RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY

K961837 · Rusch Intl. · BTR · Aug 16, 1996 · Anesthesiology

Device Facts

• Record ID: K961837
• Device Name: RUSH ORAL/NASAL TRACHEAL TUBE CUFFED MAGILL/MURPHY
• Applicant: Rusch Intl.
• Product Code: BTR · Anesthesiology
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The device is intended for oral or nasal intubation. It is intended for airway management.

Device Story

Clear, implant-tested PVC tracheal tube with radiopaque stripe; includes inflatable cuff with pilot balloon, centimeter markings, and black positioning ring; optional Murphy eye configuration. Used for oral or nasal intubation to manage patient airways. Operated by clinicians in clinical settings. Provides patent airway for ventilation; facilitates gas exchange.

Clinical Evidence

Bench testing only. Device conforms to ASTM 1242-89 and meets biocompatibility requirements per ISO 10993.

Technological Characteristics

Material: Implant-tested PVC. Standards: ASTM 1242-89, ISO 10993 (biocompatibility). Features: Radiopaque stripe, inflatable cuff, pilot balloon, centimeter markings, positioning ring, optional Murphy eye. Sizes: 4.5-11.0. Non-electronic/mechanical device.

Indications for Use

Indicated for patients requiring oral or nasal intubation for airway management.

Regulatory Classification

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.

Predicate Devices

• Sheridan HVT(TM) Tracheal Tube with X-Ray Line and 15mm. Connector High Volume Tapered Low Pressure Murphy Eye

Submission Summary (Full Text)

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Rusch INTERNATIONAL
A Subsidiary of Teleflex Incorporated (USA)

Pines Park
P.O. Box 103452
[phone]
FAX [phone]

AUG 16 1996
K961837

# 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 Regulatory Affairs Director
Rüsch International
Tall Pines Park
Jaffrey, NH 03452

Telephone: [phone]
Fax: [phone]

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.