(262 days)
Not Found.
No
The device description and other sections do not mention AI, ML, image processing, or any related technologies. The device is a standard tracheal tube.
No.
The device is used for airway management by intubation, which is a supportive rather than a therapeutic function.
No
The device is a tracheal tube used for airway management, not for diagnosing conditions or diseases.
No
The device description clearly states it is a physical tracheal tube made from PVC resin with various hardware components like a cuff, inflation line, pilot balloon, and valve. It is a tangible medical device, not software.
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 by oral or nasal intubation of the trachea." This is a direct intervention on the patient's body for a therapeutic purpose (maintaining an open airway).
- Device Description: The description details a physical device (tracheal tube) used for intubation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. This device is used in vivo (inside the body) for a medical procedure.
N/A
Input Imaging Modality: Not Found.
Intended Use / Indications for Use
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
Intended Population: Pediatric
Intended Environment of Use: Locations where ET intubation may be performed
Product codes (comma separated list FDA assigned to the subject device)
BTR
Device Description
The proposed Teleflex Medical Rusch Safety Silk Pediatric Tracheal Tube Series 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).
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October 28, 2021
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, North Carolina 27709
Re: K150603
Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR
Dear Lori Pfohl:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change for your device cleared on November 27, 2015. Specifically, FDA is updating this SE letter due to the clearance date not appearing on the original letter.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Todd Courtney, Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, 301-796-6371, todd.courtney@fda.hhs.gov.
Sincerely,
Todd D. Courtney -S
Todd Courtney Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Teleflex Medical, Inc. Lori Pfohl Senior Regulatory Affairs Specialist 2917 Weck Drive Research Triangle Park, NC 27709
Re: K150603
Trade/Device Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal tube Regulatory Class: Class II Product Code: BTR Dated: November 5, 2015 Received: November 6, 2015
Dear Ms. Pfohl:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
2
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/ReportaProblem/default.htm 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/Industry/default.htm.
Sincerely yours,
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Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
for
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
Indications for Use (Describe)
Rusch tracheal tubes are indicated for airway management by oral or nasal intubation of the trachea.
Intended Population: Pediatric
Intended Environment of Use: Locations where ET intubation may be performed
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
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 Senior Regulatory Affairs Specialist
Date Prepared
3/9/2015
Device Name
Trade Name: Rusch Safety Silk Pediatric Series Oral/Nasal Tracheal Tube
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 Rusch Safety Silk Pediatric Tracheal Tube Series tracheal tubes are sterile, single use devices that are made from Polyvinyl chloride (PVC) resin that is formulated without DEHP ("Non-DEHP" =