QUICKELS QS 200 SYSTEM

K954772 · Ferguson Medical · DRX · Jul 11, 1996 · Cardiovascular

Device Facts

• Record ID: K954772
• Device Name: QUICKELS QS 200 SYSTEM
• Applicant: Ferguson Medical
• Product Code: DRX · Cardiovascular
• Decision Date: Jul 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The Quickels QS 200 device is intended for use as a device to provide a firm and reliable attachment of an AgCl skin surface electrode to a patient or subject being measured during standard electrocardiography workups. The electrodes can be reused.

Device Story

Quickels QS 200 System; suction-based electrode attachment device for ECG workups. Replaces adhesive methods with reusable AgCl electrodes. System utilizes integrated suction pump to maintain electrode contact with patient skin; includes pressure regulation to prevent excessive or insufficient negative pressure; incorporates filtration mechanism to prevent system contamination. Used in clinical settings by healthcare providers to facilitate ECG signal acquisition. Benefits include reliable electrode placement and reusability.

Clinical Evidence

Bench testing only.

Technological Characteristics

Suction pump mechanism; AgCl electrodes; pressure regulation system; filtration mechanism for contamination control.

Indications for Use

Indicated for patients undergoing standard electrocardiography workups requiring attachment of AgCl skin surface electrodes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Welsh cup electrode (preamendment device)
• Niess Applicard System (K864260)

Submission Summary (Full Text)

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FERGUSON MEDICAL

JUL 1 1995

916-342-4133

FAX: [phone]

K954772

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 name: Quickels QS 200 System

B. Substantial equivalence: Welsh cup electrode (preamendment device) and Niess Applicard System (K864260).

C. Device description: The Quickels QS 200 System is a device that allows reusable AgCl electrodes to be attached to the skin surface 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 skin surface electrode to a patient or subject being measured during standard electrocardiography workups. The electrodes can be reused.

E. 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.

3407 Bay Avenue • Chico, California 95926 • USA

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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

Frank Ferguson
Official Correspondent