(56 days)
No
The description focuses on the physical components and materials of an infusion manifold and extension set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as an extension set with an InterLink® Micro-Infusion Manifold for administering multiple drugs and solutions, designed to reduce needle sticks. It facilitates access to an IV line but does not directly treat or diagnose a disease or condition.
No
The device is described as an extension set with an InterLink® Micro-Infusion Manifold, designed for the administration of multiple drugs and solutions, and blood sampling. It facilitates fluid delivery and access to IV lines, but there is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly details a physical medical device (extension sets, manifold, injection sites, tubing, adhesive) used for administering IV solutions and blood sampling. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "blood sampling and the administration of multiple drugs and solutions" through a vascular access device. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic (blood sampling) purposes, not for testing samples in vitro (outside the body).
- Device Description: The description focuses on the physical components and function of the manifold and extension sets for delivering fluids and accessing the IV line. There is no mention of reagents, assays, or any components used for analyzing biological samples in vitro.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, genes, pathogens, etc.)
- Providing diagnostic information based on sample analysis
- Use of reagents or assays
The device is designed for managing the flow of fluids and accessing a patient's IV line, which falls under the category of medical devices used for patient care, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Extension Sets with the InterLink® Micro-Infusion Manifold are intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions. These devices, like others containing the InterLink® injection site, are designed to reduce the risk of accidental needle sticks when used with the InterLink® cannula, as part of a "needleless" IV access system.
Product codes
Not Found
Device Description
The proposed InterLink® Micro-Infusion Manifold will be combined with various configurations of extension sets for the administration of IV solutions. The manifold incorporates three InterLink® injection sites mounted to a central barrel or solution conduit. The manifold provides multiple InterLink® access sites for bolus injection or infusion of parenteral solutions into the intravenous line. The integrated design of the manifold facilitates administration of multiple infusions with minimal fluid residual volume. Use of the InterLink® Micro-Infusion Manifold and InterLink® cannula will reduce the risk of accidental needle sticks when accessing the IV line.
There is one material in the proposed manifold which is a material new to Baxter devices. A cyanoacrylate adhesive may be used to bond the checkvalve to the manifold housing and the manifold luer to the extension set tubing. The other materials in the proposed InterLink® Micro-Infusion Manifold and the extension sets incorporating it have been previously tested and used in other marketed devices for similar IV solution administration applications.
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
The biological and chemical reactivity of the new adhesive material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed manifold have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed manifold meets or exceeds all functional requirements and support its suitability for use.
Key Metrics
Not Found
Predicate Device(s)
InterLink® T-Connector Extension Set, PDI Manifold Extension Sets
Reference Device(s)
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
APR - 2 1997
510(k) SUMMARY
InterLink® Micro-Infusion Manifold Extension Sets
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: February 3, 1997
Proposed Device: InterLink® Micro-Infusion Manifold Extension Sets
Predicate Devices:
InterLink® T-Connector Extension Set PDI Manifold Extension Sets
Proposed Device Description:
The proposed InterLink® Micro-Infusion Manifold will be combined with various configurations of extension sets for the administration of IV solutions. The manifold incorporates three InterLink® injection sites mounted to a central barrel or solution conduit. The manifold provides multiple InterLink® access sites for bolus injection or infusion of parenteral solutions into the intravenous line. The integrated design of the manifold facilitates administration of multiple infusions with minimal fluid residual volume. Use of the InterLink® Micro-Infusion Manifold and InterLink® cannula will reduce the risk of accidental needle sticks when accessing the IV line.
There is one material in the proposed manifold which is a material new to Baxter devices. A cyanoacrylate adhesive may be used to bond the checkvalve to the manifold housing and the manifold luer to the extension set tubing. The other materials in the proposed InterLink® Micro-Infusion Manifold and the extension sets incorporating it have been previously tested and used in other marketed devices for similar IV solution administration applications.
Statement of Intended Use:
Extension Sets with the InterLink® Micro-Infusion Manifold are intended for use with a vascular access device for blood sampling and the administration of multiple drugs and solutions. These devices, like others containing the InterLink® injection site, are
FEB 0 3 1997
1
designed to reduce the risk of accidental needle sticks when used with the InterLink® cannula, as part of a "needleless" IV access system.
Summary of Technological Characteristics of New Device to Predicate Devices
Extension sets with the proposed InterLink® Micro-Infusion Manifold are similar to Baxter's InterLink® T-Connector Extension Set previously found substantially equivalent under K921899. Both products incorporate the InterLink® injection site septum into the top of the manifold or T-connector in an integrated design which allows needleless access with minimal residual volume.
Extension Sets with the proposed InterLink® Micro-Infusion Manifold are also similar to the Manifold Extension Sets, manufactured by PDI Medical Products. Both Baxter and PDI manifolds consist of a one-piece integrated design with multiple access sites.
Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature
The biological and chemical reactivity of the new adhesive material has been assessed using biological methods specified in ISO Standard 10993-1 and USP Physicochemical tests. The material was found to be acceptable for its intended use.
Data regarding the functional performance of the proposed manifold have been generated. A description of the functional testing along with test results is provided. The data indicate that the proposed manifold meets or exceeds all functional requirements and support its suitability for use.
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