ELECTRO INTERSTITIAL SCAN

K102166 · Ld Technology, LLC · GZO · Dec 10, 2010 · Neurology

Device Facts

• Record ID: K102166
• Device Name: ELECTRO INTERSTITIAL SCAN
• Applicant: Ld Technology, LLC
• Product Code: GZO · Neurology
• Decision Date: Dec 10, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response. The device is not intended for use in any diagnosis. The data are stored in PC in the Backup system of the EIS-GS software. The device is intended for use on healthy adult subjects. The device is intended use in practitioner's office and clinical setting. Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician.

Device Story

EIS-GS is a programmable electro-medical system for measuring galvanic skin response. It consists of a USB-connected hardware box, six electrodes (disposable forehead, reusable hand/foot plates), and PC-based software. Operation involves sending a weak current (1.28V, 700Hz, 12µA) through 22 body pathways via tactile electrodes. The system records electrical conductivity changes over 120 seconds. Used in clinical settings by practitioners, the device transmits data via USB to a PC for storage. It provides skin conductance measurements on the PC screen. It is not diagnostic; it serves as a measurement tool for healthy adults. Benefits include non-invasive monitoring of skin conductance. The device requires the patient to remain seated during the 120-second acquisition period.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence consists of hardware calibration tests using a simulator, software verification (SRS/SDS/STD/STR), and electrical safety/EMC testing in compliance with IEC 60601-1-1 and IEC 60601-1-2.

Technological Characteristics

Hardware: USB-powered (5V), 1.28V/12µA/700Hz output. Electrodes: Ag/AgCl disposable forehead electrodes (1.575 cm2) and AISI 304 stainless steel reusable hand/foot plates. Galvanic isolation via TRACO DC/DC 4KV optocouplers. Connectivity: USB 2.0. Software: PC-based, Windows 7. Classification: Class II, BF protection. Sterilization: Not applicable (reusable/disposable components).

Indications for Use

Indicated for measurement of galvanic skin response in healthy adult subjects. Intended for use in practitioner offices and clinical settings. Contraindicated for patients with dermatological lesions, excessive perspiration, implanted electronic devices (e.g., pacemakers, defibrillators), metal pins/prostheses in extremities/joints, pregnancy, or absence of limbs. Not for use in patients unable to sit still.

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

• SUDOSCAN (K100223)

Submission Summary (Full Text)

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#### L.D Technology LLC.

510(k) Premarket Notification Number: K102166 Preparation date: June 29, 2010

DEC 10 2010

## 510(k) Summary EIS-GS (Electro Interstitial Scan-Galvanic Skin)

Name of the device: Electro Interstitial Scan-Galvanic Skin Common name: EIS-GS Regulation number: 21 CFR 882.1540 Product Code: GZO Classification: Class II Classification Advisory: Neurology

### This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92

## 1. Submitter's Identification:

Manufacturer: L.D TECHNOLOGY LLC Owner of LD Technology: MAAREK Albert Address: L.D Technology 100 N.Biscayne Blvd, Suite 500 Miami, FL, 33132, USA Tel: [phone] E mail: [e-mail]

Contact Information: Reviewer Richard Clement MD 11459 NW 34 Street Miami FL 33178 Tel: [phone] Fax: [phone] Email: [e-mail] Date of Preparation: June 29, 2010

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#### 2. Device Name/Classification

EIS-GS (Electro Interstitial Scan-GS) System components: 21 CFR 882.1540 Product Code: GZO Classification: Class II Classification Advisory: Neurology

#### 3. Predicate legally marketed device

SUDOSCAN 510(k) Number 100223: Manufacturer - Impeto Medical, 17 rue Campagne Premiere, 75014 PARIS, France.

#### 4. Device Description

The EIS-GS system is a programmable electro medical system including:

- USB plug and play hardware device including an electronic box , 6 disposable electrodes, reusable . electrodes and reusable cables
- Software installed on a computer. .

Protocol communication: USB port.

Through the 6 tactile electrodes, a weak current with a very low frequency is sending alternatively between 2 electrodes with a sequence and the EIS-GS system is recording the electrical conductivity of 22 pathways of the human body.

In accordance with the 21 CFR 882.1540, the EIS-GS system is a galvanic Skin response device that provides skin conductance measurements on the PC screen.

