(15 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a syringe for fluid aspiration and delivery, with no mention of AI or ML capabilities.
No
The description states the device is used for aspirating fluids, mixing them with bone graft materials, and delivering the composite to a surgical site. This is a delivery and mixing function, not a therapeutic treatment itself.
No
Explanation: The device is described as a syringe for aspirating and delivering fluids/graft materials. Its function is to facilitate the transport and mixing of substances, not to diagnose a condition or disease.
No
The device description clearly outlines a physical syringe with a barrel, plunger, and connector nozzle, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Intended Use: The Bone Graft Syringe is intended for the aspiration of body fluids and the delivery of those fluids (potentially mixed with bone graft material) back into the body at a surgical site. It is a tool for handling and delivering biological materials within the body, not for analyzing them outside the body to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical function of the syringe for aspiration and injection. There is no mention of any components or processes related to analyzing the composition or characteristics of the aspirated fluids for diagnostic purposes.
Therefore, the Bone Graft Syringe is a surgical instrument used for handling and delivering materials during a procedure, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.
Product codes
FMF
Device Description
The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids and reinjecting the fluids and/or composite graft materials into the body.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
OCT 02 2002
Image /page/0/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" made up of three thick, black, angled bars. To the right of the "W" is the text "WRIGHT MEDICAL TECHNOLOGY" stacked in three lines. The word "WRIGHT" is on the top line, "MEDICAL" is on the second line, and "TECHNOLOGY" is on the third line.
A Wright Medical Group Company 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of the Bone Graft Syringe.
| Submitted By: | Wright Medical Technology, Inc. |
|---|---|
| Date: | May 15, 2002 |
| Contact Person: | Roger D. Brown |
| Sr. Director, Clinical and Regulatory Affairs | |
| Proprietary Name: | Bone Graft Syringe |
| Common Name: | Piston Syringe |
| Classification Name and Reference: | 21 CFR 880.5860 Piston Syringe - Class II |
| Device Product Code and Panel: | FMF/General Hospital-80 |
DEVICE INFORMATION
A. INTENDED USE
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.
B. DEVICE DESCRIPTION
The syringe consists of a calibrated hollow barrel and a movable plunger. At the distal end of the syringe there is a male connector nozzle for fitting the female connector (hub) of a single lumen needle. The syringe can be used for withdrawing body fluids and reinjecting the fluids and/or composite graft materials into the body.
C. SUBSTANTIAL EQUIVALENCE INFORMATION
The intended use, materials, and design features of the Bone Graft Syringe are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of the Bone Graft Syringe are adequately supported by the substantial equivalence information provided within the Premarket Notification.
000017
1
Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized image of a bird or abstract human profile. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the image.
Public Health Service
OCT 02 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Wright Medical Technology, Inc. c/o Mr. Mark Job TÜV Product Service 1775 Old Highway 8 NW, Suite 104 New Brighton, MN 55112-1891
Re: K023088
Trade/Device Name: Bone Graft Syringe Regulation Number: 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: September 13, 2002 Received: September 17, 2002
Dear Mr. Job:
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 mav 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 - Mr. Mark Job
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,
At Rwd
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
K023 of
Image /page/3/Picture/1 description: The image shows the logo for Wright Medical Technology. The logo consists of a stylized "W" on the left, followed by the text "WRIGHT MEDICAL TECHNOLOGY" on the right. The text is stacked in three lines, with "WRIGHT" on the top line, "MEDICAL" on the second line, and "TECHNOLOGY" on the third line.
A Wright Medical Group Company
BONE GRAFT SYRINGE
INDICATIONS STATEMENT
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE: QN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per21 CFR 801.109) √
(Division Sign-Off) . Division of General Restorative Devices 510(k) Number
OR
Over-The Counter Use (Optional Format 1-2-96)
Atgt Rhode
(Division Sign-Off) Division of General, Restorative and Neurological Devices
KOLSO88 510(k) Number _