BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER

K961832 · Blue Ridge Medical, Inc. · CCW · Sep 6, 1996 · Anesthesiology

Device Facts

• Record ID: K961832
• Device Name: BLUE RIDGE PRODUCTS LARYNGOSCOPE BLADE COVER
• Applicant: Blue Ridge Medical, Inc.
• Product Code: CCW · Anesthesiology
• Decision Date: Sep 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5540
• Device Class: Class 1

Indications for Use

The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.

Device Story

Molded plastic cover for Miller #2 or MacIntosh #3 laryngoscope blades; covers blade and upper handle portion. Single-use; linear low density polyethylene copolymer construction. Attaches via integrated plastic clip encircling handle top. Used during endotracheal intubation by clinicians to potentially reduce blade cleaning time. Does not replace standard cleaning protocols.

Clinical Evidence

Bench testing only. Comparison of tensile strength, light absorption, and ultimate elongation between subject device and predicate.

Technological Characteristics

Material: Linear low density polyethylene copolymer (FDA approved 21 CFR 177.1520). Thickness: 1 mm. Form factor: Molded to fit Miller #2 or MacIntosh #3 blades. Attachment: Integrated plastic clip. Single-use.

Indications for Use

Indicated for use during endotracheal intubation to cover the laryngoscope blade and top of the handle.

Regulatory Classification

Identification

A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.

Predicate Devices

• Slater Sleeve (K926158)

Submission Summary (Full Text)

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K961832

SEP - 6 1996

# 510(K) SUMMARY

1) Submitter:
Blue Ridge Products, LP
Box 8664
Gray, TN 37615
[phone]
fax [phone]

Contact Person:
Mark J. Rice
General Manager

Date of Summary Preparation:
August 12, 1996

2) Name of the Device:
Blue Ridge Products Laryngoscope Blade Cover

Common Name:
Blue Ridge Products Laryngoscope Blade Cover

Classification Name:
The product is an accessory to the Laryngoscope, Rigid, 73CCW

3) Legally Marketed Equivalent Device (Predicate Device):
The predicate device is the Slater Sleeve, which is a substantially equivalent device with a cleared 510(k) (K # 926158). It is currently marketed by Tadco, Inc.

4) A Description of the Device:
This device is a molded plastic cover for a laryngoscope blade. It is made in two models, for either the Miller #2 or the MacIntosh #3 laryngoscope blade. Also, a portion of the device covers the upper portion of the laryngoscope handle. The device functions to cover the laryngoscope blade prior to use in the mouth. The device is made of a linear low density polyethylene copolymer, approved by the FDA, 21 CFR 177.1520, and is 1 mm thick. The master file number is #11624. It is made to conform to the laryngoscope blade. The cover adheres to the laryngoscope blade by a plastic clip that is formed from the plastic material that encircles the top of the laryngoscope handle. It is a single use device.

5) Statement of Intended Use:
The intended use of this device is to cover the laryngoscope blade and the top of the handle during endotracheal intubation to possibly reduce the cleaning time of the laryngoscope blade.

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This is the same intended use as the device identified as the predicate device above. The manufacturer's guidelines for cleaning the laryngoscope blade need to be followed.

6) A Summary of the Technological Characteristics of the Device Compared to the Predicate Device:

The function of the Blue Ridge device compared to the predicate device is the same, namely, they both cover the laryngoscope blade and the top portion of the handle. The predicate device is a loose fitting, flexible plastic, whereas the Blue Ridge device is molded to the shape of the laryngoscope blade. The predicate device is held in place by a rubber band around the end of the handle, whereas the Blue Ridge device is attached to the laryngoscope blade by a plastic clip around the top of the laryngoscope handle.

The non-clinical testing data comparing the Blue Ridge device and the Slater Sleeve are as follows:

| | The Blue Ridge Device | The Slate Sleeve Device |
| --- | --- | --- |
| Tensile Strength | 1900 psi | 1500-3500 psi (direction dependent) |
| Light Absorption | 12 ± 2% | 8 ± 2% |
| Ultimate Elongation | 560% | 2000-4000% (direction dependent) |