(272 days)
The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl sk in surface electrode to a patient or subject being dur ing measured standard electrocardiography workups. The electrodes can be reused.
The Quickels QS 200 System is a device that allows reusable AgCl electrodes be attached to the skin surface to using Suction rather than an adhesive.
I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, its intended use, and technological characteristics, as well as a comparison to predicate devices, but it does not include any details on acceptance criteria, study design, reported device performance, sample sizes, ground truth establishment, or expert involvement. This document appears to be a 510(k) summary for device clearance rather than a clinical study report.
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JUL 1 1998
916-342-4133 FAX: 916-343-4541
Kg54772
20 September 1995
510(k) SUMMARY
The 510 (k) summary information required by 21 CFR 807.92 is as follows:
- A . Classification name: Unknown
Common/usual name: Suction electrode system
Proprietary Quickels QS 200 System name :
- B. Substantial equivalence: Welsh electrode cup cup (preamendment device) and Niess Applicard (K864260). System
- Device description: c. The Quickels QS 200 System is a device that allows reusable AgCl electrodes be attached to the skin surface to using Suction rather than an adhesive.
- D. Intended use: The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl sk in surface electrode to a patient or subject being dur ing measured standard electrocardiography workups. The electrodes can be reused.
- ui Technological characteristics: The proposed Quickels QS 200 device utilizes a suction pump to obtain the required suction to hold the electrode in place. The suction is regulated against too much or too little negative pressure. Contaminants are prevented from entering the system by a filtration mechanism.
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The proposed device is similar to predicates in that all utilize suction in order to hold the electrode in place on the patient's skin, and also in that the electrodes are reusable.
The proposed device is different in predicates in that it utilizes a direct dynamic suction with a pumping mechanism whereas predicates utilize indirect or static suction methods.
Submitted, FERGUSON MEDICAL Establishment Registration Number 2937794
Frailetege
Frank Ferguson Official Correspondent
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(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 § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.