ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE

K052171 · Zimmer, Inc. · FRN · Oct 13, 2005 · General Hospital

Device Facts

• Record ID: K052171
• Device Name: ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE
• Applicant: Zimmer, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 13, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Zimmer Pain Management System and Zimmer Pain Management System with Patient Control Module (PCM) are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. 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

Convenience kit containing legally marketed components (pumps, catheters, introducer needles) packaged and sterilized by Zimmer. System provides slow, continuous infusion of pain medication or local anesthetic via subcutaneous, epidural, or intraoperative routes. Patient Control Module (PCM) enables patient-initiated intermittent bolus doses. Used by ambulatory patients in clinical or home settings; operated by patients or healthcare providers. Device functions as a mechanical delivery system; no electronic or software-based control. Benefits include simplified administration of regional anesthesia and postoperative pain management.

Clinical Evidence

No clinical data provided. Bench testing only; sterilization validation conducted per FDA guidance for convenience kits; previously cleared components meet ANSI/AAMI/ISO 10993-1:1997 biological evaluation standards.

Technological Characteristics

Elastomeric infusion pump kit. Components include catheters and introducer needles. Materials are those of legally marketed predicate devices. Mechanical operation; no energy source required. Sterilized via irradiation. No software or electronic components.

Indications for Use

Indicated for ambulatory patients requiring slow, continuous subcutaneous, epidural, or intraoperative infusion of pain medications or local anesthetics for postoperative pain management or regional anesthesia. Includes optional patient-controlled intermittent bolus dosing.

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

• Zimmer Ambulatory Pump Kit Pain Management System (K050433)

Submission Summary (Full Text)

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Kosz171

# OCT 1 3 2005

# 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: | August 8, 2005 |
| Trade Name: | ZIMMER AMBULATORY PUMP KIT, PAIN<br>MANAGEMENT SYSTEM with PCM |
| | ZIMMER AMBULATORY PUMP KIT, PAIN<br>MANAGEMENT SYSTEM, 3/5/8 ml/h |
| | Peelable Introducer Needle Kit |
| | Fixed Hub Catheter Kit |
| Common Name: | Pump, Infusion, Elastomeric |
| Classification Name<br>and Reference: | 21 CFR § 880.5725 |
| Predicate Devices: | Zimmer Ambulatory Pump Kit Pain Management<br>System manufactured by Zimmer Orthopaedic<br>Surgical Products, K050433, cleared April 13,<br>2005. |
| 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 |
| | 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 Management<br>System (kit) does not raise any new safety and<br>effectiveness concerns when compared to the<br>similar legally marketed devices. The Zimmer<br>Ambulatory Pump Pain Management System<br>should therefore be considered substantially<br>equivalent to the existing predicate devices. |
| Indications for Use: | The Zimmer Pain Management System and Zimmer<br>Pain Management System with Patient Control<br>Module (PCM) are indicated for the slow,<br>continuous, subcutaneous or epidural administration<br>of pain medications. It may also include the slow,<br>continuous infusion of pain medications directly<br>into an intraoperative, subcutaneous, or epidural site<br>for postoperative pain management or the<br>continuous infusion of a local anesthetic near a<br>nerve for regional anesthesia. The PCM allows for<br>intermittent bolus doses of medication on<br>patient demand. The system is convenient for use<br>by ambulatory patients. It is the responsibility of<br>the user to assure that the medication is prepared<br>and administered in accordance with the drug<br>manufacturer's package insert. |
| Comparison to Predicate Device: | The Zimmer Ambulatory Pump Pain Management<br>Kit (with and without PCM) and alternative<br>introducer needle and catheter kits are substantially<br>equivalent to the legally marketed pain management<br>kits, specifically the Zimmer Ambulatory Pump<br>Pain Management System in that the kits are similar<br>in design, materials, and indications for use. |
| Performance Data (Nonclinical | Non-Clinical Performance and Conclusions: |
| and/or Clinical): | 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 for this<br>submission. |
| 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. |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the eagle's head and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the eagle in a circular fashion.

Public Health Service

OCT 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: K052171

Trade/Device Name: Zimmer Ambulatory Pump Pain Management System and the Zimmer Ambulatory Pump Pain Management System with PCM Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 19, 2005 Received: September 26, 2005

Dear Ms. Dickey:

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 the Pour a Vous Loose, Dough 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. Dickey

Please be advised that FDA's issuance of a substantial equivalence determination does not r read 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. or mo rec or all , 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 and ibeing (22 set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirence as 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), 11 you 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 Inty overn banel Baner Barrational 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-Ling, 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

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## Indications for Use

### 510(k) Number (if known):

#### Device Name:

Zimmer Ambulatory Pump Pain Management System and the Zimmer Ambulatory Pump Pain Management System with PCM

#### Indications for Use:

The Zimmer Pain Management System and Zimmer Pain Management System with Patient The 2mmer 1 and many are indicated for the slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative, subcutaneous, or epidural site for postoperative modically anoothy into continuous infusion of a local anesthetic near a nerve for regional anesthesia. The PCM allows for intermittent bolus doses of medication on patient demand. allesthesia. The I CH and 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)

and Brancurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number _ ky 5217)