PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719

K021274 · Baxter Healthcare Corp · MEB · May 17, 2002 · General Hospital

Device Facts

• Record ID: K021274
• Device Name: PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719
• Applicant: Baxter Healthcare Corp
• Product Code: MEB · General Hospital
• Decision Date: May 17, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Device Story

The Baxter Dual Port Infusor is an elastomeric infusion pump designed for continuous medication delivery. It is a modification of the existing Infusor SV and LV lines, featuring a bifurcated tubing design with a 'Y' fitting to allow solution flow through two ports. The device operates via elastomeric pressure to deliver medication at controlled flow rates. It is intended for use in clinical settings for postoperative pain management or intraoperative site infusion. The device is contraindicated for intravenous, intra-arterial, and epidural administration. It provides a mechanical method for drug delivery, assisting clinicians in managing patient pain post-surgery.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and design similarities to the predicate device.

Technological Characteristics

Elastomeric infusion pump; bifurcated tubing with 'Y' fitting; flow rate controlled by elastomeric pressure; identical materials and technology to predicate Infusor SV/LV devices.

Indications for Use

Indicated for patients requiring slow, continuous infusion of medications into an intraoperative site or subcutaneously for postoperative pain management. Contraindicated for intravenous, intra-arterial, and epidural use.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Predicate Devices

• Infusor SV and LV Elastomeric Infusion Device

Submission Summary (Full Text)

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K02/274

MAY 1 7 2002

### ATTACHMENT 6

#### SMDA INFORMATION

# SUMMARY OF SAFETY AND EFFECTIVENESS

# Submitted by:

Vicki L. Drews Baxter Healthcare Corporation I.V. Systems Division Route 120 and Wilson Road Round Lake, IL 60073

# Date of Submission:

April 19, 2002

# Proposed Device(s):

Baxter Dual Port Infusor

Baxter Pain Mate™ Pain Management System (Convenience Kits containing the Baxter Dual Port Infusor)

#### Comparison Device(s):

Infusor SV and LV Elastomeric Infusion Device

## Description of Device(s):

The dual port line of Infusors are a modification of Baxter's currently marketed Infusor line of elastomeric infusion devices. The modification consists of adding a "Y" fitting and an additional section of administration set tubing resulting in a bifurcated tubing. This allows solution flow through two ports. There are no new materials or technology associated with the modification. In all other respects, the dual port Infusors are identical to Baxter's current Infusor SV and LV elastomeric pumps. Furthermore, the range of flow rates through each single port as well as through both ports combined, is within the current range of flow rates available in the single port Infusor devices.

## Indications for Use:

The Dual Port Infusor is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

#### Technological Characteristics:

The technological characteristics of the Dual Port Infusor are identical to those of the Infusor SV and Infusor LV devices. The Dual Port Infusor incorporates a bifurcated tubing to allow for solution flow through two ports.

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510(k) Premarket Notification Dual Port Infusor

> A contraindication has been added to the labeling of the Pain-Mate Pain Management Systems with dual port Infusors. The Dual Port Infusor devices are contraindicated for intravenous, intra-arterial, and epidural use.

# 6 May 14, 2002

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with stylized wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 7 2002

Ms. Vicki L. Drews Manager, Regulatory Affairs Baxter Healthcare Corporation I. V. Systems Division Route 120 and Wilson Road Round Lake, Illinois 60073-0490

Re: K021274

Trade/Device Name: Baxter Dual Port Infusor Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: Unclassified Product Code: MEB Dated: April 19, 2002 Received: April 22, 2002

#### Dear Ms. Drews:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 - Ms. Drews

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Runnor

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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K021274

510(k) Premarket Notification Dual Port Infusor

## ATTACHMENT 8

#### INDICATIONS FOR USE

The Dual Port Infusor line of elastomeric pumps is indicated for the slow, continuous infusion of medications directly into an intraoperative site or subcutaneously for postoperative pain management.

Patricia Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ 4 02/2

#### BAXTER CONFIDENTIAL

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7 May 14, 2002