TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)

K954771 · Laerdal Medical Corp. · BSR · May 9, 1996 · Anesthesiology

Device Facts

• Record ID: K954771
• Device Name: TRACHLIGHT STYLET & TRACHEAL LIGHTWAND (ORIGINAL APPLICATION NAME: STYLETT & TRACHEAL LIGHTWAND)
• Applicant: Laerdal Medical Corp.
• Product Code: BSR · Anesthesiology
• Decision Date: May 9, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5790
• Device Class: Class 1

Indications for Use

The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations.

Device Story

Trachlight Stylet and Tracheal Lightwand is a battery-powered, handheld device used by clinicians to assist in endotracheal intubation. The device consists of a reusable handle containing batteries and circuitry, a flexible wand with an incandescent light bulb at the tip, and a removable stylet for rigidity control. The wand is inserted into an endotracheal tube (ET) with the bulb positioned at the distal end. During intubation, the clinician observes the light emanating through the patient's neck tissue to confirm proper tracheal placement. The device serves as an alternative or adjunct to traditional laryngoscopy, simplifying and potentially accelerating the intubation process. It is non-critical and non-life supporting.

Clinical Evidence

No clinical data provided. The device relies on bench testing and compliance with safety standards (UL 544) for temperature limits and biocompatibility (USP Class V) to demonstrate safety and performance.

Technological Characteristics

Reusable handle with battery-powered electronic circuits; flexible wand with incandescent light bulb; removable stylet for rigidity. Materials contacting the patient are qualified to USP Class V (mucosal contact) standards. Tip temperature limited to 50°C per UL 544-1993, paragraph 36.2.

Indications for Use

Indicated for clinicians performing orotracheal or nasotracheal intubation to facilitate the placement of endotracheal tubes. No specific patient population age or gender restrictions are stated.

Regulatory Classification

Identification

A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.

Predicate Devices

• California Medical Products, Inc. Stylet and Tracheal Lightwand (K922842/A)
• Fiberoptic Medical Products, Inc. Imagica Fiberoptic Lighted Stylet
• Aaron Medical Industries, AARON Pediatric Surch-Lite

Submission Summary (Full Text)

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Laerdal
helping save lives
K954771/5
2-6-96

January 31, 1996

Food and Drug Administration
Center for Devices and Radiological Health (HFZ-401)
Food and Drug Administration
9200 Corporate Blvd.
Rockville, MD 20850
MAY - 9 1996
SENT VIA FAX

Re: Additional information request on K954771, Laerdal Medical Corporation’s
Trachlight Stylet & Trachlight Wand.

Dear Mr. James Lee:

Per our telephone conversation of January 30, 1996, I am providing you with the
following information that you requested.

1. Provide the summary section of the submission.
2. Provide the standard for the mucosal contact of the lightwand.

1. Summary Section of Submission

In accordance with Section 510(K) of the Food, Drug and Cosmetic Act and 21 CFR 807,
this premarket notification is being submitted.

1. Classification Name: (78FCQ) Light source, incandescent diagnostic.
Common Name: Lighted stylet for intubation.
Proprietary Name: Trachlight Stylet and Tracheal Lightwand

2. Establishment Registration:
Manufacturer: Laerdal Medical Corporation
167 Myers Corners Road
P.O. Box 1840
Wappingers Falls, NY 12590
Registration Number: 2425852

3. Device Classification: The device has been classified under Section 513 of the
Act as Class II

Laerdal Medical Corporation 167 Myers Corners Road, P.O. Box 1840, Wappingers Falls, NY 12590-8840
Telephone [phone], Fax [phone]
Customer Service [phone], Customer Service Fax [phone] or [phone] Sales Representatives [phone]

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4. Performance Standards:
Laerdal has reviewed the requirements of Section 514 of the Act and has no reason to believe that any requirements of the section are currently applicable to the device that is the subject of this notification.

5. Labeling:
Included with this notification and enclosed as Attachment 2 is the proposed labeling pertaining to the device, i.e., the immediate product label as well as the operating instructions which would accompany each shipment of the device and the Promotional and advertising materials.

6. Substantial Equivalence:
This device is similar in design, composition, and function to the following products in commercial distribution: (See Attachment 3)
a. California Medical Products, Inc. Stylet and Tracheal Lightwand (now owned and manufactured by Laerdal Medical Corporation) and reviewed on K922842/A.
b. Fiberoptic Medical Products, Inc. Imagica Fiberoptic Lighted Stylet.
c. Aaron Medical Industries, AARON Pediatric Surch-Lite.

The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations. The Trachlight includes a wand with an incandescent light bulb at its tip that is placed inside the endotracheal tube prior to intubation, with the light bulb positioned at the end of the endotracheal tube. Light from the light bulb helps provide a guide for the clinician during the intubation process, and light emanating from the light bulb can be seen through the patient’s tissue when the end of the endotracheal tube is properly positioned in the patient’s trachea.

The Trachlight consists of a reusable handle that contains the batteries and electronic circuits to apply power to the light bulb; a sterile, flexible wand that contains the light bulb at the tip; and a stylet that slides into the wand and acts as a stiffening member when needed. With the stylet inserted, the wand is more rigid and will retain its shape (e.g. for orotracheal intubation). With the stylet removed, the wand is more flexible (e.g. for nasotracheal intubation).

The Trachlight device is non-critical and non-life supporting. Primarily it is a product of convenience for the clinician who is responsible for intubating a patient. The Trachlight makes the procedure of endotracheal intubation simpler, easier, and usually quicker than the current standard practice of using a laryngoscope. The Trachlight can be used in

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Laerdal Medical Corporation

conjunction with a laryngoscope to augment that method, or can aid endotracheal intubation without the use of a laryngoscope.

Both the laryngoscope and the Trachlight use a battery powered light bulb to aid visualization. Loss of light due to the failure of the light bulb or connecting circuits presents the same inconvenience in both instruments, and such a light output failure presents no greater risk in the case of the Trachlight than for the laryngoscope.

The Trachlight shaft and lighted tip are placed inside of the Endotrachial (ET) tube, and thus are not in direct contact with the patient in normal use. Some mucosal contact is possible at the tip of the ET tube if the Trachlight tip is mispositioned by the user and placed forward of the tip of the ET tube. All Trachlight material which can contact the patient will/has been qualified biocompatible in accordance with USP class V (mucosal contact) or higher.

Even though the tip of the Trachlight will not normally contact the patient, the temperatures at the tip of the Trachlight are limited and do not exceed the UL Standard 544 requirements of 50 C. (See attached pages 54 and 55 from UL 544 paragraph 36.2; and attached letter from Dalhousie University dated September 23, 1992, which was provided as additional information in K922842).

## 2. Mucosal Contact Standard

See attached:

UL 544-1993, pages 54 and 55 paragraph 36.2

Letter from Dalhousie University dated September 23, 1992 and supplied on K922842 as additional information for that 510(k) submission.

Sincerely,


Kenneth B. Herland
Director Regulatory Affairs/Q.A.

Attachments: 3 pages