(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.
§ 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.