(86 days)
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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510(k) Sumn
Appendix B
Arbor Medical Arbor Technologies, Inc. 401 West Morgan Road Ann Arbor, MI 48108-9109 Phone: (313) 665-3300 Fax:
Date prepared: September 16, 1996
JAN 2 2 1997
Trade name: AutoPrimeTM
Contact person: Dawn I. Moore
Common name: I.V. Filter and set
Classification name: Infusion line filter and administration set (21 CFR 880.5440)
The Arbor Medical AutoPrime™ I.V. is as safe and effective as the 3M Health Care AVITM Administration Set with an 0.22um filter and the Block Medical
Verifuse® Administration Set with 1.2 um IV-3. All filters are intended to filter intravenous solutions.
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.
Technological Characteristics:
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The 0.22um filters both make a claim of passing a bacterial challenge of 107 with Pseudomonas.diminuta. referred to as a HIMA challenge. Materials of construction are the same. both filters are made with 0.22um polyethersulfone main membranes, vent filters made with .02um PTFE and housings made from modified acrylic. Bench test data is not required due to there being no technological differences that raise issues of safety or efficacy.
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The 1.2um filters both make a claim of retaining Candida Albicans. Materials of construction are the same, both filters are made with 1.2um polyethersulfone main membranes. vent filters made with .02um PTFE and housings made from blue modified acrylic. Bench test data is not required due to there being no technological differences that raise issues of safety or efficacy.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.