(139 days)
No
The summary describes "analysis software" and "proprietary SUDOSCAN acquisition control and analysis software," but there is no mention of AI, ML, or related terms, nor any description of training or test sets which are typical for AI/ML development.
No
The device is described as a medical device for measuring galvanic skin responses and collecting physiological data, not for treating any condition or disease.
Yes
The device is described as processing physiological data and analyzing cutaneous conductance, which are used to measure galvanic skin responses, indicating its use in assessing a patient's physiological state for diagnostic purposes.
No
The device description explicitly lists multiple hardware components, including electronic circuitry, a multiplexing control unit, a USB interface controller, a power converter, and connection circuitry to electrodes, all integrated into a personal computer. This indicates it is a hardware-software system, not software-only.
Based on the provided information, the SudoScan system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- The SudoScan system measures galvanic skin responses on the surface of the body. It directly interacts with the skin on the feet, hands, and forehead to collect physiological data. It does not analyze a sample taken from the patient.
The description clearly states it measures "galvanic skin responses" and collects "cutaneous conductance data collected through the chronoamperometric measurements" using electrodes placed on the patient's skin. This is a direct measurement on the body, not an analysis of a sample taken from the body.
N/A
Intended Use / Indications for Use
The SudoScan system is a medical device for the measurement of galvanic skin responses.
Product codes
GZO
Device Description
SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.
SUDOSCAN device is composed of:
- -> The analog acquisition electronic circuitry with low-noise front end
- → The multiplexing control unit for selecting the appropriate acquisition channels
- -> The signal formatting and processing capabilities
-
The optically isolated USB interface controller
- -> The power converter,
-
The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
feet, hands, forehead
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical Testing:
SUDOSCAN 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, IEC 60601-1-2 were also completed.
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.
0
`impetomedical
510(k) Summary
1. Contact Details
Applicant Name: IMPETO MEDICAL
Address:17 rue Campagne Première, 75014 PARIS, France Phone: +33 1 43 20 16 40 Fax: +33 1 43 22 80 75
JUN 1 4 2010
Name of contact person:
Kye Cheung Authorized Correspondent 4479 Shorepointe Way San Diego, CA 92130 Phone: (619) 665-2796 Fax: (858) 630-3829 Email address: kye.cheung@impeto-medical.com
Date Prepared: June 11, 2010
2. Device Name
Trade Name: SUDOSCAN
Common Name: SUDOSCAN
Classification Name: Galvanic Skin Response Measurement Device
Device Class: Class II
Device Code: GZO
Classification: 882.1540
3. Legally Marketed Predicate Device(s)
The Impeto Medical SUDOSCAN device is substantially equivalent to the EDX Epi-Scan device cleared under 510(k) K032935.
1
| 510(k) Number | Product Code | Trade Name | Manufacturer |
|---|---|---|---|
| K032935 | GZO | EDX Epi-Scan | EDX Epi-Scan |
| 130 Main Road | |||
| Huntsville, AL |
4. Device Description
SUDOSCAN device is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN device collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN device uses both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.
SUDOSCAN device is composed of:
- -> The analog acquisition electronic circuitry with low-noise front end
- → The multiplexing control unit for selecting the appropriate acquisition channels
- -> The signal formatting and processing capabilities
-
The optically isolated USB interface controller
- -> The power converter,
-
The connection circuitry to 6 electrodes placed on the feet, the hands and the forehead of the patient. is integrated into a customized touch-screen Windows XP-based Industrialgrade personal computer running the proprietary SUDOSCAN acquisition control and analysis software also responsible for archiving measurements taken on all patients.
5. Intended Use/Indications for use
SUDOSCAN device is a medical device for the measurement of galvanic skin response.
6. Substantial Equivalence Comparison
A comparison of the characteristics of the SUDOSCAN and the Epi-Scan predicate device is provided above.
| Characteristics | SUDOSCAN | Predicate Device
EDX Epi-Scan |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Measurement of galvanic skin
response | Measurement of galvanic skin
response |
| Presentation | Desktop device | Handheld device |
| Measurement
range
(Skin
conductance
range) | 10-100,000 nS/cm² | 1 - 80,000 nS/ cm² |
| Characteristics | SUDOSCAN | Predicate Device
EDX Epi-Scan |
| Measurement lower
(Skin conductance
resolution) | 1nS/cm² | 1nS/cm² |
| Acquisition duration
total | 120s | 54 time 3s=162s (6 locations with
9 points of measurement each) |
| Electrical output to
the skin | 4V max | 3V max |
| Electrical
output
frequency | Continuous | Continuous |
| Electrical output unit
duration | 1s | 3s |
| Power Density
(at
electrode) | 0,01 uA/mm² | 0.03 uA/mm² |
| User Display | VGA Color LCD 1024768 | Liquid Crystal |
| User control | Touch screen | 6 push button switches (keys) |
| Audible Indicators | Integral Speaker Optional
Headphone | Integral Speaker Optional
Headphone |
| Interface | USB (Internal) | USB (cable supplied) |
| Power source | 5V provided by USB | 2 disposable (non rechargeable)
AA batteries |
| Electrodes surface
area () | 7 to 300 cm² | 1 to 3 cm² |
| Standards met | IEC60601-1-1, EN60601-1-2
Medical Device Directive
93/42/EEC | IEC60601-1-1, EN60601-1-2
Medical
Device
Directive
93/42/EEC |
| Test report | Subject details (patient data).
Indication for referral, entered
by examining physician.
Method.
Result.
Impressions entered by
examining physician.
The measured STC values of the
test.
Three average value of 18 STC
measurements. | Subject details (patient data).
Indication for referral, entered by
examining physician.
Method.
Result.
Impressions entered by
examining physician.
The measured STC values of the
test.
One average value of 36 STC
measurements. |
2
(*) SUDOSCAN device, with its larger pre-configured electrodes, has simplified Galvanic Skin Response reading by collecting average information primarily on hands, feet and forehead. Both SUDOSCAN and the predicate device measure the Galvanic Skin Response. SUDOSCAN device is able to obtain measurements from a larger area at one time whereas EDX Epi-Scan obtains the measurements by taking several measurements over a period of time and then averaging the data.
3
7. Non-clinical Testing
SUDOSCAN 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, IEC 60601-1-2 were also completed.
8. Conclusions
Conclusions drawn from SUDOSCAN device testing demonstrate that SUDOSCAN is as safe and effective to perform measurement of Galvanic Skin Response as the legally marketed predicate device EDX Epi-scan and is substantially equivalent.
4
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure with outstretched arms, representing care and protection.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Impeto Medical c/o Mr. Kye Cheung 4479 Shorepointe Way San Diego, CA 92130
JUN 1 4 2010
Re: K100233
Trade/Device Name: Impeto Medical SudoScan Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: Class II Product Code: GZO Dated: June 4, 2010 Received: June 4, 2010
Dear Mr. Cheung:
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.
5
Page 2 - Mr. Kye Cheung
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) (2.1 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/ucm11.5809.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 vours.
Esa Rimin k
Malvina B. Eydelman, MOD Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE
K100233 510(k) Number: To Be Assigned By FDA
Device Name: Impeto Medical SudoScan
Indications for Use:
The SudoScan system is a medical device for the measurement of galvanic skin responses.
Prescription Use X (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)
PETER G. Como
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices .
510(k) Number K100233