The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.

The CWAS 100 measures the following physiologic signals:

Bilateral differences in surface EMG along the spine
Heart Rate
Skin temperature
Galvanic Skin Resistance
Body fat percentage in subjects eighteen years and older

Device Description

The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The CWAS 100 contains the following five sensor types: (1) surface EMG, (2) IR Plethsmograph, (3), Skin temperature, (4) Galvanic Skin Resistance and (5) IR Body Composition Analyzer.

Hardware: The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.

Software: The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.

AI/ML Overview

This document describes the CWAS 100 electromyograph, a multi-modality physiologic monitoring device. The provided text outlines the device's indications for use, description, and a comparison to predicate devices, but does not contain information about a specific study or acceptance criteria demonstration for the CWAS 100 itself.

The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The performance specifications listed are for the CWAS 100's components and are largely presented as equivalent to or derived from the predicate devices. There is no section detailing a study to prove these specifications are met for the CWAS 100.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies cannot be extracted from the provided text for the CWAS 100. The provided information is limited to the device's stated specifications and equivalence claims based on predicate devices.

Based on the provided text, the following information can be extracted or inferred:

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

Component	Feature	Acceptance Criteria (Stated Specification for CWAS 100)	Reported Device Performance (Implied from substantial equivalence)
EMG	Electrodes	4 ea. Smart Sensors	Meets specification (implied by equivalence to predicate)
	Calibrated Range	0.1 – 999 uV	0.1 – 999 uV
	Input Bias Current	Less than 2.0 Picoamperes	Less than 2.0 Picoamperes
	Differential Input Impedance	Greater than 1,000,000 Megaohms	Greater than 1,000,000 Megaohms
	Common Mode Rejection	150 dB	150 dB
	Bandwidth	20-500 Hz (50/60 Hz notch)	20-500 Hz (50/60 Hz notch)
	Noise	Less than 0.1 uV (inputs shorted)	Less than 0.1 uV (inputs shorted)
	Detector	Log power detector, 250 mS averaging filter	Log power detector, 250 mS averaging filter
Temperature	Calibrated Range	55°F - 120°F	55°F - 120°F
	Accuracy	±0.2ºF nominal	±0.2ºF nominal
	Sensors	Two thermopile, fixed 2.5" apart	Two thermopile, fixed 2.5" apart
IR Plethsmograph	Output Voltage	5 - 50 mV, typical at rest	5 - 50 mV, typical at rest
	Output Impedance	1 kΩ, nominal	1 kΩ, nominal
Galvanic Skin Resistance	Measurement Method	Constant Current Conductance	Constant Current Conductance
	Sensor Type	2 each 1x2 cm gold-plated brass	2 each 1x2 cm gold-plated brass
	Current Density	1.5 uA per cm²	1.5 uA per cm²
	Measurement Range	1-100 Siemens	1-100 Siemens
	Filtering	3 pole Low Pass Fo at 6 Hz	3 pole Low Pass Fo at 6 Hz
	Output Format	Logarithmic 40 dB range	Logarithmic 40 dB range
Futrex IR Body Composition Analyzer	Measurement Method	Near Infrared Photo Reflectance	Near Infrared Photo Reflectance
	Transmitters	Sequenced IR LEDs, > 750 nM	Sequenced IR LEDs, > 750 nM
	Measurement Range	3% - 45% Body Fat	3% - 45% Body Fat
Instrument Console	Output	Isolated USB	Isolated USB
	A/D converter	16 bit, 16 channel	16 bit, 16 channel

The "Reported Device Performance" for the CWAS 100 in this table is based on its stated specifications and the claim of substantial equivalence to predicate devices, rather than results from an independent performance study specifically for the CWAS 100 that is detailed in the provided text. The submission focuses on demonstrating equivalence to predicate devices which have presumably already met their performance criteria.

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

Not provided. The document describes device specifications and predicate comparisons but does not detail a study with a test set of data.

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)

Not provided. No study with a test set and associated ground truth establishment by experts is described.

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

Not provided. No study with a test set is described.

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

Not done / Not applicable. The CWAS 100 is a physiologic monitoring device, not an AI-powered diagnostic tool requiring human reader interpretation in the context of an MRMC study. The document does not describe any AI component or any study involving human readers.

