STRYKER PAINPUMP2

K030661 · Stryker Instruments · MEA · May 30, 2003 · General Hospital

Device Facts

• Record ID: K030661
• Device Name: STRYKER PAINPUMP2
• Applicant: Stryker Instruments
• Product Code: MEA · General Hospital
• Decision Date: May 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

Device Story

Stryker PainPump2 is an electromechanical ambulatory infusion pump kit. It delivers medication at a continuous hourly flow rate with an optional patient-controlled bolus dose feature. The system includes an infusion pump, infusion sets, introducer needles, a syringe, and catheter securement accessories. It is used for pain management and antibiotic administration at intraoperative sites, or for regional anesthesia by delivering local anesthetics near nerves. The device is intended for clinical use to assist in postoperative pain control. By providing controlled, localized delivery of anesthetics or antibiotics, it aims to improve patient comfort and recovery outcomes.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use comparisons to existing predicate devices.

Technological Characteristics

Electromechanical ambulatory infusion pump. Kit includes infusion sets, introducer needles, syringe, and catheter securement accessories. Designed for continuous flow and patient-controlled bolus delivery. Routes: intraoperative, perineural, percutaneous, intramuscular, subcutaneous.

Indications for Use

Indicated for patients requiring controlled delivery of medication for pain management or antibiotic administration, including postoperative regional anesthesia via intraoperative, perineural, percutaneous, intramuscular, or subcutaneous routes.

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

• I-Flow Corporation infusion pump systems
• I-Flow catheters
• Sims Portex catheters

Submission Summary (Full Text)

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KA30661

MAY 3 0 2003

stryker
INSTRUMENTS

4100 East Milham Avenue,
Kalamazoo, MI 49001
Phone [phone],
800-383-8217

## Device Name:

| Trade Name: | Stryker PainPump2 |
|----------------------|-------------------------------------------------|
| Common Name: | Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA : 21 CFR 880.5725, Class II |

## Device Sponsor:

| Manufacturer: | Stryker Instruments |
|---------------|---------------------------|
| | 4100 E. Milham Avenue |
| | Kalamazoo, MI 49001 |
| | Registration No.: 1811755 |

Regulatory Class: Class II

## Summary of Safety and Effectiveness:

The Stryker PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes.

The Stryker PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

The Stryker PainPum2 is a kit that is comprised of an infusion set(s), introducer needle(s), syringe, and catheter securement accessories.

The Stryker PainPump2 infusion pump is equivalent in intended use, safety, and effectiveness to existing infusion pump systems being marketed by I-Flow Corporation.

The Stryker PainPump2 catheters are equivalent in intended use, safety, and effectiveness to existing catheters being marketed by companies such as I-Flow and Sims Portex.

The Stryker PainPump2 does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker PainPump2 is substantially equivalent to these existing devices.

By: Nicole Petty

Nicole Petty Regulatory Analyst

Dated: 5-8-03

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 3 0 2003

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K030661

Trade/Device Name: Stryker PainPump2 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 27, 2003 Received: March 3, 2003

Dear Ms. Petty:

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. Petty

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). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours.

Susan Runner

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number: Device Name: Stryker PainPump2 Indications For Use: PainPump2 delivers controlled amounts of medication directly to the intraoperative site for pain management and/or antibiotic administration. The pump infuses the medication at an hourly flow rate and provides the option for patient controlled bolus doses. Medications are infused through intramuscular or subcutaneous routes. PainPump2 is also intended for controlled delivery of local anesthetics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The- Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Pulver Crescent

510(k) Number: K030661