(21 days)
Not Found
No
The summary describes a mechanical system for delivering bone graft materials and does not mention any AI or ML components or functionalities.
No
The device is described as a "Graft Delivery System" indicated for "delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site." Its function is to deliver materials, not to treat a disease or condition itself.
No
Explanation: The device is described as a "Graft Delivery System" indicated for the "delivery of allograft, autograft, or synthetic bone graft materials" and for "facilitating pre-mixing of bone graft materials." This describes a device used for therapeutic delivery and preparation of materials, not for diagnosing a condition or disease.
No
The device description and intended use clearly describe a "Graft Delivery System" which is a physical device used to deliver bone graft materials. There is no mention of software as the primary or sole component.
Based on the provided information, the Symphony Graft Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of bone graft materials to an orthopedic surgical site and for facilitating pre-mixing of these materials. This is a surgical device used in vivo (within the body) during a procedure.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. The Symphony Graft Delivery System does not perform any such tests.
- Device Description: While the description is "Not Found," the intended use clearly places it as a surgical tool, not a diagnostic test.
- Other Sections: The lack of information on image processing, AI/ML, imaging modality, performance metrics like sensitivity/specificity, and training/test sets further supports that this is not a diagnostic device.
The device is a tool used in orthopedic surgery to handle and deliver bone graft materials, which is a therapeutic or reconstructive purpose, not a diagnostic one.
N/A
Intended Use / Indications for 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.
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.
Product codes
FMF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopedic surgical site
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All medical grade materials have undergone biocompatibility testing in accordance with US Pharmacopoeia XXII Class VI guidelines.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).
0
:
X. 510 (k) Summary
| SUBMITTER: | DePuy AcroMed, Inc.
325 Paramount Drive
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
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. | |
| MATERIALS: | Acetal Copolymer, 17-4 Stainless Steel, Polycarbonate | |
| PERFORMANCE
DATA: | All medical grade materials have undergone
biocompatibility testing in accordance with US
Pharmacopoeia XXII Class VI guidelines. | |
1
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.
2
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 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
3
Indications for Use III.
| 510(k) Number (if known): | K022246 |
|---|---|
| --------------------------- | --------- |
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.
(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) | X | OR Over-The-Counter |
|---|---|---|
| ------------------------------------------------ | -------------------------------------------------------- | --------------------- |
for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
| 510(k) Number | K022246 |
|---|---|
| --------------- | --------- |