwell.com
Date Prepared	August 5, 2016

2. Device Name:

Proprietary name	Cadwell Sierra Summit, Cadwell Sierra Ascent
Common name	Diagnostic Electromyograph
Device Class	Class II
Classification name	Electromyograph, DiagnosticStimulator, Electrical, Evoked ResponseDevice, Nerve Conduction Velocity MeasurementStimulator, Auditory, Evoked ResponseStimulator, Photic, Evoked ResponseStimulator, Mechanical, Evoked Response
Product Code, Regulation	IKN 21 CFR 890.1375GWF 21 CFR 882.1870JXE 21 CFR 882.1550GWJ 21 CFR 882.1900GWE 21 CFR 882.1890GZP 21 CFR 882.1880

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3. Predicate Devices:	510(k) Number	Device Name
Primary Predicate	K112052	Carefusion Nicolet EDX with Viking Software
Reference Predicates	K971214	Cadwell Kilowin (Easy II EEG, Sierra IIEMG/EP, Cascade IOM)

4. Device Description:

The Sierra Summit provides a variety of test protocols spanning the various test modalities above.

The Cadwell Sierra Summit consists of the following major components:

Sierra Summit console base unit with integrated control panel ●
Amplifier (available in two types: 2 channel with two non-switched differential channels, or a 12 ● channel with 4 non-switched differential and 8 switched referential channels. The number of available channels is controlled by a software license)
Laptop or Desktop computer (Windows OS) with keyboard and mouse ●
Display monitor ●
Summit software

The Sierra Summit has the following optional accessories/components:

Remote Head Box (for 3-12 channel amplifier) ●
StimTroller (Hand Held Electrical Stimulator)
Electrical Stimulator Switch Box ●
Footswitch (single) ●
Visual Stimulators (LED Goggles, LCD Checks)
VEP Calibration Sensor
Headphones or other auditory transducers
Reflex Hammer
Temperature Probe ●
Cart
Isolation Transformer or Medical Grade Power Strip
Printer

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5. Indications for Use

Sierra Summit:

The listed modalities do include overlap in functionality. In general, Nerve Conduction Studies measure the electrical responses of the peripheral nerve; Electromyography measures the electrical activity of the muscle, and Evoked Potentials measure the electrical activity from the central nervous system. The interface for third-party non-invasive imaging display and control is used to visualize the morphology and location of nerves and muscles, and serves as an aid in confirming the results of the aforementioned modalities.

Cadwell Sierra Summit is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

Sierra Ascent:

Cadwell Sierra Ascent is indicated for use by qualified medical practitioners. This device does not provide any diagnostic conclusion about the patient's condition to the user.

6. Summary of Technical Characteristics Compared to the Predicate Devices

The Cadwell Sierra Summit and Ascent are substantially equivalent to predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have the same technological characteristics to its predicate device through comparison in areas that include intended use, design, functionality, principle of operation, specifications, material composition, and performance.

