(45 days)
K96184C
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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 is described as a tracheal tube intended for airway management, facilitating intubation. It acts as a conduit for air and does not actively treat a disease or condition.
No
Explanation: The device is an endotracheal tube used for airway management and intubation, not for diagnosing a medical condition. Its description mentions intubation and airway management, which are therapeutic/supportive procedures.
No
The device description clearly describes a physical tracheal tube made of PVC with a radiopaque stripe, centimeter markings, and a black tip. This is a hardware device, not software.
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 procedure performed directly on a patient to manage their airway, not a test performed on a sample taken from a patient.
- Device Description: The description details a physical tube used for insertion into the trachea. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
This device is a medical device used for a therapeutic or procedural purpose, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The device is intended for oral or nasal intubation. It is intended for airway management.
Product codes
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Device Description
The Rusch Oral/Nasal Tracheal Tube, Plain, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black tip area 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
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Based on test data, the device conforms to ASTM 1242-89. The device is biocompatible per the requirements of ISO 10993.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
K96184C
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
l'ines Park ey, NH 03452 (613) 532-7706 FAX (603) 532-8211
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JUN 27 1998
Substantial Equivalence 510(k) Summary Rüsch Oral/Nasal Tracheal Tube, Plain- MagIII/Murphy
To: Whom it May Concern
Date: May 10, 1996
Submitter/Contact- Name and Address:
Miss Karenann J. Brozowski Group Regulatory Affairs Director Rüsch International Tall Pines Park Jaffrey, NH 03452
Telephone: (603) 532-7706 Fax: (603) 532-8211
Device Details:
Trade Name: Rüsch Oral/Nasal Tracheal Tube, Plain- Magill/Murphy
Common Name: Tracheal Tube
Classification Name: Tube, Tracheal(w/wo Connector 73BTR)
Predicate Legally Marketed Device:
Sheridan Uncuffed Tracheal Tube Magill/Murphy Type
Image /page/0/Picture/14 description: The image shows the logo for Rusch International, a subsidiary of Teleflex Incorporated (USA). The logo is in black and white and features a stylized, bold font for the word "Rusch." Below the main wordmark, the word "INTERNATIONAL" is printed in a smaller, sans-serif font. The text "A Subsidiary of Teleflex Incorporated (USA)" is located at the bottom of the logo in an even smaller font size.
K96184C
1
Device Description:
The Rusch Oral/Nasal Tracheal Tube, Plain, Magill/Murphy consists of a clear implant tested PVC tracheal tube with radiopaque stripe. The main tube is graduated with multiple centimeter markings to allow easy determination of intubated length. A black tip area 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 2.0-7.0 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.