(133 days)
Not Found
No
The summary describes standard signal processing and analysis software, with no mention of AI or ML terms, training data, or performance metrics typically associated with AI/ML models.
No
The device is used to measure galvanic skin response to aid in the assessment of sudomotor function, not to provide therapy or treatment.
Yes
The SUDOSCAN System is stated to be a "medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function," indicating its role in evaluating bodily function to assist in diagnosis.
No
The device description explicitly lists hardware components such as "analog acquisition electronic circuitry," "multiplexing control unit," "optically isolated USB interface controller," "power converter," and "4 electrodes." While it includes proprietary software, it is part of a larger system with significant hardware components.
Based on the provided information, the SUDOSCAN System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to measure galvanic skin response to aid in the assessment of sudomotor function. This is a physiological measurement taken directly from the patient's body.
- Device Description: The device description details electrodes placed on the hands and feet to collect physiological data (cutaneous conductance). This is a direct measurement from the patient.
- Lack of mention of biological samples: There is no mention of the device analyzing biological samples such as blood, urine, tissue, etc., which is a defining characteristic of IVD devices.
- Anatomical Site: The device interacts directly with the patient's skin (hands and feet). IVD devices typically analyze samples outside of the body.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. The SUDOSCAN System directly measures a physiological response from the patient's body, placing it in the category of a non-IVD medical device.
N/A
Intended Use / Indications for Use
The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function.
SUDOSCAN is indicated for use in the general adult population.
Product codes (comma separated list FDA assigned to the subject device)
GZO
Device Description
SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.
The SUDOSCAN system is composed of:
- analog acquisition electronic circuitry with low-noise front end
- multiplexing control unit for selecting the appropriate acquisition channels
- optically isolated USB interface controller
- power converter
- 4 electrodes placed on the feet and the hands
- touch-screen computer running the proprietary SUDOSCAN software
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands, Feet
Indicated Patient Age Range
general adult population.
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)
The modifications that are the subject of this 510(k) are to the indication statement, labeling and minor software and hardware upgrades. Therefore the performance testing provided in K100233 is applicable to this 510(k). Since its clearance in K100233, the SUDOSCAN was additionally tested for compliance with the following standards:
- IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: 2007 (Third Edition) Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- -ANSI/AAMI PC69:2007 Active implantable medical devices-Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators.
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).
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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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that creates a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2014
IMPETO Medical c/o Calley Herzog Biologics Consulting Group, Inc. 400 N Washington Street Suite 100, Medical Devices Division Alexandria, VA 22314
Re: K141872
Trade/Device Name: SUDOSCAN Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic Skin Response Measurement Device Regulatory Class: Class II Product Code: GZO Dated: October 21, 2014 Received: October 23, 2014
Dear Ms. Herzog:
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
1
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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" (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 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,
Felipe Aquel -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) K141872
Device Name SUDOSCAN
Indications for Use (Describe)
The SUDOSCAN System is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function.
SUDOSCAN is indicated for use in the general adult population.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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ട. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the SUDOSCAN is provided below.
| Device Common Name: | Galvanic Skin Response Measurement Device |
|---|---|
| Device Proprietary Name: | SUDOSCAN |
| Submitter: | Marie-Laure Névoret, MD |
| Medical Director, North America | |
| IMPETO Medical, Inc. | |
| 8910 University Center Lane | |
| Suite 615 | |
| San Diego, CA 92122 | |
| Contact: | Calley Herzog |
| Consultant, Medical Devices | |
| Biologics Consulting Group, Inc. | |
| Email: cherzog@bcg-usa.com | |
| Classification Regulation: | 21 CFR 882.1540, Class II |
| Panel: | Neurology |
| Product Code: | GZO |
| Date Prepared: | July 7, 2014 |
| Predicate Device: | K100233. SUDOSCAN. IMPETO Medical |
Indication for Use:
The SUDOSCAN system is a medical device for the measurement of galvanic skin response to aid in the assessment of sudomotor function.
SUDOSCAN is indicated for use in the general adult population.
Device Description:
SUDOSCAN is based on two well-known principles, reverse iontophoresis and electrochemistry. SUDOSCAN collects physiological data by means of chronoamperometry and processes them with analysis software. SUDOSCAN devices use both technologies, coupled and complemented with exclusive software which analyzes cutaneous conductance data collected through the chronoamperometric measurements.
The SUDOSCAN system is composed of:
- analog acquisition electronic circuitry with low-noise front end
- multiplexing control unit for selecting the appropriate acquisition channels
- optically isolated USB interface controller
4
- power converter
- 4 electrodes placed on the feet and the hands
- touch-screen computer running the proprietary SUDOSCAN software
Performance Data:
The modifications that are the subject of this 510(k) are to the indication statement, labeling and minor software and hardware upgrades. Therefore the performance testing provided in K100233 is applicable to this 510(k). Since its clearance in K100233, the SUDOSCAN was additionally tested for compliance with the following standards:
- IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
- IEC 60601-1-2: 2007 (Third Edition) Medical Electrical Equipment Part 1-2: General -Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility
- -ANSI/AAMI PC69:2007 Active implantable medical devices-Electromagnetic compatibility-EMC test protocols for implantable cardiac pacemakers and implantable cardioverter defibrillators.
