(133 days)
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.
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
The provided text is a 510(k) Summary for the SUDOSCAN device (K141872). It compares the proposed device to a predicate device (K100233), which is itself an earlier version of the SUDOSCAN.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy) for a new clinical study. Instead, it argues for substantial equivalence based on technological characteristics and a change in indication statement and labeling compared to its own predicate device. The performance data section refers back to the testing provided in the K100233 submission.
The "Performance Data" section states: "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)."
This implies that the performance of the device, in terms of its ability to measure galvanic skin response, is considered unchanged from the predicate and thus already "meets acceptance criteria" from its previous clearance. The acceptance criteria would have been established during the K100233 submission.
The table below summarizes the technological characteristics of the proposed device as presented in the "Device Comparison Table" within the document, rather than specific performance metrics from a new study designed to meet pre-defined acceptance criteria for this 510(k).
| Feature / Characteristic | Proposed Device (SUDOSCAN K141872) | Predicate Device (SUDOSCAN K100233) |
|---|---|---|
| Indication for Use | To aid in the assessment of sudomotor function in the general adult population. | Measurement of galvanic skin responses. |
| Operating Characteristics | Measures difference in skin conductance; provides feedback to physicians, not to diagnose; skin contact pads measure skin conductance. | Measures difference in skin conductance; provides 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 1024*768 | VGA Color LCD 1024*768 |
| 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 | 212 cm² |
| Electrode Surface Area (Foot) | 269 cm² | 269 cm² |
| Electrode Surface Area (Head) | N/A | 7 cm² |
| Electrode Patient Contact Material (Hand & Feet) | Stainless Steel (AISI 304) | Stainless Steel (AISI 304) |
| Electrode Patient Contact Material (Head) | N/A | Nickel Silver Alloy |
| Standards Met | IEC60601 -1 -1, EN60601-1-2, ANSI/AAMI PC69 | IEC60601 -1 -1, EN60601-1-2 |
| Test Report (STC measurements) | Hand: Average of 6 STC measurements; Foot: Average of 6 STC measurements (Total 12) | Hand: Average of 6 STC measurements; Foot: Average of 6 STC measurements; Head: Average of 6 STC measurements (Total 18) |
2. Sample size used for the test set and the data provenance
The document for K141872 explicitly states that no new performance testing was conducted for this submission (K141872) related to the device's ability to measure galvanic skin response. It relies on the performance testing from the predicate device (K100233). Therefore, information on a "test set" and "data provenance" for this specific 510(k) application is not provided as new clinical performance data was not generated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no new clinical performance testing was conducted for K141872, this information is not available in the provided document. The original ground truth establishment would have occurred for the K100233 submission.
4. Adjudication method for the test set
Not applicable, as no new clinical test set and associated performance evaluation were conducted for K141872.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The SUDOSCAN device is a diagnostic measurement device for sudomotor function, not an AI-assisted interpretation tool for images or other complex data requiring human reader interaction in the way a MRMC study typically evaluates. No MRMC study is mentioned or relevant to this device's function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone measurement system. The document does not describe "algorithm only" performance in the context of interpretation or diagnosis being done without human involvement. The device measures galvanic skin response, and a physician interprets the results. The statement "Used to provide feedback to physicians, not to diagnose" reinforces the human-in-the-loop aspect for diagnosis, but the measurement itself is standalone. The performance testing for K100233 would have established the accuracy of these standalone measurements.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that the device measures galvanic skin response, which is a physiological parameter, the ground truth for the original K100233 submission would likely have involved:
- Reference standards for conductivity measurements: Calibration against known electrical standards.
- Correlation with clinical conditions: For its intended use in assessing sudomotor function, the ground truth would have been established by comparing SUDOSCAN measurements with other validated methods for assessing sudomotor function or with clinical diagnoses of conditions affecting sudomotor function, possibly including expert clinical assessment or other established diagnostic tests.
- The provided document for K141872 does not specify the ground truth methodology for K100233.
8. The sample size for the training set
Not applicable. The document describes a 510(k) submission for an existing device with minor changes and expanded indications, relying on the previous clearance. It does not discuss a "training set" in the context of machine learning model development.
9. How the ground truth for the training set was established
Not applicable, as this submission does not involve a machine learning model requiring a training set with established ground truth.
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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 (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, MDMedical Director, North AmericaIMPETO Medical, Inc.8910 University Center LaneSuite 615San Diego, CA 92122 |
| Contact: | Calley HerzogConsultant, Medical DevicesBiologics 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
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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 amedical device for theresponse to aid in the assessmentof sudomotor function.SUDOSCAN is indicated for usein the general adult population. | The SUDOSCAN system is amedical device for themeasurement of galvanic skinresponses. | |
| Operating Characteristics | 1. Measures difference inskin conductance.2. Used to provide feedbackto physicians, not todiagnose.3. Skin Contact Padsmeasure skinconductance. | 1. Measures difference inskin conductance.2. Used to provide feedbackto physicians, not todiagnose.3. Skin Contact Padsmeasure skinconductance. | |
| Electrode Placement | Hands, Feet | Hands, Feet, Forehead | |
| Skin ConductanceMeasurement 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 UnitDuration | 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 OptionalHeadphone | Internal Speaker and OptionalHeadphone | |
| 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 ContactMaterial | Hand and Feet Electrodes:Stainless Steel (AISI 304) | Hand and Feet Electrodes:Stainless Steel (AISI 304)Head Electrode: Nickel SilverAlloy | |
| 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 - enteredby examining physician- Method- Result- Impressions - entered byexamining physician- Measured STC values of thetest- Two average values of 12 STC*measurements:- Hand: Average value of6 STC measurements- Foot: Average value of 6STC measurements | - Subject details (patient data)- Indication for referral - enteredby examining physician- Method- Result- Impressions - entered byexamining physician- Measured STC values of thetest- Three average values of 18 STCmeasurements:- Hand: Average value of6 STC measurements- Foot: Average value of 6STC measurements- Head: Average value of6 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.
§ 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.