(48 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard galvanic skin response measurement hardware and software.
No
The device is described as a medical device for the "measurement of galvanic skin response" and provides "values." It is explicitly stated that "It is the physician's responsibility to make proper judgments based on these numbers," indicating it is a diagnostic or measurement tool, not a device that provides therapy.
Yes
The device measures galvanic skin response and provides values. While it states that the physician is responsible for making proper judgments based on these numbers, the act of providing measurements related to the body's physiological responses (sweat glands) for the purpose of aiding a physician's judgment falls under the scope of a diagnostic device.
No
The device description explicitly states it includes a "USB plug and play hardware device including an electronic box, 2 reusable cables... and 2 tactile electrodes." This indicates the device is not solely software.
Based on the provided information, the SudoC device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (like blood, urine, tissue). The SudoC device measures galvanic skin response directly on the surface of the skin (sole of the foot). It does not analyze a biological sample.
- The description focuses on measuring a physiological response (galvanic skin response/conductance) in vivo. This is a measurement taken from a living organism, not a test performed on a sample outside the body.
- The intended use describes measuring a physiological parameter related to sweat glands. While sweat is a biological product, the device is measuring the electrical properties of the skin related to sweat gland activity, not analyzing the composition of the sweat itself.
Therefore, the SudoC device falls under the category of a medical device that measures a physiological parameter, but it is not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.
The SudoC 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.
Product codes
GZO
Device Description
The SudoC 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 2 tactile electrodes placed on the sole of each foot.
- Software installed on a computer. ●
As a galvanic skin response measurement device, it measures the skin resistance (i.e., conductance).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sole of each foot
Indicated Patient Age Range
general adult population
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modifications perform to the proposed device do not change the performance of the device has shown with:
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- New risk management
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- Software verification (SRS/SDS/STD/STR)
- Summary of Design Control Activities and Declaration of Design control conformity.
- Comparison of the conductance values using stainless steel electrodes versus conductive disposable cloth electrode.
- The removal of the hand electrodes does not affect the performance of the galvanic skin response measurement is performed in the area with the higher density of sweat glands (sole of the feet).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2015
LD Technology LLC Albert Maarek CEO 100 N. Biscayne Blvd. Suite 502 Miami. Florida 33132
Re: K152216 Trade/Device Name: SudoC Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: July 28, 2015 Received: August 7, 2015
Dear Albert Maarek:
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 devicerelated 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding 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.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 Industry and Consumer Education 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,
Michael J. Hoffmann -S
for Carlos L. Peña, PhD, MS 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) K152216
Device Name SudoC
Indications for Use (Describe)
SudoC device is a medical device for the measurement of galvanic skin response related to the sweat glands.
The SudoC 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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L.D Technology LLC.
Image /page/3/Picture/1 description: The image contains the logo for LD Technology. The logo consists of a green plant inside of a circle on the left, and the text "LD Technology" on the right. The text is in a light green color and the word "Technology" is italicized.
510(k) Premarket Notification Number: Special 510k number K152216 Preparation date: July 28, 2015
Special 510(k) Summary SudoC
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.87
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- Device Trade Name of the device: SudoC 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: 305-379-9900 Fax: 305 397 1115 Email: albert.ldteck@gmail.com
- Device Trade Name of the device: SudoC Device Common name: Galvanic Skin Response Regulation number: 21 CFR 882.1540 Product Code: GZO Classification: Class II Classification Advisory: Neurology
3. Predicate legally marketed (unmodified) device
Trade name: SudoPath, Common name: Galvanic skin response 510K number K131568 Applicant and Manufacturer: LD TECHNOLOGY LLC (Same as new device) Product code GZO.
4. Intended use
SudoC is a Galvanic skin response measurement device related to the function of the sweat glands.
The SudoC 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 modified SudoPath / unmodified SudoPath 13
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| Specifications | SudoC | SudoPath k 131568 |
|---|---|---|
| Intended use | Galvanic Skin Response measurement device related to the function of the sweat glands | Galvanic Skin Response device measurement |
| Prescription for use | Physician | Physician |
| Hardware | Same Hardware with exactly the same specification | SudoPath Hardware |
| Material used in contact with the patient | Conductive disposable cloth electrode | Stainless steel |
| Fundamental Scientific Technology | Sympathetic skin potential response and sweat glands | Sympathetic skin potential response and sweat glands |
| Number of electrodes in contact with the patient | 4 | 4 |
| Sequence of measurement | Software control and sequence between feet. | Software control and sequence between feet and hands |
| Time of measurement for each pathway | Software control , each pathway is measured during 30 seconds | Software control , each pathway is measured during 30 seconds |
| Cleaning and disinfection | Ethyl or isopropyl alcohol (70-90%) for lead wires and cables. Electrodes are single use. | Ethyl or isopropyl alcohol (70-90%) for electrodes, lead wires and cables |
| Standards met | IEC 60601-1 -1 | |
| IEC 60601-1-2 | IEC 60601-1-1 | |
| IEC60601-1-2 | ||
| Range of conductance measurements | 1 to 120 micro Siemens | 1 to 120 micro Siemens |
| Data acquisition duration | 120s | 120s |
| electrical output to skin | 1.28V | 1.28V |
| active surface area of electrode | 44 cm2 for each disposable electrode placed on the feet | 272 cm2 for the hand plates |
| 330 cm2 for the foot plates | ||
| current density at electrodes |