(207 days)
Not Found
No
The summary describes a device that measures galvanic skin response and provides quantitative results and asymmetry values. There is no mention of AI, ML, or any algorithms that would suggest learning or complex pattern recognition beyond basic calculations and data display. The performance studies focus on electrical safety, EMC, and software verification/validation, not on the performance of an AI/ML model.
No
The device is indicated for measurement to aid in assessment and provides information to the physician for inclusion in their decision-making process, but it does not directly treat or alleviate a medical condition.
Yes
The device is indicated for the measurement of galvanic skin response to aid in the assessment of sudomotor function, and provides information for the physician's decision-making process regarding sweat gland dysfunction. While it does not provide a direct diagnosis, it gathers data used for diagnostic purposes.
No
The device description explicitly lists multiple hardware components including a custom electronics box, USB cable, electrode lead cables, and electrodes, in addition to the software.
Based on the provided information, the QBioScan device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The QBioScan measures galvanic skin response by applying electrodes to the surface of the skin (hands, feet, forehead). It's measuring a physiological response in vivo, not analyzing a sample like blood, urine, or tissue in vitro (outside the body).
- The device description focuses on electrical measurements and electrochemical reactions on the skin surface. It describes the interaction between electrodes and chloride ions released by sweat glands, which is a measurement taken directly from the body.
- The intended use is for measuring galvanic skin response to aid in the assessment of sudomotor function. This is a physiological measurement, not a diagnostic test performed on a biological sample.
Therefore, the QBioScan falls under the category of a medical device that performs a physiological measurement, but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function.
The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.
Product codes (comma separated list FDA assigned to the subject device)
GZO
Device Description
QBioScan™ is a galvanic skin response measurement device intended for the collection and display of galvanic skin response recorded by the device consists of the following components:
- . an off-the-shelf computer with proprietary device software pre-installed
- . a custom electronics box that houses the QBioScan circuitry
- a USB cable to connect the electronics box to the computer .
- reusable electrode lead cables .
- reusable hand and foot electrodes and optional disposable forehead electrodes .
- . an off-the-shelf printer (optional)
The device allows for a evaluation of sweat gland function based on a measuring method where patients are in contact with surface electrodes (reusable stainless-steel plates and optional disposable electrodes) and are exposed to an incremental low voltage (under the 60601-1 standard safety limits). The device tests the electrochemical reaction between electrodes and the chloride ion released by the stimulated sweat glands. This active test method provides information and evidence of a sweat gland dysfunction that might otherwise not be detectable in a physiological examination. The Bioelectrical Conductance (BEC, in micro-Siemens, uS) representing galvanic skin response for the hands and feet are expressed as quantitative results along with an asymmetry value expressed as the percent difference between the BEC values of the right / left hands and the right / left feet.
The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Hands, Feet, Forehead
Indicated Patient Age Range
general adult population
Intended User / Care Setting
medical clinics, healthcare practices and out-patient departments of hospitals.
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 QBioScan™ device was subjected to the following non-clinical performance testing:
Electrical Safety and Electromagnetic Compatibility (EMC) Testing The device was submitted for testing and was found to be in compliance with the requirements of IEC 60601-1, 30 Edition and EN 60601-1-2, 30 Edition.
Software Verification and Validation Testing
Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.
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.
0
Image /page/0/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 image of three human profiles facing right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 19, 2015
Medeia, Inc. % Daniel Lehtonen Regulatory Consultant Compliance and Regulatory Services LLC 3771 Southbrook Drive Dayton, Ohio 45430
Re: K150804
Trade/Device Name: QBioScan Regulation Number: 21 CFR 882.1540 Regulation Name: Galvanic skin response measurement device Regulatory Class: Class II Product Code: GZO Dated: September 14, 2015 Received: September 16, 2015
Dear Mr. Lehtonen:
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
1
related adverse events) (21 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 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" (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.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,
Michael J. Hoffmann -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
2
Indications for Use
510(k) Number (if known) K150804
Device Name
QBioScan
Indications for Use (Describe)
QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function.
The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.
