(28 days)
K955515, K810761A
Not Found
No
The device description and intended use describe a physical filter for plasma products, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a filter designed to prevent pulmonary embolization by filtering microaggregate debris from plasma derivative products, not to treat a disease or condition itself.
No
The device is a filter designed to remove microaggregate debris from plasma derivative products, preventing pulmonary embolization. It is a therapeutic device, not a diagnostic one.
No
The device description clearly describes a physical filter used for filtering plasma derivative products, which is a hardware component.
Based on the provided information, the Alpha Micron®-20/40 Microaggregate Filter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter microaggregate debris from plasma derivative products before administration to a patient to prevent pulmonary embolization. This is a physical process applied to a product that will be introduced into the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a filter used in conjunction with syringes or administration sets to physically remove particles from a plasma derivative product. It does not describe any components or processes related to analyzing a biological sample for diagnostic purposes.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is clearly intended for use in the preparation and administration of a therapeutic product, not for diagnostic testing.
N/A
Intended Use / 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.
Product codes
80 CAK
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Pulmonary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K955515, K810761A
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510{k} Summary of Safety and Effectiveness Section II:
FEB 1 4 1997
Alpha Therapeutic Corporation Submitter: 5555 Valley Boulevard Los Angeles, California 90032
Establishment Registration Number: 2022872
Contact Person: M. Sue Preston (213) 225-2221 Phone Number: Facsimile Number: (213) 227-7613
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:
-
- Alpha Micron®-20 Microaggregate Filter, 510(k) Number K955515
-
- 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
1
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.