MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM

K022246 · Depuyacromed · FMF · Aug 2, 2002 · General Hospital

Device Facts

• Record ID: K022246
• Device Name: MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM
• Applicant: Depuyacromed
• Product Code: FMF · General Hospital
• Decision Date: Aug 2, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Symphony Graft Delivery System is indicated for the delivery of allograft, 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 specific blood component(s) as deemed necessary by the clinical use requirements.

Device Story

Symphony Graft Delivery System is a piston syringe device used in orthopedic surgery. It functions as a delivery tool for bone graft materials (allograft, autograft, or synthetic) and as a mixing chamber for graft materials combined with fluids (I.V. fluids, blood, plasma, platelet-rich plasma, or bone marrow). Operated by surgeons or clinical staff in an OR setting, the device allows for the preparation and controlled application of graft material to the surgical site. By facilitating consistent mixing and delivery, the device assists in the surgical placement of bone graft materials, potentially improving procedural efficiency and graft handling.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with US Pharmacopoeia XXII Class VI guidelines.

Technological Characteristics

Piston syringe design. Materials: Acetal Copolymer, 17-4 Stainless Steel, Polycarbonate. Biocompatibility: USP Class VI compliant. Manual operation; no energy source or software.

Indications for Use

Indicated for patients requiring delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. No specific age or gender restrictions noted.

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

• Symphony Graft Delivery System (K003286)
• Symphony Graft Delivery System (K010320)

Submission Summary (Full Text)

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K022246

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## X. 510 (k) Summary

| SUBMITTER: | DePuy AcroMed, Inc.<br>325 Paramount Drive<br>Raynham, MA 02767 | AUG 02 2002 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | July 11, 2002 | |
| CLASSIFICATION NAME: | Piston Syringe | |
| PROPRIETARY NAME: | Symphony Graft Delivery System (GDS) | |
| PREDICATE DEVICES: | Symphony Graft Delivery System (K003286, K010320) | |
| INTENDED USE: | The Symphony Graft Delivery System is indicated for the<br>delivery of allograft, autograft, or synthetic bone graft<br>materials to an orthopedic surgical site. In addition, it is<br>designed to facilitate pre-mixing of bone graft materials<br>with I.V. fluids, blood, plasma, platelet rich plasma, bone<br>marrow or other specific blood component(s) as deemed<br>necessary by the clinical use requirements. | |
| MATERIALS: | Acetal Copolymer, 17-4 Stainless Steel, Polycarbonate | |
| PERFORMANCE<br>DATA: | All medical grade materials have undergone<br>biocompatibility testing in accordance with US<br>Pharmacopoeia XXII Class VI guidelines. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle or bird with three lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the image in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 2 2002

DePuy AcroMed Karen F. Jurczak 325 Paramount Drive Raynham, Massachusetts 02767

Re: K022246

Trade Name: Modification to Symphony Graft Delivery System Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: July 11, 2002 Received: July 12, 2002

Dear Ms. Jurczak:

We have reviewed your Section 510(k) premarket 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) 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. Karen F. Jurczak

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely vours.

Mark McMillan

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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## Indications for Use III.

| 510(k) Number (if known): | K022246 |
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Device Name: Symphony Graft Delivery System

Indications For Use:

The Symphony Graft Delivery System is indicated for the delivery of allograft, 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 specific blood component(s) as deemed necessary by the clinical use requirements.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: Use:<br>(Per 21 CFR 801.109) | <div style="display:flex; align-items:center;">X</div> | OR Over-The-Counter |
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for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

| 510(k) Number | K022246 |
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