(130 days)
EIS-GS (Electro Interstitial Scan-GS) is a medical device for the measurement of galvanic skin response. The device is not intended to be used for any diagnosis. The data are stored in the PC in the backup system of the EIS-GS software. The device is intended for use only in healthy adult subjects. The device is intended for use only in practitioner's office and clinical setting. Prescription Use Caution: Federal law restricts this device to sale by or on the order of a physician.
The EIS-GS system is a programmable electro medical system including: USB plug and play hardware device including an electronic box, 6 disposable electrodes, reusable electrodes and reusable cables. Software installed on a computer. Protocol communication: USB port. Through the 6 tactile electrodes, a weak current with a very low frequency is sending alternatively between 2 electrodes with a sequence and the EIS-GS system is recording the electrical conductivity of 22 pathways of the human body. In accordance with the 21 CFR 882.1540, the EIS-GS system is a galvanic Skin response device that provides skin conductance measurements on the PC screen.
The provided document is a 510(k) Premarket Notification for the EIS-GS (Electro Interstitial Scan-Galvanic Skin) device. It describes the device, its intended use, and claims substantial equivalence to a predicate device (SUDOSCAN).
However, the document does not contain typical acceptance criteria for device performance in terms of clinical accuracy (e.g., sensitivity, specificity, accuracy against a gold standard) or the results of a primary clinical study designed to prove such performance.
Instead, the submission focuses on technical specifications, verification, validation, and safety standards to demonstrate substantial equivalence to an existing legally marketed device.
Here's a breakdown of the requested information based on the provided text, with clear indications where the information is not available:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance/Evidence |
|---|---|
| Functional Performance (Implied by equivalence) | - Measures galvanic skin response. |
- Record intensity changes of 22 body parts/pathways following weak current/tension (1.28V, very low frequency).
- Skin conductance measurement range: 1 to 120 micro Siemens (Predicate: 10 to 100 micro Siemens).
- Data acquisition duration: 120s.
- Electrical output to the skin: 1.28 V (Predicate: 4 V maximum).
- Electrical output unit duration: 1s.
- Power density at electrode:
§ 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.