(29 days)
Not Found
No
The summary describes a standard galvanic skin response measurement device that provides raw values. There is no mention of AI, ML, or any algorithms that process the data beyond basic measurement.
No
The device is described as a measurement device that provides values for a physician to interpret, and there is no mention of it being used for therapy or treatment.
Yes
Explanation: The device provides values (measurements) that a physician uses to make judgments, which aligns with the definition of a diagnostic device. It measures galvanic skin response, which is a physiological indicator used in diagnosis.
No
The device description explicitly states it includes hardware components: "USB plug and play hardware device including an electronic box, 2 reusable cables to connect the box to electrodes and 4 tactile electrodes".
Based on the provided information, the SudoPath device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SudoPath's Function: The SudoPath device measures galvanic skin response (skin resistance/conductance) by placing electrodes on the surface of the skin (feet and hands). This is a measurement taken on the body, not from a sample taken from the body.
- Intended Use: The intended use describes it as a galvanic skin response measurement device that provides values for the physician to interpret. This aligns with a physiological measurement device, not an IVD.
Therefore, the SudoPath device falls under the category of a medical device that performs a physiological measurement, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GZO
Device Description
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sole of the feet and on the palm of the hands.
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)
-
- New risk management
- Software verification (SRS/SDS/STD/STR)
- Summary of Design Control Activities and Declaration of Design control conformity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
The modified device SudoPath is complying with the Items required under §807.87 for a special 510k submission.
§ 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.
0
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
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
- 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: 305-379-9900 Fax: 305 397 1115 Email: albert.ldteck@gmail.com
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.
- 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 | |
| same specification | EIS-GS Hardware | |
| Material used in contact | ||
| with the patient | Stainless steel | Stainless steel |
| AgAgCl disposable electrodes | ||
| Fundamental Scientific | Sympathetic skin response and | Sympathetic skin response and sweat |
| Technology | sweat glands | glands |
| Number of electrodes in | ||
| contact with the patient | 4 | 6 |
| Number of conductance | ||
| 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 |
| tactile electrodes | ||
| Time of measurement | Software control , each pathway is | Software control , each pathway is |
| for each pathway | measured during 30 seconds and 4 | |
| times (2 pathways 2 times) | measured during 1 seconds and 88 | |
| times (22 pathways 4 times) | ||
| Cleaning and | ||
| disinfection | Ethyl or isopropyl alcohol (70-90%) | Ethyl or isopropyl alcohol (70-90%) |
| 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 | 128s |
| electrical output to skin | 1.28V | 1.28V |
| active surface area of | 272 cm2 for the hand plates | |
| 330 cm2 for the foot plates | 15.75 cm2 for forehead electrodes | |
| 272 cm2 for the hand plates | ||
| 330 cm2 for the foot plates | ||
| current density at | ||
| electrodes | 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
5
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 (800) 638-2041 or (301) 796-7100 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 (800) 638 2041 or (301) 796-7100 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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