# EIS-GS system features

#### Hardware feature:

To Record the intensity changes of 22 body parts/pathways following the sending of a weak current and an imposed weak tension (1.28V) with a very low frequency. The data are transmitted via the USB port from the hardware to the PC (software).

#### Software chart flow

Image /page/1/Figure/15 description: The image shows a diagram of a system with several layers. The top layer is labeled "BACKUP", and below that is a layer labeled "Measurement of 22 skin conductance values". The next layer is labeled "PROTOCOL COMMUNICATION", and the bottom layer is labeled "HARDWARE". Arrows connect the layers, indicating the flow of information or data between them.

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### 5. Intended use and indications for use

EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response.

The device is not intended for use in any diagnosis.

The data are stored in PC in the Backup system of the EIS-GS software.

The device is intended for use on healthy adult subjects.

The device is intended use in practitioner's office and clinical setting.

Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician

# 6. Performances, specifications and materials Technical specifications

# Hardware technical specifications:

| Power supply | USB interface |
|----------------------------------------------|-----------------------------------|
| Current in operating mode | 1.28 V Frequency 700 Hz and 12 μA |
| Power consumption | 200mA |
| Classification | Class II |
| Degree of protection against electric shocks | BF |
| Operating mode | Continuous use |
| Galvanic decoupling of the analogical part, | TRACO DC/DC 4 KV |
| Dimensions in mm | 128 X 143 X 33 |
| Weight kg | 1,2 |

# Accessories

| Component | Technical specifications |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Disposable forehead electrodes<br>Ref 3M dot | Ag/AgCl 1.575 cm2 |
| Reusable hand plates Ref CPA 3504 -AR<br>CPA 3504 -AL | Polished stainless steel grade AISI 304 Size:272 cm2 |
| Reusable feet plates Ref. CPA 3504-F | Polished stainless steel grade AISI 304 Size :330 cm2 |
| Audio-type cables to connect electrodes/<br>plates to the box Ref. PG395/15RN | 1.5m long armored insulated cables.<br>Color-coded for ease of use. Red one on the left<br>Black one on the right |
| Calibration Box Ref.CPA 5509 | Box including Different resistors 80 and 100 KOhms |
| USB cable. Ref. USB cable | 2 m long USB 2.0 |

#### 7. Contraindications

- Dermatological lesions in contact with the electrodes or excessive perspiration. ● Risk: The conductivity values will be changed and the results not accurate.
- This device should not be used in association with or presence of defibrillators, cardiac . pacemakers, patients connected to electronic life support devices, or any implanted electronic device.

Risk: The injected voltage and current could provoke injury to the patient.

- People unable to be held seated. .

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Risk: The calibration of the device was performed the patient in sitting position, and therefore in other position, the conductivity values will be changed and the results not accurate.

- Metal pins or prostheses on the level of the extremities or the joints. . Risk: the conductivity values will be changed and the results not accurate
- This device should not be used on pregnant women. . Risk: The effects on the fetus, as well as accuracy of readings are unknown.
- An absence of one or more limbs. ●
- Risk: The conductivity values will be changed and the results not accurate
- Do not use the system in the following conditions : .
- The Floor in synthetic material.

Risk: The floor in synthetic material will increase the Electrostatic discharge and the device could short and in this case a message will appear and the measurement will stop (i.e. troubleshooting).

- / Relative humidity < 30%.
Risk: The low humidity will increase the Electrostatic discharge and the device could short and in this case a message will appear and the measurement will stop (i.e. troubleshooting).

- Presence of MRI or MR or CT scan.
Risk: The Electromagnetic environment could short the device and in this case a message will appear and the measurement will stop (i.e. troubleshooting).

## Disclaimers

- The device is not intended to be use to diagnose any disease or condition since it is intended for use in generally healthy subjects only.
#### 8. Undesirable side effects:

- Some patients may experience skin irritation or hypersensitivity due to the electrical > stimulation or electrical conductive medium.
- The device should be used only with the leads and electrodes recommended for use by the > manufacturer.

## 9. Substantial equivalence

## Predicate legally marketed device

SUDOSCAN 510(k) number 100223: Manufacturer Impeto Medical 17 rue Campagne Premiere, 75014 PARIS, France.

