STRYKER PAINPUMP by STRYKER CORP.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings and head. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 31 2001

Ms. Nicole Petty Stryker Corporation Instrument Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K014091

Trade/Device Name: Stryker PainPump Regulation Number: 880.5725 Regulation Name: Pump, Infusion Regulatory Class: II Product Code: MEB Dated: December 11, 2001 Received: December 12, 2001

Dear Ms. Petty:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your because in 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 mendments, or to devices that have been reclassified in accordance with the provisions of Anchunona, or to avirisand Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvin uppression (the Act. The general controls provisions of the Act include controls provibions or aregistration, 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 (1 Nr.), it hay of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or routish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not I teast 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.

{1}------------------------------------------------

Page 2 - Ms. Petty

You must comply with all the Act's requirements, including, but not limited to: registration 1 od intol compry with 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 es read in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as better in 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 This letter will and w you've of 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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Ulatowski Timott Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

1 of _________________________________________________________________________________________________________________________________________________________________________

Indications for Use Statement

510(k) K014091
Number

Stryker PainPump Device Name

Intended to provide continuous infusion of a local anesthetic Indications directly into the intraoperative site for postoperative pain management.

Duke Weind for Pat Cucinotta

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __ 01409

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).