K Number
K191491
Device Name
EZ-Cover
Manufacturer
Date Cleared
2020-06-05

(366 days)

Product Code
Regulation Number
892.1570
Panel
RA
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Probe cover can be used to minimize contamination between patient and ultrasound scanning procedures for external intact skin. This may help with easier cleaning and disinfection of the probe. This product is not intended for use of probes with endocavity or intraoperative use.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "EZ-Cover," which is a probe cover used to minimize contamination between patient and ultrasound scanning procedures for external intact skin. This document primarily focuses on regulatory approval and does not contain specific information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details about AI/algorithm performance.

Therefore, I cannot provide the requested information based on the input text. The text does not describe a study that proves the device meets acceptance criteria in the manner requested (e.g., performance metrics, statistical analysis).

§ 892.1570 Diagnostic ultrasonic transducer.

(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.