#### Similarities

- Same intended use and same technology
#### New characteristics:

- Small change as shown in the device comparison table below
# Devices' Comparison Table

Table comparison for EIS-GS/SUDOSCAN K100223

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| Specifications | EIS-GS | SUDOSCAN K 100223 |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended use | Measurement of the galvanic skin response | Measurement of the galvanic skin response |
| Power supply | 5V (power supplied by USB port and<br>computer connected to the 120 V power<br>supply) | 5V (power supplied by USB port and computer<br>connected to the 120 V power supply) |
| Skin conductance<br>measurement | 1 to 120 micro Siemens | 10 to 100 micro Siemens |
| Data acquisition<br>duration | 120s | 120s |
| Electrical output to the<br>skin | 1.28 V | 4 V maximum |
| Electrical output unit<br>duration | 1 s | 1 s |
| Power density at<br>electrode | < 0.01 UA/mm2 | < 0.01 UA/mm2 |
| Electrical Classification | Class II | Class II |
| Degree of protection<br>against electric shocks | BF | BF |
| Sequence of the<br>measurement | Managed by the software | Managed by the software |
| Display | PC screen . Operating system window 7 | PC touch screen. Operating system window XP |
| Electrodes<br>specifications | 3 pairs of electrodes from 15- 330 cm2 | 3 pairs of electrodes from 7-300 cm2 |
| Accessories | cable and Reusable electrodes (Large Plates<br>and disposable electrodes) | cable and Reusable electrodes (Large Plates and<br>disposable electrodes) |
| Output | USB interface | USB interface / Bluetooth |
| Electrical isolation<br>between the patient<br>and the AC mains<br>energy. | galvanic isolation between the Analog part<br>and digital part :<br>Optocouplers<br>AC/AC converter | galvanic isolation between the Analog part and<br>digital part :<br>Optocouplers<br>AC/AC converter |

| Other specifications | EIS-GS | SUDOSCAN K 100223 |
|---------------------------|-------------------------------------|-------------------------------------|
| Anatomic site | Tactile electrodes | Tactile electrodes |
| Where used | Practitioner | Practitioner |
| Cleaning and disinfection | Ethyl or isopropyl alcohol (70-90%) | Ethyl or isopropyl alcohol (70-90%) |
| Standards met | IEC 60601-1-1<br>IEC 60601-1-2 | IEC 60601-1-1<br>IEC60601-1-2 |

# 11. Performance and Effectiveness

# EIS-GS

- 1. Calibration tests (simulator)
- 2. Software verification (SRS/SDS/STD/STR).

# 12. General Safety Concerns

The small changes in the characteristics do not change the general safety to the legally marketed The sman changes in the marketers.com tests reports. (IEC 60601-1-2 and IEC 60601-1-1.

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#### 13. Standards

IEC60601-1-1 Issued: 2000/12/14 Ed: 2 Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems IEC 60601-1-2 Issued: 2001/09/30 Ed: 2 Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral Standard: Electromagnetic Compatibility - Req. and Tests - Including Section 6 manual review

# 14. Non-clinical Testing

EIS-GS 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 -1-1, IEC 60601-1-2 were also completed.

#### Conclusion

EIS-GS is equivalent in performance, technology, safety and efficacy to the legally marketed predicate device.

Signature:

.

Albert MAAREK

Premarket notification [510K] Number: K102166

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.

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

L.D. Technology, LLC c/o Richard Clement, MD 11459 NW 34 Street Miami, Florida 33178

DEC 1 0 2010

Re: K102166

Trade/Device Name: Electro Interstitial Scan - Galvanic Skin (EIS-GS) Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: November 24, 2010 Received: December 1, 2010

Dear Dr. Clement:

We have reviewed vour 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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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) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/ucm115809.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 yours,

Rikhmb

Malvina B. Eydelman, M. 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

510(k) Number: K102166

Device Name: EIS-GS (Electro Interstitial Scan-Galvanic Skin)

EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response.

The device is not intended to be used for any diagnosis. The data are stored in the PC in the backup system of the EIS-GS software. The device is intended for use only in healthy adult subjects. The device is intended for use only in practitioner's office and clinical setting.

Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 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)

Michael Hoffman

vision Sign/C Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number k102166

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