CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM

K072330 · Biomet, Inc. · FMF · Dec 6, 2007 · General Hospital

Device Facts

• Record ID: K072330
• Device Name: CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
• Applicant: Biomet, Inc.
• Product Code: FMF · General Hospital
• Decision Date: Dec 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

CDO™ System The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements. Graft Preparation System The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

Device Story

CDO™ System and Graft Preparation System are manual orthopedic delivery tools. CDO™ System comprises curved delivery cannula, modified syringe, flexible plunger, and optional adaptor tip. Graft Preparation System comprises modified syringe with check valve, plunger, nozzle cap, and end cap. Devices facilitate manual mixing and delivery of bone graft materials (allograft, autograft, synthetic) combined with biological fluids (blood, plasma, bone marrow) to surgical sites. Operated by clinicians in orthopedic surgical settings. Devices function as mechanical piston syringes to dispense graft material. No electronic or automated components.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing.

Technological Characteristics

Manual piston syringe systems. Components include cannula, syringe, plunger, check valve, and caps. Materials and processing methods are consistent with predicate devices. No energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. Facilitates pre-mixing of graft material with I.V. fluids, blood, plasma concentrate, 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.

Predicate Devices

• IMBIBE II Syringe (K030208)
• Symphony Graft Delivery System (K022246)
• Graft Delivery System (K021071)

Submission Summary (Full Text)

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072330

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Image /page/0/Picture/2 description: The image shows the logo for Biomet Biologics, Inc. The logo is in black and white and features the company name in a bold, sans-serif font. The word "BIOMET" is stacked on top of the words "BIOLOGICS, INC." The logo has a simple and modern design.

November 30, 2007

Biomet Biologics, Inc. Applicant/Sponsor:

DEC 0 6 2007

Paula Deming, RN, BSN Contact Person:

Curved Delivery Option (CDO™ System) & Graft Preparation System Proprietary Name:

Common Name: Piston Syringe

Classification Name: FMF (21 CRF 880.5860)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: CDO™ System

IMBIBE II Syringe (Orthovia, Inc., Malvern, PA) K030208 K022246 Symphony Graft Delivery System (DePuy AcroMed, Raynham, MA)

Graft Preparation System

Graft Delivery System (Biomet Biologics, Inc., Warsaw, IN) K021071

# Device Description:

CDO™ System

The CDO™ System consists of a curved delivery cannula, a modified syringe, a flexible plunger and an optional syringe adaptor tip.

# Graft Preparation System

The Graft Preparation System consists of a modified syringe with a check valve, plunger, nozzle cap and end cap.

#### Indications for Use:

CDO™ System

The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

### Graft Preparation System

The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate premixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

Summary of Technologies: The overall designs, materials and processing methods are similar to the predicate devices to which substantial equivalence is claimed for both the CDO™ and Graft Preparation Systems.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the devices were functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

Biomet® and CDO™ trademarks herein are the property of Biomet, Inc., or its subsidiaries.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the circle.

Public Health Service

DEC 0 6 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet Biologics, Inc. % Paula Deming Regulatory Specialist PO Box 587 Warsaw, Indiana 46581

Re: K072330

Trade/Device Name: Curved Delivery Option (CDO™) and Graft Preparation System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 30, 2007 Received: December 03, 2007

Dear Ms. Paula Deming:

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. Paula Deming

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 Millican

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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# Indications for Use

510(k) Number (if known): K072330

Device Name: Curved Delivery Option (CDO™ System) and Graft Preparation System

Indications For Use:

CDO™ System

The CDO™ System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, platelet-rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

### Graft Preparation System

The Graft Preparation System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft material with I.V. fluids, blood, plasma concentrate, plateletrich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.

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

Over-The-Counter Use NO (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)

Barbara Buell
Division Sign Off

al. Restorative. and Neurological Devices

510(k) Number_KO72330