CWAS 1000

K033452 · Fasstech · IKN · Nov 28, 2003 · Physical Medicine

Device Facts

• Record ID: K033452
• Device Name: CWAS 1000
• Applicant: Fasstech
• Product Code: IKN · Physical Medicine
• Decision Date: Nov 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1375
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended 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 Skin temperature Galvanic Skin Resistance Body fat percentage in subjects eighteen years and older

Device Story

CWAS 100 is a non-invasive, multi-modality physiologic monitoring device. Inputs include surface EMG (spine), heart rate (IR plethysmograph), skin temperature (thermopile), galvanic skin resistance (constant current conductance), and body fat percentage (near-infrared photo reflectance). Hardware consists of an instrument console with five sensor types and a PC connection via isolated USB. Software displays real-time signals, allows user entry of additional physiologic data (blood pressure, lung capacity, strength), and generates a summary report. Used in clinical settings; operated by healthcare providers. Output provides objective physiologic data to assist clinicians in patient assessment. Benefits include consolidated monitoring of multiple physiologic parameters in a single report.

Clinical Evidence

Bench testing only. No clinical data provided. Performance specifications verified through electrical and physical testing, including common mode rejection (150 dB), bandwidth (20-500 Hz), and sensor accuracy (±0.2°F for temperature).

Technological Characteristics

Multi-modality monitor with 16-bit A/D conversion. Sensors: surface EMG (low-noise preamplifiers), IR plethysmograph, thermopile, GSR (gold-plated brass), and IR body composition (pin photodiode, IR LEDs >750 nM). Connectivity: isolated USB to PC. Power: UL2601 compliant internal supply with DC-to-DC patient isolation. Construction: impact-resistant ABS/aluminum. Software: real-time signal display and reporting.

Indications for Use

Indicated for subjects eighteen years and older for the measurement of physiologic signals including bilateral surface EMG along the spine, heart rate, skin temperature, galvanic skin resistance, and body fat percentage.

Regulatory Classification

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.

Predicate Devices

• Insight Millennium III (K023209)
• Biofeedback System/3 (K914920)
• Futrex 6100/XL (K963271)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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:

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.

510(k) Summary Fasstech CWAS 100

{1}------------------------------------------------

# 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.

{2}------------------------------------------------

# K033452 3of 6

## Predicate Device Comparison Chart

| Component | Feature | CWAS 100 | Insight<br>Millennium III | Futrex 6100 | Biofeedback<br>System/3 |
|-----------------------------|--------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------|-------------------------------------|
| Surface EMG | | Yes | Yes | N/A | N/A |
| | Calibrated Range | 0.1 - 999 uV | 0.1 – 999 uV | N/A | N/A |
| | Common Mode<br>Rejection | 150 dB | 150 dB | N/A | N/A |
| | Bandwidth | 20-500 Hz (50/60<br>Hz notch) | 20-500 Hz (50/60<br>Hz notch) | N/A | N/A |
| Skin<br>Temperature | | 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 | | |
| IR<br>Plethsmograph | | Yes | Yes | N/A | N/A |
| | Output Voltage | 5 - 50 mV, typical<br>at rest | 5 - 50 mV, typical<br>at rest | N/A | N/A |
| | Output Impedance | 1 kΩ, nominal | 1 kΩ, nominal | N/A | N/A |
| Instrument<br>Console | | | | | |
| | Output | Isolated USB | Isolated USB | N/A | N/A |
| | A/D converter | 16 bit, 16<br>channel | 16 bit, 16<br>channel | N/A | N/A |
| | Controls | None | None | N/A | N/A |
| | Indicators | Rear Panel:<br>Green LED<br>Power Indicator<br>Front Panel:<br>Green LED PC<br>connect Indicator | Rear Panel:<br>Green LED<br>Power Indicator<br>Front Panel:<br>Green LED PC<br>connect Indicator | N/A | N/A |
| | Power | 12 VDC, 28 W<br>converter,<br>internal. | 12 VDC, 28 W<br>converter,<br>internal. | N/A | N/A |
| | Physical | 3.5"H x<br>8.375"W x 9"D.<br>Weight 3 lbs. 11<br>oz | 3.5"H x<br>8.375"W x 9"D.<br>Weight 3 lbs. 11<br>oz | N/A | N/A |
| Range of Motion<br>Sensor | | No | Yes | N/A | N/A |
| Algometer | | No | Yes | | |
| IR Body | | Yes | N/A | Yes | N/A |
| Composition<br>Analyzer | | | | | |
| | Measurement<br>Method | Near Infrared<br>Photo Reflectance | N/A | Near Infrared<br>Photo Reflectance | N/A |
| | Transmitters | Sequenced IR<br>LEDs , > 750 nM | N/A | Sequenced IR<br>LEDs , > 750 nM | N/A |
| | Measurement<br>Range | 3% - 45% Body<br>Fat | N/A | 3% - 45% Body<br>Fat | N/A |
| Galvanic Skin<br>Resistance | | Yes | N/A | N/A | Yes |
| | Measurement<br>Method | Constant Current<br>Conductance | N/A | N/A | Constant Current<br>Conductance |
| | Sensor Type | 2 each 1x2 cm<br>gold-plated brass | N/A | N/A | 2 each 1.0 cm2<br>gold-plated brass |
| | Current Density | 1.5 uA per cm2 | N/A | N/A | 3.0 uA per cm2 |
| | Measurement<br>Range | 1-100 Siemens | N/A | N/A | 0.8 - 50 Siemens |
| | Filtering | 3 pole Low Pass<br>F0 at 6 Hz | N/A | N/A | 12 Hz low pass,<br>18dB/oct |
| | Output Format | Logarithmic 40<br>dB range | N/A | N/A | A.C. logarithmic |

:

510(k) Summary
Fasstech
CWAS 100

Page 4/7

{3}------------------------------------------------

# 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.

Page 5/7

{4}------------------------------------------------

KD33452 5 of 6

| IR Plethsmograph | | |
|-------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Sensor Type | IR Plethsmograph (attached to finger with<br>Velcro) |
| | 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 electrodes<br>1 each temperature sensor<br>1 each IR Plethsmograph sensor<br>1 each GSR sensor<br>1 each Futrex IR Body Composition sensor |
| | Output: | Isolated USB |
| | A/D converter: | 16 bit, 16 channel |
| | Controls: | None |
| | Indicators: | Rear Panel: Green LED Power Indicator<br>Front Panel: Green LED PC connect Indicator |
| | Power: | 12 VDC, 28 W converter, internal. |
| | Physical: | Case Material: Impact resistant, flame retardant<br>ABS.<br>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

Page 6/7

{5}------------------------------------------------

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

Page 7/7

{6}------------------------------------------------

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.

{7}------------------------------------------------

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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

{8}------------------------------------------------

# 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