ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM

K050433 · Zimmer Orthopaedic Surgical Products · FRN · Apr 13, 2005 · General Hospital

Device Facts

• Record ID: K050433
• Device Name: ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM
• Applicant: Zimmer Orthopaedic Surgical Products
• Product Code: FRN · General Hospital
• Decision Date: Apr 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Device Story

Zimmer Ambulatory Pump Pain Management System is a convenience kit containing legally marketed components. It facilitates continuous infusion of pain medication into intraoperative, subcutaneous, or epidural sites. The system is designed for ambulatory patients to manage postoperative pain. The device is used in clinical or home settings under the direction of a healthcare provider, who ensures medication preparation follows the drug manufacturer's instructions. The kit is provided non-sterile and undergoes irradiation sterilization by a contract facility. The system does not alter the intended use of the individual components included in the kit.

Clinical Evidence

No clinical data provided; bench testing only. Sterilization impact was evaluated per FDA guidance for convenience kits. Previously cleared components meet applicable sections of ANSI/AAMI/ISO 10993-1:1997 for biological evaluation.

Technological Characteristics

Convenience kit containing legally marketed infusion pump components. Sterilization via irradiation. Materials comply with ANSI/AAMI/ISO 10993-1:1997. No electronic or software components; purely mechanical infusion system.

Indications for Use

Indicated for patients requiring continuous infusion of medications into intraoperative, subcutaneous, or epidural sites for postoperative pain management; suitable for ambulatory patients.

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

• Accufuser, Accufuser Plus, & Standard Procedure Kit (K033039)
• PainPump® Local Anesthesia Kit (K031249)

Submission Summary (Full Text)

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

APR 1 3 2005

# 3 3

## Summary of Safety and Effectiveness

| Submitter: | Zimmer Orthopaedic Surgical Products<br>200 West Ohio Avenue<br>P.O. Box 10<br>Dover, Ohio 44622 |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy J. Dickey<br>Regulatory Compliance Manager<br>Telephone: [phone]<br>Fax: [phone] |
| Date: | February 21, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP PAIN<br>MANAGEMENT SYSTEM |
| Common Name: | Pump, Infusion, Elastomeric |
| Classification Name<br>and Reference: | Pump, Infusion, Elastomeric<br>21 CFR § 880.5725 |
| Predicate Devices: | Accufuser, Accufuser Plus, & Standard Procedure<br>Kit manufactured by McKinley, Inc., K033039,<br>cleared October 7, 2003. |
| | PainPump® Local Anesthesia Kit, manufactured by<br>Stryker Corporation, K031249, cleared July 21,<br>2003. |
| Device Description: | The Zimmer Ambulatory Pump Pain Management<br>System is a convenience kit that is comprised of<br>legally marketed devices. The devices are<br>purchased non-sterile and subsequently packaged in<br>tray kits by Zimmer. Once packaged, the kit will be<br>sent to a contract sterilizer for irradiation<br>sterilization. The proposed convenience kit does not<br>change the intended use of the legally marketed<br>devices which comprise the kit. |
| | The Zimmer Ambulatory Pump Pain<br>Management System (kit) does not raise any<br>new safety and effectiveness concerns when<br>compared to the similar legally marketed<br>devices. The Zimmer Ambulatory Pump<br>Pain Management System should therefore<br>be considered substantially equivalent to<br>the existing predicate devices. |
| Indications for Use: | The Zimmer Pain Management System is indicated<br>for patients requiring continuous infusion of<br>medications directly into an intraoperative,<br>subcutaneous or epidural site for postoperative pain<br>management. The system is convenient for use by<br>ambulatory patients. It is the responsibility of the<br>user to assure that the medication is prepared and<br>administered in accordance with the drug<br>manufacturer's package insert. |
| Comparison to Predicate Device: | The Zimmer Ambulatory Pump Pain Management<br>Kit is substantially equivalent to the legally<br>marketed pain management kits, specifically the<br>McKinley Accufuser, Accufuser Plus, & Standard<br>Procedure Kit and the Stryker PainPump® Local<br>Anesthesia Kit in that the kits are similar in design,<br>materials, and indications for use. |
| Performance Data (Nonclinical<br>and/or Clinical): | Non-Clinical Performance and Conclusions:<br>The devices in this kit have been tested to determine<br>the impact of sterilization as per the guidance<br>document, "Sterilized convenience kits for clinical<br>'and surgical use; final guidance for industry,"<br>January 7, 2002 was utilized as guidance<br>for this submission.<br>The previously cleared devices have been tested and<br>does meet the applicable sections of the<br>ANSI/AAMI/ ISO 10993-1:1997, "Biological<br>evaluation of Medical Devices. |
| Clinical Performance and Conclusions: | Clinical data and conclusions were not needed for<br>this kit. |

. '

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

:

: :

:

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

APR 1 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Cindy J. Dickey Regulatory Compliance Manager Zimmer Orthopaedic Surgical Products 200 West Ohio Avenue P.O. Box 10 Dover, Ohio 44622-0010

Re: K050433

K030455
Trade/Device Name: Zimmer Ambulatory Pump Kit, Pain Management System Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 21, 2005 Received: February 22, 2005

Dear Ms. Dickey:

We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your because of the device is substantially equivalent (for the relevelect above and have attermclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, of to devroos that nave of Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approval upprivation (The Act. The general controls provisions of the Act include controls provisions of the restration, 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 (oo as additional controls. Existing major regulations affecting (I MA), It may be subject to tach adam adam frederal Regulations, Title 21, Parts 800 to 898. In your device can be found in the Beas nouncements concerning your device in the Federal Register.

{3}------------------------------------------------

#### Page 2 - Ms. Dickey

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 mean that I DA mas made a actes and regulations administered by other Federal agencies. of the Act of ally I oderal blacks and survey including, but not limited to: registration r ou intest comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alla listing (21 CF R Part 807), as ality systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality sjoceans (Sections (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) I mis letter will and in you to began finding of substantial equivalence of your device to a premarket nonnomical - The evice 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), If you desire specific at not tee for younce 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 may overn of Small Manufacturers, International and Consumer Assistance at its toll-free Division [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

{4}------------------------------------------------

### Indications for Use

510(k) Number (if known): KOSO4 33

Device Name:

Zimmer Ambulatory Pump Kit, Pain Management System

#### Indications for Use:

The Zimmer Ambulatory Pump Kit, Pain Management System is indicated for patients requiring continuous infusion of medications directly into an intraoperative, subcutaneous or epidural site for postoperative pain management. The system is convenient for use by ambulatory patients. It is the responsibility of the user to assure that the medication is prepared and administered in accordance with the drug manufacturer's package insert.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Page 1 of 1

Ar Dr

Sign-Off) Civision of Anesthesiology, General Hospital, Intection Control, Dental Devices

(!)(k) Number. 1595433

000031