Type of Use (Select one or both, as applicable)
| X Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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3
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the Requirements of Safe Medical Device systems Act 1990 and 21 CFR Sec. 807.92
510(k) Number:
a1 APPLICANT INFORMATION:
Date Prepared: March 16, 2015 Name: Medeia, Inc. Address: 80 S.W. 8th St. Suite 2000 Miami, FL 33130
| Contact Person: | Slav Danev |
|---|---|
| Phone Number: | +1 800 433 4609 |
| Fax Number: | +1 800 433 4609 |
| Email: | danev@medeia-inc.com |
NAME OF DEVICE: a2
| Trade Name: | QBioScanTM, model HW4 |
|---|---|
| Common Name: | Galvanic Skin Measurement Device |
| Classification Name: | Galvanic Skin Measurement Device (21 CFR 882.1540 / GZC) |
a3 PREDICATE DEVICE:
| Device Name: | Sudoscan |
|---|---|
| K Numbers: | K100233 and K141872 |
| Manufacturer: | Impeto Medical |
| 17, rue Campagne Première | |
| 75014 Paris - France |
The FDA database for recalls was searched during the writing of this 510(k) submission and no recalls for the predicate device or manufacturer were found.
DESCRIPTION OF THE DEVICE: a4
QBioScan™ is a galvanic skin response measurement device intended for the collection and display of galvanic skin response recorded by the device consists of the following components:
- . an off-the-shelf computer with proprietary device software pre-installed
- . a custom electronics box that houses the QBioScan circuitry
- a USB cable to connect the electronics box to the computer .
- reusable electrode lead cables .
- reusable hand and foot electrodes and optional disposable forehead electrodes .
- . an off-the-shelf printer (optional)
The device allows for a evaluation of sweat gland function based on a measuring method where patients are in contact with surface electrodes (reusable stainless-steel plates and optional disposable electrodes) and are exposed to an incremental low voltage (under the 60601-1 standard safety limits). The device tests the electrochemical reaction between electrodes and the chloride ion released by the stimulated sweat glands. This active test method provides information and evidence of a sweat gland dysfunction that might otherwise not be detectable in a physiological examination. The Bioelectrical Conductance (BEC, in micro-Siemens, uS) representing galvanic skin response for the hands and feet are expressed as quantitative results
4
along with an asymmetry value expressed as the percent difference between the BEC values of the right / left hands and the right / left feet.
The device does not provide any direct diagnosis rather the device provides information to the physician for inclusion in their decision making process.
STATEMENT OF INTENDED USE: a5
QBioScan is indicated for the measurement of galvanic skin response to aid in the assessment of the sudomotor function.
The device is intended for use on the general adult population in medical clinics, healthcare practices and out-patient departments of hospitals.
TECHNOLOGICAL CHARACTERISTIC COMPARISON: a6
Determination of the bioelectrical conductance value of the hands and feet via application of a variable amplitude low voltage, low current excitation is the technological principle of both the subject and predicate devices. The following table shows the similarities and differences between the devices. The differences have no material impact on the equivalence between the devices.
| Proposed Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| 510(k) Number | N/A | K100233 | K141872 |
| Device Name | QBioScan™ | SUDOSCAN | SUDOSCAN |
| Manufacturer | Medeia, Inc. | IMPETO Medical | IMPETO Medical |
| Classification Regulation | 882.1540, Class II | 882.1540, Class II | 882.1540, Class II |
| Product Code | GZO | GZO | GZO |
| Indication | QBioScan is indicated for | ||
| the measurement of | |||
| galvanic skin response to | |||
| aid in the assessment of | |||
| the sudomotor function. | |||
| The device is intended for | |||
| use on the general adult | |||
| population in medical | |||
| clinics, healthcare | |||
| practices and out-patient | |||
| departments of hospitals. | The SUDOSCAN system | ||
| is a medical device for the | |||
| measurement of galvanic | |||
| skin responses. | 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. | |||
| Operating Characteristics | • Measures difference in | ||
| skin conductance. | |||
| • Used to provide | |||
| feedback to physicians, | |||
| not to diagnose. | |||
| • Skin Contact Pads | |||
| measure skin | |||
| conductance. | • Measures difference in | ||
| skin conductance. | |||
| • Used to provide | |||
| feedback to physicians, | |||
| not to diagnose. | |||
| • Skin Contact Pads | |||
| measure skin | |||
| conductance. | • Measures difference in | ||
| skin conductance. | |||
| • Used to provide | |||
