(207 days)
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.
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.
The QBioScan device does not appear to have acceptance criteria for clinical performance explicitly stated in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device (Sudoscan) primarily through technological characteristics and non-clinical testing.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As there are no specific performance acceptance criteria for clinical outcomes mentioned, a table cannot be fully provided. The non-clinical testing refers to compliance with safety and EMC standards and software V&V, which are typically pass/fail.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1, 3rd Edition | Found to be in compliance with the requirements of IEC 60601-1, 3rd Edition. |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2, 3rd Edition | Found to be in compliance with the requirements of EN 60601-1-2, 3rd Edition. |
| Software Verification & Validation | Follow FDA guidance for software in medical devices; "moderate" level of concern. | Software verification and validation testing were conducted following the FDA guidance document. (Implied: testing was successful and met requirements for a "moderate" level of concern software.) |
| Technological Equivalence (Non-Clinical) | Similar operating characteristics, measurement range, resolution, electrical output, etc. to predicate device. | The 510(k) submission argues for substantial equivalence based on a comparison of technological characteristics (see table in section a6). Differences noted (e.g., electrode surface area, some electrode materials, acquisition duration, user control) were deemed to have "no material impact on the equivalence between the devices." |
2. Sample Size Used for the Test Set and Data Provenance
- No clinical test set was used for a performance study. The document explicitly states: "No Clinical testing was necessary to determine substantial equivalence."
- Data Provenance: Not applicable for clinical testing. For the non-clinical testing (electrical safety, EMC, software V&V), the data would have been generated internally by Medeia, Inc. or by a contract testing laboratory.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Not applicable as no clinical test set with human subjects requiring ground truth establishment was used.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. The document states, "No Clinical testing was necessary to determine substantial equivalence." This type of study would fall under clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a standalone performance study. The device is a "galvanic skin response measurement device" which directly measures a physiological signal. While it processes data and displays it, it's not an "algorithm only" device in the context of, for example, an AI diagnostic tool. The focus is on the device's ability to accurately measure the physiological parameter, which is addressed through the technological comparison to the predicate and non-clinical safety/EMC testing.
7. The Type of Ground Truth Used
- Not applicable for clinical validation, as no clinical studies were performed. For the technical aspects, the "ground truth" would be the established safety standards (IEC 60601-1, EN 60601-1-2) and the functional specifications of the device itself (for software V&V).
8. The Sample Size for the Training Set
- Not applicable. This device is a measurement device, not an AI/machine learning device that requires a training set in the conventional sense. Its "training" would be its design and engineering to accurately measure galvanic skin response.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no training set in the context of AI/ML.
Summary of Approach:
The manufacturer, Medeia, Inc., pursued a 510(k) pathway for substantial equivalence. Their strategy was to demonstrate that the QBioScan device shares the same intended use and similar technological characteristics with a legally marketed predicate device (Sudoscan), and that any differences do not raise new questions of safety or effectiveness. This allowed them to forgo clinical testing and rely on non-clinical (electrical safety, EMC, software verification, and validation) testing, alongside a detailed technological comparison.
§ 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.