SMITH & NEPHEW GRAFT DELIVERY SYSTEM

K041976 · Smith & Nephew, Inc. · FMF · Aug 23, 2004 · General Hospital

Device Facts

• Record ID: K041976
• Device Name: SMITH & NEPHEW GRAFT DELIVERY SYSTEM
• Applicant: Smith & Nephew, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Aug 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Indications for Use

The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Device Story

System comprises manifold, manifold housing, graft chamber, and accessory syringes. Used to pre-mix bone graft materials with fluids (I.V. fluids, blood, plasma, bone marrow) and deliver the mixture to orthopedic surgical sites. Operated by clinicians in surgical settings. Manual operation; facilitates graft preparation and delivery; improves convenience and consistency of graft application.

Clinical Evidence

Bench testing only; data indicates device performs as an effective mixing device for bone grafting and fluid components.

Technological Characteristics

Manual piston syringe system (21 CFR 880.5860). Components include manifold, manifold housing, graft chamber, and accessory syringes. Mechanical mixing and delivery principle.

Indications for Use

Indicated for delivery of allograft, autograft, or synthetic bone graft materials to orthopedic surgical sites; facilitates pre-mixing of graft materials with fluids including I.V. fluids, blood, plasma, platelet-rich plasma, or bone marrow.

Regulatory Classification

Identification

A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.

Submission Summary (Full Text)

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AUG 2 3 2004

# Summary of Safety and Effectiveness Smith & Nephew, Inc. Graft Delivery System

## Contact Person and Address

Kim Kelly Project Manager, Clinical and Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 East Brooks Road Memphis, TN 38116 [phone]

#### Device Description

The Smith & Nephew Graft Delivery System is used to conveniently pre-mix desired fluid components and bone graft materials, with delivery of the resultant mixture to an orthopedic surgical site. The system contains several components including a manifold, manifold housing, graft chamber, and accessory syringes.

### Device Classification Name

21 CFR 880.5860 Piston Syringe, Class II

#### Indications for Use

The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

#### Test Data

A review of the test data indicated that the Smith & Nephew Graft Delivery System will perform as intended as an effective mixing device for bone grafting and desired fluid components.

#### Substantial Equivalence Information

The substantial equivalence of the Smith & Nephew Graft Delivery System is substantiated by its similarities in design features, principal of operation, indications for use, and material composition as existing graft delivery components and syringes distributed by other competitive predicate systems.

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Public Health Service

AUG 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kun P. Kelly Project Manager. Regulatory and Clinical Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K041976

Trade/Device Name: Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 19, 2004 Received: july 22, 2004

Dear Ms. Kelly:

We have reviewed your Section 510(k) premarket notification of intent to market the device w on a re row 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 for use stated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conniner of provised in accordance with the provisions of the Federal Food. Drug, de reces mar na re over 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. Iisting 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 ( FR 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. Kim P. Kelly

This letter will allow you to begin marketing your device as described in your Section 510(k) prematics 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 vou 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 other general miternational 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,

Miriam C. Provost

tal 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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# Smith & Nephew Graft Delivery System Indications Statement

The Smith & Nephew Graft Delivery System is intended for the delivery of allograft and autograft or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with I.V. fluids, blood, playma, platelet rich plasma, bone marrow or other specified blood components as deemed necessary by the clinical use requirements.

Prescription Use X (Per 21 CFR 801, Subpart D)

OR

Over-The Counter Use (Per 21 CFR 807, Subpart C)

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

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Concurrence of CDRH, Office of Device Evaluation

Miriam C. Proust

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________