ARTHREX MIXING AND DELIVERY SYSTEM

K121124 · Arthrex, Inc. · FMF · May 16, 2012 · General Hospital

Device Facts

• Record ID: K121124
• Device Name: ARTHREX MIXING AND DELIVERY SYSTEM
• Applicant: Arthrex, Inc.
• Product Code: FMF · General Hospital
• Decision Date: May 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended Use

The Arthrex Mixing and Delivery System, like the predicates, is intended to provide the surgeons with a means to mix and deliver graft material to an orthopedic surgical site. Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Device Story

System comprises piston syringe (3mL or 14mL), movable plunger, cap, straight/curved (tuohy) delivery needles, mating obturator, luer connectors, and funnel. Used in orthopedic surgical sites by surgeons to mix and deliver bone graft materials (allograft, autograft, synthetic) with fluids (blood, plasma, bone marrow). Funnel facilitates syringe barrel filling; plunger/syringe mechanism enables manual mixing and delivery. Provided empty or pre-filled. Device simplifies graft preparation and application, potentially improving surgical efficiency and graft placement accuracy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Piston syringe system; 3mL or 14mL barrel volumes; includes needles, obturator, luer connectors, and funnel. Manual operation. Biocompatible materials. No software or electronic components.

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 I.V. fluids, blood, plasma, platelet-rich plasma, bone marrow, or other blood components as required by clinical needs.

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

• Medtronic Graft Delivery Syringe (K062986)
• DePuy Symphony Graft Delivery System (K012738)
• Arthrex Aspirate Kit (K062365)

Submission Summary (Full Text)

{0}------------------------------------------------

Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System

# 3 510(k) Summary of Safety and Effectiveness

| Date Summary Prepared | April 11, 2012 |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA |
| 510(k) Contact | Christina Flores<br>Regulatory Affairs Specialist<br>Arthrex, Inc.<br>1370 Creekside Boulevard<br>Naples, FL 34108-1945 USA<br>Telephone: [phone], ext. 1819<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name | Arthrex Mixing and Delivery System |
| Common Name | Piston Syringe |
| Product Code -Classification<br>Name<br>CFR | Syringe, Piston<br>FMF<br>21 CFR 880.5860 |
| Predicate Device | K062986 Medtronic Graft Delivery Syringe<br>K012738, DePuy Symphony Graft Delivery System<br>K062365 Arthrex Aspirate Kit |
| Purpose of Submission | This Traditional 510(k) premarket notification is<br>submitted to obtain clearance for the Arthrex Mixing and<br>Delivery System. |
| Device Description and Intended<br>Use | The Arthrex Mixing and Delivery System consists of a<br>piston syringe with a movable plunger and cap to facilitate<br>mixing and delivery; straight and curved (tuohy) delivery<br>needles; a mating obturator for delivery needles; luer<br>connectors; and a funnel to facilitate filling of the syringe<br>barrel. The system will be offered with either a 3mL or 14<br>mL syringe barrel and may be provided either empty or<br>pre-filled with allograft, autograft, or synthetic bone graft<br>materials.<br>The Arthrex Mixing and Delivery System, like the<br>predicates, is intended to provide the surgeons with a<br>means to mix and deliver graft material to an orthopedic<br>surgical site. |
| | Arthrex Mixing and Delivery System is indicated for the<br>delivery of allograft, autograft, or synthetic bone graft<br>materials to all orthopedic surgical sites. In addition, it is<br>designed to facilitate pre-mixing of allograft, autograft, or<br>synthetic bone graft materials with I.V. fluids, blood,<br>plasma, platelet rich plasma, bone marrow or other specific<br>blood component(s) as deemed necessary by the clinical<br>use requirements. |
| Substantial Equivalence<br>Summary | The Arthrex Mixing and Delivery System is substantially<br>equivalent to the predicate devices, in which the basic<br>features and intended uses are the same. Any differences<br>between the Arthrex Mixing and Delivery System and the<br>predicates are considered minor and do not raise questions<br>concerning safety and effectiveness.<br>Based on the biocompatibility and mechanical testing<br>performed, Arthrex, Inc. has determined that the Arthrex<br>Mixing and Delivery System is substantially equivalent to the marketed predicate devices. |

Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • - Arthrex Hier - 1970 - 210cables - Fax: [phone] • website: www.arthrex.com

{1}------------------------------------------------

Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System

Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: [phone] or 239-643-5553 • Fax: [phone] • website: www.arthrex.com

{2}------------------------------------------------

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108

MAY 1 6 2012

Re: K121124

Trade/Device Name: Arthrex Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 7, 2012 Received: May 8, 2012

Dear Ms. Flores:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

{3}------------------------------------------------

### Page 2 - Ms. Christina Flores

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson Director .

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System

# 2 Indications for Use Form

510(k) Number:

Device Name:

Arthrex Mixing and Delivery System

The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.

Prescription Use_X_AND/OR Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

l of 1

Neil R. Orden for mxm

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K121124

Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: [phone] or 239-643-5553 • Fax: [phone] • website: www.arthrex.com

5