(90 days)
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.
The Symphony Graft Delivery System Syringe is designed specifically to collect, mix and deliver bone graft materials to a surgical site. The Graft Chamber component of the Symphony GDS can be provided either empty or pre-filled with human allograft
The provided text describes the 510(k) summary for the Symphony Graft Delivery System (K012738), which is a device intended for the delivery of bone graft materials. However, the document does not contain information about acceptance criteria, device performance metrics, or any study involving human readers or ground truth establishment.
The "PERFORMANCE DATA" section only states that the resins used for the device components meet biocompatibility requirements (Tripartite Biocompatibility Guidance for Medical Devices, Pharmacopeia XXII, Class VI, and FDA modified ISO 10993-1 tests). This is a statement about material safety and biocompatibility, not about the performance of the device in its intended use (delivery of graft material).
Therefore, I cannot provide the requested information from the given text. The text does not describe a study that proves the device meets specific performance acceptance criteria related to its function of delivering bone graft materials.
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| VIII. 510(k) Summary | K012738 | |
|---|---|---|
| SUBMITTER: | DePuy AcroMed, Inc.325 Paramount DriveRaynham, MA 02780 | NOV 1 4 2001 |
| CONTACT PERSON: | Karen F. Jurczak | |
| DATE PREPARED: | August 15, 2001 | |
| CLASSIFICATION NAME: | Piston Syringe | |
| PROPRIETARY NAME: | Symphony Graft Delivery System | |
| PREDICATE DEVICES: | Symphony Graft Delivery System (K003286, K010320) | |
| INTENDED USE: | The Symphony Graft Delivery System is indicated for thedelivery of allograft, autograft, or synthetic bone graftmaterials to an orthopedic surgical site. In addition, it isdesigned to facilitate pre-mixing of bone graft materialswith I.V. fluids, blood, plasma, platelet rich plasma, bonemarrow or other specific blood component(s) as deemednecessary by the clinical use requirements. | |
| MATERIALS: | Medical grade polycarbonate resinMedical grade High Density Polyethylene | |
| PERFORMANCE DATA: | The resins, from which the components of the SymphonyGraft Delivery System are manufactured, meet therequirements set forth in the Tripartite BiocompatibilityGuidance for Medical Devices. This Guidance includestesting requirements for Pharmacopeia XXII, Class VI aswell as the FDA modified ISO 10993-1 tests forbiocompatibility for human body fluid contact of 30 days orless. | |
| DESIGN: | The Symphony Graft Delivery System Syringe is designedspecifically to collect, mix and deliver bone graft materialsto a surgical site. The Graft Chamber component of theSymphony GDS can be provided either empty or pre-filledwith human allograft |
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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 is a circular emblem with the department's name encircling an abstract symbol. The symbol resembles a stylized caduceus, featuring a staff with a serpent entwined around it, representing health and medicine. The logo is rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 4 2001
Ms. Karen F. Jurczak Regulatory Affairs Associate DePuy AcroMed, Inc. 325 Paramount Drive Raynham, Massachusetts 02767
Re: K012738
Trade/Device Name: Symphony Graft Delivery System (GDS) Regulation Number: 878.4820 Regulation Name: Surgical instrument motors and accessories/attachments Regulatory Class: I Product Code: GEY Dated: August 15, 2001 Received: August 16, 2001
Dear Ms. Jurczak:
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. 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
lo Mark n Mellum
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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IV. Indications for Use
| 510(k) Number (if known): | K012738 |
|---|---|
| --------------------------- | --------- |
| NOV 1 4 2001 | |
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| -- | -------------- |
Device Name: Symphony Graft Delivery System
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.
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use: Use:(Per 21 CFR 801.109) | OR Over-The-Counter |
|---|---|
| ------------------------------------------------ | --------------------- |
for (Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number: K012738
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.