SUDO PATH

K131568 · Ld Technology, LLC · GZO · Jun 28, 2013 · Neurology

Device Facts

• Record ID: K131568
• Device Name: SUDO PATH
• Applicant: Ld Technology, LLC
• Product Code: GZO · Neurology
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended Use

SudoPath is a Galvanic skin response measurement device. The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers. The device is indicated for use in general adult population Prescription Use: Federal law restricts this device to sale by or on the order of a physician.

Device Story

SudoPath is a programmable electro-medical system for measuring skin resistance (conductance). System includes USB-connected electronic box, cables, and 4 tactile electrodes placed on palms and soles. Device measures sympathetic skin response and sweat gland activity. Operation involves software-controlled sequence measuring 4 pathways over 120 seconds. Output consists of 4 conductance values (1-120 micro Siemens) displayed on a computer. Used in clinical settings by physicians to obtain objective data for clinical judgment. Device benefits patients by providing quantitative galvanic skin response metrics to assist in neurological assessment.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software verification (SRS/SDS/STD/STR), and design control activities.

Technological Characteristics

Stainless steel electrodes; 4-electrode configuration; 1.28V electrical output; conductance range 1-120 micro Siemens; current density < 0.01 UA/mm2. Connectivity via USB to PC. Standards met: IEC 60601-1-1, IEC 60601-1-2. Disinfection via 70-90% ethyl or isopropyl alcohol.

Indications for Use

Indicated for general adult population for measurement of galvanic skin response. Prescription use only.

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

• EIS-GS (K102166)

Submission Summary (Full Text)

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#### L.D Technology LLC.

Image /page/0/Picture/2 description: The image shows a logo with the words "LID Technology" next to a circular graphic. The graphic contains a circle with a design inside that resembles a stylized plant or electronic component. The word "LID" is in a simple, blocky font, while "Technology" is in a more stylized, italicized font.

510{k) Premarket Notification Number: Special 510k Preparation date: February 16, 2013

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JUN 2 8 2013

#### Special 510(k) Summary SudoPath

#### This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.87

1. Device Trade Name of the device: SudoPath Device Common name: Galvanic Skin Response Regulation number: 21 CFR 882.1540 Product Code: GZO Classification: Class II Classification Advisory: Neurology

Submitter's Identification: 2. Manufacturer: L.D TECHNOLOGY LLC

CEO of LD Technology: Albert MAAREK Address: L.D Technology 100 N.Biscayne Blvd, Suite 502 Miami, FL, 33132, USA Tel: [phone] Fax: [phone] Email: [e-mail]

#### 3. Predicate legally marketed (unmodified) device

Trade name: EIS-GS, Common name: Galvanic skin response 510K number K102166 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device SudoPath) Product code GZO.

#### 4. Intended use

SudoPath is a Galvanic skin response measurement device.

The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers.

The device is indicated for use in general adult population

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

5. Device Description and Comparison Devices' comparison Table SudoPath / EIS -GS

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| Specifications | SudoPath | EIS-GS k 102166 |
|-----------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Intended use | Galvanic Skin Response device | Galvanic Skin Response device |
| Prescription for use | Physician | Physician |
| Hardware | Same Hardware with exactly the<br>same specification | EIS-GS Hardware |
| Material used in contact<br>with the patient | Stainless steel | Stainless steel<br>AgAgCl disposable electrodes |
| Fundamental Scientific | Sympathetic skin response and | Sympathetic skin response and sweat |
| Technology | sweat glands | glands |
| Number of electrodes in<br>contact with the patient | 4 | 6 |
| Number of conductance<br>values | 4 | 22 |
| Sequence of | Software control and simplified | Software control , all the possibilities |
| measurement | sequence between feet and hands | of measurements between the 6<br>tactile electrodes |
| Time of measurement | Software control , each pathway is | Software control , each pathway is |
| for each pathway | measured during 30 seconds and 4<br>times (2 pathways 2 times) | measured during 1 seconds and 88<br>times (22 pathways 4 times) |
| Cleaning and<br>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 |
| Range of conductance<br>measurements | 1 to 120 micro Siemens | 1 to 120 micro Siemens |
| Data acquisition<br>duration | 120s | 128s |
| electrical output to skin | 1.28V | 1.28V |
| active surface area of | 272 cm2 for the hand plates<br>330 cm2 for the foot plates | 15.75 cm2 for forehead electrodes<br>272 cm2 for the hand plates<br>330 cm2 for the foot plates |
| current density at<br>electrodes | < 0.01 UA/mm2 | < 0.01 UA/mm2 |

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#### Type of device

- SudoPath is a programmable electro medical system including:
- USB plug and play hardware device including an electronic box, 2 reusable cables to connect � the box to electrodes and 4 tactile electrodes placed on the sole of the feet and on the palm of the hands.
- Software installed on a computer. .

As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).

#### Comparison with the legally marketed (unmodified) device:

The submission is complying with the Items required under §807.87 Similarities:

The modified device SudoPath has the following similarities to EIS-GS which has previously received 510(k) clearance:

- . has the same intended use,
- uses the same Hardware and not affect the hardware manufacture process .
- Has the same material in used accessories ●
- Do not affect the Fundamental Scientific Technology .
- Do not change the prescription use .

#### Modifications:

Trade name: Change of the Trade name of the device

Accessories: The 2 frontal disposable electrodes are no longer used

Software: New design and change in time and sequence of measurement and therefore in displayed results of conductance value (Only 4 values and not 22)

Indication for use were updated to match with the cleared devices with the same intended use Labeling :Label on the box was modified with the new trade name of the device (SudoPath Replace EIS-GS)

Instructions for Use were modified according to the new design of the software and new process of measurement and displayed results of conductance values .

#### 6. Substantial Equivalence

The modified device SudoPath is complying with the Items required under §807.87 for a special 510k submission.

#### Performances and Effectiveness

- 1. New risk management
2. Software verification (SRS/SDS/STD/STR)

3. Summary of Design Control Activities and Declaration of Design control conformity

#### 12. General Safety Concerns

The new device uses the same Hardware and not affects the hardware manufacture process and has the same material in used accessories

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### Conclusions

The SudoPath device is equivalent in performances, technology, safety and efficacy to the legally marketed (unmodified) predicate device

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Signature:

Albert MAAREK

Premarket notification [510K] Number: K131568

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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 stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings or feathers. The symbol is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 28, 2013

LD Technology LLC c/o Mr. Albert Maarek 100 N. Biscayne Blvd. Ste 500 Miami, FL 33132

> K131568 Trade/Device Name: SudoPath Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: May 28, 2013 Received: May 30, 2013

Dear Mr. Maarek:

Re:

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.

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

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Page 2 - Mr. Albert Maarek

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 contact 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/Resources/or You/Industry/default.htm. Also, please note the regulation entitled, "Mishranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.ida.gov/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industrv/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K131568

## Device Name: SudoPath

Indications For Use:

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

The SudoPath provides values. It is the physician's responsibility to make proper judgments based on these numbers.

The device is indicated for use in general adult population

Prescription Use: 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)

# Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

K131568 510(k) Number

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