PAINPUMP2

K043466 · Stryker Instruments · FRN · May 10, 2005 · General Hospital

Device Facts

• Record ID: K043466
• Device Name: PAINPUMP2
• Applicant: Stryker Instruments
• Product Code: FRN · General Hospital
• Decision Date: May 10, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes. 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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes. The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous. The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. This results in a reduction of hospital length of stay.

Device Story

Electromechanical infusion pump; delivers controlled medication/narcotics/antibiotics to intraoperative sites, surgical wounds, or near nerves. Inputs: user-defined hourly flow rate and patient-controlled bolus dosing. Operation: electromechanical delivery mechanism. Output: continuous infusion and bolus doses. Used in clinical settings for postoperative pain management; reduces narcotic reliance and hospital length of stay. Operated by clinicians or patients (via bolus option).

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Electromechanical infusion pump; provides continuous hourly flow and patient-controlled bolus dosing. Routes: intramuscular, subcutaneous, epidural, intraoperative, perineural, percutaneous. Class II device.

Indications for Use

Indicated for patients requiring pain management or antibiotic administration via intramuscular, subcutaneous, epidural, intraoperative, perineural, or percutaneous routes. Used for postoperative regional anesthesia and surgical wound site pain management. Prescription use only.

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 PainPump1 (K042405)
• Stryker PainPump2 (K042405)
• I-Flow Elastomeric Pump w/ Bolus (K040337)

Submission Summary (Full Text)

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4100 E. Milham Avenue
Kalamazoo, MI 49001 t: 269 323 7700 f: 800 965 6505 www.stryker.com

K043466

stryker

instruments

## 510(k) Summary
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| Trade Name: | Stryker PainPump2. Stryker PainPump2 Blockaid |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Infusion Pump; Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA |
| Equivalent to: | K042405, Stryker PainPump1 and Stryker PainPump2; K040337, I-Flow Elastomeric Pump w/ Bolus |
| Device Description: | PainPump2<br>PainPump2 is an electromechanical pump designed to deliver controlled amounts of medication to the patient for pain management and/or antibiotic delivery. Medication is delivered to the treatment site using an hourly flow rate or combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia) dosing option. Pain Management routes of administration may be intramuscular, subcutaneous or epidural. Antibiotic routes of administration may be intramuscular or subcutaneous. |
| Indications for Use: | PainPump2<br>The Stryker PainPump2 delivers controlled amounts of medication and narcotics directly to the intraoperative site for pain management. The pump infuses the medication at an hourly flow rate and provided the option for patient controlled bolus doses. Medications and narcotics are infused through intramuscular, subcutaneous, and epidural routes.<br><br>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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.<br><br>The Stryker PainPump2 is intended for controlled delivery of local anesthetics and narcotics in close proximity to nerves for postoperative regional anesthesia and pain management. Routes of administration may be intraoperative, perineural, or percutaneous.<br><br>The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management. This results in a reduction of hospital length of stay. |
| Submitted by: | Jennifer Mars<br>Regulatory Affairs Representative |
| Date submitted: | Signature |

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with three lines above them that resemble a flag or banner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 0 2005

Ms. Jennifer Mars Senior Regulatory Affairs Representative Stryker Instruments Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K043466

Trade/Device Name: Stryker PainPump2 Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: April 18, 2005 Received: April 19, 2005

Dear Ms. Mars:

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. Mars

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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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## Indications for Use Statement

510(k) Number:

K043466

Device Name:

Stryker PainPump2

## Indications for Use:

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

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 provided the option for patient controlled bolus doses. Medications are infused through intramuscular and subcutaneous routes.

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

The Stryker PainPump2 is also intended to significantly decrease narcotic use and pain when used to deliver local anesthetics to surgical wound sites or close proximity to nerves when compared with narcotic only pain management.

Prescription Use (Per 21 CFR 801 Subpart D)

OR

Over-The- Counter Use (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Cen On

Anesthesiology, General Hospital, nimi Dontal Davis

Number: K043461