1. General
	This Submission	This Submission	Reference Predicate	Primary Predicate
Characteristics		Cadwell SierraSummit	Cadwell Sierra Ascent(variant of Summit)	Cadwell Kilowin(Sierra II EMG/EP)(K971214)	Carefusion Nicolet EDXwith Viking Software(K112052)
1.1 Indicationsfor Use
		Cadwell Sierra Summitis indicated foracquisition, display,storage, transmission,analysis, and reportingof electrophysiologicaland environmentaldata includingElectromyography(EMG), NerveConduction Studies(NCS), EvokedPotentials (EP), andAutonomic Reponses(RR IntervalVariability). TheCadwell Sierra Summitis used as an aid in thelocation of neuralstructures or muscle,to detect thephysiologic function ofthe nervous system,and to support thediagnosis ofneuromusculardiseases or conditions.The listed modalitiesdo include overlap infunctionality. Ingeneral, NerveConduction Studiesmeasure the electricalresponses of theperipheral nerve;Electromyographymeasures theelectrical activity ofthe muscle, andEvoked Potentialsmeasure the electricalactivity from thecentral nervoussystem. The interfacefor third-party non-invasive imagingdisplay and control is	Cadwell Sierra Ascent isindicated foracquisition, display,storage, transmission,analysis, and reportingof electrophysiologicaland environmentaldata includingElectromyography(EMG), NerveConduction Studies(NCS), andSomatosensory EvokedPotentials (SEP). TheCadwell Sierra Ascent isused as an aid in thelocation of neuralstructures or muscle, todetect the physiologicfunction of the nervoussystem, and to supportthe diagnosis ofneuromusculardiseases or conditions.The listed modalities doinclude overlap infunctionality. Ingeneral, NerveConduction Studiesmeasure the electricalresponses of theperipheral nerve;Electromyographymeasures the electricalactivity of the muscle,and Evoked Potentialsmeasure the electricalactivity from thecentral nervous system.Cadwell Sierra Ascent isindicated for use byqualified medicalpractitioners. Thisdevice does notprovide any diagnosticconclusion about the	Kilowin is anelectrodiagnosticdevice designed tomeasure and displaythe electrical signalsgenerated byperipheral nerve,muscle, and centralnervous system. Itwill acquire the datanecessary forelectroencephalography (EEG),electronystagmography (ENG),electrocardiology(ECG),electromyography(EMG), nerveconduction velocity(NCV, F Wave, and Hreflex), evokedpotentials (EP,brainstem, visual,somatosensory),repetitive nervestimulation and sleepassessment.The Kilowininstrument is designedfor use during theduration of theprocedure only.Use of the proposeddevice is to beadministered underthe direction of atrained physician,surgeon, neurologist,or electrophysiologistin the operating roomor clinic.The Kilowin device(s)are intended for useduring	The CareFusion NicoletEDX is intended for theacquisition, display,analysis, storage,reporting, andmanagement ofelectrophysiologicinformation from thehuman nervous andmuscular systemsincluding NerveConduction (NCS),Electromyography(EMG), EvokedPotentials (EP),Autonomic Responsesand Intra-Operativemonitoring includingElectroencephalography(EEG).Evoked Potentials (EP)includes Visual EvokedPotentials (VEP),Auditory EvokedPotentials (AEP),Somatosensory EvokedPotentials (SEP),Electroretinography(ERG),Electrooculography(EOG), P300, MotorEvoked Potentials(MEP). The Nicolet EDXwith Viking Softwaremay be used todetermine autonomicresponses to physiologicstimuli by measuring thechange in electricalresistance between twoelectrodes (Galvanic SkinResponse). Autonomictesting also includesassessment of RRInterval variability. Thelisted modalities doinclude overlan in

	used to visualize themorphology andlocation of nerves andmuscles, and serves asan aid in confirmingthe results of theaforementionedmodalities.Cadwell Sierra Summitis indicated for use byqualified medicalpractitioners. Thisdevice does notprovide any diagnosticconclusion about thepatient's condition tothe user.	patient's condition tothe user.	electroencephalograpy (EEG),electronystagmography (ENG),electromyography(EMG), nerveconduction velocity(NCV, F wave, and Hreflex), evokedpotentials (brainstem,visual,somatosensory)repetitive nervestimulation testingand sleep assessment.	functionality. In general,Nerve ConductionStudies measure theelectrical responses ofthe nerve,Electromyographymeasures the electricalactivity of the muscleand Evoked Potentialsmeasure electricalactivity from the CentralNervous System.The Nicolet EDX withViking Software isintended to be used by aqualified healthcareprovider.
1.2 Warnings	Items related to off-label use or misuse.	Items related to off-label use or misuse.	Items related to off-label use or misuse.	Items related to off-labeluse or misuse.
1.3 Contra-indications	Items related todesign and indicateduse limitations, suchas, not for use in thepresence offlammable anestheticsor in conjunction withdefibrillationequipment.	Items related to designand indicated uselimitations, such as, notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillationequipment.	Items related todesign and indicateduse limitations, suchas, not for use in thepresence offlammable anestheticsor in conjunction withdefibrillationequipment.	Items related to designand indicated uselimitations, such as, notfor use in the presenceof flammableanesthetics or inconjunction withdefibrillation equipment.
2. General Design
2.1 GeneralSystems Approach	Computer basedequipment withdedicated hardwareperipherals /components.	Computer basedequipment withdedicated hardwareperipherals /components.	Computer basedequipment withdedicated hardwareperipherals /components.	Computer basedequipment withdedicated hardwareperipherals /components.
2.2 User InputDevice	Windows mouse/keyboard driven graphic interface with dedicated control panel.	Windows mouse/keyboard driven graphic interface with dedicated control panel.	Windows mouse/keyboard driven graphic interface with dedicated control panel.	Windows mouse/keyboard driven graphic interface with dedicated control panel.
2.3 User OutputDevice	Digital color display and commercial printers.	Digital color display and commercial printers.	Digital color display and commercial printers.	Digital color display and commercial printers.
2.4 Patient Inputs	1 to 12 channel amplifier, isolated.	2 channel amplifier, isolated.	2 or 4 channel amplifier, isolated.	2 to 8 channel amplifier, isolated.
2.5 SignalAcquisition	Analog to digital conversion at 100 kHz (EMG channels), 25 kHz (EP channels).	Analog to digital conversion at 100 kHz.	Analog to digital conversion at 76.8 kHz (2 channel), 38.4 kHz (4 channel).	Analog to digital conversion at 48kHz sample rate
2.6 Trigger Input(synchronizationto externalevents).	Yes (4)	Yes (2)	No	Yes (2)
2.7 TriggerOutput(synchronizationfor externaldevices)	Yes (4)	Yes (2)	Yes (1)	Yes (2)
2.8 Footswitchfor hands-freeoperation	Yes	Yes	Yes	Yes
2.9 Use ofstandard softwareplatform(OperatingSystem)	Yes, Microsoft Windows	Yes, Microsoft Windows	Yes, Microsoft Windows	Yes, Microsoft Windows
2.10Customization ofprotocols	Via storage / retrieval of user defined settings	Via storage / retrieval of user defined settings	Via storage / retrieval of user defined settings	Via storage / retrieval of user defined settings
2.11 Applicationflexibility /expandability	Via software update	Via software update	Via software update	Via software update
2.12 SafetyStandards	U.S. and Canada:UL60601-1:2006 CSA C22.2#601.1 ANSI/AAMI ES60601-1:2006 CSA C22.2#60601-1:2008	U.S. and Canada:UL60601-1:2006 CSA C22.2#601.1 ANSI/AAMI ES60601-1:2006 CSA C22.2#60601-1:2008	UL60601CSA601-1EN60601-1 (safety)EN60601-1-1 (medical systems)EN60601-2-40(EMG/FP equipment)	EN/IEC 60601-1:1998+A1:1991+A2:1995IEC 60601-1-1:2000EN/IEC 60601-1-2:Ed. 2.0+A1:2004IEC 60601-2-40:1998, Ed. 1
	IEC60601-1:2005 Ed.3 EN60601-1-2:2007 ENISO14971:2012 IEC60601-1-6:2010 IEC62366:2007 60601-1 Ed2: IEC60601-1Ed.2 IEC60601-2-40:1998 EMC: IEC60601-1-2:2007 EN60601-1-2:2007 FCC Part 15Subpart BSection15.107 &15.109 LED Goggles lightoutput: ISO 15004 European Community CE Mark 0344Quality ManagementSystem EN ISO13485:2012	IEC60601-1:2005 Ed.3 EN60601-1-2:2007 ENISO14971:2012 IEC60601-1-6:2010 IEC62366:2007 60601-1 Ed2: IEC60601-1Ed.2 IEC60601-2-40:1998 EMC: IEC60601-1-2:2007 EN60601-1-2:2007 FCC Part 15Subpart BSection 15.107& 15.109 European Community CE Mark 0344Quality ManagementSystem EN ISO13485:2012	EN60601-1-1-2 (EMC)ISO 13485 (qualitysystem)	ED1Rev:2003/06/30CAN/CSA-C22.2 no. 601-1-M90Issue:1990/01/01Rev:2003/11European Community(CE Mark)
2.13 Patientcircuitry isolation	Optic/transformer	Optic/transformer	Optic/transformer	Optic/transformer

