(84 days)
Not Found
No
The 510(k) summary describes a mechanical device for delivering bone graft material and does not mention any software, algorithms, or AI/ML capabilities.
No.
The device is intended for delivery and mixing of bone graft materials, not for direct therapeutic treatment itself.
No
The device is described as a "Graft Delivery System" intended for delivering bone graft materials to a surgical site and facilitating premixing of these materials. Its components include a syringe, applicator, and connectors. There is no mention of it being used to identify or analyze medical conditions or diseases.
No
The device description explicitly lists physical components like a syringe barrel, end cap, plunger, and funnel, indicating it is a hardware device.
Based on the provided information, the FibriJet® Graft Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site." It also facilitates the mixing of bone graft materials with fluids. This is a surgical delivery system, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details components like a syringe barrel, plunger, and applicators, consistent with a delivery system for surgical materials.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the FibriJet® Graft Delivery System falls under the category of a surgical device for delivering bone graft materials, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Product codes
FMF
Device Description
The FibriJet® Graft Delivery System consists of the Graft Delivery Device, a dual liquid applicator, a blending connector and cups and lids. The Graft Delivery Device itself consists of a syringe barrel, end cap, plunger and funnel.
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)
Not Found
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
JUN - 9 2010
510(k) SUMMARY
FIBRIJET® GRAFT DELIVERY SYSTEM
| SUBMITTED BY: | |
|---|---|
| ---------------------- | -- |
Micromedics, Inc. 1270 Eagan Industrial Road St.Paul, MN 55121-1385
CONTACT PERSON:
TELEPHONE: FAX:
Tom Lopac, Manager of Quality & Regulatory Affairs tlopac@micromedics.com 651-452-1977 651-452-1787
DATE PREPARED:
March 15, 2010
TRADE NAME:
FibriJet® Graft Delivery System
COMMON NAME: PRO CODE:
Piston Syringe FMF
SUBSTANTIALLY EQUIVALENT PREDICATE DEVICES:
Curved Delivery Option & Graft Preparation System (Biomet Biologics, Warsaw, IN) K072330 Harvest Graft Delivery System (Harvest Technologies Corp., Plymouth, MA) K043261
DEVICE DESCRIPTION:
The FibriJet® Graft Delivery System consists of the Graft Delivery Device, a dual liquid applicator, a blending connector and cups and lids. The Graft Delivery Device itself consists of a syringe barrel, end cap, plunger and funnel.
INDICATIONS FOR USE:
FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
TECHNOLOGICAL CHARACTERISTICS:
The FibriJet® Graft Delivery System has the same technological characteristics and is similar in overall design, materials and configuration compared to the predicate devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN - 9 2010
Micromedics, Inc. % Mr. Tom Lopac Quality Manager 1270 Eagan Industrial Road Saint Paul, Minnesota 55121-1385
Re: K100754
Trade/Device Name: FibriJet® Graft Delivery Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: June 2, 2010 Received: June 3, 2010
Dear Mr. Lopac:
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. Iisting 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
.
2
Page 2 - Mr. Tom Lopac
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.
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/ReportalProblem/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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
urs,
elkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
Device Name: FibriJet® Graft Delivery Syringe
Indications for Use:
FibriJet® Graft Delivery System is intended for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site. In addition, it is designed to facilitate the premixing of bone graft materials with fluids such as I.V. fluids, blood, plasma concentrate, platelet rich plasma, bone marrow or other specified blood components deemed necessary by the clinical use requirements.
Prescription Use: X (Per 21 CFT 801.109)
Over-The-Counter
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden for mxm.
(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number Page 5-1