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K Number
K043425
Device Name
SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER)
Manufacturer
SHEATHING TECHNOLOGIES, INC.
Date Cleared
2005-02-28

(77 days)

Product Code
ITX
Regulation Number
892.1570
Type
Traditional
Panel
RA
Reference & Predicate Devices
K931403,K882383
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Sheathes Needle Guide provides guidance for a needle, catheter, biopsy apparatus, or other interventional device by positioning it relative to the ultrasound apparatus, of other moreman as aring a diagnostic ultrasound procedure in order to perform a biopsy or precise needle placement.

Device Description

The Sheathes Needle Guide system consists of 4 primary components which are used to provide interventional tool in relation to the ultrasound image. Three components (a transducer cover, a guide clip, and retainer clip) are single use disposable, while the fourth component, the adapter, is a reusable component, providing a system interface to various transducers.

AI/ML Overview

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria for the "Sheathes Needle Guide System."

The document is a 510(k) premarket notification for the Sheathes Needle Guide System, aiming to demonstrate substantial equivalence to legally marketed predicate devices. It lists the trade name, common name, classification, product equivalence, and intended use of the device.

However, it does not provide:

  • A table of acceptance criteria and reported device performance.
  • Details on sample sizes or data provenance for any studies.
  • Information on experts, ground truth establishment, or adjudication methods.
  • Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
  • Sample size or ground truth establishment for a training set.

§ 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.