SUDOSCAN

K141872 · Impeto Medical, Inc. · GZO · Nov 21, 2014 · Neurology

Device Facts

• Record ID: K141872
• Device Name: SUDOSCAN
• Applicant: Impeto Medical, Inc.
• Product Code: GZO · Neurology
• Decision Date: Nov 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1540
• Device Class: Class 2

Intended 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 Story

SUDOSCAN measures galvanic skin response using reverse iontophoresis and electrochemistry; collects physiological data via chronoamperometry through four stainless steel electrodes (hands and feet). Proprietary software analyzes cutaneous conductance data; produces quantitative measurements of sudomotor function. Used in clinical settings; operated by healthcare professionals. Output displayed on touch-screen computer; assists physicians in assessing sudomotor function. Benefits include non-invasive, objective assessment of sudomotor function.

Clinical Evidence

Bench testing only. Performance testing from K100233 remains applicable. Additional testing performed for compliance with IEC 60601-1:2005, IEC 60601-1-2:2007, and ANSI/AAMI PC69:2007.

Technological Characteristics

Materials: Stainless steel (AISI 304) electrodes. Sensing: Chronoamperometry, reverse iontophoresis, electrochemistry. Electrical: 4V max output, continuous frequency. Connectivity: USB interface. Form factor: 4-electrode system with touch-screen computer. Standards: IEC 60601-1, IEC 60601-1-2, ANSI/AAMI PC69.

Indications for Use

Indicated for use in the general adult population to aid in the assessment of sudomotor function via measurement of galvanic skin response.

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

• SUDOSCAN (K100233)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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)

| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.25 3.33325L5.91667 10.6666L2.75 7.5" stroke="#000000" stroke-linecap="round" stroke-linejoin="round" stroke-width="1.5"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
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| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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<br>Medical Director, North America<br>IMPETO Medical, Inc.<br>8910 University Center Lane<br>Suite 615<br>San Diego, CA 92122 |
| Contact: | Calley Herzog<br>Consultant, Medical Devices<br>Biologics Consulting Group, Inc.<br>Email: [e-mail] |
| 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

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- 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<br>medical device for theresponse to aid in the assessment<br>of sudomotor function.<br>SUDOSCAN is indicated for use<br>in the general adult population. | The SUDOSCAN system is a<br>medical device for the<br>measurement of galvanic skin<br>responses. | |
| Operating Characteristics | 1. Measures difference in<br>skin conductance.<br>2. Used to provide feedback<br>to physicians, not to<br>diagnose.<br>3. Skin Contact Pads<br>measure skin<br>conductance. | 1. Measures difference in<br>skin conductance.<br>2. Used to provide feedback<br>to physicians, not to<br>diagnose.<br>3. Skin Contact Pads<br>measure skin<br>conductance. | |
| Electrode Placement | Hands, Feet | Hands, Feet, Forehead | |
| Skin Conductance<br>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<br>Duration | 1 second | 1 second | |
| Power Density (at electrode) | $0.01 μA/mm²$ | $0.01 μA/mm²$ | |
| User Display | VGA Color LCD 1024*768 | VGA Color LCD 1024*768 | |
| User Control | Touch screen | Touch screen | |
| Audible Indicators | Internal Speaker and Optional<br>Headphone | Internal Speaker and Optional<br>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<br>Material | Hand and Feet Electrodes:<br>Stainless Steel (AISI 304) | Hand and Feet Electrodes:<br>Stainless Steel (AISI 304)<br>Head Electrode: Nickel Silver<br>Alloy | |
| Standards Met | IEC60601 -1 -1, EN60601-1-2,<br>ANSI/AAMI PC69 | IEC60601 -1 -1, EN60601-1-2 | |
| Test Report | - Subject details (patient data)<br>- Indication for referral - entered<br>by examining physician<br>- Method<br>- Result<br>- Impressions - entered by<br>examining physician<br>- Measured STC values of the<br>test<br>- Two average values of 12 STC*<br>measurements:<br>- Hand: Average value of<br>6 STC measurements<br>- Foot: Average value of 6<br>STC measurements | - Subject details (patient data)<br>- Indication for referral - entered<br>by examining physician<br>- Method<br>- Result<br>- Impressions - entered by<br>examining physician<br>- Measured STC values of the<br>test<br>- Three average values of 18 STC<br>measurements:<br>- Hand: Average value of<br>6 STC measurements<br>- Foot: Average value of 6<br>STC measurements<br>- Head: Average value of<br>6 STC measurements | |

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*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.