RUSCH TRACHEOFIX-SET

• K Number: K972423
• Device Name: RUSCH TRACHEOFIX-SET
• Manufacturer: RUSCH INTL.
• Date Cleared: 1998-02-13 ( 231 days)
• Product Code: JOH , NOV
• Regulation Number: 868.5800
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

The Rusch TracheoFix-Set (TFS) is a single patient disposable tracheostomy Tube for airway management of tracheostomized patients.

Device Description

The TracheoFix-Set consists of the following:

• . outer tube with low pressure cuff and pilot balloon, flexible fixation flange and turn lock fastener (the flange is not adjustable).
• luer activated valve for cuff inflation/deflation .
• luer activated valve for carr inituseem.
  Inner tube with standard taper and a replacement inner . tube
• introducer .
• standard connector .
• neck band .
  · neck band
  The Rusch TracheoFix-Set is a sterile, single patient, The Rusch fracheorin , pressure tracheostomy tube.

AI/ML Overview

The provided text is a 510(k) summary for the Rusch TracheoFix-Set, a tracheostomy tube. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices.

Crucially, this document focuses on regulatory equivalence and does NOT contain information about specific acceptance criteria, performance studies, or clinical trial data on the device itself. It is a regulatory submission, not a scientific publication detailing performance metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because the provided text does not contain this information.

The document only states that the device is "substantially equivalent in design, use, and materials" to predicate devices and that its "technological characteristics are the same as or equivalent to predicate devices." This substantial equivalence claim is the basis for its clearance, not a demonstration of specific performance against acceptance criteria in a clinical study.

Regulation Number and Section

§ 868.5800 Tracheostomy tube and tube cuff.

(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.