← Product Code [FPB](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB) · K964283 # AUTOPRIME (K964283) _Arbor Technologies, Inc. · FPB · Jan 22, 1997 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K964283 ## Device Facts - **Applicant:** Arbor Technologies, Inc. - **Product Code:** [FPB](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB.md) - **Decision Date:** Jan 22, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5440 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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: (313) 665-3300 Fax: (313) 665-3516 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. Page 5 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K964283](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FPB/K964283) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com