(130 days)
SUDOSCAN 510(k) Number 100223
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No
The document describes a galvanic skin response device that measures electrical conductivity. There is no mention of AI, ML, or any algorithms that would process the data beyond simple measurement and display. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is described as a measurement device for galvanic skin response and is explicitly stated as "not intended to be used for any diagnosis," which suggests it does not directly treat or alleviate a medical condition.
No
The "Intended Use / Indications for Use" section explicitly states, "The device is not intended to be used for any diagnosis."
No
The device description explicitly states that the EIS-GS system includes hardware components such as a USB plug and play hardware device, an electronic box, disposable electrodes, reusable electrodes, and reusable cables. While it also includes software, it is not solely software.
Based on the provided information, the EIS-GS device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states: "The device is not intended to be used for any diagnosis." IVD devices are specifically intended for use in the diagnosis of disease or other conditions.
- Device Description: The description focuses on measuring electrical conductivity and galvanic skin response, which are physiological measurements taken directly from the patient's body, not from in vitro samples (like blood, urine, or tissue).
- Lack of In Vitro Sample Handling: There is no mention of the device interacting with or analyzing biological samples outside of the body.
Therefore, the EIS-GS device, as described, falls under the category of a medical device that performs physiological measurements, not an in vitro diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GZO
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Tactile electrodes
Indicated Patient Age Range
adult
Intended User / Care Setting
practitioner's office and clinical setting
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Calibration tests (simulator)
- Software verification (SRS/SDS/STD/STR).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SUDOSCAN 510(k) Number 100223
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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 electrodes | |
| Ref 3M dot | Ag/AgCl 1.575 cm2 |
| Reusable hand plates Ref CPA 3504 -AR | |
| 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/ | |
| plates to the box Ref. PG395/15RN | 1.5m long armored insulated cables. |
| Color-coded for ease of use. Red one on the left | |
| 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 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 | |
| computer connected to the 120 V power | ||
| supply) | 5V (power supplied by USB port and computer | |
| connected to the 120 V power supply) | ||
| Skin conductance | ||
| measurement | 1 to 120 micro Siemens | 10 to 100 micro Siemens |
| Data acquisition | ||
| duration | 120s | 120s |
| Electrical output to the | ||
| skin | 1.28 V | 4 V maximum |
| Electrical output unit | ||
| duration | 1 s | 1 s |
| Power density at | ||
| electrode |