2.14 System	Summit base console	Ascent base console	Kilowin base console	EDX base console
Components	including 2 electrical	including 1 electrical	including 1 electrical	including 2 electrical
	stimulators, auditory	stimulator, trigger	stimulator, auditory	stimulators, auditory
	stimulator, trigger	input/output, Control	and visual stimulator,	stimulator, trigger
	input/output, LED	Panel, USB Hub, dual	trigger output, LED	input/output, LED
	goggle interface,	speakers;	goggle interface,	goggle interface;
	Control Panel, USB		Control Panel,
	Hub, dual speakers;	2 Ch. Amplifier;	Ethernet port, single	Control panel;
		Computer, monitor,	speaker.	Amplifier;
	1-2 Ch. Amplifier;	keyboard, mouse,		Computer, monitor,
	3-12 Ch. Amplifier;	printer;	2 Ch. Amplifier	keyboard, mouse,
	Computer, monitor,		4 Ch. Amplifier	printer;
	keyboard, mouse,		Computer, monitor,
	printer;		keyboard, mouse,
			printer
2.15 System	USB	USB	Ethernet (RJ-45)	USB
computer
interface
2.16 System	Mains (100-240 VAC)	Mains (100-240 VAC)	Mains (100-240 VAC)	Mains (100-240 VAC)
power supply	thru an isolation	thru an isolation	thru an isolation	thru an isolation
	transformer	transformer depending	transformer	transformer
	depending on system	on system	depending on system
	configuration	configuration
2.17 Amplifier	12 VDC from base	12 VDC from base	12 VDC from base	15 VDC from base
power supply	console	console	console	console
2.18 Size (L/W/D)	37.6 x 38.1 x 6.4 (base	37.6 x 38.1 x 6.4 (base		35.6 x 34.3 x 8.6 (base
cm	console)	console)		console)
2.19 Weight kg	3.4 (base console)	3.4 (base console)		3.5 (base console)

