(28 days)
The intended use of the Alpha Micron®-20/40 Microaggregate Filter is for filtering microaggregate debris from plasma derivative products to prevent pulmonary embolization.
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.
The provided text is a 510(k) summary for a medical device (Alpha Micron®-20/40 Microaggregate Filter) and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically associated with AI/ML devices or diagnostic accuracy studies.
The document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. Substantial equivalence for this type of device typically relies on demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device. This is often achieved through comparison of materials, design, manufacturing processes, and performance specifications rather than a clinical study with acceptance criteria in the context of diagnostic accuracy.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text because it describes a hardware microaggregate filter, not a device requiring such detailed performance evaluation.
The provided text does not contain the information requested for the following reasons:
- Type of Device: The device described is a physical "Microaggregate Filter" for blood products, not a diagnostic or AI/ML-driven device that would typically involve acceptance criteria and studies related to diagnostic accuracy, such as those involving radiologists or pathology.
- Study Design: The document outlines the device's description, intended use, and claim of "substantial equivalence" to predicate devices. Substantial equivalence for this type of device is usually demonstrated through comparative technical specifications and performance data (e.g., flow rate, filtration efficiency) rather than clinical studies with "ground truth" established by experts in the diagnostic sense.
- Missing Information: There is no mention of acceptance criteria formulated as performance metrics (e.g., sensitivity, specificity, accuracy), sample sizes for test sets, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or details about training sets.
{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.
§ 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.