Substantial Equivalence:
The indication for use for the predicate device (K100233) is similar to that of the subject device. There are two differences, first is the addition of the phrase "to aid in the assessment of sudomotor function" which does not constitute a new intended use. It clarifies the utility of the device. Second is the addition of the phrase "indicated for use in the general adult population". This also does not constitute a new intended use, but clarifies to intended user population.
The technological characteristics of the subject device are identical to that of the predicate. The only difference is that the head electrodes are no longer used or provided and there have been minor upgrades to the device software and hardware. The technological characteristics are substantially equivalent to the predicate device as shown in Table 1.
| Proposed Device | Predicate Device | |
|---|---|---|
| Device Name | SUDOSCAN | SUDOSCAN |
| Manufacturer | IMPETO Medical | IMPETO Medical |
| 510(k) Number | TBD | K100233 |
| Classification Regulation | 882.1540, Class II | 882.1540, Class II |
| Product Code | GZO | GZO |
| Table 1: | Device Comparison Table | ||
|---|---|---|---|
| Proposed Device | Predicate Device | ||
| Indication | The SUDOSCAN system is a | ||
| medical device for theresponse to aid in the assessment | |||
| of sudomotor function. | |||
| SUDOSCAN is indicated for use | |||
| in the general adult population. | The SUDOSCAN system is a | ||
| medical device for the | |||
| measurement of galvanic skin | |||
| responses. | |||
| Operating Characteristics | 1. Measures difference in | ||
| skin conductance. |
- Used to provide feedback
to physicians, not to
diagnose. - Skin Contact Pads
measure skin
conductance. | 1. Measures difference in
skin conductance. - Used to provide feedback
to physicians, not to
diagnose. - Skin Contact Pads
measure skin
conductance. | |
| Electrode Placement | Hands, Feet | Hands, Feet, Forehead | |
| Skin Conductance
Measurement Range | 10-100,000 nS/cm² | 10-100,000 nS/cm² | |
| Skin Conductance Resolution | 1 nS/cm² | 1 nS/cm² | |
| Acquisition Duration (total) | 120 seconds | 120 seconds | |
| Electrical Output to the skin | 4 V max | 4 V max | |
| Electrical Output Frequency | Continuous | Continuous | |
| Electrical Output Unit
Duration | 1 second | 1 second | |
| Power Density (at electrode) | $0.01 μA/mm²$ | $0.01 μA/mm²$ | |
| User Display | VGA Color LCD 1024768 | VGA Color LCD 1024768 | |
| User Control | Touch screen | Touch screen | |
| Audible Indicators | Internal Speaker and Optional
Headphone | Internal Speaker and Optional
Headphone | |
| Interface | (USB) Internal | (USB) Internal | |
| Power Source | 5 V provided by USB | 5 V provided by USB | |
| Electrode Surface Area | Hand: 212 cm² | Hand: 212 cm² | |
| | Foot: 269 cm² | Foot: 269 cm² | |
| | Head: N/A | Head: 7 cm² | |
| | Proposed Device | Predicate Device | |
| Electrode Patient Contact
Material | Hand and Feet Electrodes:
Stainless Steel (AISI 304) | Hand and Feet Electrodes:
Stainless Steel (AISI 304)
Head Electrode: Nickel Silver
Alloy | |
| Standards Met | IEC60601 -1 -1, EN60601-1-2,
ANSI/AAMI PC69 | IEC60601 -1 -1, EN60601-1-2 | |
| Test Report | - Subject details (patient data)
- Indication for referral - entered
by examining physician - Method
- Result
- Impressions - entered by
examining physician - Measured STC values of the
test - Two average values of 12 STC*
measurements: - Hand: Average value of
6 STC measurements - Foot: Average value of 6
STC measurements | - Subject details (patient data) - Indication for referral - entered
by examining physician - Method
- Result
- Impressions - entered by
examining physician - Measured STC values of the
test - Three average values of 18 STC
measurements: - Hand: Average value of
6 STC measurements - Foot: Average value of 6
STC measurements - Head: Average value of
6 STC measurements | |
5
6
*STC: Standard Conductances; the terminology used to describe the ionic current measured by the SUDOSCAN device electrodes.
Substantial Equivalence Conclusion
Based on intended use and technological characteristics, the SUDOSCAN can be found substantially equivalent to the submitter's own predicate device, the SUDOSCAN as cleared in K100233.