(69 days)
No
The summary describes a mechanical device (Huber Needle Extension Sets) and its performance characteristics, with no mention of AI or ML technologies.
No
The device is described as an "Extension Set" for administering solutions and drugs, and its primary function is to provide a "needleless" IV access system to reduce accidental needle sticks. It is an accessory for drug administration, not a device that itself provides therapy or treatment.
No
The device is described as an extension set for administering solutions and drugs into vascular implant ports, focusing on reducing needle stick risks. Its purpose is therapeutic delivery, not diagnosis. This is further supported by the performance studies which focus on flow rate, volume, pressure, and tensile strength, all indicative of a delivery device rather than a diagnostic one.
No
The device description clearly outlines physical components (Huber Needle Extension Sets, injection sites) and performance testing related to physical properties (flow rate, pressure, tensile strength), indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of solutions and drugs into vascular implant ports." This describes a device used in vivo (within the body) for delivering substances.
- Device Description: The description details components like Huber needles and extension sets, which are used for accessing and delivering substances into the vascular system.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples like blood, urine, or tissue.
The device described is a medical device used for drug delivery, not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
Baxter's proposed Huber Needle Extension Sets have the same intended use as the Micro-Med, Inc. Core Resistant Huber Infusion Sets covered by K950597. They are intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site. like other products containing the InterLink® injection site are 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
Not Found
Device Description
The proposed products consist of a line of Huber Needle Extension Sets which may be manufactured in four basic types:
Huber Needle Extension Set without an injection site Huber Needle Extension Set with a standard injection site Huber Needle Extension Set with an InterLink® Y-injection site (Y-Site) Huber Needle Extension Set with an InterLink® T-injection site (T-Site)
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 sets has been generated. Testing included flow rate, total volume, pressure testing of set bonds and tensile strength testing. Performance testing indicates that the proposed sets meet or exceed all functional requirements and support their suitability for use.
Key Metrics
Not Found
Predicate Device(s)
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
510(k) SUMMARY Huber Needle Extension Sets
JUN 2 6 1996
Submitted by:
Mary Ellen Snyder Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared: April 15, 1996
Proposed Device: Huber Needle Extension Sets
Predicate Devices: Micro-Med, Inc. Core Resistant Huber Needle Infusion Set Baxter Solution Administration Sets with InterLink® Injection Site Baxter InterLink® T-Connector Extension Sets
Proposed Device Description:
The proposed products consist of a line of Huber Needle Extension Sets which may be manufactured in four basic types:
Huber Needle Extension Set without an injection site Huber Needle Extension Set with a standard injection site Huber Needle Extension Set with an InterLink® Y-injection site (Y-Site) Huber Needle Extension Set with an InterLink® T-injection site (T-Site)
Statement of Intended Use:
Baxter's proposed Huber Needle Extension Sets have the same intended use as the Micro-Med, Inc. Core Resistant Huber Infusion Sets covered by K950597. They are intended for the administration of solutions and drugs into vascular implant ports. The proposed Huber Needle Extension Sets with InterLink® Y-Site or InterLink® T-Site. like other products containing the InterLink® injection site are 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.
1
Summary of Technological Characteristics of New Device to Predicate Devices
The proposed sets will be manufactured for Baxter by Micro-Med, Inc. and are similar to Micro-Med, Inc. Huber Needle Infusion Sets cleared under K950597. Like the Micro-Med, Inc. sets, the proposed sets will be used to administer drugs and solutions through vascular implant ports. The same Huber needle and winged body needle securement component which is used in the Micro-Med. Inc. sets to access implantable ports will be used in the proposed sets. Like the Micro-Med, Inc. sets, the proposed Huber Needle Extension Sets will vary in needle gauge, needle length, tubing diameter and set length.
The proposed sets will also incorporate components which are used in currently marketed Baxter solution administration sets. For example, the same InterLink® preslit injection site used in other Baxter InterLink® sets and covered by K925126 and K883638 will be incorporated into the proposed set line. The InterLink® injection site is designed to reduce the risk of accidental needle sticks when used with the InterLink® cannula.
All solution contacting components for the proposed sets are used in Micro-Med, Inc. Huber Infusion Sets or in other marketed Baxter solution administration sets. Therefore, the proposed set line results from a combination of previously cleared components and set configurations. The main differences include adaptation of the Tconnector component for an in-line tubing connection and use of a cyanoacrylate adhesive to bond the outside of the set tubing to the needle wing body. The adhesive is applied to the bond area such that there is no contact with the solution path of the set.
Discussion of Nonclinical Tests; Conclusions Drawn from Nonclinical Tests
Data regarding the functional performance of the proposed sets has been generated. Testing included flow rate, total volume, pressure testing of set bonds and tensile strength testing. Performance testing indicates that the proposed sets meet or exceed all functional requirements and support their suitability for use.
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