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

Not done / Not applicable. The CWAS 100 is a hardware-based physiologic monitoring device with software to display and report data. It does not rely on an "algorithm only" performance in the sense of an AI diagnostic tool. Its performance is linked to the accuracy and range of its sensors, which are claimed to be substantially equivalent to predicate devices. No standalone performance study details are provided.

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

Not provided / Not applicable. No study requiring external ground truth for performance evaluation is described for the CWAS 100. The device's performance relies on its physical measurements and their accuracy, which are presented as specifications rather than being evaluated against a "ground truth" derived from patient data. For the IR Body Composition Analyzer, the predicate device Futrex 6100/XL likely established its accuracy against a gold standard for body fat measurement, but this specific detail for this submission is not provided.

8. The sample size for the training set

Not provided. No training set for an algorithm is mentioned as the device is not described as an AI/ML-based system.

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

Not provided. No training set for an algorithm is mentioned.

Summary

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Section 1: Device Name

Electromyograph, Diagnostic Common or Usual Name: Proprietary Model Name: CWAS 100 Electromyograph, Diagnostic Regulation Name: Regulation Number: 21 CFR 890.1375

Section 2: Indications for Use

The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.

The CWAS 100 measures the following physiologic signals:

파 Bilateral differences in surface EMG along the spine
체 Heart Rate
Skin temperature 보
트 Galvanic Skin Resistance
Body fat percentage in subjects eighteen years and older

Device Description Section 3:

Hardware

The CWAS 100 hardware consists of an instrument console and five different sensor types. All five sensor types plug directly into the front panel of the CWAS 100 Instrument Console. The CWAS 100 Console is powered via a UL2601 listed power supply. The Instrument Console is connected to a personal computer (IBM compatible) via an isolated USB port connection.

Software

The CWAS 100 software displays real-time surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, allowing the user to ensure that readings are stable prior to data collection. The CWAS 100 software allows the user to: (1) enter patient information, (2) record surface EMG, heart rate, skin temperature, Galvanic Skin Resistance, and Body Composition, and (3) print out a data report which summarizes the results of the above sensors as well as blood pressure, vital lung capacity, and chest, leg and back strength, which are data provided by the user.

510(k) Summary Fasstech CWAS 100

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K033452 20f6

Predicate Device Section 4:

The CWAS 100 is an expansion of the Insight Millennium III, a device that we have previously registered with FDA. The CWAS 100 differs from the Insight Millennium III in the following manners:

1. Hardware: Addition of two new sensors, and the elimination of two previous sensors.
Software: The Insight Millennium III software has been modified to: (1) add the display and 2. reporting functionality for the two new CWAS 100 sensors, (2) remove the display and reporting functionality for the two eliminated Insight Millennium III sensors, and (3) add the functionality to have the user enter other physiologic data about the patient, and incorporate this information into the reporting function.

The balance of this section documents the substantial equivalence of CWAS 100 to the following three products:

Manufacturer	Predicate Device Name	510(k) Number
Insight Millennium III	Fasstech	K023209
Biofeedback System/3	Davicon	K914920
Futrex 6100/XL	Futrex, Inc.	K963271

The CWAS 100 is equivalent to these legally marketed devices in the following ways:

The physical characteristics and electrical characteristics (performance characteristics) of the 트 CWAS 100 are equivalent to the Insight Millennium III. The only difference is the addition of two sensor types (Galvanic Skin Resistance and IR Body Composition Analyzer), and the elimination of two sensors that were part of the Insight Millennium III (Algometer and Inclinometer).
. The physical characteristics and electrical characteristics (performance characteristics) of the CWAS 100 Galvanic Skin Resistance sensor is equivalent to the Biofeedback System/3 Galvanic Skin Resistance sensor
비 The CWAS 100 IR Body Composition Analyzer sensor is the Futrex 6100/XL sensor. This sensor is registered with FDA, and has been combined with the CWAS 100 for user convenience.

The CWAS 100 differs from these legally marketed devices in the following ways:

The device types listed above have been combined for reasons of user convenience. ■
피 The CWAS 100 data report combines a variety of physiologic data for user convenience.

