(407 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a tracheostomy tube, with no mention of AI or ML capabilities.
Yes
The device is used for airway management of tracheostomized patients, providing an artificial airway and access to the patient's trachea, which are therapeutic interventions.
No
The device description clearly states its purpose is to "provide an artificial airway, in order to provide access to the patient's airway" and is "introduced into a tracheotomy incision". This indicates a therapeutic or supportive function rather than diagnostic. There is no mention of it being used to detect, monitor, or identify a medical condition.
No
The device description clearly outlines a physical medical device (tracheostomy tube set) made of materials like PVC and stainless steel, with various physical components and accessories. The performance studies focus on physical properties and bonding strength, not software validation.
Based on the provided information, the Rusch TracFlex Plus Tracheostomy Tube Set is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "airway management of tracheostomized patients" and to "provide an artificial airway." This is a direct intervention on the patient's body to manage their breathing, not a test performed on samples taken from the body to diagnose a condition.
- Device Description: The description details a physical tube inserted into the trachea to facilitate breathing. It does not mention any components or processes related to analyzing biological samples.
- Anatomical Site: The device is used in the trachea, which is part of the respiratory system, not a site from which samples are typically collected for in vitro diagnostic testing.
- Performance Studies: The performance studies focus on the physical properties and functionality of the tube (bonding strength, collapse, herniation, etc.), not on the accuracy or reliability of diagnostic results.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Rusch TracFlex Plus Tracheostomy Tube Set does not perform this function.
N/A
Intended Use / Indications for Use
The Rusch TracFlex Plus Tracheostomy Tube Set is used in airway management of tracheostomized patients
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =
§ 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.
0
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4908 919-433-4996 Fax: -------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Contact Person
SEP 06 2013
Lori Pfohl Regulatory Affairs Specialist
Device Name
Trade Name: Rusch TracFlex Plus Tracheostomy Tube Set
Common Name: Tracheostomy Tube
Classification Name: Tube Tracheostomy and tube cuff (Class II per 21 CFR 868.5800, Product Code JOH)
Predicate Device
Rusch Ultra TracheoFlex Teleflex Medical, Inc - K964056
Device Description and Changes to Predicate
The Rusch TracFlex Plus Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 7-11mm in 1 mm increments, with accessories which may be included in a set or sold separately. The device is used to provide an artificial airway, in order to provide access to the patient's airway. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =