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K Number
K190591
Device Name
Safergel Sterile Ultrasound Gel
Manufacturer
Safersonic US, Inc.
Date Cleared
2019-10-04

(211 days)

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

The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

Device Description

The Safergel Sterile Ultrasound Gel is a sterile, water-soluble, translucent, clear ultrasonic gel intended for noninterventional and interventional diagnostic and therapeutic ultrasound. Safergel serves the purpose of providing an acoustic bridge for ultrasonic examinations. The gel is intended for use in all diagnostic ultrasound procedures which require coupling gel or fluid.

AI/ML Overview

This is a 510(k) clearance letter for a sterile ultrasound gel. As such, the document primarily focuses on the regulatory review process and substantial equivalence to a predicate device. It does not contain the kind of performance study data and acceptance criteria typically found for AI/ML-powered diagnostic devices.

Therefore, I cannot provide the requested information from the given text. The document does not describe:

  • Acceptance criteria for device performance.
  • A study proving the device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Details about expert readers or ground truth establishment.
  • MRMC studies or standalone algorithm performance.

The product in question is a "Safergel Sterile Ultrasound Gel," which is a consumable medical device used to facilitate ultrasound imaging, not an AI/ML diagnostic software.

§ 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.