(272 days)
The Quickels QS 100 device i s intended for use as a device to provide a firm reliable attachment of and an AgCl skin surface electrode to a patient or subject being measured during standard electrocardiography workups. The electrodes can be reused.
The Quickels QS 100 System is a device that allows reusable AgCl electrodes be attached to the to skin surface using Suction rather than an adhesive. The proposed Quickels QS 100 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.
The provided text is a 510(k) summary for a medical device called the "Quickels QS 100 System." This document is a pre-market notification to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed predicate device. It is not a detailed clinical study report and therefore does not contain the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, or expert involvement for a typical performance study.
The document primarily focuses on:
- Device Classification and Naming: Identifying the device and its proposed names.
- Substantial Equivalence: Comparing the Quickels QS 100 System to existing predicate devices (Walsh cup electrode and Niess Applicard System) to demonstrate it's "substantially equivalent." This is a regulatory pathway, not a detailed performance study against predefined acceptance criteria.
- Device Description: Briefly explaining what the device is and how it works.
- Intended Use: Stating the purpose of the device.
- Technological Characteristics: Describing the key features of the device, particularly its suction mechanism.
Therefore, I cannot populate the requested table and answer the specific questions because the provided text does not contain that level of detail about a performance study.
To reiterate, the document is a regulatory submission for substantial equivalence, not a clinical study report that would typically include acceptance criteria, sample sizes, ground truth establishment, or expert adjudication methodologies.
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U. II K
916-342-4133 FAX: 916-343-4541
20 September 1995
510(k) SUMMARY
The 510 (k) summary information required by 21 CFR 807.92 is as follows:
- Classification name: Unknown A .
Common/usual name: Suction electrode system
Proprietary name: Quickels QS 100 System
- B. Substantial equivalence: Walsh cup electrode (preamendment device) and Niess Applicard System (K864260) .
- c. Device description: The Quickels QS 100 System is a device that allows reusable AgCl electrodes be attached to the to skin surface using Suction rather than an adhesive.
- D. Intended use: The Quickels QS 100 device i s intended for use as a device to provide a firm reliable attachment of and an AgCl skin surface electrode to a patient or subject being measured during standard electrocardiography workups. The electrodes can be reused.
- E. Technological character istics: The proposed Quickels QS 100 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 Contaminants are prevented from pressure. 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
Frank Fox
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.