(272 days)
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No
The summary describes a mechanical device for attaching electrodes using suction, with no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No.
The device is intended for attaching electrodes for standard electrocardiography workups, which is a diagnostic procedure, not a therapeutic one.
No
This device is for attaching electrodes for standard electrocardiography workups, not for diagnosing a condition itself. It facilitates a measurement, but doesn't interpret or diagnose.
No
The device description explicitly states it is a "device that allows reusable AgCl electrodes be attached to the skin surface to using Suction rather than an adhesive," indicating a physical hardware component for attachment.
Based on the provided information, the Quickels QS 200 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a firm and reliable attachment of a skin surface electrode for standard electrocardiography workups. This is a device used on the patient's body to facilitate a physiological measurement, not a device used to examine specimens from the body (like blood, urine, or tissue) to diagnose or monitor a condition.
- Device Description: The description confirms it's a device for attaching electrodes to the skin using suction.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing tests on specimens, or providing diagnostic information based on in vitro analysis.
Therefore, the Quickels QS 200 is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
skin surface
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Niess Applicard (K864260)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Ferguson Medical. The logo consists of a stylized letter "M" on the left, followed by the words "FERGUSON" and "MEDICAL" stacked on top of each other on the right. The logo is black and white and has a bold, modern design.
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.
1
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