3. Design - Acquisition
3.1 Number of	1 to 12	2	2 or 4	2 to 8
channels
3.2 CMRR	>115 dB	>115 dB	>115 dB	>110 dB
3.3 Noise	<0.6 uV RMS	<0.6 uV RMS	<2 uV RMS	<0.6uV RMS (from 2Hz
				to 10kHz)
3.4 Input	>1000 ΜΩ	>1000 ΜΩ	>1000 ΜΩ	>1000 ΜΩ
Impedance
3.5 Low Filter	0.3 Hz to 2 kHz	0.3 Hz to 2 kHz	0.04 Hz to 2 kHz	0.05 Hz to 5 kHz
3.6 High Filter	30 Hz to 20 kHz	30 Hz to 20 kHz	30 Hz to 10 kHz	30 Hz to 20 kHz
3.7 Notch Filter	50/60 selectable	50/60 selectable	50/60 selectable	50/60 selectable
3.8 A/D	16 bit	16 bit	16 bit	24 bit
conversion
3.9 Sampling rate	600 kHz	200 kHz	153.6 kHz	384 kHz
(cumulative)
3.10 Time base	0.1 to 10,000 ms	0.1 to 10,000 ms	0.1 to 10,000 ms	0.01 to 5000 ms
range
3.11 Number of	Single	Single	Single	Multiple
Time bases
allowed
3.12 Trigger mode	Free-run, internal, external	Free-run, internal, external	Free-run, external	Free-run, internal, external
3.13 Signal delay (pre/post)	-9 to +9 divisions, depending on time base	-9 to +9 divisions, depending on time base	-9 to +9 divisions, depending on time base	-3000 to +500 ms
3.14 Impedance meter	0.1Ω to 100 kΩ	0.1Ω to 100 kΩ	0.1Ω to 100 kΩ	500Ω to 480kΩ
4. Design – Stimulators
4.1 Electrical Stimulator
4.1.1 Type	Constant Current	Constant Current	Constant Current	Constant Current or Constant Voltage
4.1.2 Number	1 or 2	1	1	1 or 2
4.1.3 Maximum Output	100mA or 400V	100mA or 400V	100mA or 400V	100mA or 400V
4.1.4 Duration	0.05 to 1 ms	0.05 to 1 ms	0.05 to 1 ms	0.01 to 1 ms
4.1.5 Mode	Single or Train	Single or Train	Single or Train	Single or Train
4.1.6 Biphasic	Yes	Yes	No	Yes
4.2 Auditory Stimulator
4.2.1 Type	Click, Pip, Burst	N/A	Click, Pip, Burst	Click, Pip, Burst
4.2.2 Intensity	0 to 140 dB pSPL	N/A	0 to 128 dB pSPL	0 to 139 dB pSPL
4.2.3 Polarity	Condensation, Rarefaction, Alternating	N/A	Condensation, Rarefaction, Alternating	Condensation, Rarefaction, Alternating
4.2.4 Tone Frequency	250 to 8000 Hz	N/A	250 to 8000 Hz	250 to 8000 Hz
4.2.5 Click Duration	0.05 to 1 ms	N/A	0.1 ms	0.05 to 1 ms
4.2.6 Side	Left, Right, Both	N/A	Left, Right, Both	Left, Right, Both
4.2.7 Transducers	TDH 39, Inserts, Bone Vibrator	N/A	TDH 39, Inserts, Bone Vibrator	TDH 39, TIP 300, Bone Vibrator
4.3 Visual Stimulator
4.3.1 Type	LCD Checks, LED Goggles	N/A	CRT Checks, LED Goggles	CRT Checks, LED Goggles
4.3.2 Latency Delay Calibrator (for LCD Checks)	Yes	N/A	N/A	N/A
5. EMG Application Modules
5.1 Free Run Acquisition	Yes	Yes	Yes	Yes
5.2 Nerve Conduction Study (NCS)	Yes	Yes	Yes	Yes
5.3 StimulatorTriggered	Yes	Yes	Yes	Yes
5.4 SignalTriggeredAcquisition	Yes	Yes	Yes	Yes
5.5 SpontaneousActivity (SPA)	Yes	Yes	Yes	Yes
5.6 Single FiberEMG (SFEMG)	Yes	No	Yes	Yes
5.7 Motor UnitAnalysis	Yes	Yes	Yes	Yes
5.8 F-Wave	Yes	Yes	Yes	Yes
5.9 H Reflex	Yes	Yes	Yes	Yes
5.10 SympatheticSkin Response(SSR)	Yes	Yes	Yes	Yes
5.11 RR IntervalVariability	Yes	No	Yes	Yes
5.12 RepetitiveNerve Stim	Yes	Yes	Yes	Yes
6. Evoked Potential Application Modules
6.1Somatosensory EP(SEP)	Yes	Yes	Yes	Yes
6.2 Auditory EP(AEP)	Yes	No	Yes	Yes
6.3 Visual EP (VEP)	Yes	No	Yes	Yes
6.4 P300	Yes	No	Yes	Yes
7. Other Application Modules
7.1 Multi-modalityIONM	No	No	No	Yes
7.2 EEG	No	No	No	Yes
7.3 ENG	No	No	No	Yes
7.4 ECG	No	No	No	No
7.5 Sleep (PSG)	No	No	No	No
8. Image Display and Control Interface
8.1 Display andcontrol of non-invasive third-party imagingmodality(example:Ultrasound)	YesIntegrated(concurrent)ultrasound displayand control using theTelemed UltrasoundSystem (K113184)with Echo Wave IIsoftware.	No	No	NoSupports ultrasound byrunning a third-partyscanner in a non-integrated, non-concurrent format(launched separatelyfrom desktop). IntersonUSB Ultrasound ProbeSystem K070907

