MODIFICATION TO STRYKER PAINPUMP

K031249 · Stryker Instruments · FRN · Jul 21, 2003 · General Hospital

Device Facts

• Record ID: K031249
• Device Name: MODIFICATION TO STRYKER PAINPUMP
• Applicant: Stryker Instruments
• Product Code: FRN · General Hospital
• Decision Date: Jul 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker PainPump 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. Medications are infused through intramuscular or subcutaneous routes. The Stryker PainPump 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 PainPump is an infusion pump system for controlled delivery of medication (pain management/antibiotics/local anesthetics) to intraoperative sites or near nerves. System components include pump, introducer needles, infusion sets, syringes, dressings, and attachment straps. Available in fill volumes 120-270 cc with flow rates 0.60-8.32 cc/hr. Used in clinical settings by healthcare providers for postoperative regional anesthesia and pain management. Device provides continuous infusion to manage patient pain and facilitate recovery.

Clinical Evidence

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

Technological Characteristics

Infusion pump system; fill volumes 120-270 cc; flow rates 0.60-8.32 cc/hr. Kit includes pump, needles, infusion sets, syringes, and dressings. Mechanical infusion mechanism. No software or electronic components described.

Indications for Use

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

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

• Stryker infusion pump systems
• I-Flow Corporation infusion pump systems
• Sgarlato infusion pump systems

Reference Devices

• Stryker catheters
• I-Flow catheters
• Sims Portex catheters

Submission Summary (Full Text)

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JUL 2 1 2003

K03 1249

**INSTRUMENTS**

4100 East Million Avenue Kalamazço, MI 40001 Phone [phone] [phone]

## Device Name:

| Trade Name: | Stryker PainPump |
|----------------------|------------------------------------------|
| Common Name: | Infusion Pump |
| Classification Name: | Pump, Infusion: 21 CFR 880.5725, Class I |

Device Sponsor:

| Manufacturer: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>Registration No.: 1811755 |
|-------------------|--------------------------------------------------------------------------------------------------|
| Regulatory Class: | Class II |

## Summary of Safety and Effectiveness:

The Stryker PainPump 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. Medications are infused through intramuscular or subcutaneous routes.

The Stryker PainPump 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 PainPump kit models are available in fill volumes from 120 to 270 cc and flow rates from 0.60 - 8.32 cc/hr. Each pump kit consists of a pump, introducer needle(s), infusion set(s), syringe(s), dressing(s), attachment strap, and accessories.

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

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

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

By: Nicole Petty
Regulatory Analyst

Dated: 7-15-03

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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo features the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle are three stylized human profiles facing to the right, with wavy lines below them.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 1 2003

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

Re: K031249

Trade/Device Name: Stryker Painpump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: FRN Product Code: II Dated: April 17, 2003 Received: April 18, 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 dc 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. Nicole 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 (OS) 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.

Sincerely yours,

Susan Runner, DDDS, 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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KO31249

510(k) Number:

Device Name:

Stryker PainPump

Indications For Use:

The Stryker PainPump 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. Medications are infused through intramuscular or subcutaneous routes,

The Stryker PainPump 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)

Van Nostrum

y, General Hospital. Intection Control, Dental Devic

510(k) Number: