(95 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and material properties of a standard tracheal tube, with no mention of AI or ML capabilities.
No
The device, a tracheal tube, is used for airway management and intubation, which are supportive functions rather than direct treatment or therapy for a disease or condition.
No
The device is a tracheal tube used for airway management, specifically for oral or nasal intubation. Its purpose is to facilitate breathing, not to diagnose a medical condition.
No
The device description clearly describes a physical medical device made of PVC with a radiopaque stripe, cuff, pilot balloon, and other physical components. It is not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "oral or nasal intubation" and "airway management." This is a direct intervention on the patient's body to manage their airway.
- Device Description: The description details a physical tube used to facilitate breathing, including features like a cuff, markings, and a positioning ring. These are all components of a device used for a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such testing on specimens.
This device is a medical device used for a therapeutic procedure (airway management), not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device is intended for oral or nasal intubation. It is intended for airway management.
Product codes
73BTR
Device Description
The Rusch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The cuff is inflated via a pilot balloon using any lock-tip or luer taper syringe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black positioning ring is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiopaque stripe
Anatomical Site
airway
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
Bench/Laboratory Testing: Based on test data, the device conforms to ASTM 1242-89. The device is biocompatible per the requirements of ISO 10993.
Key Metrics
Not Found
Predicate Device(s)
Sheridan HVT(TM) Tracheal Tube with X-Ray Line and 15mm. Connector High Volume Tapered Low Pressure Murphy Eye
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. The logo is in black and white and features the word "Rusch" in a stylized font. Below the word "Rusch" is the word "INTERNATIONAL" in a smaller, sans-serif font. Underneath that, it says "A Subsidiary of Teleflex Incorporated (USA)".
Pines Park
AUG 1 6 1996
Substantial Equivalence 510(k) Summary Rüsch Oral/Nasal Tracheal Tube, Cuffed- Magill/Murphy
To: Whom it May Concern
Date: May 10, 1996
Submitter/Contact- Name and Address:
Miss Karenann J. Brozowski Group Requlatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452
Telephone: (603) 532-7706 (603) 532-8211 Fax:
Device Details:
Trade Name: Rüsch Oral/Nasal Tracheal Tube, Cuffed- Magill/Murphy
Common Name: Tracheal Tube
Classification Name: Tube, Tracheal(w/wo Connector 73BTR)
Predicate Legally Marketed Device:
Sheridan HVT(TM) Tracheal Tube with X-Ray Line and 15mm. Connector High Volume Tapered Low Pressure Murphy Eye
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Device Description:
The Rusch Oral/Nasal Tracheal Tube, Cuffed, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The cuff is inflated via a pilot balloon using any lock-tip or luer taper syringe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black positioning ring is present on the tube to aid in visualization of the tube. An optional Murphy eye provides an alternative opening. The eye is the difference between the Murphy and the Magill Tube. The device is for Nasal/Oral use.
Device Intended Use:
The device is intended for oral or nasal intubation. It is intended for airway management.
Technological Characteristics of the Device:
The device is manufactured according to ASTM 1242-89. It is equivalent in design and intended use with the Sheridan product. Both of the products are PVC with the same general appearance.
The Rusch Tracheal Tube comes in sizes 4.5-11.0 inclusive.
Bench/Laboratory Testing:
Based on test data, the device conforms to ASTM 1242-89.
The device is biocompatible per the requirements of ISO 10993.