ORTHOGUARD AB ANTIMICROBIAL SLEEVE

K022676 · Smith & Nephew, Inc. · JEC · Sep 23, 2002 · Orthopedic

Device Facts

• Record ID: K022676
• Device Name: ORTHOGUARD AB ANTIMICROBIAL SLEEVE
• Applicant: Smith & Nephew, Inc.
• Product Code: JEC · Orthopedic
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pine/wire.

Device Story

OrthoGuard AB Antimicrobial Sleeve is a polyurethane tubing accessory; designed to surround orthopaedic pins and wires used in external bone fixation. Device features antimicrobial coating on inner and outer surfaces; coating consists of gentamicin complexed with lauryl sulfate in a nitrocellulose and polyurethane matrix. Device functions as a physical barrier and antimicrobial agent to inhibit bacterial colonization on the pin/wire surface. Used in clinical settings during external fixation procedures; applied by orthopaedic surgeons or clinical staff. Benefits patient by reducing risk of pin-site infection.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by comparison of technological and performance characteristics to predicate device.

Technological Characteristics

Polyurethane tubing; antimicrobial coating (gentamicin complexed with lauryl sulfate in nitrocellulose/polyurethane matrix). Form factor: sleeve for pins/wires. Sterilization method not specified.

Indications for Use

Indicated for use as an accessory surrounding orthopaedic pins and wires during external fixation of bones to inhibit bacterial colonization on the pin/wire.

Regulatory Classification

Identification

A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.

Predicate Devices

• OrthoGuard AB Antimicribial Pin Sleeves (K012193)

Submission Summary (Full Text)

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## 510(k) Summary of Safety and Effectiveness OrthoGuard AB Antimicrobial Sleeve

Ka226 76

| Submitted By: | Smith & Nephew, Inc.<br>Orthopaedic Division<br>1450 Brooks Road<br>Memphis, TN 38116 |
|-------------------------------------|---------------------------------------------------------------------------------------|
| Date: | August 7, 2002 |
| Contact Person: | Janet Johnson Green<br>Director, Regulatory Affairs |
| Proprietary Name: | OrthoGuard AB Antimicrobial Sleeve |
| Common Name: | Antimicrobial Pin/Wire Sleeve |
| Classification Name and Reference: | Smooth or threaded metallic bone fixation<br>fastener (21 CFR 888.3040) |
| Device Product Code and Panel Code: | JEC / NJA - Orthopedics/87 |

#### Predicate Device / Substantial Equivalence Information

The OrthoGuard AB Antimicrobial Wire Sleeve is similar to the OrthoGuard AB Antimicribial Pin Sleeves included in 510(k) K012193. The following properties of the wire sleeve are the same as for the pin sleeves currently offered: intended use, material and coating formulation, manufacturing and coating method, labeling, and sterilization method. While the OrthoGuard AB Antimicrobial Wire Sleeve is not identical to the predicates, any differences that may exist do not significantly affect the safety or effectiveness. Therefore, the OrthoGuard AB Antimicrobial Wire Sleeve is substantially equivalent to the predicate devices.

#### Device Description

The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane.

### Intended Use

The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.

### Technological and Performance Characteristics

The technological and performance characteristics of the OrthoGuard AB Antimicrobial Sleeve were compared to the predicate device. The results of this comparison support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the three branches of government. The logo is surrounded by a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Ms. Janet Johnson Green Director, Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K022676

Trade/Device Name: OrthoGuard AB Antimicrobial Sleeve Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC and NJA Dated: August 8, 2002 Received: August 12, 2002

Dear Ms. Green:

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.

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.

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Page 2 -- Ms. Janet Johnson Green

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Mark n Millan

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# OrthoGuard AB Antimicrobial Sleeve Indications Statement

The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pine/wire.

Mark N. Mulkeron

Mivicia al. Restorative Division C and Neurological L evices

510(k) Number: K022676