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Indications for Use: MedSource Endotracheal Tube: The device is intended for oral or nasal intubation and for airway management.

Indications for Use: MedSource Pre-Loaded Endotracheal Tube and Stylet: The device is intended for oral or nasal intubation and for airway management.

MedSource Pre-Loaded Endotracheal Tube (Cuffed & Uncuffed) with and without Stylet:
• Constructed of Polyvinylchloride
• Single lumen tube with or without a cuff;
• Tapered tip with Murphy Eye;
• Clear medical-grade tubing(polyvinyl) with graduations;
• Connector with check valve;
• Pre-loaded with Stylet having a low friction coating;
• Various sizes
• Sterile Single-Use Device

The provided document is a 510(k) Summary for a medical device called "MedSource Endotracheal Tube" and "MedSource Pre-Loaded Endotracheal Tube and Stylet." This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device, and thus does not include extensive clinical study details like acceptance criteria or device performance data in the way a PMA (Pre-Market Approval) or clinical trial report would.

Therefore, the document explicitly states that "No clinical studies were conducted for safety or effectiveness." This means that the information requested about acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth for a study is not available in this submission.

Instead of clinical studies, the submission relies on demonstrating substantial equivalence to existing predicate devices based on:

1. Intended Use: The MedSource devices have the same intended use (oral or nasal intubation and airway management) as the predicate devices.
2. Materials of Construction: The materials (Polyvinyl Chloride) are the same or equivalent to the predicate devices.
3. Product Features: Both MedSource and predicate devices have features like a Murphy's Eye and Pilot balloon (where applicable).
4. Instructions for Use: The instructions for use are the same or similar.
5. Technological Characteristics: A table comparing characteristics shows direct equivalence for materials, sizes, manual method of use, Murphy's Eye, Pilot Balloon, and the option with/without Stylet.
6. Compliance with Standards: The device complies with applicable sections of ISO 5361:1999 (Anaesthetic and respiratory equipment - Tracheal tubes and connectors) and ISO10993-1 edition-1997-12-15 (Biological Evaluation Of Medical Devices—Part 1: Evaluation and Testing).

The FDA's letter (Page 4 of the document) confirms that the device was deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed without the need for a new premarket approval or clinical trials.

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