(205 days)
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.
This document is a 510(k) premarket notification for the Laerdal Medical Corporation's Trachlight Stylet & Trachlight Wand. It is dated January 31, 1996, and responds to a request for additional information from the FDA.
Based on the provided text, there is no direct mention of specific clinical acceptance criteria or a study designed to prove the device meets such criteria in terms of clinical performance (e.g., successful intubation rates, time to intubation, complication rates). The document focuses on regulatory classification, substantial equivalence to predicate devices, and safety aspects related to material biocompatibility and temperature limits.
It primarily addresses two points:
- Summary Section of Submission: This covers the classification name, common name, proprietary name, establishment registration, device classification (Class II), performance standards (none specifically applicable per Section 514 of the Act), labeling, and substantial equivalence to other marketed devices. It describes the Trachlight's function as a lighted stylet to facilitate endotracheal tube placement.
- Mucosal Contact Standard: This section details that materials that could contact the patient are qualified biocompatible (USP class V or higher) and that the tip temperature does not exceed UL Standard 544 requirements of 50°C.
Therefore, many of the requested details about acceptance criteria and study design are not present in this document because it is focused on regulatory submission information rather than a clinical performance study.
Here's an attempt to answer the questions based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: | |
| 1. Biocompatibility for potential mucosal contact | All Trachlight material which can contact the patient will/has been qualified biocompatible in accordance with USP class V (mucosal contact) or higher. |
| 2. Tip Temperature Limit (following UL Standard 544) | The temperatures at the tip of the Trachlight are limited and do not exceed the UL Standard 544 requirements of 50°C. (Reference to UL 544-1993, pages 54 and 55 paragraph 36.2; and a letter from Dalhousie University dated September 23, 1992, provided in K922842). |
| Functionality (Implied from substantial equivalence and description): | |
| 3. Facilitate endotracheal tube placement | The Trachlight is designed to facilitate the placement of endotracheal tubes of various sizes and lengths for both orotracheal and nasotracheal intubations. It makes the procedure of endotracheal intubation simpler, easier, and usually quicker than the current standard practice of using a laryngoscope. It can be used in conjunction with a laryngoscope or without a laryngoscope. Light from the light bulb helps provide a guide for the clinician and can be seen through the patient's tissue when the ET tube is properly positioned in the trachea. This is based on substantial equivalence to predicate devices. |
| 4. Non-critical and non-life supporting | The Trachlight device is non-critical and non-life supporting. |
| 5. Light output failure presents no greater risk than comparator | Loss of light due to the failure of the light bulb or connecting circuits presents the same inconvenience in both instruments (Trachlight and laryngoscope), and such a light output failure presents no greater risk in the case of the Trachlight than for the laryngoscope. |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical test set or study with a sample size for evaluating clinical performance. The safety criteria (biocompatibility, temperature) are likely based on laboratory testing and material specifications, not a patient-based test set in the context of clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical performance test set or ground truth establishment by experts is described in this regulatory submission.
4. Adjudication method for the test set
Not applicable, as no clinical performance test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a lighted stylet, not an AI-assisted diagnostic tool or a device that involves "human readers."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety criteria:
- Biocompatibility: Ground truth is established by chemical and biological testing results against USP Class V standards.
- Temperature: Ground truth is established by direct temperature measurements against the UL Standard 544.
For clinical performance, no specific ground truth or study is described, as the device's efficacy is asserted through substantial equivalence to existing devices.
8. The sample size for the training set
Not applicable. This document does not describe the development or validation of an algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/0 description: The image shows the Laerdal logo. On the left side of the logo, there is a drawing of two people. One person is lying down, and the other person is kneeling and performing CPR. To the right of the drawing, the word "Laerdal" is written in a bold, sans-serif font. Below the word "Laerdal", the phrase "helping save lives" is written in a smaller, italicized font.
January 31, 1996
K954771/s'
2-6-96
Food and Drug Administration Center for Devices and Radiological Health (HFZ-401) Food and Drug Administration 9200 Corporate Blvd. Rockville, MD 20850 SENT VIA FAX
MAY - 9 1996
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.
-
- Provide the summary section of the submission.
-
- 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 |
-
- 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 (914) 297-7770. Fax (911) 297-1137
- Device Classification: The device has been classified under Section 513 of the Act as Class II
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Page 2 K954771 Laerdal Medical Corporation
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.
న్. 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.
- 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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Page 3 K954771 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 no mally 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,
Sincerely,
Kenneth Habireed
Kenneth B. Herland Director Regulatory Affairs/Q.A.
Attachments: 3 pages
§ 868.5790 Tracheal tube stylet.
(a)
Identification. A tracheal tube stylet is a device used temporarily to make rigid a flexible tracheal tube to aid its insertion into a patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.