AUTOPRIME

K964283 · Arbor Technologies, Inc. · FPB · Jan 22, 1997 · General Hospital

Device Facts

• Record ID: K964283
• Device Name: AUTOPRIME
• Applicant: Arbor Technologies, Inc.
• Product Code: FPB · General Hospital
• Decision Date: Jan 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arbor Medical AutoPrime™ I.V. is 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 nonlipid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.

Device Story

AutoPrime™ I.V. is an infusion line filter and administration set; used to filter intravenous solutions during parenteral nutrition delivery. Device incorporates air-eliminating filters to remove particulates and air from infusion lines. 0.22um filter variant targets nonlipid admixtures; 1.2um filter variant targets lipid admixtures. Operated by clinicians in clinical settings. Device ensures patient safety by preventing infusion of precipitates or air into the bloodstream.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established via comparison of materials and performance specifications to predicate devices.

Technological Characteristics

Infusion line filter and administration set. Materials: polyethersulfone main membranes (0.22um or 1.2um), 0.02um PTFE vent filters, modified acrylic housings. Air-eliminating design. No electronic or software components.

Indications for Use

Indicated for patients requiring intravenous therapy, specifically for the filtration of central or peripheral parenteral nutrition admixtures. 0.22um filter for nonlipid containing admixtures; 1.2um filter for lipid containing admixtures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• 3M Health Care AVI™ Administration Set (0.22um filter)
• Block Medical Verifuse® Administration Set (1.2um filter)

Submission Summary (Full Text)

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5964283
510(k) Summary
CONFIDENTIAL
JAN 22 1997

# Appendix B

Arbor Medical
Arbor Technologies, Inc.
401 West Morgan Road
Ann Arbor, MI 48108-9109
Phone: [phone]
Fax: [phone]

Contact person: Dawn I. Moore
Date prepared: September 16, 1996
Trade name: AutoPrime™
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 AVI™ 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 nonlipid containing admixtures, and a 1.2um air eliminating filter for lipid containing admixtures.

Technological Characteristics:

1. The 0.22um filters both make a claim of passing a bacterial challenge of $10^{7}$ 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.

2. 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.

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