(84 days)
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No
The summary describes a physical filter incorporated into intravenous solution sets and does not mention any AI or ML components or functionalities.
No
The device is described as a filter incorporated into solution sets for administering intravenous solutions, and its function is to filter the solution, not to directly treat a medical condition.
No
Explanation: The device is a filter incorporated into solution sets for administering intravenous solutions, and its described function is to filter solutions, not to diagnose medical conditions.
No
The device is a physical filter incorporated into intravenous solution sets, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the administration of intravenous solutions." This describes a device used in vivo (within the body) for delivering fluids, not for testing samples in vitro (outside the body) to diagnose conditions.
- Device Description: The device is a filter incorporated into "solution sets for the administration of intravenous solutions." This further reinforces its role in delivering fluids to a patient.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue), detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a medical device used for therapeutic or supportive purposes, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466.
Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration sets. Baxter is making no changes to the design, components or materials of the Millipore filter.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Data regarding the functional performance of the 0.22 micron filter were generated by Millipore. Testing included Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Housing Integrity/Female Luer Fitment, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Outlet Deflection Stress, In-Line Filter Wettability, Bacterial Endotoxins, Bioburden Evaluation, Burst Strength, and MVI Resistance. The data indicate that the filter meets or exceeds all functional requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Abbott Solution Sets with 0.22 Micron Filter, Baxter Solution Sets with 0.22 Micron Filter
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
FEB 2 5 1997
510(k) SUMMARY
Solution Administration Sets with 0.22 Micron Filter
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: November 26, 1996
Proposed Device: 0.22 Micron Filter Sets
Predicate Devices:
Abbott Solution Sets with 0.22 Micron Filter Baxter Solution Sets with 0.22 Micron Filter
Proposed Device Description:
The subject of this submission is the Millipore 0.22 micron filter which Baxter intends to incorporate into various configurations of solution sets for the administration of intravenous solutions. The filter is manufactured by Millipore and has been recently cleared for marketing in Abbott solution administration sets covered by K960466.
Baxter will purchase the 0.22 micron filter from Millipore and incorporate it into currently marketed solution administration sets. Baxter is making no changes to the design, components or materials of the Millipore filter.
Summary of Technological Characteristics of New Device to Predicate Devices
The Millipore 0.22 micron filter to be incorporated in Baxter solution administration sets is identical to that which has been recently cleared for marketing in Abbott solution administration sets under K960466 for the same intended use. Baxter is making no changes to the design, components, or materials of the Millipore filter. The proposed Baxter sets are identical to currently marketed Baxter sets except for the change in the 0.22 micron filter to the Millipore I.V. Express™ filter. All other components of the solution administration sets remain unchanged.
NOV 26 1996
1
Discussion of NonClinical Tests
Data regarding the functional performance of the 0.22 micron filter were generated by Millipore. Testing included Reverse Pressure Filter Integrity, Unit Venting, Gravity Flow, Inlet Axial Stress, Housing Integrity/Female Luer Fitment, Forward Pressure Filter Integrity, Downstream Particle Count, Accelerated Endurance, Outlet Deflection Stress, In-Line Filter Wettability, Bacterial Endotoxins, Bioburden Evaluation, Burst Strength, and MVI Resistance. The data indicate that the filter meets or exceeds all functional requirements.
Conclusions Drawn from Nonclinical Tests
Functional, microbiological, and drug compatibility data indicate that the proposed filter meets or exceeds all functional requirements and support its suitability for use in Baxter sets.