(163 days)
To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway. To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient.
The Endotracheal Mucosal Atomization Device (MADett) is a disposable, sterile device that converts a topical solution into a fine particle spray for application into the trachea bevond the ETT. The clinician connects the device in line between the endotracheal tube and the ventilation device. The clinician then attaches a syringe of topical medication to the luer lock fitting of the atomizer and delivers medications into the trachea while simultaneously ventilating the patient.
The provided text is a 510(k) summary for the Endotracheal Mucosal Atomization Device (MADett). It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a formal study with quantitative performance metrics.
Therefore, many of the requested sections about acceptance criteria, study details, and performance measures are not directly addressed in the provided document. The 510(k) process relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through comparison of indications, technological characteristics, and materials, rather than presenting novel clinical study performance data against predefined acceptance criteria for the new device.
Here's an analysis based on the provided text, outlining what can and cannot be answered:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria or specific quantitative performance metrics for the MADett device. Its substantial equivalence argument is based on a qualitative comparison of features and intended use with predicate devices.
| Acceptance Criteria (Not explicitly stated for MADett) | Reported Device Performance (Not explicitly stated for MADett) |
|---|---|
| No specific, quantifiable acceptance criteria or performance metrics are provided in the document for the MADett device. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use. | No specific, quantifiable performance data is reported for the MADett device against acceptance criteria in this document. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. No test set or clinical study demonstrating performance against acceptance criteria is described. The submission is a comparison to predicate devices, not a performance study.
- Data Provenance: Not applicable. No study data is presented. The "data" consists of a comparison of device characteristics to existing predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment for a test set is mentioned as part of this 510(k) summary.
4. Adjudication Method for the Test Set:
Not applicable. No test set adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or described in this document. The submission type (510(k) for substantial equivalence) typically does not require this type of study for devices like an atomizer, especially when demonstrating equivalence to already marketed devices.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. This is a medical device (an atomizer), not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. Type of Ground Truth Used:
Not applicable. No ground truth was established for a performance study. The "truth" in this submission relates to the functional and material characteristics of the MADett being sufficiently similar to the predicate devices. The closest concept might be the "truth" that the predicate devices are legally marketed and safe/effective.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established:
Not applicable. This is not an AI/ML device requiring a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Based on the document):
The document describes a substantial equivalence determination process, not a "study that proves the device meets acceptance criteria" in the typical sense of a clinical trial or performance study with quantitative outcomes.
The "study" presented is a comparative analysis of the MADett device against three predicate devices already on the market:
- Stat-Med® (Sheridan)
- EMT® Emergency Medicine Tube (Mallinckrodt Medical)
- MedPort™ Emergency Medication Airway Tube Adapter (Greenfield Medical Products)
The "acceptance criteria" for this 510(k) submission are implicitly demonstrating that the MADett is "substantially equivalent" to these predicates in terms of:
- Intended Use: All four devices share the same intended use: "To establish a path in which to inject medication into the lungs of a patient who is being ventilated through an intubated airway" and "To establish a means in which to introduce medication into an intubated airway without interrupting the flow of life-supporting ventilation to the patient."
- Technological Characteristics:
- Similarities: User-controlled medication/dosage, target population (intubated patients), power source (piston syringe), similar skill level required, luer lock compatible injection port, disposable.
- Differences (Acknowledged but deemed "minimal" and not raising new safety/effectiveness questions):
- MADett has a "fine particle spray mist" delivery form, while predicates have "droplet particle spray mist."
- MADett has a 20-inch semi-rigid cannula that inserts into the ETT, whereas Stat-Med's is part of the ETT, EMT's varies with ETT length, and MedPort™ has no cannula.
- MADett fits 7.0-9.0 ETT, while predicates have slightly different fitting ranges or are integral to the ETT.
- Materials: Polycarbonate and polyvinyl chloride for MADett are described as "similar materials" to those used in predicate devices (e.g., polypropylene and polyvinyl chloride). The submission states that performance testing data and biocompatibility data for these materials were provided elsewhere in the 510(k) and addendums (though not detailed in this summary).
Conclusion of the "Study" (Rationale for Substantial Equivalence):
Wolfe Tory Medical, Inc. concluded that the MADett fulfills the requirements for substantial equivalency because:
- All four devices (MADett and the three predicates) have the same intended use.
- Although there are minimal technological differences (primarily the MADett being a separate device with its lumen positioned within the ETT, unlike predicates where the lumen is often embedded in the ETT wall), these differences do not raise new questions regarding safety and effectiveness.
- The MADett is made of similar materials to the predicate devices, and these materials have supporting performance and biocompatibility data.
The FDA's decision to clear the device K021044 for marketing confirms their agreement with this assessment of substantial equivalence.
§ 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).