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The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids.

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The provided text is a Food and Drug Administration (FDA) 510(k) clearance letter for a medical device called the "Churchill Medical Systems Extension Set." This type of document declares that a device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

However, this document does NOT contain any information about acceptance criteria for device performance, nor does it describe any study related to device performance.

The letter focuses on the regulatory process of 510(k) clearance, confirming that the device can be marketed based on its substantial equivalence to pre-existing devices. It mentions:

• Device Name: Churchill Medical Systems Extension Set
• Regulation Number: 880.5440
• Regulation Name: Intravascular Administration Set
• Regulatory Class: II
• Product Code: FPA
• Indications for Use: "The Churchill Medical Systems Extension Sets is an accessory device used to deliver medical fluids."

Since the content does not describe acceptance criteria or a study proving the device meets those criteria, I cannot fill out the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies.

The document is purely a regulatory clearance notice, not a performance study report.

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