(221 days)
Not Found
No
The summary describes a purely mechanical device (tracheal tube) and explicitly states that AI, DNN, or ML were not found in the document.
No.
The device, a tracheal tube, is used for airway management, which is a supportive function rather than directly treating a disease or condition.
No
Explanation: The device is a tracheal tube used for airway management, which is a therapeutic rather than a diagnostic function. It does not analyze patient data or provide information about the presence, absence, or nature of a disease or condition.
No
The device description clearly states it is a physical tube made of P.V.C. with a stainless steel reinforcing spiral, indicating it is a hardware 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" through tracheal intubation. This is a procedure performed directly on a patient's body to establish an airway.
- Device Description: The device is a physical tube designed to be inserted into the trachea.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. This device does not perform any such analysis of specimens.
The device described is a medical device used for a therapeutic or diagnostic procedure performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The device is designed as single use, sterile, uncuffed tracheal tube for oral or nasal tracheal intubation and indicated for airway management.
Product codes
Not Found
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tracheal
Indicated Patient Age Range
Pediatric
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K844296, K860105, K830352, K841872
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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