(221 days)
The device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management.
The device, which is equivalent to other devices currently being marketed, consists of a clear 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.
I am sorry, but the provided text from the regulatory submission K954585 for the "Rüsch Pediatric Reinforced Tracheal Tube - Uncuffed, sterile" does not contain the information requested regarding acceptance criteria or a study proving the device meets acceptance criteria.
This document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices already on the market. It explains that the new device is substantially equivalent in design, use, and materials to existing devices and therefore no difference in safety and effectiveness is forecasted.
It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample sizes, data provenance, or specific studies.
- Information about expert involvement or ground truth establishment.
- Adjudication methods.
- MRMC comparative effectiveness studies.
- Standalone algorithm performance.
- Information on training sets or their ground truth.
Therefore, I cannot fulfill your request based on the provided text.
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Image /page/0/Picture/0 description: The image shows the logo for "RUSCH. INTERNATIONAL Group Regulatory Affairs A Subsidiary of Teleflex Incorporated (USA)". The word "RUSCH." is in large, bold, black letters. Below that, the words "INTERNATIONAL Group Regulatory Affairs" are in a smaller font, and below that is the text "A Subsidiary of Teleflex Incorporated (USA)".
Tall Pines Park Jaffrev, NH 03452 (603) 532-7706 FAX (603) 532-8211 or 6108
MAY 10 1996
To: Whom it may concern
Substantial Equivalence 510(k) Summary
Reference: Rüsch Pediatric Reinforced Tracheal Tube - Uncuffed, sterile
The Rüsch Pediatric Reinforced Tracheal Tube - Uncuffed, sterile for tracheal intubation applied for in this application is substantially equivalent in design, use and materials to the: Sheridan Reinforced Uncuffed Tracheal Tube - K844296 & K860105 SIMS/Concord/Portex Pediatric Reinforced Silicone Tracheal Tube - K830352 NCC/Mallinckrodt Reinforced tracheal tube uncuffed without Magill curve - K841872 currently in inter-state commerce.
i ( The device, which is equivalent to other devices currently being marketed, consists of a clear 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 device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management. It will be available in a variety of sizes from 2.0 mm to 8.0 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 29 September 1995
11
§ 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).