ALPHA MICRON 20/40 MICROAGGREGATE FILTER

K970225 · Alpha Therapeutic Corp. · CAK · Feb 14, 1997 · General Hospital

Device Facts

• Record ID: K970225
• Device Name: ALPHA MICRON 20/40 MICROAGGREGATE FILTER
• Applicant: Alpha Therapeutic Corp.
• Product Code: CAK · General Hospital
• Decision Date: Feb 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

Device Story

Device filters microaggregate debris from plasma derivative products; prevents pulmonary embolization. Used via syringe or administration set; spike end inserted into plasma derivative container. Plasma derivative drawn through filter during aspiration or infusion. Operated by clinicians in clinical settings. Output is filtered plasma derivative; facilitates safe administration of blood products.

Technological Characteristics

Microaggregate filter for plasma derivatives. Designed for syringe or administration set integration. Class II device (21 CFR § 880.5440).

Indications for Use

Indicated for patients receiving plasma derivative products to prevent pulmonary embolization by filtering microaggregate debris.

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

• Alpha Micron®-20 Microaggregate Filter (K955515)
• Alpha Micron®-40 Microaggregate Filter (K810761A)

Submission Summary (Full Text)

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X970225

# Section II: 510(k) Summary of Safety and Effectiveness

FEB 14 1997

**Submitter:** Alpha Therapeutic Corporation
5555 Valley Boulevard
Los Angeles, California 90032

**Establishment Registration Number:** 2022872

**Contact Person:** M. Sue Preston
**Phone Number:** [phone]
**Facsimile Number:** [phone]

## Device Name:

**Proprietary Name:** Alpha Micron®-20/40 Microaggregate Filter
**Common / Usual Name:** Microaggregate Filter
**Product Code:** 80 CAK (Microfilter, Blood Transfusion)
**Classification Name:** Intravascular Administration Set (21 CFR § 880.5440)
**Classification:** Class II (performance standards)

## Devices for Which Substantial Equivalence is Claimed:

1. Alpha Micron®-20 Microaggregate Filter, 510(k) Number K955515
2. Alpha Micron®-40 Microaggregate Filter, 510(k) Number K810761A

## Device Description:

The Alpha Micron®-20/40 Microaggregate Filter is a filter used for the filtration of microaggregate debris from plasma derivative products in order to aid in the prevention of pulmonary embolization. The device is designed to be utilized in either of two applications; by syringe, or by administration set. The syringe is inserted into the exposed inlet of the filter while the spike end is inserted into the bottle (or bag) of the plasma derivative. The blood plasma derivative is aspirated through the filter into the syringe resulting in

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filtration. The administration set is placed into the exposed inlet of the filter while the spike end is attached to an infusion set. The plasma derivative is drawn through the filter during administration resulting in filtration.

## Intended Use of the Device:

The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.

## Substantial Equivalence:

The Alpha Micron®-20/40 Microaggregate Filter is substantially equivalent to several other legally marketed devices in the United States. Two such devices are currently legally marketed by Alpha Therapeutic Corporation. The Alpha Micron®-20/40 Microaggregate Filter functions in a manner identical to, and is intended for the same use as, both the Alpha Micron®-20 Microaggregate Filter and the Alpha Micron®-40 Microaggregate Filter. Both of these devices are currently manufactured by Alpha Therapeutic Corporation.