PAINPUMP1; PAINPUMP2

K042405 · Stryker Corp. · FRN · Oct 14, 2004 · General Hospital

Device Facts

• Record ID: K042405
• Device Name: PAINPUMP1; PAINPUMP2
• Applicant: Stryker Corp.
• Product Code: FRN · General Hospital
• Decision Date: Oct 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

PainPump1 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 intraoperatively and postoperatively through intramuscular or subcutaneous routes. PainPump1 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. PainPump1 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. 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 intraoperatively and postoperatively 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. 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.

Device Story

Stryker PainPump1 and PainPump2 are infusion pumps for pain management and antibiotic delivery. PainPump1 is a disposable syringe infuser using sustained vacuum pressure for continuous hourly flow. PainPump2 is an electromechanical pump providing continuous hourly flow with an optional patient-controlled bolus (PCA) feature. Both devices deliver medication to intraoperative sites, surgical wounds, or near nerves via intramuscular, subcutaneous, perineural, or percutaneous routes. Used in clinical settings to provide regional anesthesia; intended to reduce patient narcotic requirements. Healthcare providers manage pump settings; patients may trigger bolus doses on PainPump2. Output is controlled medication delivery to the treatment site.

Clinical Evidence

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

Technological Characteristics

PainPump1: Disposable syringe infuser, vacuum-driven. PainPump2: Electromechanical infusion pump. Both support continuous hourly flow; PainPump2 includes PCA bolus capability. Routes: intramuscular, subcutaneous, perineural, percutaneous.

Indications for Use

Indicated for patients requiring pain management or antibiotic administration via intraoperative, postoperative, intramuscular, subcutaneous, perineural, or percutaneous routes. Intended for delivery of local anesthetics for regional anesthesia and pain management to reduce narcotic 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

• Stryker PainPump1 (K031249)
• PainPump2 (K030661)
• I-Flow Elastomeric Pump w/ Bolus (K040337)

Submission Summary (Full Text)

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K04 2405

OCT 1 4 2004

4100 F. Milham Avenue
Kalamazoo, MI 49001
1: 269 323 7700 f: 800 965 6505 www.stryker.com

Image /page/0/Picture/3 description: The image shows the word "stryker" in a bold, sans-serif font. The letters are all lowercase except for the "S", which is uppercase. There is a small registered trademark symbol to the upper right of the "r".

Instruments

## 510(k) Summary

| Trade Names: | Stryker PainPump1 and Stryker PainPump2 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Infusion Pump; Electromechanical Ambulatory Infusion Pump |
| Classification Name: | Pump, Infusion, PCA |
| Equivalent to: | K031249, Stryker PainPump1; K030661, PainPump2,<br>K040337; I-Flow<br>Elastomeric Pump w/ Bolus |
| Device Description: | PainPump1<br>PainPump1 is a disposable syringe infuser which uses sustained vacuum pressure to<br>deliver a continuous infusion of medication to the patient for pain management<br>an/or antibiotic delivery. Medication is delivered to the treatment site using an<br>hourly flow rate. The routes of administration may be intramuscular or<br>subcutaneous. |
| | PainPump2<br>PainPump2 is an electromechanical pump designed to deliver controlled amounts of<br>medication to the patient for pain management and/or antibiotic delivery.<br>Medication is delivered to the treatment site using an hourly flow rate or<br>combination of hourly flow rate and bolus PCA (Patient Controlled Analgesia)<br>dosing option. The routes of administration may be intramuscular or subcutaneous. |
| Indications for Use: | PainPump1<br>The Stryker PainPump1 delivers controlled amounts of medication directly to the<br>intraoperative site for pain management and/or antibiotic administration. The pump<br>infuses the medication at an hourly flow rate. Medications are infused through<br>intramuscular or subcutaneous routes.<br><br>The Stryker PainPump1 is also intended for controlled delivery of local anesthetics<br>in close proximity to nerves for postoperative regional anesthesia and pain<br>management. Routes of administration may be intraoperative, perineural, or<br>percutaneous. |
| | The Stryker PainPump1 is also intended to significantly decrease narcotic use and<br>pain when used to deliver local anesthetics to surgical wound sites or close<br>proximity to nerves when compared with narcotic only pain management. |

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### PainPump2

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 Medications are infused through intramuscular, or controlled bolus doses. subcutaneous routes.

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

Submitted by:

Jennifer Mars Regulatory Affairs Representative

Jennifer Mars
Signature

Date submitted:

October 13, 2004

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 4 2004

Ms. Jennifer Mars Regulatory Affairs Representative Stryker Corporation Instrument Division 4100 E. Milham Avenue Kalamazoo, Michigan 49001

Re: K042405

Trade/Device Name: PainPump1 and PainPump2 Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: August 31, 2004 Received: September 7, 2004

Dear Ms. Mars:

We have reviewed your Section 510(k) premarket notification of intent to market the device We liave reviewed your becalen by (1) process is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in indications for use stated in the energently is cogniture date of the Medical Device interstate collimitelee prior to that have been reclassified in accordance with the provisions of Amendinents, or to devices mat nave oose (Act) that do not require approval of a premarket the Federal Pood, Drug, and Cosmette 190 (1920) - ...
approval application (PMA). You may, therefore, market the device, subject to the general approval application (1 he Act. The general controls provisions of the Act include controls provisions of the Fict. "The gistration, 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 II your device is classified (boo as a vierns. Existing major regulations affecting (1 MA), it may of subject to back ademic to begulations, Title 21, Parts 800 to 898. In your device can be found in firsher 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 moan that I Drived statutes and regulations administered by other Federal agencies. or the Free of any I vath all the Act's requirements, including, but not limited to: registration r ou muse compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 es result of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet resist 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), 11 Jou donto 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 yours,

Susan Ruoppes

Dr. Chia-Lin, Ph.D.

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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# 05

### Indications for Use Statement

| 510(k) Number: | K042405 |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Stryker PainPump: PainPump1 and PainPump2 |
| Indications for Use: | PainPump1 delivers controlled amounts of medication directly to the<br>intraoperative site for pain management and/or antibiotic administration.<br>The pump infuses the medication at an hourly flow rate. Medications are<br>infused intraoperatively and postoperatively through intramuscular or<br>subcutaneous routes.<br><br>PainPump1 is also intended for controlled delivery of local anesthetics in<br>close proximity to nerves for postoperative regional anesthesia and pain<br>management. Routes of administration may be intraoperative, perineural,<br>or percutaneous.<br><br>PainPump1 is also intended to significantly decrease narcotic use<br>and pain when used to deliver local anesthetics to surgical wound<br>sites or close proximity to nerves when compared with narcotic<br>only pain management.<br><br>PainPump2 delivers controlled amounts of medication directly to the<br>intraoperative site for pain management and/or antibiotic administration.<br>The pump infuses the medication at an hourly flow rate and provides the<br>option for patient controlled bolus doses. Medications are infused<br>intraoperatively and postoperatively through intramuscular or<br>subcutaneous routes.<br><br>PainPump2 is also intended for controlled delivery of local anesthetics in<br>close proximity to nerves for postoperative regional anesthesia and pain<br>management. Routes of administration may be intraoperative, perineural,<br>or percutaneous.<br><br>PainPump2 is also intended to significantly decrease narcotic use<br>and pain when used to deliver local anesthetics to surgical wound<br>sites or close proximity to nerves when compared with narcotic<br>only pain management. |
| Prescription Use<br>X<br>(Per 21 CFR 801 Subpart D) | OR<br>Over-The- Counter Use<br>(21 CFR 807 Subpart C) |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chris Lowe

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

510(k) Number: K042465