(273 days)
The ILM Endotracheal Tube is indicated for airway management by oral intubation of the trachea.
The ILM ETT is a straight, cuffed, wire-reinforced tracheal tube, with a Murphy Eye. It is available in a three sizes with internal diameters of 7.0mm, 7.5mm and 8.0mm. The airway tube is made from silicone and features a stainless steel reinforcing wire to prevent kinking or occlusion of the tube. The tip of the tube is molded from a softer grade of silicone for passage through the vocal cords. The airway tube features an inflatable silicone cuff for sealing the tube in the trachea. The tip of the ILM ETT is beveled in two directions to aid passage of the tube through the trachea. Depth markings are printed on the airway tube (in centimeters). These indicate the distance to the distal tip of the tube. The tube also has a printed black line to indicate its caudal surface. The ILM ETT features a small diameter silicone tube connected to a pilot balloon with a luer check valve for inflation of the cuff. The ILM ETT can be connected to the anesthesia circuit by a removable 15mm standard male connector which conforms to ISO5356-1 (1987). A connector is supplied with each ILM ETT. The ILM ETT is designed to be compatible with the LMA-Fastrach (an oropharyngeal airway). To ensure compatibility, a marker line indicates when the tube passes through the LMA-Fastrach. In addition, the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach.
The provided text is a 510(k) summary for the ILM Endotracheal Tube (ILM ETT) and a subsequent FDA approval letter. It outlines the device's description, intended use, and comparison to a predicate device. However, it does not contain any information regarding specific acceptance criteria, a scientific study, device performance metrics, sample sizes, expert involvement, or statistical methods.
The core of the submission for the ILM ETT is a claim of substantial equivalence to an existing legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube. The document explicitly states:
"The ILM ETT and the Euromedical Silicone Wire-Reinforced Endotracheal Tube have identical performance, and with the exception of the labeling, they are the same device. The two devices use the same materials and are dimensionally identical. They are molded and assembled in the same manufacturing plant to the same specifications (except for the labeling)."
Therefore, the "acceptance criteria" and "study" are implicitly tied to demonstrating this substantial equivalence, rather than a de novo performance study against concrete numerical thresholds.
Here's an analysis based on the provided text, highlighting what's missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical/Physical Equivalence to Predicate Device: | |
| Identical materials | Confirmed: "The two devices use the same materials" |
| Dimensionally identical | Confirmed: "and are dimensionally identical." |
| Molded and assembled to same specifications (except labeling) | Confirmed: "They are molded and assembled in the same manufacturing plant to the same specifications (except for the labeling)." |
| Functional Equivalence to Predicate Device: | |
| Identical performance | Confirmed: "The ILM ETT and the Euromedical Silicone Wire-Reinforced Endotracheal Tube have identical performance..." |
| Compatibility with LMA-Fastrach: | |
| Marker line indicates tube passage | Confirmed: "a marker line indicates when the tube passes through the LMA-Fastrach." |
| Inflation line mounted close to rear to ensure unobstructed passage | Confirmed: "the inflation line is mounted close to the rear of the ILM ETT to ensure unobstructed passage of the tube through the LMA-Fastrach." |
Critically Missing: The document does not provide specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum leak rate, specific airflow resistance) nor quantitative performance data for the ILM ETT itself. Its performance is asserted as being identical to the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable in the context of a de novo performance study. The "test" for substantial equivalence relied on a direct comparison of specifications and manufacturing processes to the predicate device.
- Data Provenance: Not applicable. No clinical or performance data is presented. The equivalence claim is based on manufacturing and design documents.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable. No dedicated expert panel was used to establish ground truth for a test set, as no performance study data is presented. The FDA reviewers are the "experts" who evaluate the substantial equivalence claim based on the provided technical documentation.
- Qualifications of Experts: N/A for establishing ground truth data. The FDA reviewers fall under "Division of Cardiovascular, Respiratory, and Neurological Devices." The approval letter is signed by an "Acting Director" with "Ph.D., M.D." qualifications, indicating medical and scientific expertise.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. There was no test set requiring multi-reader adjudication. The process was a regulatory review of documentation for substantial equivalence.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No. The provided document makes no mention of an MRMC study. This is a 510(k) submission based on substantial equivalence, not a comparative clinical trial.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a medical device, an endotracheal tube, not an algorithm or AI system. Its "performance" is inherently human-in-the-loop during its use for intubation.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness profile of the predicate device. The applicant's submission relies on the assertion that the ILM ETT is materially and functionally identical to this already approved device. Therefore, the ground truth is the regulatory acceptance and historical performance of the predicate device.
8. The Sample Size for the Training Set:
- Sample Size: Not applicable. There is no AI component or "training set" for this device.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not applicable, as there is no training set.
Summary of the "Study" (in the context of a 510(k) based on substantial equivalence):
The "study" here is essentially the comparison and verification of design specifications, materials, and manufacturing processes between the proposed ILM ETT and the legally marketed predicate device, the Euromedical™ ILM (Intubating Laryngeal mask) 100% Silicone Wire-Reinforced Endotracheal Tube.
The applicant provided documentation to the FDA asserting that the two devices are:
- Identical in performance.
- Made from the same materials.
- Dimensionally identical.
- Molded and assembled in the same manufacturing plant to the same specifications (except for labeling changes, which were minor administrative updates).
The FDA reviewed this documentation and, based on the submitted evidence, concluded that the ILM Endotracheal Tube was "substantially equivalent" to the predicate device. This substantial equivalence effectively "proves" that the device meets the (implicit) acceptance criteria of being as safe and effective as a device already on the market. There was no independent performance study conducted, or at least, none is described in this summary.
§ 868.5730 Tracheal tube.
(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).