MEDTRONIC GRAFT DELIVERY SYRINGE

K062986 · Medtronic Sofamor Danek USA, Inc. · FMF · Dec 8, 2006 · General Hospital

Device Facts

• Record ID: K062986
• Device Name: MEDTRONIC GRAFT DELIVERY SYRINGE
• Applicant: Medtronic Sofamor Danek USA, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.

Device Story

Manual piston syringe used by surgeons in orthopaedic surgical settings. Device functions as a mixing and delivery tool for bone graft materials; allows combination of autologous blood or bone marrow with graft substrates (allograft, autograft, demineralized bone, or synthetic). Surgeon manually operates syringe to dispense material directly into surgical site. Facilitates graft placement; improves handling of graft materials during orthopaedic procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Piston syringe design; manual operation; non-powered. Materials and dimensions consistent with predicate piston syringes. Class II device under 21 CFR 880.5860.

Indications for Use

Indicated for use by surgeons to mix autologous blood or bone marrow with bone graft materials (allograft, autograft, demineralized bone, or synthetic) and deliver the mixture to orthopaedic surgical sites.

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.

Predicate Devices

• Harvest Technologies Corp.'s Harvest Graft Delivery System (K043261)
• Depuy's Symphony Graft Delivery System (K003286)
• Imbibe Piston Syringe (K011087)
• Imbibe Bone Marrow Aspiration Syringe (K023074)
• Imbibe II Piston Syringe (K030208)

Submission Summary (Full Text)

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# Medtronic Graft Delivery Syringe 510(K) Summary - K062986 December 2006

DEC - 8 2006

- I. Company: Medtronic USA, Inc. 1800 Pyramid Place Memphis, TN 38132
Contact: Christine Scifert Group Director, Regulatory Affairs [phone]

- II. Proposed Proprietary Trade Name: Medtronic Graft Delivery Syringe Classification Name: Piston Syringe Product Code: FMF Regulation No .: 880.5860
#### III. Product Description/Purpose of Application

The purpose of this application is to notify the FDA of our intent to market the Medtronic Graft Delivery Syringe as a means to deliver graft material to an orthopedic surgical site.

#### IV. Indications

The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, autograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.

#### V. Substantial Equivalence

Documentation was provided which demonstrated the Medtronic Graft Delivery Syringe to be substantially equivalent to previously cleared graft delivery systems such as Harvest Technologies Corp.'s Harvest Graft Delivery System, (K043261, SE 03/11/05), Depuy's Symphony Graft Delivery System, K003286 (01/18/01), the Imbibe Piston Syringe (K011087, SE 09/19/01), the Imbibe Bone Marrow Aspiration Syringe (K023074, SE 03/11/03) and the Imbibe II Piston Syringe, (K030208, SE 04/16/03).

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Public Health Service

Image /page/1/Picture/12 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic Sofamor Danek % Mr. Lee Grant Supervisor, Regulatory Affairs 1800 Pyramid Place Memphis, Tennessee 38132

DEC - 8 2006

Re: K062986

Trade/Device Name: Medtronic Graft Delivery Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: November 10, 2006 Received: November 13, 2006

Dear Mr. Grant:

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 - Mr. Lee Grant

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,

Mark N. Melkerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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December - 2006

## 510(k) Number (if known): K062986

### Medtronic Graft Delivery Syringe Device Name:

Indications for Use: The Medtronic Graft Delivery Syringe is intended to provide the surgeon with a means to mix autologous blood or bone marrow with allograft, demineralized bone, or synthetic bone graft materials and to deliver these materials to all orthopaedic surgical sites.

Prescription Use ---------x (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number_