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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the EIS-GS (Electro Interstitial Scan-Galvanic Skin) device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (SUDOSCAN).

However, the document does not contain typical acceptance criteria for device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy against a gold standard) or the results of a primary clinical study designed to prove such performance.

Instead, the submission focuses on technical specifications, verification, validation, and safety standards to demonstrate substantial equivalence to an existing legally marketed device.

Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available:

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

Acceptance Criteria (Stated or Implied)	Reported Device Performance/Evidence
Functional Performance (Implied by equivalence)	- Measures galvanic skin response.- Record intensity changes of 22 body parts/pathways following weak current/tension (1.28V, very low frequency).- Skin conductance measurement range: 1 to 120 micro Siemens (Predicate: 10 to 100 micro Siemens).- Data acquisition duration: 120s.- Electrical output to the skin: 1.28 V (Predicate: 4 V maximum).- Electrical output unit duration: 1s.- Power density at electrode: < 0.01 UA/mm2.
Accuracy (Calibration)	- Calibration tests (simulator) were performed. (Specific acceptance criteria for these tests and their numerical results are not provided).
Software Functionality	- Software verification (SRS/SDS/STD/STR) was performed. (Specific acceptance criteria and results are not provided).
Electrical Safety	- Passed IEC 60601-1-1 Ed: 2 (General requirements for safety - Collateral standard: Safety requirements for medical electrical systems).- Achieved Class II classification.- Degree of protection against electric shocks: BF.- Galvanic isolation between analog and digital parts (optocouplers, AC/AC converter).
Electromagnetic Compatibility (EMC)	- Passed IEC 60601-1-2 Ed: 2 (Medical Electrical Equipment Part 1-2: General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility - Req. and Tests - Including Section 6 manual review).
Substantial Equivalence to SUDOSCAN (K100223)	- Same intended use and same technology as SUDOSCAN.- Comparison table provided showing similar specifications for power supply, data acquisition, power density, electrical classification, protection, sequence of measurement, anatomical site, cleaning, and standards met. Minor differences noted (e.g., skin conductance range, electrical output voltage, specific electrode sizes, display OS, output options).- Conclusion: EIS-GS is equivalent in performance, technology, safety, and efficacy to the predicate device.
Intended Use Compliance	- Will be used for measurement of galvanic skin response.- Not for diagnosis.- For healthy adult subjects.- In practitioner's office and clinical setting.- Prescription Use only.
Risk Mitigation (Contraindications, Undesirable Side Effects)	- Document lists contraindications (dermatological lesions, defibrillators/pacemakers, inability to sit, metal implants, pregnancy, absence of limbs, synthetic floor, low humidity, MRI/CT presence) and undesirable side effects (skin irritation/hypersensitivity). These are accepted as part of safe use by the FDA's clearance.

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

Not Available. The document primarily relies on technical verification and validation against standards and a comparison to a predicate device. It does not describe a clinical study with a "test set" of patient data for performance evaluation in terms of diagnostic accuracy or clinical outcomes. The "calibration tests (simulator)" are mentioned, but no sample size for a test set is provided.

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 Applicable/Available. Since no clinical test set with human subjects and a corresponding ground truth is described for performance evaluation, this information is not present. The device is for "measurement of galvanic skin response" and "not intended for use in any diagnosis," which suggests its performance isn't being assessed against a diagnostic ground truth established by experts.

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

Not Applicable/Available. No clinical test set requiring adjudication 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

No. This device is a galvanic skin response measurement tool, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not relevant and was not performed or described.

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

Not Applicable. The device itself is a standalone measurement tool (algorithms are integrated into its software to record and process the raw electrical conductivity data). The context of "standalone performance" often refers to algorithms designed to interpret data (e.g., detect disease) without human input, which is not the stated intended use of the EIS-GS (it measures, but does not diagnose). The performance mentioned relates to calibration and software verification, not clinical accuracy in a diagnostic sense.

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

Not Applicable. The document describes "calibration tests (simulator)" which would imply a known, controlled electrical input as a ground truth for verifying measurement accuracy. However, no specific details about this ground truth (e.g., standard reference resistors, known voltage/current outputs) are provided. For clinical claims or diagnostic accuracy, no such ground truth is mentioned because the device is explicitly not for diagnosis.

8. The sample size for the training set

Not Applicable/Available. The document does not describe the use of machine learning or AI models that would require a "training set" in the context of typical AI device submissions. The device appears to be based on established physiological measurement principles and programmed algorithms rather than learned models.

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

Not Applicable/Available. As no training set for a machine learning model is described, this information is not relevant or provided.

Summary

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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: 305-379-9900 E mail: albert.ldteck@gmail.com

Contact Information: Reviewer Richard Clement MD 11459 NW 34 Street Miami FL 33178 Tel: 305-594-2145 Fax: 305-594 2174 Email: richardclementmd@yahoo.com 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 electrodesRef 3M dot	Ag/AgCl 1.575 cm2
Reusable hand plates Ref CPA 3504 -ARCPA 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/plates to the box Ref. PG395/15RN	1.5m long armored insulated cables.Color-coded for ease of use. Red one on the leftBlack 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 andcomputer connected to the 120 V powersupply)	5V (power supplied by USB port and computerconnected to the 120 V power supply)
Skin conductancemeasurement	1 to 120 micro Siemens	10 to 100 micro Siemens
Data acquisitionduration	120s	120s
Electrical output to theskin	1.28 V	4 V maximum
Electrical output unitduration	1 s	1 s
Power density atelectrode	< 0.01 UA/mm2	< 0.01 UA/mm2
Electrical Classification	Class II	Class II
Degree of protectionagainst electric shocks	BF	BF
Sequence of themeasurement	Managed by the software	Managed by the software
Display	PC screen . Operating system window 7	PC touch screen. Operating system window XP
Electrodesspecifications	3 pairs of electrodes from 15- 330 cm2	3 pairs of electrodes from 7-300 cm2
Accessories	cable and Reusable electrodes (Large Platesand disposable electrodes)	cable and Reusable electrodes (Large Plates anddisposable electrodes)
Output	USB interface	USB interface / Bluetooth
Electrical isolationbetween the patientand the AC mainsenergy.	galvanic isolation between the Analog partand digital part :OptocouplersAC/AC converter	galvanic isolation between the Analog part anddigital part :OptocouplersAC/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 60601-1-1IEC 60601-1-2	IEC 60601-1-1IEC60601-1-2

11. Performance and Effectiveness

EIS-GS

1. Calibration tests (simulator)
1. 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 (800) 638-2041 or (301) 796-7100 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

Page 1 of 1

Regulation Number and Section

§ 882.1540 Galvanic skin response measurement device.

(a)
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.(b)
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.