(135 days)
Not Found
No
The device description details a purely mechanical system for delivering bone graft material. There is no mention of software, data processing, or any components that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also explicitly marked as "Not Found".
No
The device is described as a delivery system for bone graft material to an orthopedic surgical site, not a device that itself provides therapy.
No
The device is a delivery system for bone graft material and does not gather or analyze data for diagnostic purposes.
No
The device description clearly outlines multiple physical components made of various materials (graft tube, plunger, handle, end cap, loading device, etc.) and mentions sterilization via gamma irradiation, indicating it is a hardware-based medical device. There is no mention of software as a component or function.
Based on the provided information, the Graftgun Universal Graft Delivery System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." This describes a surgical tool used to physically place material within the body.
- Device Description: The description details a mechanical system for dispensing material. It does not mention any components or functions related to testing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Graftgun does not perform any such analysis.
- Anatomical Site: The device is used at an "orthopedic surgical site," which is a location within the body, not a laboratory setting for analyzing samples.
The Graftgun is a surgical delivery system, not a diagnostic device.
N/A
Intended Use / Indications for Use
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material.
The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site.
Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer.
The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
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
Bone graft application to an orthopedic surgical site in an operating room environment.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 19, 2017
SurGenTec. LLC Mr. Travis Greenhalgh CEO 7601 N Federal Highwav # 150B Boca Raton, Florida 33487
Re: K170675
Trade/Device Name: Graftgun Universal Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: March 3, 2017 Received: March 6, 2017
Dear Mr. Greenhalgh:
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 Actinclude requirements for annual registration, listing 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
1
related adverse events) (21 CFR 803): 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170675
Device Name
Graftgun Universal Graft Delivery System
Indications for Use (Describe)
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
Type of Use (Select one or both, as applicable)
IX Prescription Use (Part 21 CFR 801 Subpart D)
D Over-The-Counter Use (21 CFR 801 Subpart C)
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CONFIDENTIAL
3
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Image /page/3/Picture/1 description: The image contains the Surgentec logo, which features a stylized blue and gray symbol on the left, followed by the word "SURGENTEC" in a bold, sans-serif font. Above and to the right of the logo, the text "K170675" is displayed. A registered trademark symbol is located to the right of the word "SURGENTEC".
7601 N Federal Highway #150B Boca Raton, FL 33487 P:916-759-7999 E: Customerservice@SurGenTec.com www.SurGenTec.com
Premarket Notification 510(k) Summary Graftgun Universal Graft Delivery System
1. Submitter Information:
| Owner: | SurGenTec, LLC |
|---|---|
| Address: | 7601 N Federal Hwy # 150B |
| Boca Raton, FL 33487 | |
| Contact: | Travis Greenhalgh, CEO |
| Telephone: | (916) 759-7999 |
| Email: | travis@SurGenTec.com |
| Date Submitted: | March 3, 2017 |
2. Name of Device:
| Trade Name: | Graftgun Universal Graft Delivery System |
|---|---|
| Common Name: | Graft Delivery Device |
| Regulation Number: | 21 CFR 880.5860 |
| Regulation Name: | Syringe, Piston |
| Regulatory Class: | Class II |
| Product Code: | FMF |
| Proposed Panel: | General Hospital |
3. Legally Marketed Predicate Device:
| Predicate #1: | K161568 - Bone Solutions Mixing and Delivery System
[Bone Solutions, Inc.; cleared 09/16/2016] |
|---------------|----------------------------------------------------------------------------------------------------------|
| Predicate #2: | K142661 - Bi-Portal Bone Graft Delivery System
[Spinal Surgeries Strategies, LLC; cleared 12/11/2014] |
4. Device Description
The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable device intended for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
The device system consists of: a graft tube for containing and delivering the desired graft material to the surgical site; a plunger to express the graft material from the graft tube; an actuating handle to advance the plunger down the length of the graft tube via a ratcheting mechanism; and an end cap to retain the graft material in the graft tube until ready for use. The system also contains a syringe style loading device for loading the graft tube with graft material.
The system is designed such that the graft tube can be filled with the desired graft material, attached to the actuating handle and plunger for use, then removed and refilled or replaced with a new graft tube. The kit comprises two graft tubes. One
4
graft tube is capable of containing 5.0 cc of graft material and the second can contain up to 7.5 cc. Both graft tubes are marked with a graduated scale to measure the volume of graft placed. The graft tube does not have a Luer lock mechanism; the device does not require a needle or similar attachment, the graft tube contents being expressed directly from the tip of the graft tube into the graft site.
Components are made of one or more of the following materials: polycarbonate, polypropylene, self-lubricating silicone, stainless steel, acrylonitrile butadiene styrene, and silicone elastomer.
The device is packaged in a thermoformed tray with a Tyvek lid. Each tray is then packaged individually in a Tyvek-PE film pouch and an outer paperboard carton. The packaged device system is sterilized via gamma irradiation.
5. Indications for Use
The Graftgun Universal Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.
6. Technological Characteristics and Substantial Equivalence
The Graftgun Universal Graft Delivery System is substantially equivalent to the predicates, the devices having the same intended use and basic method of operation. The table below compares the indications and key technological attributes of the subject device to the predicates.
| Comparator | New Device
Graftgun System | Predicate #1
Bone Solutions
[K161568] | Predicate #2
Bi-Portal [K142611] |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code;
Common Name | FMF; Syringe, Piston (21 CFR 880.5860) | | |
| Indications for
Use | Intended to be used
for the delivery of
hydrated allograft,
autograft, or synthetic
bone graft material to
an orthopedic
surgical site. | Intended to be used for
the delivery of hydrated
allograft, autograft, or
synthetic bone graft
material to an
orthopedic surgical site. | Intended for the
delivery of hydrated
allograft or autograft to
an orthopedic surgical
site. |
| Intended Use | Bone graft application to an orthopedic surgical site in an operating room
environment | | |
| Mechanism of
Operation | Graft material
expressed from graft
tube via a plunger,
operated by a ratchet-
actuated handle.
Material expressed
from graft tube
directly to graft site. | Graft material
expressed from graft
tube via a plunger,
operated by either
thumb pressure or a
rotary assist drive.
Device requires
attachment to a Luer
compatible device for | Graft material
expressed from graft
tube via a plunger,
operated by thumb or
palm pressure. Material
expressed from graft
tube directly to graft
site. |
5
Graftgun Universal Graft Delivery System SurGenTec, LLC
| Comparator | New Device
Graftgun System | Predicate #1
Bone Solutions
[K161568] | Predicate #2
Bi-Portal [K142611] |
|------------------------------|-------------------------------------------------------|----------------------------------------------------|-----------------------------------------------|
| | | dispensing graft
material to the graft
site. | |
| Sterility | Sterile, single use
only; SAL 10-6; γ
radiation | Sterile, single use only;
SAL 10-6; EO gas | Sterile, single use only;
SAL 10-6; EO gas |
| Patient-Contact
Materials | Polypropylene,
polycarbonate | Polypropylene,
polycarbonate | Polypropylene |
| Volume | Up to 7.5ml in graft
tube | Up to 14.0 ml | Up to 4.0 ml in graft
tube |
7. Conclusion
The Graftgun Universal Graft Delivery System is substantially equivalent in intended use, principal of operation, and materials to the Bone Solutions Mixing and Delivery System and Bi-Portal Bone Graft Delivery System predicate devices. The difference in plunger actuation and method of sterilization are minor and do not raise any new safety or effectiveness issues for the Graftgun Universal Graft Delivery System for its intended indications.