SHEATHES (NON-LATEX), STERILE

• K Number: K990175
• Device Name: SHEATHES (NON-LATEX), STERILE
• Manufacturer: SHEATHING TECHNOLOGIES, INC.
• Date Cleared: 1999-04-21 ( 92 days)
• Product Code: ITX
• Regulation Number: 892.1570
• Type: Traditional
• Panel: RA
• Reference & Predicate Devices: N/A

Intended Use

STERILE NON-LATEX PROBE COVERS ARE INDICATET) DURING DIAGNOSTIC ULTRASOUND PROCEDURES in CASES WHERE.. PATIENT SENSITIVITY TO LATEX is SPECULATIVE.

Device Description

Sheathes (Non-Latex), Sterile

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a non-latex sterile sheath, not a study report or clinical trial. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, study details, or performance data for a device.

The clearance letter simply states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It does not provide any specific quantitative acceptance criteria or the results of any performance studies.

To answer your questions, I would need a different document, such as a summary of safety and effectiveness data (SSE) or a clinical study report that was part of the 510(k) submission.

Regulation Number and Section

§ 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.