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Image /page/7/Picture/0 description: The image is a logo for Cadwell. The logo is black and white and features a circle with a heartbeat line going through it. The word "CADWELL" is written in bold, sans-serif letters to the right of the circle.

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Image /page/8/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. The "C" is replaced with a circle containing a waveform symbol. The letters are connected, creating a single, unified design. The overall impression is modern and professional.

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Image /page/9/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, sans-serif font. To the left of the word, there is a circular graphic with a waveform inside, resembling a heart rate monitor. The waveform extends horizontally to connect with the letter "C" of the word "CADWELL", creating a unified logo.

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Image /page/10/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white line running through it, resembling a heartbeat symbol. The letters of the word are connected, forming a single, unified shape.

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Image /page/11/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. The "O" in "CADWELL" is represented by a circle with a line running through it, resembling a heart rate monitor symbol. The letters are connected, creating a single, unified shape.

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Image /page/12/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a black circle with a white heartbeat symbol inside. The heartbeat symbol extends to the letter "C" in "CADWELL", connecting the symbol to the word.

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Image /page/13/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word, there is a circular graphic with a white line running through it, resembling a heartbeat or electrical signal. The letters of the word are connected, forming a single, unified shape.

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Image /page/14/Picture/0 description: The image is a logo for "CADWELL". The logo is in black and white and features a stylized design. The first letter, "C", is represented by a circle with a line going through it. The rest of the letters are in a bold, sans-serif font.

7. Summary of Performance Testing

Biocompatibility:

The Sierra Summit and Ascent have no patient contact materials, and therefore this section does not apply.

The hand-held StimTroller, LED Goggles, and accessories for use with the Sierra Summit and Ascent have patient contact materials and are made from medical grade biocompatible materials.

The appropriate component materials for these accessories were verified to be biocompatibility 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.

Software:

The Cadwell Sierra Summit and Ascent software contains MODERATE level of 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 Mav 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 software complies with its predetermined specifications and the applicable guidance documents.

Electrical Safety:

The Sierra Summit was tested as worst case for safety and essential performance in accordance with the following standard(s):

ANSI/AAMI ES60601-1: 2005/(R)2012, A1:2012, 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 Code).

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Image /page/15/Picture/0 description: The image shows the word "CADWELL" in a stylized, bold, black font. To the left of the word is a black circle with a white line running through it, resembling a heartbeat symbol. The letters of the word are connected, creating a unified design. The overall impression is a strong and recognizable logo.

Test results indicate that the Sierra Summit and Ascent comply with the applicable standards.

Electromagnetic Compatibility:

The Sierra Summit was tested as worst case 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 Sierra Summit and Ascent comply with the applicable standards.

Performance Testing - Bench:

The Sierra Summit was tested as worst case 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 60601-2-40: 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.
MIL-STD-810E, Environmental Test Methods and Engineering Guidelines
ISTA Procedure 2a, Partial simulation performance test procedure Packaged-products 150 lb (68 ● kg) or less.

Test results indicate that the Sierra Summit and Ascent comply with the predetermined specifications and the applicable standards.

8. Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the Sierra Summit and Ascent. The results of these activities demonstrate that the Summit and Ascent are as safe, effective, and performance is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 890.1375 Diagnostic electromyograph.

(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).