(52 days)
No
The description details a standard syringe for aspiration and delivery of bone graft substitute, with no mention of AI/ML capabilities or data processing.
No
The device is a syringe used for aspiration and expulsion of fluids and bone graft substitutes, but it does not directly treat or diagnose a disease or condition; it is an instrument used in a procedure.
No
The intended use describes the device for the aspiration of fluids and for holding bone graft substitute, which are interventional/therapeutic applications, not diagnostic ones.
No
The device description clearly describes a physical syringe with a barrel, plunger, and end cap, which are hardware components.
Based on the provided information, the TruGraft™ BGS Syringe is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the aspiration of fluids (like blood, plasma) and preloaded bone graft substitute. This is a procedure performed in vivo (within the body) for therapeutic or surgical purposes, not for diagnostic testing of samples in vitro (outside the body).
- Device Description: The description details a standard syringe used for handling and delivering materials, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples for diagnostic purposes. It's a tool for handling and delivering materials during a medical procedure.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TruGraft™ BGS Syringe's function falls outside this definition.
N/A
Intended Use / Indications for Use
The TruGraft™ BGS Syringe is intended for use as a piston syringe for the aspiration of fluids, such as autologous blood, plasma or other blood components. The TruGrafi™ Syringe provides the surgeon with a convenient way to mix autologous blood with the PolyGraft® BGS. PolyGraft® TCP or other bone graft substitute and deliver the material to the orthopaedic surgical site. PolyGraft® BGS and PolyGrafi® TCP are intended to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft® material is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.
Product codes
MQV, FMF
Device Description
The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.
The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
the skeletal system (i.e., the extremities, spine and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeon
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)
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
JAN - 7 2005
510 (k) SUMMARY
| Submitter | Contact |
|---|---|
| Gabriele G. Niederauer, Ph.D. | |
| OsteoBiologics, Inc. | Director of Research and Development |
| 12500 Network, Suite 112 | Phone: 210-690-2131 (ext. 228) |
| San Antonio, Texas 78249, USA | Fax: 210-690-2559 |
| E-mail: gabi@obi.com |
| Date of Summary: | November 15, 2004 |
|---|---|
| Common Name: | Kit: Bone Void Filler and Bone Graft Delivery |
| Syringe | |
| Proprietary Name: | TruGraft™ BGS Syringe |
| Device Classification: | Filler, Calcium Sulfate Preformed Pellets (Product |
| Code MQV) is a Class II device, per 21 CFR | |
| 888.3045 |
510(k) Number:
Description of Device: The TruGraft™ BGS Syringe is a device that can be filled with OsteoBiologics, Inc. products: PolyGraft® BGS or PolyGraft® TCP (K030288 and K033707 respectively) or other bone graft substitute. The TruGrafTM BGS Syringe can be provided as a kit configuration. The convenience kit provides the TruGrafTM BGS Syringe loaded (filled) with a variety of bone graft substitutes.
The TruGrafi™ BGS Syringe is a standard piston syringe that consists of a barrel, plunger and removable end cap. The distal end of the barrel is threaded to allow connection to adapters. While without the attachment, the open end allows for filling of the bone graft material. A cap is available to seal the end of the barrel, enclosing the syringe contents. The piston/plunger assembly is used to expel contents or facilitate in the collection into the barrel of the syringe.
Intended Use: The TruGraft™ BGS Syringe is intended for use as a piston syringe for the aspiration of fluids, such as autologous blood, plasma or other blood components. The TruGrafi™ Syringe provides the surgeon with a convenient way to mix autologous blood with the PolyGraft® BGS. PolyGraft® TCP or other bone graft substitute and deliver the material to the orthopaedic surgical site. PolyGraft® BGS and PolyGrafi® TCP are intended to be used to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stability of the bony structure. The PolyGraft® material is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Substantial Equivalence: The TruGrafi™ BGS Syringe is substantially equivalent in design, function, and performance to the Imbibe™ Bone Marrow Aspiration Syringe [K011087] on Sep 19, 2001, IMBIBETM II Syringe [K030208] and Vitoss®-Filled Cartridge [K032130].
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
JAN - 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Gabriele G. Niederauer, Ph.D. Director of Research and Development OsteoBiologics, Inc. 12500 Network, Suite 112 San Antonio, Texas 78249
Re: K043172
Trade/Device Name: TruGraft™ BGS Syringe Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: II Product Code: MQV, FMF Dated: November 15, 2004 Received: November 26, 2004
Dear Dr. Niederauer:
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 - Gabriele G. Niederauer, Ph.D.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mo loter with action. The FDA finding of substantial equivalence of your device to a legally premaince noticated 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) 276-0120. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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
2.4 Indications for Use (Form)
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: TruGrafi™ BGS Syringe
Indications For Use:
TruGraft™ BGS Syringe is indicated for the aspiration of fluids, such as autologous blood, plasma or other blood components with preloaded bone graft substitute.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K043172
510(k) Premarket Notification: TruGraft™ BGS Syringe