(85 days)
Locking Needle Sheath with InterLink® Injection Site, InterLink® Universal Vial Adapter
Locking Needle Sheath with InterLink® Injection Site, InterLink® Universal Vial Adapter
No
The description focuses on a mechanical adapter for converting injection sites and does not mention any software, algorithms, or data processing that would indicate AI/ML.
No
This device is an adapter designed to convert an injection site to a needleless system, primarily for safety (reducing needle sticks). It does not directly treat or diagnose a medical condition.
No
The device is an adapter designed to convert a conventional injection site to a needleless access system, primarily aimed at reducing the risk of accidental needle sticks. It does not perform any diagnostic functions or provide information about a patient's health status.
No
The device description clearly outlines a physical adapter made of plastic and rubber materials, designed to convert a conventional injection site. It describes physical components like a plastic spike and a slot.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to convert an injection site on an IV administration set to a needleless system for administering solutions. This is a device used for the delivery of substances into the body, not for testing samples taken from the body.
- Device Description: The description details a mechanical adapter for connecting to an IV set. It does not involve any components or processes related to analyzing biological samples.
- 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 or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for use in the administration of IV solutions, which falls under the category of medical devices used for treatment or delivery, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The proposed adapter will be used to convert a conventional needle-accessed vinjection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a "needleless" IV access system.
Product codes
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Device Description
The proposed InterLink® Adapter for Conventional Y-Site is designed to convert a conventional (needle-accessed) y-injection site to an InterLink® injection site (needleless access). The InterLink® injection site is incorporated into the top of the adapter to allow access to conventional injection sites with InterLink® cannulae. The adapter contains a plastic spike to pierce the conventional Y-site septum and a slot which connects to the arm of the Y-site. There are no new materials involved in the proposed adapter. All plastic and rubber materials used have been previously tested and used in other Baxter devices for similar I.V. 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
Data regarding the functional performance of the proposed adapter have been generated. A description of the functional testing along with test results is provided. Testing was performed with Baxter and competitive sets including Abbott, IMED. IVAC, Burron Medical and McGaw sets. Studies evaluated the integrity of the seal between the adapter and set Y-Site and the security of the adapter on the Y-Site. The data indicate that the proposed adapter meets or exceeds all functional requirements and support its suitability for use with the intended sets.
Key Metrics
Not Found
Predicate Device(s)
Locking Needle Sheath with InterLink® Injection Site, InterLink® Universal Vial Adapter
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
OCT 1 8 1996
InterLink® Adapter for Conventional Y-Site
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
July 23, 1996
Proposed Device: InterLink® Adapter for Conventional Y-Site
Predicate Devices:
Locking Needle Sheath with InterLink® Injection Site InterLink® Universal Vial Adapter
Proposed Device Description:
The proposed InterLink® Adapter for Conventional Y-Site is designed to convert a conventional (needle-accessed) y-injection site to an InterLink® injection site (needleless access). The InterLink® injection site is incorporated into the top of the adapter to allow access to conventional injection sites with InterLink® cannulae. The adapter contains a plastic spike to pierce the conventional Y-site septum and a slot which connects to the arm of the Y-site. There are no new materials involved in the proposed adapter. All plastic and rubber materials used have been previously tested and used in other Baxter devices for similar I.V. solution administration applications.
Statement of Intended Use:
The proposed adapter will be used to convert a conventional needle-accessed vinjection site on a Baxter or competitive solution administration set to an InterLink® injection site. This device, like other products containing the InterLink® injection site is designed to reduce the risk of accidental needle sticks when used in conjunction with the InterLink® cannula, as part of a "needleless" IV access system.
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s:\510k\inadpsum
1
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed InterLink® Adapter for Conventional Y-Site is similar to Baxter's Locking Needle Sheath (NeedleLock) with InterLink® Injection Site previously found substantially equivalent under K914048. Both products incorporate the Interlink® injection site into the top of the device to allow access to conventional iniection sites with InterLink® cannulae. Both devices have a means for piercing the conventional ysite septum and both have a slot which connects to the arm of the Y-site.
The NeedleLock with InterLink® Injection Site consists of independent NeedleLock and injection site components bonded together. The proposed adapter differs in that the InterLink® injection site is integrated into the housing which results in a more compact component. The adapter contains a plastic spike to pierce the y-site septum whereas the NeedleLock device has a needle for septum penetration. The slot of the NeedleLock is L-shaped and is twisted to lock onto the v-arm. The adapter has a Ushaped slot which is positioned over the y-arm after spike penetration.
The proposed InterLink® Adapter for Conventional Y-Site is also similar to the InterLink® Universal Vial Adapter, covered by K924064. Both adapters incorporate the InterLink® injection site and allow standard needle-accessed components (Y-sites or vial stoppers) to be accessible with the InterLink® blunt cannula. Both adapters use a spike to pierce the Y-site or vial stopper which remains fully seated and secure after penetration without use of a locking mechanism.
Discussion of NonClinical Tests and Referenced Studies Reported in Published Literature
Data regarding the functional performance of the proposed adapter have been generated. A description of the functional testing along with test results is provided. Testing was performed with Baxter and competitive sets including Abbott, IMED. IVAC, Burron Medical and McGaw sets. Studies evaluated the integrity of the seal between the adapter and set Y-Site and the security of the adapter on the Y-Site. The data indicate that the proposed adapter meets or exceeds all functional requirements and support its suitability for use with the intended sets.