(308 days)
No
The device description and performance studies focus on the physical properties and safety of a tracheal tube, with no mention of AI or ML capabilities.
No
The device is indicated for airway management, which is a supportive function rather than a therapeutic one designed to treat or cure a disease or condition.
No
The device is a tracheal tube used for airway management, acting as a direct intervention rather than providing diagnostic information about a patient's condition.
No
The device description clearly states it is a physical tracheal tube made from PVC with various hardware components like a cuff, inflation line, and connector.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that the Rusch tracheal tubes are used for "airway management by oral or nasal intubation of the trachea." This is a procedure performed directly on the patient's body to establish an airway, not a test performed on a sample outside the body.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analysis of biological samples, which are hallmarks of IVD devices.
Therefore, based on the provided information, the Rusch tracheal tube is a medical device used for direct patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Rusch tracheal tubes are indicated for oral or nasal intubation for airway management.
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
Product codes
BTR
Device Description
The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).
0
JUN 0 6 2014
510(k) SUMMARY
Rusch Safety Silk Tracheal Tube Series
Name, Address, Phone and Fax Number of Applicant
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-491-8960 919-433-4996 Fax:
Contact Person
Lori Pfohl Regulatory Affairs Specialist
Date Prepared
6/3/2014
Device Name
Trade Name: Rusch Safety Silk Tracheal Tube Series
Common Name: Tracheal Tube
Classification Name: Tube, Tracheal (Class II per 21 CFR 868.5730, Product Code BTR)
Predicate Devices
Teleflex Medical's Rusch Oral/Nasal (Safety Clear Plus) Tracheal Tube Cuffed, Magill/Murphy - K993786
Teleflex Medical's Rusch Oral/Nasal Tracheal Tube Cuffed, Magill/Murphy -K961837
Device Description
The proposed Teleflex Medical Super Safety Silk and Nasal Safety Silk tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =