STRYKER AUTO IRRIGATION SYSTEM

K061108 · Stryker · FRN · Feb 2, 2007 · General Hospital

Device Facts

• Record ID: K061108
• Device Name: STRYKER AUTO IRRIGATION SYSTEM
• Applicant: Stryker
• Product Code: FRN · General Hospital
• Decision Date: Feb 2, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone.

Device Story

Stryker Auto Irrigation System provides on-demand irrigation for bone surgery. System comprises enclosure with peristaltic pump, attachable irrigation cassette, and sensor plug. Used in conjunction with Maestro Pneumatic System. Operates by delivering controlled fluid flow to surgical site to provide cooling during cutting, shaping, or removal of bone. Intended for clinical use by healthcare professionals. Benefits patient by preventing thermal injury to bone tissue during high-speed instrumentation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and performance characteristics relative to the predicate device.

Technological Characteristics

Peristaltic pump system; includes enclosure, irrigation cassette, and sensor plug. Mechanical fluid delivery mechanism. No software or electronic processing described.

Indications for Use

Indicated for providing controlled, cooling irrigation during bone cutting, shaping, and removal procedures when used with the Maestro Pneumatic System. Contraindicated for use with fluids other than those specifically for surgical irrigation.

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

• Anspach Irrigation Pump and Irrigation Pump II (K030576)

Submission Summary (Full Text)

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K061108

stryker®

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

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FEB - 2 2007

Instruments

| 510(k) Summary | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Sponsor: | Stryker Instruments<br>4100 E. Milham Avenue<br>Kalamazoo, MI 49001<br>(p) 269-323-7700<br>(f) 269-324-5412 |
| Registration No .: | 1811755 |
| Trade Name: | Stryker Auto Irrigation System |
| Common Name: | Auto Irrigator |
| Classification Name: | Pump, Infusion (FRN) |
| Equivalent to: | K030576 Anspach Irrigation Pump and Irrigation Pump II |
| Device Description: | The Stryker Auto Irrigation System provides on-demand irrigation using a<br>peristaltic pump. The system consists of an enclosure containing the pump,<br>an attachable irrigation cassette and a sensor plug. |
| Indications for Use: | The Stryker Auto Irrigation System is intended for use with the Maestro<br>Pneumatic System for providing controlled, cooling irrigation during cutting,<br>shaping and removal of bone. |
| Contraindications | • The Stryker Auto Irrigation System is contraindicated for use with any<br>fluids other than those specifically for surgical irrigation. |
| Substantial Equivalence<br>(SE) Rational: | The Stryker Auto Irrigation System has the same intended use as the<br>Anspach Irrigation Pump and Irrigation Pump II. This device and the<br>predicate device have the same technological characteristics, the same<br>operating principles and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker Auto<br>Irrigation System is substantially equivalent to a legally marketed device. |
| Submitted by: | Valerie Franck<br>Regulatory Affairs Representative |

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Signature

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Date submitted:

K061108

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 2 2007

Ms. Valerie Franck Regulatory Affairs Representative Stryker Stryker Instruments Division 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K061108

Trade/Device Name: Stryker Auto Irrigation System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: January 26, 2007 Received: January 30, 2007

Dear Ms. Franck:

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. Franck

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 (OS) 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.

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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510(K) Number (if known): _

Device Name: Stryker Auto Irrigation System

### Indications for Use

The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone.

#### Contraindications

- · The Stryker Auto Irrigation System is contraindicated for use with any fluids other than those specifically for surgical irrigation.
Prescription Use _ X and/or Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

K061108

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintron Bm

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