(118 days)
Not Found
Not Found
No
The summary describes a change in materials for an empty plastic container used for drug admixtures, focusing on sterilization methods, environmental impact, and user safety. There is no mention of any computational or analytical capabilities that would involve AI or ML.
No.
The device is an empty plastic container used for the preparation and administration of drug admixtures, not for therapeutic purposes itself.
No
Explanation: The device is an empty plastic container used for the preparation and administration of drug admixtures. It does not perform any diagnostic function.
No
The device description clearly states it is a plastic container with changes to materials for sheeting, ports, and medication sites, indicating a physical hardware 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 "preparation and administration of drug admixtures." This describes a container used for holding and delivering medications, not for performing tests on biological samples to diagnose conditions.
- Device Description: The description focuses on the materials and function of a container for drug admixtures. It discusses sterilization methods, recycling, and user safety related to the container itself, not diagnostic testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
The device is clearly intended for the delivery of therapeutic substances, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Baxter is currently marketing a line of empty Viaflex® plastic containers used for the preparation and administration of drug admixtures.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Baxter is currently marketing a line of empty Viaflex® plastic containers used for the preparation and administration of drug admixtures. We propose to change the materials of the container sheeting, administration and medication ports and medication site and market the container under the tradename IntraVia™ Container, Empty. The primary reason for the change in container materials is to allow a change in sterilization methods from ETO to gamma sterilization. In addition, use of the including use of standard thermoplastic methods for recycling and reduction in the amounts of environmental contaminants released during incineration of PVC such as hydrochloric acid and dioxins. The material change in the medication site is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The biological and chemical reactivity of the new container materials have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The materials were found to be acceptable for their intended use. Data regarding the functional performance of the proposed empty IV container and its drug compatibility characteristics have been generated. Functional performance studies included residual volume, fill volume, spike insertion/removal force and burst testing. Performance testing indicate that the proposed container meets or exceeds all functional requirements and support its suitability for use. Drug compatibility studies were conducted with commonly admixed drugs or those that have a high potential to adsorb to the container under representative storage conditions. Results of drug compatibility evaluations support the suitability of the new container for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Viaflex® Empty Plastic Container
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).
0
510(k) Premarket Notification IntraVia™ Empty Plastic Container
510(k) SUMMAR Y
参考资料
Submitted by:
Mary Ellen Snyder MAR 3 1 1997 Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: November 26, 1996
Proposed Device: IntraVia™ Empty Plastic Container
Predicate Devices: Viaflex® Empty Plastic Container
Proposed Device Description:
Baxter is currently marketing a line of empty Viaflex® plastic containers used for the preparation and administration of drug admixtures. We propose to change the materials of the container sheeting, administration and medication ports and medication site and market the container under the tradename IntraVia™ Container, Empty.
The primary reason for the change in container materials is to allow a change in sterilization methods from ETO to gamma sterilization. In addition, use of the including use of standard thermoplastic methods for recycling and reduction in the amounts of environmental contaminants released during incineration of PVC such as hydrochloric acid and dioxins. The material change in the medication site is being made to improve user safety by eliminating the potential for sensitivity reactions associated with natural rubber proteins.
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed IntraVia™ container is the same in overall design and intended use as the currently marketed Viaflex® container. The IntraVia™ container differs from the Viaflex® container in material composition and sterilization method.
1
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
The biological and chemical reactivity of the new container materials have been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The materials were found to be acceptable for their intended use.
Data regarding the functional performance of the proposed empty IV container and its drug compatibility characteristics have been generated. Functional performance studies included residual volume, fill volume, spike insertion/removal force and burst testing. Performance testing indicate that the proposed container meets or exceeds all functional requirements and support its suitability for use.
Drug compatibility studies were conducted with commonly admixed drugs or those that have a high potential to adsorb to the container under representative storage conditions. Results of drug compatibility evaluations support the suitability of the new container for its intended use.