COLLEAGUE PUMP SYRINGE ADAPTER SET

K982672 · Baxter Healthcare Corp · FPA · Sep 4, 1998 · General Hospital

Device Facts

• Record ID: K982672
• Device Name: COLLEAGUE PUMP SYRINGE ADAPTER SET
• Applicant: Baxter Healthcare Corp
• Product Code: FPA · General Hospital
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.

Device Story

Device is an IV administration set component; facilitates connection between standard syringe and Colleague® volumetric infusion pump. Features injection-molded female luer-lock adapter and vent cap for air inlet; enables fluid delivery from syringe to patient vascular system. Used in clinical settings by healthcare providers; operates as part of electronic infusion system. Benefits include direct syringe-to-pump compatibility for fluid administration.

Clinical Evidence

Bench testing only. Data generated to confirm functional performance requirements met or exceeded.

Technological Characteristics

Injection-molded plastic set; includes female luer-lock syringe adapter and vent cap. Materials previously cleared for IV administration applications. Designed for use with electronic volumetric infusion pump.

Indications for Use

Indicated for administration of fluids from a syringe container to a patient's vascular system via an electronic infusion device.

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

• Baxter Solution Set with Microbore Tubing
• Imed Vented Gemini® Syringe Set

Submission Summary (Full Text)

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SEP 4 1998

# 510(k) SUMMARY Colleague® Pump Syringe Adapter Set

### Submitted by:

Linda Coleman Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073

#### Date Prepared:

August 20, 1998

# Proposed Device:

Colleague® Pump Syringe Adapter Set

#### Predicate Devices:

Baxter Solution Set with Microbore Tubing Imed Vented Gemini® Syringe Set

#### Proposed Device Description:

The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a standard syringe source container to a patient's vascular system using the Colleague® volumetric infusion pump. The only design difference between the proposed set and other Baxter IV administration sets is the container attachment mechanism which will allow the set to be directly connected to a syringe. This mechanism is an injection molded component which provides a female luer-lock attachment (syringe adapter) and a means for air inlet into the syringe (i.e., vent cap). Therefore, as air enters the syringe, fluid delivery is allowed through the Colleague® Pump Syringe Adapter Set.

# Statement of Intended Use:

The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.

# Summary of Technological Characteristics of New Device to Predicate Devices

The proposed set has the same design as the currently marketed Baxter Solution Set with Microbore Tubing with the exception of the container attachment mechanism and fewer set components. The container attachment mechanism is similar to that used on the currently

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marketed Imed Vented Gemini® Syringe Set. The solution contact materials used in the proposed device were previously tested and used in other Baxter devices for similar IV solution administration applications.

# Discussion of Nonclinical Tests and Referenced Studies Reported in Published Literature

Data regarding the functional performance of the proposed Colleague® Pump Syringe Adapter Set have been generated and submitted. The data indicate that the proposed set meets or exceeds all functional requirements.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping human profiles facing to the right. The emblem is rendered in a bold, black color, contrasting with the white background.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1998 SEP

Ms. Linda Coleman Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073

Re: K982672 Colleague® Pump Syringe Adapter Set Trade Name: II Requlatory Class: Product Code: FPA Dated: July 30, 1998 Received: July 31, 1998

Dear Ms. Coleman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class TT (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Coleman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general " information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

S. Sutman fr

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indication for Use

510(k) Number: Not Available

Colleague® Pump Syringe Adapter Set Device Name:

#### Indication for Use:

The Colleague® Pump Syringe Adapter Set will be used to administer fluids from a container to a patient's vascular system using an electronic infusion device.

Patricia Creciente

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

510(k) Number K982672

**Prescription Use**
**(Per 21 CFR 801.109)**