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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.

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:

1. All four devices (MADett and the three predicates) have the same intended use.
2. 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.
3. 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.

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To assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen airway tube.

A device that relies on anatomical differences between the trachea and the esophagus. By applying negative pressure to the endotracheal tube, the rigid trachea remains open allowing free aspiration of air into the EDD, whereas the fibromuscular esophagus collapses around the endotracheal tube and thus prevents aspiration of air.

The provided text describes a 510(k) Summary for an Esophageal Intubation Device (EID). This document focuses on demonstrating substantial equivalence to a predicate device rather than outright proving device performance against specific, pre-defined acceptance criteria with a rigorous study design. Therefore, the information provided does not fully align with the typical structure of an acceptance criteria and study report for novel device approval.

However, based on the information provided, we can infer and construct the closest possible response to your request:

1. Table of Acceptance Criteria and Reported Device Performance

It's important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable way for the new device. Instead, it relies on demonstrating that the EID performs comparably to the predicate device in its ability to detect the placement of a double lumen airway tube.

2. Sample Size Used for the Test Set and Data Provenance

The "test set" in this context refers to the Wafai et al. study's patient population where the EID was evaluated.

• Sample Size: 58 patients (20 tracheas, 38 esophagi).
• Data Provenance: The study by Wafai et al. took place in patients undergoing elective surgery. The country of origin is not specified, but the journal name "Anesthesiology" suggests an international or US-based context. The study is described retrospectively.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number or qualifications of experts used to establish the ground truth. The study design implies direct observation or verification of tube placement (e.g., surgical observation of where the tube was placed) rather than expert consensus on imaging. The phrase "The Combitube... was placed into 20 tracheas and 38 esophagi of patients" suggests the placement itself was the ground truth.

4. Adjudication Method for the Test Set

Not applicable. The study involved a direct determination of tube placement and the EID's output. There's no mention of an adjudication process for the EID's readings.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes a study where the device (EID) was used by clinicians to make a determination, but it does not compare human readers with and without AI assistance to measure an effect size. The study is a direct performance evaluation of the EID.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in the sense that the EID itself is a standalone physical device that provides an output (air return or no air return). The "algorithm" here is the physical principle of the device detecting negative pressure in the trachea vs. esophageal collapse. The study evaluates this standalone device's performance.

7. The Type of Ground Truth Used

The ground truth was established by direct observation/placement of the esophageal/tracheal double lumen airway tube in either the trachea or esophagus during elective surgery. This can be considered a form of clinical observation/procedure-based ground truth, as the actual anatomical placement was known.

8. The Sample Size for the Training Set

Not applicable. This device is a physical diagnostic tool based on anatomical principles, not a machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model.

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