PIONEER SILICOAT STERNAL CABLE

K993286 · Pioneer Surgical Technology · JDQ · Nov 23, 1999 · Orthopedic

Device Facts

• Record ID: K993286
• Device Name: PIONEER SILICOAT STERNAL CABLE
• Applicant: Pioneer Surgical Technology
• Product Code: JDQ · Orthopedic
• Decision Date: Nov 23, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.

Device Story

Pioneer SilCoat Sternal Cable System consists of cables and associated crimps used for sternal fixation. Cables feature a central portion coated with silver, with a monofilament wire welded to one end and an attached needle. System includes various cable lengths and needle types. Device is used by surgeons in clinical settings (e.g., OR) to stabilize the sternum post-sternotomy or fracture. Operation involves securing the cable around the sternum and using the provided cylindrical crimp to fasten. The silver coating is a design modification to the predicate Songer Sternal Cable System; no clinical claims regarding infection reduction are made. Benefit is mechanical stabilization of the sternum to facilitate bone fusion.

Clinical Evidence

No clinical studies performed. Evidence consists of bench testing comparing the SilCoat system to the predicate Songer Sternal Cable System. Static yield load testing and fatigue life curves indicate equivalent performance.

Technological Characteristics

Bone fixation cerclage system. Components: cables with silver-coated central portion, welded monofilament wire, needle, and cylindrical crimp. Materials: biocompatible materials (crimp and cable). Sterilization: double barrier sterile packaging. Connectivity: none. Software: none.

Indications for Use

Indicated for closure of the sternum following sternotomy or sternal fracture to stabilize the sternum and promote fusion.

Regulatory Classification

Identification

A bone fixation cerclage is a device intended to be implanted that is made of alloys, such as cobalt-chromium-molybdenum, and that consists of a metallic ribbon or flat sheet or a wire. The device is wrapped around the shaft of a long bone, anchored to the bone with wire or screws, and used in the fixation of fractures.

Predicate Devices

• SONGER™ Cable System (K922952, K935481, K941213)

Submission Summary (Full Text)

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### NOV 23 1999

#### SPECIAL 510(k) DEVICE SUMMARY VI.

## Pioneer Surgical Technology Special 510(k): Device Modification For Pioneer SilCoat Sternal Cable

#### ADMINISTRATIVE INFORMATION

| <b>Manufacturer Identification<br/>And Sponsor</b> | Pioneer Surgical Technology<br>375 River Park Circle<br>Marquette, Michigan 49855-1781<br>Telephone: [phone]<br>Facsimile: [phone] |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Official Contact</b> | Amy H. Mommaerts, Manager<br>Regulatory Affairs |

Date Prepared

September 30, 1999

#### MODIFIED DEVICE IDENTIFICATION

| Proprietary Name | Pioneer SilCoat Sternal Cable |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| Common Name | Cerclage, Bone Fixation |
| Classification Name<br>And Reference | Cerclage, Bone Fixation<br>Regulation Number: CFR 888.3010<br>Classification Number: 87JDQ II |
| Previously Cleared Device<br>Name and 510(k) Numbers | SONGER™ Cable System:<br>K922952; K935481; and K941213 |

#### Modified Device Description

The Pioneer SilCoat Sternal Cable System consists of cables and associated crimps. Each cable; has a central portion coated with silver, a monofilament wire is welded to one end of the cable with an attached needle. The cables will be offered with various types of needles, and in several cable lengths. A cylindrical crimp supplied with each cable is used to crimp the cable. The crimp and cable are made of similar biocompatible materials. The system will be double barrier sterile packaged in various quantities.

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#### Intended Use

The Pioneer SilCoat Sternal Cable System is intended for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the sternum to promote fusion.

#### Technological Characteristic Compared to Previously Cleared Device

Pioneer Surgical Technology considers the SilCoat cable to be substantially equivalent in function, design, and use to the Songer™ Sternal Cable System without the silver coating.

#### Performance Data

Static tests comparing the Songer™ Sternal Cable System with the Pioneer SilCoat cable system show they are similar. An ANOVA of the yield load with an α=0.01, P-value=0.017 shows no difference. Fatigue life curves show the SilCoat cable to be equivalent to the non-coated cable construct.

Pioneer Surgical Technology makes no claim in regard to the silver coated cables effect on reducing infection. No clinical studies have been performed to make any such claims.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 1999

Ms. Amy H. Mommaerts Manager, Regulatory Affairs Pioneer Surgical Technology 375 River Park Circle Marquette, Michigan 49855-0627

K993286 Re: Pioneer SilCoat Sternal Cable Trade Name: Regulatory Class: II Product Code: JDQ Dated: November 10, 1999 November 12, 1999 Received:

Dear Ms. Mommaerts:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. ਬ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Amy H. Mommaerts

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Neil R.P. Ogden for
James F. Dillard III

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Pioneer Surgical Technology

# Indications for Use For Pioneer SilCoat Sternal Cable System

The Pioneer SilCoat Sternal Cable is indicated for use in closure of the sternum after sternotomy or fracture of the sternum stabilizing the stemum to promote fusion.

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Pioneer Surgical Technology