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THIS DEVICE IS USED AS AN ACCESSORY FOR WHICH CAN BE CONNECTED TO A FEMALE LUER CONNECTOR, ie; WINGED INFUSION SET OR AN I.V. SET, FOR INFUSION OF MEDICATION TO A PATIENT. IT IS STERILE , DISPOSABLE & "ONE-DIRECTIONAL FLUID FLOW DEVICE".

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This document is a marketing clearance letter from the FDA for a medical device, the "Exel Injection Plug W/Cap." It confirms that the device is substantially equivalent to a predicate device and can be marketed.

The document does NOT contain information about acceptance criteria, study details, or device performance metrics for the Exel Injection Plug W/Cap.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The letter primarily focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study.

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THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALISIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINCLE USE DEVICE.

EXEL SINGLE NEEDLE AVF

I am sorry, but the provided text, which appears to be an FDA 510(k) clearance letter for the "Excel AVF Single Needle for Blood Pheresis" device, does not contain the information required to answer your request.

The document is a regulatory communication establishing substantial equivalence for the device. It focuses on:

• Device Name: Excel AVF Single Needle for Blood Pheresis
• Manufacturer: Exel International, Inc.
• Regulatory Class: II (21 CFR 876.5540)
• Indications for Use: "THIS DEVICE IS USED IN CONJUNCTION WITH A HEMO-DIALYSIS MACHINE FOR BLOOD PHERESIS. THIS DEVICE IS A STERILE, SINGLE USE DEVICE."
• Date of Clearance: May 5, 1998

This type of document does not typically include detailed information about acceptance criteria, specific device performance studies, sample sizes, expert qualifications, adjudication methods, or AI-related aspects (like MRMC studies, standalone algorithm performance, or training set details). These details would usually be found in the manufacturer's 510(k) submission itself, not in the FDA's clearance letter.

Therefore, I cannot populate the table or answer the specific questions you've posed based on the provided text.

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THIS DEVICE IS ESED FOR IMPUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT.

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I am sorry, but the provided text does not contain the necessary information to describe the acceptance criteria, the study details, or the device performance as requested. The document is a 510(k) clearance letter from the FDA for an "Exel I.V. Administration Set," indicating that the device has been deemed substantially equivalent to a predicate device.

The letter discusses regulatory aspects, such as:

1. Device Type: Exel I.V. Administration Set.
2. Regulatory Class: II.
3. Product Code: FPA.
4. Indications For Use: "THIS DEVICE IS USED FOR INFUSION OF SOLUTIONS AND MEDICATION INTRAVENOUSLY INTO THE PATIENT."
5. FDA Clearance Date: December 18, 1997.

However, it does not include:

• A table of acceptance criteria or reported device performance.
• Details about sample sizes, data provenance, or ground truth establishment for any studies.
• Information on expert usage, adjudication methods, or MRMC comparative effectiveness studies.
• Specifics on standalone algorithm performance or training set details.

This document is a regulatory approval, not a scientific study report. Therefore, I cannot fulfill your request based solely on the provided text.

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