(209 days)
Not Found
No
The description focuses on the physical components and function of a standard tracheal tube, with no mention of AI or ML capabilities.
Yes
The device, a cuffed tracheal intubation tube, is used for airway management, which is a therapeutic intervention to maintain or create an open airway in a patient.
No
The device is a cuffed tracheal intubation tube used for airway management, not for diagnosing conditions.
No
The device description clearly outlines physical components like a PVC tube, stainless steel spiral, cuff, valve, and pilot balloon, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "single use, sterile, cuffed tracheal intubation and indicated for airway management." This describes a device used in vivo (within the body) for a medical procedure (airway management).
- Device Description: The description details a physical tube designed to be inserted into the trachea. It describes its components and how it functions 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 treatment.
IVD devices are used to perform tests in vitro (outside the body) on biological samples. This device is clearly designed for direct use within the patient's airway.
N/A
Intended Use / Indications for Use
The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The device, which is equivalent to other devices currently being marketed, consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector. The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
Tall Pines Park Jaffrev, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
Image /page/0/Picture/1 description: The image shows the logo for RUSCH International Group Regulatory Affairs, a subsidiary of Teleflex Incorporated (USA). The logo is in black and white and features the word "RUSCH" in large, bold letters. Below the company name is the text "INTERNATIONAL Group Regulatory Affairs" in a smaller font. The text "A Subsidiary of Teleflex Incorporated (USA)" is located below the company's regulatory affairs section.
JUN 27 1988
To: Whom it may concern
Substantial Equivalence 510(k) Summary
Reference: Rusch Reinforced Tracheal Tube - Cuffed, sterile
The Rusch Reinforced Endotracheal Tube - Cuffed, sterile for tracheal intubation applied for in this application is substantially equivalent in design, use and materials to the:
Sheridan Reinforced Cuffed Tracheal Tube - K844296 SIMS/Concord/Portex Reinforced Cuffed Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced Tracheal Tube Cuffed currently being marketed and sold in inter-state commerce.
The device, which is equivalent to other devices currently being marketed, consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector.
The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.
The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management. It will be available in a variety of sizes from 5.0 mm to 11.0 mm internal diameters in steps of 0.5 mm.
Based upon the equivalence in materials, design and intended use between this tube and others presently being marketed and sold, no difference in safety and effectiveness is forecasted.
signed
Authorized, Regulatory Affairs Department October 10, 1995