RUSCH OPTOSAFE

K960240 · Rusch Intl. · CAE · Apr 19, 1996 · Anesthesiology

Device Facts

• Record ID: K960240
• Device Name: RUSCH OPTOSAFE
• Applicant: Rusch Intl.
• Product Code: CAE · Anesthesiology
• Decision Date: Apr 19, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5110
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation.

Device Story

Single-use, sterile, oropharyngeal airway; clear, implant-tested PVC tube in hooked shape; bonded to PVC bite block and flange via polyurethane adhesive. Used for oral insertion to maintain patent airway and provide conduit for fiberoptic tracheal intubation. Operated by clinicians in clinical settings. Output is physical airway access; facilitates intubation procedure; benefits patient by preventing airway obstruction and enabling controlled tracheal access.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and intended use comparison to predicate.

Technological Characteristics

Materials: Implant-tested PVC, polyurethane adhesive. Form factor: Hooked oral airway with integrated bite block and flange. Sizes: 5-17 mm nominal inner diameter. Single-use. Sterile.

Indications for Use

Indicated for patients requiring an oropharyngeal airway to maintain a patent airway and facilitate fiberoptic tracheal intubation.

Regulatory Classification

Identification

An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.

Predicate Devices

• Williams Airway Intubator (K830767)

Submission Summary (Full Text)

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RÜSCH.
INTERNATIONAL
Group Regulatory Affairs
A Subsidiary of Teleflex Incorporated (USA)

Tall Pines Park
Jaffrey, NH 03452
[phone]
FAX [phone] or 6108

To: Whom it may concern

K960240
APR 19 1996
K960240

# Substantial Equivalence 510(k) Summary

Reference: Rüsch Optosafe

The Rüsch Optosafe, sterile, for oral insertion to provide an airway though the patient's mouth and allow fiberoptic tracheal intubation is substantially equivalent in design, use and materials to the Williams Airway Intubator K830767 currently being marketed and sold in inter-state commerce.

The device consists of a clear, implant tested, PVC tube formed into the conventional hooked shape of an oral airway. The tube is bonded with a polyurethane adhesive to a clear implant tested PVC bite block and flange molding. The flange is printed with the manufacturer's name, date code and size (nominal inner diameter of tube).

The device is designed as a single use, sterile, oropharyngeal airway to maintain a patent airway through the mouth to the pharynx and allow fiberoptic tracheal intubation. It will be available in a variety of sizes from 5 to 17 mm inside diameters.

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
11 January 1996