| feedback to physicians, | |||
| not to diagnose. | |||
| • Skin Contact Pads | |||
| measure skin | |||
| conductance. | |||
| Electrode Surface Area | Hand: 384 cm² | ||
| Foot: 384 cm² | |||
| Head: 7 cm² | Hand: 212 cm² | ||
| Foot: 269 cm² | |||
| Head: 7 cm² | Hand: 212 cm² | ||
| Foot: 269 cm² | |||
| Head: N/A | |||
| Electrode Placement | |||
| (Anatomic Sites) | Hands, Feet, Forehead | Hands, Feet, Forehead | Hands, Feet |
| Electrode Materials | Head Electrode: | ||
| • Stainless Steel with | |||
| Ag/AgCl layer (cleared | |||
| electrode) | |||
| Hand and Foot Electrode: | |||
| • AISI 304 Stainless Steel | Head Electrode: | ||
| • Nickel Silver Alloy | |||
| Hand and Foot Electrode: | |||
| • AISI 304 Stainless Steel | Hand and Foot Electrode: | ||
| • AISI 304 Stainless Steel | |||
| Skin Conductance | |||
| Measurement Range | 10 - 100 µS/cm² | 10 - 100 µS/cm² | 10 - 100 µS/cm² |
| Proposed Device | Predicate Device | Predicate Device | |
| 510(k) Number | N/A | K100233 | K141872 |
| Skin Conductance Resolution | 1 nS/cm² | 1 nS/cm² | 1 nS/cm² |
| Acquisition Duration (total) | 120, 300 or 600 seconds | 120 seconds | 120 seconds |
| Electrical Output to the skin | 4 V max | 4 V max | 4 V max |
| Electrical Output Frequency | Continuous | Continuous | Continuous |
| Electrical Output Unit | |||
| Duration | 1 second | 1 second | 1 second |
| Power Density (at electrode) | 0.01 μΑ/mm² | 0.01 μΑ/mm² | 0.01 μΑ/mm² |
| User Display | Computer Display | VGA Color LCD | VGA Color LCD |
| User Control | Computer provided with | ||
| system | Touch screen | Touch screen | |
| Audible Indicators | Internal Computer Speaker | ||
| and Optional Headphone | Internal Speaker and | ||
| Optional Headphone | Internal Speaker and | ||
| Optional Headphone | |||
| Output Report | • Subject details (patient | ||
| data) | |||
| • Indication for referral | |||
| [entered by examining | |||
| physician] | |||
| • Method | |||
| • Results | |||
| • Impressions [entered by | |||
| examining physician] | |||
| • Measured STC† values | |||
| of the test | |||
| • 4 average values of 12 | |||
| STC measurements: | |||
| • Two STC for each | |||
| Hand: | |||
| Average value of a | |||
| minimum of 6 STC | |||
| measurements | |||
| • Two STC for each | |||
| Foot: | |||
| Average value of a | |||
| minimum of 6 STC | |||
| measurements | |||
| • Head: | |||
| Average value of a | |||
| minimum of 6 STC | |||
| measurements | • Subject details (patient | ||
| data) | |||
| • Indication for referral | |||
| [entered by examining | |||
| physician] | |||
| • Method | |||
| • Results | |||
| • 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 | |||
| • Results | |||
| • 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 | |||
| • Head: | |||
| Average value of 6 | |||
| STC measurements | |||
| Interface | USB from laptop | (USB) Internal | (USB) Internal |
| Power Source | 5 V provided by USB | 5 V provided by USB | 5 V provided by USB |
| Electrical Safety Standards | IEC 60601-1 | ||
| EN 60601-1-2 | IEC 60601-1 | ||
| EN 60601-1-2 | IEC 60601-1 | ||
| EN 60601-1-2 | |||
| ANSI/AAMI PC69 | |||
| Electrical Safety Classification | Class II | ||
| Type BF Applied Part | Class I | ||
| Type BF Applied Part | Class I | ||
| Type BF Applied Part |
5
Medeia, Inc.
「 STC- Standard Conductance; the terminology used to describe the ionic current measured by the predicate device electrodes
Based on comparisons of device technological characteristics, features, materials, intended use and performance the QBioScan™ has been shown to be substantially equivalent to the commercially available and legally marketed Sudoscan device.
6
b1 NON-CLINICAL TESTING:
The QBioScan™ device was subjected to the following non-clinical performance testing:
Electrical Safety and Electromagnetic Compatibility (EMC) Testing The device was submitted for testing and was found to be in compliance with the requirements of IEC 60601-1, 30 Edition and EN 60601-1-2, 30 Edition.
Software Verification and Validation Testing
Software verification and validation testing were conducted following the FDA guidance document for software contained in medical devices. The software was considered to be a "moderate" level of concern since a failure or latent flaw could indirectly result in a minor injury to the patient through incorrect or delayed information or through action of the operator.
b2 CLINICAL TESTING:
No Clinical testing was necessary to determine substantial equivalence.
b3 CONCLUSIONS DRAWN FROM TESTING:
Based on information obtained on the predicate device with reference to the design specification, electrical safety / EMC testing and intended use, the QBioScan™ device was subjected to the same type of testing. The results support the conclusion that the QBioScan™ device is substantially equivalent to the Sudoscan device from Impeto Medical.