(218 days)
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 to provide an artificial airway for tracheostomized patients, which is a therapeutic intervention to manage their breathing.
No
The device is a tracheostomy tube used for airway management, not for diagnosing medical conditions.
No
The device description clearly outlines a physical medical device (tracheostomy tube set) made of PVC and stainless steel, with various hardware components and accessories. It is not a software-only device.
Based on the provided information, this device 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 therapeutic and supportive function, not a diagnostic one.
- Device Description: The device is a physical tube inserted into the trachea. It does not involve testing samples from the body (like blood, urine, or tissue) to diagnose a condition.
- Lack of Diagnostic Language: The description focuses on the physical characteristics and function of the tube for airway management. There is no mention of analyzing biological samples or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients.
Product codes
JOH
Device Description
The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 3-6mm 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. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus Pediatric 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
MAY 2 3 2014
Teleflex Medical, Incorporated 2917 Weck Drive Research Triangle Park, NC 27709 USA Phone: 919-433-4908 919-433-4996 Fax:
Contact Person
Lori Pfohl Regulatory Affairs Specialist
Device Name
Trade Name: Rusch TracFlex Plus Pediatric 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 Devices
K023918 - Rusch Crystal Clear Tracheostomy Sets, Cuffed and Cuffless K122235 - Rusch TracFlex Plus Tracheostomy Tube Set (Reference)
Device Description and Changes to Predicate
The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is a sterile, single patient use tracheotomy tube, available in sizes 3-6mm 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. The device is introduced into a tracheotomy incision in the patient's neck that provides access to the trachea. The TracFlex Plus Pediatric tracheostomy tube is made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" = : .
5
Page 2 - Lori Pfohl
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.hum for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
:
:
Sincerely yours.
Teiashri P
Erin 1. Keith. M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K133173
Device Name Rusch TracFlex Plus Pediatric Tracheostomy Tube Set
Indications for Use (Describe)
The Rusch TracFlex Plus Pediatric Tracheostomy Tube Set is used in airway management of tracheostomized patients.
Patient Population: Pediatric Patients per below:
| Pediatric Subgroup | Approximate Age Range |
|---|---|
| Neonate/Newborn | Birth to 28 days |
| Infant | 29 days to Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."