(209 days)
The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management.
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 provided document is a 510(k) Substantial Equivalence Summary for the Rusch Reinforced Tracheal Tube - Cuffed, sterile. This document is for a medical device regulatory submission and does not contain any information about clinical studies, acceptance criteria, or performance data of the kind requested.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to pre-existing devices based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria.
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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
§ 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).