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K033452 3of 6

Predicate Device Comparison Chart

Component	Feature	CWAS 100	InsightMillennium III	Futrex 6100	BiofeedbackSystem/3
Surface EMG		Yes	Yes	N/A	N/A
	Calibrated Range	0.1 - 999 uV	0.1 – 999 uV	N/A	N/A
	Common ModeRejection	150 dB	150 dB	N/A	N/A
	Bandwidth	20-500 Hz (50/60Hz notch)	20-500 Hz (50/60Hz notch)	N/A	N/A
SkinTemperature		Yes	Yes	N/A	N/A
	Calibrated Range	55°F - 120°F	55°F - 120°F
	Accuracy	$\pm$ 0.2°F nominal	$\pm$ 0.2°F nominal
IRPlethsmograph		Yes	Yes	N/A	N/A
	Output Voltage	5 - 50 mV, typicalat rest	5 - 50 mV, typicalat rest	N/A	N/A
	Output Impedance	1 kΩ, nominal	1 kΩ, nominal	N/A	N/A
InstrumentConsole
	Output	Isolated USB	Isolated USB	N/A	N/A
	A/D converter	16 bit, 16channel	16 bit, 16channel	N/A	N/A
	Controls	None	None	N/A	N/A
	Indicators	Rear Panel:Green LEDPower IndicatorFront Panel:Green LED PCconnect Indicator	Rear Panel:Green LEDPower IndicatorFront Panel:Green LED PCconnect Indicator	N/A	N/A
	Power	12 VDC, 28 Wconverter,internal.	12 VDC, 28 Wconverter,internal.	N/A	N/A
	Physical	3.5"H x8.375"W x 9"D.Weight 3 lbs. 11oz	3.5"H x8.375"W x 9"D.Weight 3 lbs. 11oz	N/A	N/A
Range of MotionSensor		No	Yes	N/A	N/A
Algometer		No	Yes
IR Body		Yes	N/A	Yes	N/A
CompositionAnalyzer
	MeasurementMethod	Near InfraredPhoto Reflectance	N/A	Near InfraredPhoto Reflectance	N/A
	Transmitters	Sequenced IRLEDs , > 750 nM	N/A	Sequenced IRLEDs , > 750 nM	N/A
	MeasurementRange	3% - 45% BodyFat	N/A	3% - 45% BodyFat	N/A
Galvanic SkinResistance		Yes	N/A	N/A	Yes
	MeasurementMethod	Constant CurrentConductance	N/A	N/A	Constant CurrentConductance
	Sensor Type	2 each 1x2 cmgold-plated brass	N/A	N/A	2 each 1.0 cm2gold-plated brass
	Current Density	1.5 uA per cm2	N/A	N/A	3.0 uA per cm2
	MeasurementRange	1-100 Siemens	N/A	N/A	0.8 - 50 Siemens
	Filtering	3 pole Low PassF0 at 6 Hz	N/A	N/A	12 Hz low pass,18dB/oct
	Output Format	Logarithmic 40dB range	N/A	N/A	A.C. logarithmic

510(k) Summary
Fasstech
CWAS 100

Page 4/7

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K033452 4 of 6

Section 5: Performance Specification

The CWAS 100 specifications are summarized below:

EMG

Electrodes:

Calibrated Range: Input Bias Current: Differential Input Impedance: Common Mode Rejection: Bandwidth: Noise: Detector: Controls:

Temperature

Calibrated Range: Accuracy: Sensors:

Controls: Physical:

Size:

510(k) Summary Fasstech CWAS 100

4 ea. Smart Sensors with low-noise preamplifiers integral to electrode assemblies 0.1 – 999 uV Less than 2.0 Picoamperes Greater than 1,000,000 Megaohms 150 dB 20-500 Hz (50/60 Hz notch) Less than 0.1 uV (inputs shorted) Log power detector, 250 mS averaging filter. None

55°F - 120°F ±0.2ºF nominal Two thermopile, fixed 2.5" apart (center-tocenter) Enter button Case Material: Impact-resistant, Aluminum with 0.5" ABS Plastic Outer Ring. 5.5"L x 3.5"W x 2.5"H. Weight 15 oz.

