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The NovaMed MRI Conditional laryngoscope set is used to facilitate and aid in tracheal intubation in a Magnetic Resonance (MR) environment, not to exceed a 3.0 Tesla static magnetic field.

The NovaMed MRI Conditional laryngoscope handle, battery, and blades are standard blades and handles that have been specially treated to be useable in a magnetic resonance (MR) environment. Testing has been performed according to ASTM F2052-02 in a 3.0 Tesla environment. There are many handle and blade configurations offered.

The NovaMed MRI Conditional Laryngoscope set was evaluated for safety in a Magnetic Resonance (MR) environment up to 3.0 Tesla. The primary study was to determine the device's magnetic attraction in this environment.

1. Acceptance Criteria and Reported Device Performance

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Indicated for use as an esophageal stethoscope to listen to patient heart and breathe sounds while a patient is under anesthesia or sedation. Optionally it may be used as a temperature sensor to monitor patient temperature. The electrical conductors are YSI 400 or 700 series compatible. They can be provided "clean, non-sterile" or "sterile".

The NovaMed esophageal stethoscopes are long tubes which at the distal end have openings in the side wall and tip end. These openings are covered by a thin non-inflatable cuff to prevent secretions from entering in the distal end. A temperature sensor or electrical conductor can be placed inside the distal end with connecting wires running internally and exiting the proximal end of the stethoscope. The proximal end is fitted with a standard slip fit luer for connection to any standard earpiece or to the Lifesound electronic stethoscope (K844804). The insulated temperature sensor wires are terminated with standard connectors for fitting to standard cables which connect to the temperature monitor. They are available is various lengths, diameters (sizes), with or without temperature, and packaged clean, non-sterile and sterile.

The provided text describes a 510(k) premarket notification for the "Lifesound Esophageal Stethoscope and Temperature Sensor." This document focuses on demonstrating substantial equivalence to previously approved predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with defined quantitative metrics.

Here's a breakdown of the requested information based on the provided text, and where information is not available due to the nature of a 510(k) submission for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document is a 510(k) premarket notification. For devices like an esophageal stethoscope, often the "acceptance criteria" are demonstrating substantial equivalence to pre-existing, legally marketed devices. There are no explicit quantitative performance criteria or a study designed to measure and report against them in this document. The "performance" section explicitly states "None applicable." The device's performance is assumed to be equivalent to the predicate devices.

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

• Sample Size: Not applicable. The document does not describe a performance study with a test set of data/patients. The submission relies on a comparison to predicate devices, inferring their established safety and effectiveness.
• Data Provenance: Not applicable. There is no performance data presented in the document itself.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable. There is no ground truth established for a test set in this 510(k) submission as no new clinical or performance study data is presented.

4. Adjudication Method for the Test Set

• Not applicable. No test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a passive medical instrument (stethoscope/temperature sensor). MRMC studies are typically for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret and make decisions. This submission does not involve such a study.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)

• Not applicable. This device is a physical instrument, not an algorithm. Therefore, no standalone algorithm performance study was conducted or described.

7. Type of Ground Truth Used

• Not applicable. No ground truth is established or used within the context of a performance study for this submission. The "ground truth" for a 510(k) submission like this is essentially that the predicate devices are already deemed safe and effective.

8. Sample Size for the Training Set

• Not applicable. This device is a physical instrument, not an AI/ML algorithm. Therefore, there is no training set involved.

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

• Not applicable. As there is no training set, no ground truth needed to be established for it.

Summary of the Study (or lack thereof) for Device Acceptance:

The "study" that proves the device meets "acceptance criteria" in this context is the 510(k) Substantial Equivalence pathway. The applicant, NovaMed LLC, demonstrates that their "Lifesound Esophageal Stethoscope and Temperature Sensor" is substantially equivalent to two legally marketed predicate devices:

1. Biomedical Concepts (NovaMed) esophageal stethoscope (K864858)
2. Shore Medical (K982193)

The key arguments for substantial equivalence are:

• Intended Use: Identical (esophageal stethoscope for heart/breath sounds, optional temperature sensing).
• Technological Characteristics: Similar design, materials (PVC for air pathway), and functional principles. The temperature sensor is compatible with standard YSI 400/700 series.
• Performance: The document explicitly states "Performance: None applicable," indicating that for this type of device and submission, no new performance data was required to establish substantial equivalence beyond the design and material comparison. The FDA's letter concurs with the substantial equivalence determination based on the provided information.

Thus, the device meets its "acceptance criteria" not through a new performance study with quantitative results, but by demonstrating that it is as safe and effective as devices already on the market through a detailed comparison of its features and intended use.

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