SUDOSCAN

K100233 · Impeto Medical · GZO · Jun 14, 2010 · Neurology

Device Facts

• Record ID: K100233
• Device Name: SUDOSCAN
• Applicant: Impeto Medical
• Product Code: GZO · Neurology
• Decision Date: Jun 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

SUDOSCAN device is a medical device for the measurement of galvanic skin response.

Device Story

SUDOSCAN is a desktop medical device for measuring galvanic skin response (GSR). It utilizes reverse iontophoresis and electrochemistry principles to collect physiological data via chronoamperometry. The system includes analog acquisition circuitry, a multiplexing control unit, and connection circuitry for six electrodes placed on the patient's feet, hands, and forehead. It is integrated into a customized touch-screen Windows XP-based industrial-grade PC. The device processes cutaneous conductance data using proprietary software to calculate skin conductance values. The system provides a report including patient data, referral indications, and measured skin conductance values. It is intended for use by healthcare professionals to assist in clinical assessment. The device benefits patients by providing a non-invasive, automated method for measuring skin conductance over a larger surface area compared to traditional handheld devices, with a shorter total acquisition duration.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including verification of device specifications, software validation, and electrical safety/electromagnetic compatibility testing in compliance with IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Desktop device; Windows XP-based industrial PC; touch-screen interface. Sensing via 6 electrodes (7-300 cm² surface area). Principles: reverse iontophoresis and electrochemistry (chronoamperometry). Electrical output: 4V max, continuous frequency. Connectivity: USB interface. Power: 5V via USB. Standards: IEC60601-1-1, EN60601-1-2, MDD 93/42/EEC.

Indications for Use

Indicated for the measurement of galvanic skin response in patients.

Regulatory Classification

Identification

A galvanic skin response measurement device is a device used to determine autonomic responses as psychological indicators by measuring the electrical resistance of the skin and the tissue path between two electrodes applied to the skin.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

Predicate Devices

• EDX Epi-Scan (K032935)

Submission Summary (Full Text)

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# `impetomedical

## 510(k) Summary

### 1. Contact Details

K100233

Applicant Name: IMPETO MEDICAL

Address:17 rue Campagne Première, 75014 PARIS, France Phone: [phone] Fax: [phone]

JUN 1 4 2010

#### Name of contact person:

Kye Cheung Authorized Correspondent 4479 Shorepointe Way San Diego, CA 92130 Phone: [phone] Fax: [phone] Email address: [e-mail]

Date Prepared: June 11, 2010

#### 2. Device Name

Trade Name: SUDOSCAN

Common Name: SUDOSCAN

Classification Name: Galvanic Skin Response Measurement Device

Device Class: Class II

Device Code: GZO

Classification: 882.1540

#### 3. Legally Marketed Predicate Device(s)

The Impeto Medical SUDOSCAN device is substantially equivalent to the EDX Epi-Scan device cleared under 510(k) K032935.

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| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---------------|--------------|--------------|----------------|
| K032935 | GZO | EDX Epi-Scan | EDX Epi-Scan |
| | | | 130 Main Road |
| | | | Huntsville, AL |

#### 4. Device Description

SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.

SUDOSCAN device is composed of:

- -> The analog acquisition electronic circuitry with low-noise front end
- → The multiplexing control unit for selecting the appropriate acquisition channels
- -> The signal formatting and processing capabilities
- > The optically isolated USB interface controller
- -> The power converter,
- > The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.

#### 5. Intended Use/Indications for use

SUDOSCAN device is a medical device for the measurement of galvanic skin response.

#### 6. Substantial Equivalence Comparison

A comparison of the characteristics of the SUDOSCAN and the Epi-Scan predicate device is provided above.

| Characteristics | SUDOSCAN | Predicate Device<br>EDX Epi-Scan |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Measurement of galvanic skin<br>response | Measurement of galvanic skin<br>response |
| Presentation | Desktop device | Handheld device |
| Measurement<br>range<br>(Skin<br>conductance<br>range) | 10-100,000 nS/cm² | 1 - 80,000 nS/ cm² |
| Characteristics | SUDOSCAN | Predicate Device<br>EDX Epi-Scan |
| Measurement lower<br>(Skin conductance<br>resolution) | 1nS/cm² | 1nS/cm² |
| Acquisition duration<br>total | 120s | 54 time 3s=162s (6 locations with<br>9 points of measurement each) |
| Electrical output to<br>the skin | 4V max | 3V max |
| Electrical<br>output<br>frequency | Continuous | Continuous |
| Electrical output unit<br>duration | 1s | 3s |
| Power Density<br>(at<br>electrode) | 0,01 uA/mm² | 0.03 uA/mm² |
| User Display | VGA Color LCD 1024*768 | Liquid Crystal |
| User control | Touch screen | 6 push button switches (keys) |
| Audible Indicators | Integral Speaker Optional<br>Headphone | Integral Speaker Optional<br>Headphone |
| Interface | USB (Internal) | USB (cable supplied) |
| Power source | 5V provided by USB | 2 disposable (non rechargeable)<br>AA batteries |
| Electrodes surface<br>area (*) | 7 to 300 cm² | 1 to 3 cm² |
| Standards met | IEC60601-1-1, EN60601-1-2<br>Medical Device Directive<br>93/42/EEC | IEC60601-1-1, EN60601-1-2<br>Medical<br>Device<br>Directive<br>93/42/EEC |
| Test report | Subject details (patient data).<br>Indication for referral, entered<br>by examining physician.<br>Method.<br>Result.<br>Impressions entered by<br>examining physician.<br>The measured STC values of the<br>test.<br>Three average value of 18 STC<br>measurements. | Subject details (patient data).<br>Indication for referral, entered by<br>examining physician.<br>Method.<br>Result.<br>Impressions entered by<br>examining physician.<br>The measured STC values of the<br>test.<br>One average value of 36 STC<br>measurements. |

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(*) SUDOSCAN device, with its larger pre-configured electrodes, has simplified Galvanic Skin Response reading by collecting average information primarily on hands, feet and forehead. Both SUDOSCAN and the predicate device measure the Galvanic Skin Response. SUDOSCAN device is able to obtain measurements from a larger area at one time whereas EDX Epi-Scan obtains the measurements by taking several measurements over a period of time and then averaging the data.

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#### 7. Non-clinical Testing

SUDOSCAN device has been thoroughly tested through verification of specifications and validation, including software validation. Electrical safety and electromagnetic compatibility testing in compliance with IEC 60601-1, IEC 60601-1-2 were also completed.

#### 8. Conclusions

Conclusions drawn from SUDOSCAN device testing demonstrate that SUDOSCAN is as safe and effective to perform measurement of Galvanic Skin Response as the legally marketed predicate device EDX Epi-scan and is substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure with outstretched arms, representing care and protection.

#### Public Health Service

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

Impeto Medical c/o Mr. Kye Cheung 4479 Shorepointe Way San Diego, CA 92130

JUN 1 4 2010

Re: K100233

Trade/Device Name: Impeto Medical SudoScan Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: Class II Product Code: GZO Dated: June 4, 2010 Received: June 4, 2010

Dear Mr. Cheung:

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.

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Page 2 - Mr. Kye Cheung

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 device-related adverse events) (2.1 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Esa Rimin k

Malvina B. Eydelman, MOD Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE

K100233 510(k) Number: To Be Assigned By FDA

Device Name: Impeto Medical SudoScan

Indications for Use:

The SudoScan system is a medical device for the measurement of galvanic skin responses.

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

PETER G. Como

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices .

510(k) Number K100233