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KD33452 5 of 6

IR Plethsmograph
	Sensor Type	IR Plethsmograph (attached to finger withVelcro)
	Output Voltage:	5 - 50 mV, typical at rest
	Output Impedance:	1 kΩ, nominal
	Weight:	28 grams
	Sensor Size:	15 x 15 x6.3 mm
Galvanic Skin Resistance
	Measurement Method:	Constant Current Conductance
	Sensor Type:	2 each 1x2 cm gold-plated brass
	Current Density:	1.5 uA per cm²
	Measurement Range:	1-100 Siemens
	Filtering:	3 pole Low Pass Fo at 6 Hz
	Output Format:	Logarithmic 40 dB range
Futrex IR Body Composition Analyzer
	Measurement Method:	Near Infrared Photo Reflectance
	Sensor Type	Pin Photodiode
	Transmitters:	Sequenced IR LEDs , > 750 nM
	Measurement Range:	3% - 45% Body Fat
	Dimensions:	2.3" diameter, and 0.8" height
Instrument Console
	Inputs:	4 each EMG electrodes1 each temperature sensor1 each IR Plethsmograph sensor1 each GSR sensor1 each Futrex IR Body Composition sensor
	Output:	Isolated USB
	A/D converter:	16 bit, 16 channel
	Controls:	None
	Indicators:	Rear Panel: Green LED Power IndicatorFront Panel: Green LED PC connect Indicator
	Power:	12 VDC, 28 W converter, internal.
	Physical:	Case Material: Impact resistant, flame retardantABS.3.5"H x 8.375"W x 9"D. Weight 3 lbs. 11 oz.

Section 6: Patient Safety

The CWAS 100 patient isolation is assured by the following two electrical isolation barriers:

Medical-Grade Universal Power Supply: This device is a UL2601 compliant AC line to 1. 12 VDC, 28 W converter. This internal power supply is partitioned from all other circuitry via an earthed steel chassis. The power supply accepts 85-264 VAC, and 47-63 Hz via a IEC 60320 fused input module.
510(k) Summary Fasstech CWAS 100

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K03452 6 of b

This supply provides low-level isolated power to the Non-Patient Side of the CWAS 100 circuitry, as well as power to the DC-to-DC isolation converter that powers to the Patient Side (see #2 below).

DC-to-DC Patient Isolation Converter: This converter is a UL2601 compliant DC-to-DC 2. converter, and meets the dielectric withstand and leakage current requirements of the UL2601 standard for Patient Care Equipment with isolated patient leads.
This converter supplies all power to patient-applied parts and related circuitry. Each of the direct patient-applied parts have individual current limiters for fault condition.

In addition, the Patient Side of the CWAS 100 is isolated from the host PC as follows:

Signals are converted from analog voltages to 16 bit 3. Optically Isolated Data Link: digital values by the analog-to-digital converter (ADC). The digital data is sent to and from the USB of the PC across an optically isolated data link.
This optical link is UL2601 compliant, providing the dielectric withstand and low leakage current characteristics specified in UL2601.

Section 7: Conclusion

The CWAS 100 is substantially equivalent to the predicate devices. Furthermore, the device is safe and effective for its intended use.

510(k) Summary Fasstech CWAS 100

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an image of a stylized eagle with three human profiles incorporated into its design. The eagle's head is facing left, and the profiles are stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 8 2003

Fasstech c/o Mr. Ned Devine Entela, Inc. 3033 Madison Avenue S.E. Grand Rapids, Michigan 49548

Re: K033452

Trade/Device Name: CWAS 100 Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic electromyograph Regulatory Class: II Product Code: IKN Dated: November 13, 2003 Received: November 14, 2003

Dear Mr. Devine:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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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Page 2 - Mr. Ned Devine

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page Lof 1

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CWAS 100

Indications for Use:

The CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. The device measures several physiologic signals, and its software generates a report.

The CWAS 100 measures the following physiologic signals:

Bilateral differences in surface EMG along the spine �
Heart Rate 트
피 Skin temperature
Galvanic Skin Resistance 방
Body fat percentage in subjects eighteen years and older 트

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Merle A. Milliken

ivision Sign-Off ivision of General, Restorative and Neurological Devices

510(k) Number K033452

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).