SYRINGEFILTER

K960928 · Arbor Technologies, Inc. · BSN · Apr 4, 1997 · Anesthesiology

Device Facts

• Record ID: K960928
• Device Name: SYRINGEFILTER
• Applicant: Arbor Technologies, Inc.
• Product Code: BSN · Anesthesiology
• Decision Date: Apr 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5130
• Device Class: Class 2

Intended Use

The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version. The intended use is the same. Testing for both the original and the proposed versions of this filter are the same. Both versions of the 0.2um have passed the HIMA Challenge.

Device Story

Syringefilter device; 0.2um pore size; used for filtration applications. Device consists of plastic housing and membrane. Operation involves manual attachment to syringe for fluid filtration. Intended for clinical or laboratory use. Benefits include removal of particulates/contaminants from fluids.

Clinical Evidence

Bench testing only; passed HIMA Challenge; Class VI material testing.

Technological Characteristics

Plastic housing and membrane; 0.2um pore size; Class VI compliant materials; sterilization method consistent with original device.

Regulatory Classification

Identification

An anesthesia conduction filter is a microporous filter used while administering to a patient injections of local anesthetics to minimize particulate (foreign material) contamination of the injected fluid.

Predicate Devices

• Arbor Medical Syringefilter (original version)

Submission Summary (Full Text)

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K960928

# APR - 4 1997

## Appendix C Summary of Safety and Effectiveness

The revised Arbor Medical Syringefilter is as safe and effective as the original. The proposed plastic housings and membrane have passed Class VI testing as did the original housings and membrane. The proposed product is manufactured the same as the original. The method of sterilization is the same as the original version. The intended use is the same. Testing for both the original and the proposed versions of this filter are the same. Both versions of the 0.2um have passed the HIMA Challenge.

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