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Per FDA Safety Alert: Hazards of Precipitation Associated with Parental Nutrition, issued April 18, 1994, an IV filter is indicated for use when infusing either central or peripheral parenteral nutrition admixtures. Both pore sizes of filters are being offered. a 0.22um air eliminating filter for nonligid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.

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This document is a 510(k) summary for a medical device called AutoPrime™ I.V. Filter and set. It does not contain the information requested in your prompt regarding acceptance criteria and study details for a device's performance, especially for AI/algorithm-based devices.

The document focuses on:

• Device Identification: Trade name, common name, classification, contact person.
• Predicate Device Comparison: Stating that the AutoPrime™ is as safe and effective as two other named I.V. administration sets.
• Intended Use: Filtering intravenous solutions, specifically mentioning parenteral nutrition admixtures based on an FDA Safety Alert.
• Technological Characteristics: Comparing the 0.22um and 1.2um filters to their predicate counterparts, noting similarities in bacterial/Candida retention claims and materials of construction.
• Lack of Bench Test Data Requirement: Stating that bench test data is "not required due to there being no technological differences that raise issues of safety or efficacy."

Therefore, I cannot provide the requested information (acceptance criteria, device performance table, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) from this document. This document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on detailed performance validation studies as typically conducted for novel AI/machine learning devices.

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