STRYKER ANTIMIC CATHETER

K072702 · Stryker Instruments, Instruments Div. · BSO · Mar 19, 2008 · Anesthesiology

Device Facts

• Record ID: K072702
• Device Name: STRYKER ANTIMIC CATHETER
• Applicant: Stryker Instruments, Instruments Div.
• Product Code: BSO · Anesthesiology
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5120
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Stryker AntiMic Catheter is intended to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter is contraindicated for the epidural space and in neonatal populations. The Stryker AntiMic Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Device Story

Stryker AntiMic Catheter is a medical catheter designed for use with Stryker Pain Pump Systems to deliver medication to surgical wound sites. Available in standard and extended fenestration lengths (2.5", 5.0", 10"), the device features a closed tip with radially arranged lateral holes for fluid distribution. The catheter incorporates an antimicrobial agent on its inner and outer surfaces to inhibit microbial growth and reduce the risk of the device becoming microbially compromised. It is not intended to treat existing infections. Used in clinical settings by healthcare providers for pain management, the device facilitates targeted drug delivery to surgical sites, potentially improving patient comfort and reducing infection risks associated with catheter use.

Technological Characteristics

Catheter with closed tip and radial fenestrations. Incorporates an antimicrobial agent on inner and outer surfaces. Designed for use with Stryker Pain Pump Systems. No specific materials or software algorithms described.

Indications for Use

Indicated for continuous or intermittent delivery of medication (local anesthetics/narcotics) to surgical wound sites for pre-, peri-, and postoperative pain management. Contraindicated for epidural space use and neonatal populations.

Regulatory Classification

Identification

An anesthesia conduction catheter is a flexible tubular device used to inject local anesthetics into a patient and to provide continuous regional anesthesia.

Predicate Devices

• I-Flow: On-Q SilverSoaker Catheter (K051401)
• Vygon: MultiCath Expert (K061250)
• Stryker Pain Pump2 (K043466)

Submission Summary (Full Text)

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

K072702

MAR 1 9 2008

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

:

stryker

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 AntiMic Catheter Kit |
| Common Name: | Antimicrobial Catheter |
| Classification Name: | Anesthesia, Conduction Catheters (BSO) |
| Equivalent to: | K051401 I-Flow: On-Q SilverSoaker Catheter<br>K061250 Vygon: MultiCath Expert<br>K043466 Stryker Pain Pump2 |
| Device Description: | The Stryker AntiMic catheter is intended to be used with the Stryker<br>Pain Pump Systems. Catheters are available in the following sizes:<br>Standard; and 2.5", 5.0", and 10" Extended Fenestration. The<br>Standard catheter has a closed tip with three holes arranged radially<br>along the lateral surface at the distal end of the device. The Extended<br>Fenestration catheters have a closed tip with multiple holes arranged<br>radially along the lateral surface at the distal end of the device.<br><br>The catheter contains an antimicrobial agent that is intended to<br>inhibit the growth of microorganisms and reduce the possibility of the<br>catheter becoming microbially compromised. |
| Indications for Use: | The Stryker AntiMic Catheter is intended to provide continuous or<br>intermittent delivery of medication (such as local anesthetics or<br>narcotics) to or around surgical wound sites for preoperative,<br>perioperative, and postoperative pain management. The Stryker<br>AntiMic Catheter is contraindicated for the epidural space and in<br>neonatal populations.<br>The Stryker AntiMic Catheter contains an antimicrobial agent which<br>may destroy or inhibit the growth of microorganisms on both the |

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

| | inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections. |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial Equivalence (SE) Rational: | The Stryker AntiMic Catheter has the same intended use as the I- Flow On-Q Silver Soaker Catheter and the same technology of the antimicrobial process as the Vygon MultiCath Expert Catheter. This device and the predicate devices have the same technological characteristics, use the same patient contacting materials and have similar performance characteristics. |
| Safety and Effectiveness: | Based upon the comparison to the predicate devices, the Stryker AntiMic Catheter is substantially equivalent to legally marketed devices. |

Submitted by:

Julie Pryor Regulatory Affairs Representative

Julie Riya

---

Signature
9/21/07

Date submitted:

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Julie Pryor Regulatory Affairs Representative Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

MAR 1 9 2008

Re: K072702

Trade/Device Name: Stryker AntiMic Catheter Kit Regulation Number: 21 CFR 868.5120 Regulation Name: Anesthesia Conduction Catheter Regulatory Class: II Product Code: BSO Dated: February 15, 2008 Received: February 19, 2008

Dear Ms. Pryor:

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.

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

Page 2 - Ms. Pryor

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 (QS) 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,

Sudie J. Michie Omd.

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}------------------------------------------------

Page 1 of 1

510(K) Number (if known):

Device Name: Stryker AntiMic Catheter Kit

## Indications for Use

The Stryker AntiMic Catheter Kit is intended to provide continuous or intermittent delivery of medication (such as local anesthetics) to or around surgical wound sites for preoperative, perioperative, and postoperative pain management. The Stryker AntiMic Catheter Kit is contraindicated for the epidural space and in neonatal populations.

The Stryker AntiMic Catheter Kit contains an anti-microbial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.

Prescription Use X (Part 21 CFR 801 Subpart D) and/or

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suor Runner fr MH

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

510(k) Number: K072702