(23 days)
No
The 510(k) summary describes a mechanical syringe for fluid aspiration and delivery, with no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is described as a piston syringe for aspirating and delivering fluids or graft materials, which are procedural tools rather than devices directly providing therapy.
No
Explanation: The device is described as a piston syringe for aspirating and re-injecting fluids/graft materials. It is not used to identify or analyze a condition, disease, or its components.
No
The device description clearly states it is a "Bone Graft Syringe," which is a physical medical device used for aspiration and delivery of fluids and materials. 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:
- Intended Use: The intended use clearly states the device is for "aspiration of bone marrow, autologous blood, plasma, or other body fluids" and for "mix[ing] bone graft materials with aspirated fluids and deliver[ing] the composite graft material to the orthopedic surgical site." This describes a device used for collecting and delivering substances within the body or for preparing materials for use in the body.
- Device Description: The description reinforces this by stating it's used for "withdrawing body fluids and re-injecting the fluids and/or composite graft materials into the body."
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples outside the body to diagnose, monitor, or screen for diseases or conditions. IVDs typically involve reagents, test strips, analyzers, or other components used for in vitro testing.
Therefore, the Bone Graft Syringe, as described, is a medical device used for surgical procedures involving the collection and delivery of biological materials, not for in vitro diagnostic testing.
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
Additional sizes of the previously cleared Bone Graft Syringe (510(k): K023088) are being added to the current product offering. The syringe can be used for withdrawing body fluids and re-injecting 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 (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
AUG 23 2006
K062173
Image /page/0/Picture/1 description: The image shows the word "WRIGHT." in a bold, sans-serif font. Below the word is a graphic of three horizontal lines that are angled downwards and slightly overlap each other. The lines appear to be thicker on the left side and taper off towards the right. There is a small "TM" symbol in the bottom right corner of the graphic.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the Food and Drug Administration Rule to implement provisions of the Safe m accordance with and 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: | July 27, 2006 |
| Contact Person: | Wesley L. Reed |
| Regulatory Affairs Specialist II | |
| 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 Code: | 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
Additional sizes of the previously cleared Bone Graft Syringe (510(k): K023088) are being added to the current product offering. The syringe can be used for withdrawing body fluids and re-injecting 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 the same as the predicate devices previously cleared for market. The safety and effectiveness of the Bone Graft Syringe is adequately supported by the substantial equivalence information provided within the Premarket Notification.
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1
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2006
Wright Medical Technology, Inc. % Mr. Wesley L. Reed Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002
Re: K062173
Trade/Device Name: Bone Graft Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: July 27, 2006 Received: June 31, 2006
Dear Mr. Reed:
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.
2
Page 2 - Mr. Wesley L. Reed
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for Pato Mz
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kob2473
Indications for Use
510(k) Number (if known):
Device Name: Bone Graft Syringe
Indications For Use:
The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone w 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
1 of 1
(Division Sign-Division of General, Restorative and Neurological Devices
510(k) Number /K062173