(272 days)
Not Found
No
The summary describes a mechanical device using suction for electrode attachment and does not mention any AI or ML components or functions.
No
The device is described as an attachment mechanism for electrodes used in electrocardiography workups, not for treating a disease or condition.
No.
The device's intended use is to attach electrodes to a patient for electrocardiography workups, not to diagnose a condition itself.
No
The device description explicitly mentions physical components like a suction pump and a filtration mechanism, indicating it is a hardware device, not software-only.
Based on the provided information, the Quickels QS 100 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "providing a firm reliable attachment of and an AgCl skin surface electrode to a patient or subject being measured during standard electrocardiography workups." This describes a device used on the patient's body for a physiological measurement (ECG), not a device used to test samples outside the body (in vitro).
- Device Description: The description focuses on the mechanical function of attaching electrodes to the skin using suction. It doesn't mention any analysis of biological samples or substances.
- Lack of IVD Characteristics: The description and intended use do not align with the typical definition of an IVD, which involves examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
Therefore, the Quickels QS 100 is a medical device used for patient monitoring (specifically ECG), but it does not fit the criteria of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
Unknown A
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Walsh cup electrode, Niess Applicard System (K864260)
Reference Device(s)
Not Found
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)
Not Found
§ 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 font is bold and sans-serif, and the entire logo is in black.
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.
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
Frank Fox
Frank Ferguson Official Correspondent