HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE

K961495 · Baxter Healthcare Corp · FPA · Jun 26, 1996 · General Hospital

Device Facts

• Record ID: K961495
• Device Name: HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Jun 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Huber needle extension sets facilitate drug/solution delivery into vascular implant ports; consists of Huber needle, winged body, and tubing; available with/without injection sites (standard, InterLink® Y-site, or T-site). Used in clinical settings by healthcare providers. InterLink® components enable needleless IV access to reduce accidental needle stick risk. Device functions as fluid path extension; connects to implantable ports. Benefits include secure port access and needleless safety features.

Clinical Evidence

Bench testing only. Performance testing included flow rate, total volume, pressure testing of set bonds, and tensile strength testing. Results indicate sets meet or exceed functional requirements.

Technological Characteristics

Components: Huber needle, winged body, tubing, InterLink® pre-slit injection sites. Materials: All solution-contacting components previously cleared in predicate sets. Assembly: Cyanoacrylate adhesive used for external bonding of tubing to needle wing body (non-solution contacting). Configurations: Varying needle gauge, length, tubing diameter, and set length.

Indications for Use

Indicated for administration of solutions and drugs into vascular implant ports in patients requiring IV access.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Micro-Med, Inc. Core Resistant Huber Needle Infusion Set (K950597)
• Baxter Solution Administration Sets with InterLink® Injection Site (K925126, K883638)
• Baxter InterLink® T-Connector Extension Sets

Submission Summary (Full Text)

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K961495

# 510(k) SUMMARY

Huber Needle Extension Sets

JUN 26 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.

APR 15 1996 157

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510(k) Summary
Huber Needle Extension Sets
Page 2

# 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® pre-slit 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 T-connector 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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