Graftgun Universal Graft Delivery System

K180937 · SurGenTec, LLC · FMF · May 10, 2018 · General Hospital

Device Facts

• Record ID: K180937
• Device Name: Graftgun Universal Graft Delivery System
• Applicant: SurGenTec, LLC
• Product Code: FMF · General Hospital
• Decision Date: May 10, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

Intended 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.

Device Story

Graftgun Universal Graft Delivery System is a sterile, single-use, disposable piston-type syringe for delivering bone graft material to orthopedic surgical sites. System consists of a 5cc graft tube, plunger, actuating handle with ratcheting mechanism, and loading cap. Clinician squeezes trigger to advance plunger and express graft material. Radiopaque ring marker on tube allows X-ray visualization. Device modification allows for pre-loading of graft material by a registered graft facility, followed by sterilization and shipping to the surgical site, rather than manual loading by the clinician. Used in orthopedic surgery; operated by physicians or surgical staff. Benefits include standardized graft delivery and reduced intraoperative preparation time.

Clinical Evidence

Bench testing only. No clinical data provided. Verification testing included FMEA, functionality tests, tube bend tests, ink scratch-off tests, tube burst tests, and ring pull-off tests performed on devices subjected to the graft manufacturer's filling, freezing, and storage processes.

Technological Characteristics

Materials: Medical grade polycarbonate, polypropylene, and stainless steel (316L, 316F, 304H, 304HC, ABS). Principle: Ratcheting piston-type syringe. Dimensions: Graft tube 7.17 inches long, 0.350 inches diameter; loading syringe 4.538 inches long, 0.716 inches diameter. Connectivity: None. Sterilization: Gamma irradiation (SAL 10^-6).

Indications for Use

Indicated for delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Regulatory Classification

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.

Predicate Devices

• Graft Delivery Device (K170675)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 10, 2018

SurGenTec. LLC % Stephen Inglese Quality Solutions and Support PO Box 8271 Holland, Michigan 49422

Re: K180937

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: April 10, 2018 Received: April 10, 2018

Dear Stephen Inglese:

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, 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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## Page 2 - Stephen Inglese

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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

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# K180937

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

| | Form Approved: OMB No. 0910-0120 |
|--|----------------------------------|
| | Expiration Date: 06/30/2020 |
| | See PRA Statement below. |

**Indications for Use**

| 510(k) Number (if known) | NA K180937 |
|--------------------------|------------------------------------------|
| Device Name | Graftgun Delivery Universal Graft 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)

∑ Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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#### 5.0 510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Graft and Syringe Prefilled Tubes is provided below.

| Device Common Name: | Graft Delivery Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | Graftgun Universal Graft Delivery<br>System |
| Submitter: | SurGenTec, LLC<br>7601 N Federal Hwy #150A<br>Boca Raton, FL 33487<br>Telephone: [phone] |
| Contact: | Stephen W Inglese<br>CEO, Founder<br>Quality Solutions and Support, LLC<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 21, 2018 |
| Classification Regulation | 21 CFR 880.5860 Class II |
| Panel: | Orthopedics or General Hospital |
| Product Code: | FMF |
| Predicate Device: | K170675 – Graft Delivery Device<br>This predicate has not been subject to a<br>design related recall. |

#### De vice Description:

The Graftgun Universal Graft Delivery System is a sterile, single-use, disposable piston type syringe intended for the delivery of prepared allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

#### Indication 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.

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### Comparison of Technological Characteristics with the Predicate Device:

The graft tube as demonstrated in Figure 1 is made up of:

Figure 1, the dispensing unit is comprised of: a graft tube 5cc 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 a loading cap to retain the graft material in the graft tube while it is filled by the loading device. The syringe graft tubes also have a radiopaque ring marker (not pictured) 2.0mm from the graft tube tip to allow for visualization of the graft tube position under X-ray.

Figure 1

Image /page/4/Picture/6 description: The image shows a black and light blue Graftgun. The Graftgun has a handle with a trigger and a long, clear tube with markings on it. The markings on the tube are numbered from -1 to -5.

- Fully assembled Graft Gun dispensing unit. The unit graft tube is to the left Figure 1 and the base of the plunger is shown to the right. Upon squeezing the trigger mechanism on the handle, the plunger is advanced down the length of the graft tube to express the graft material from the graft tube tip into the intended graft site. The graft tube is 7.17 inches in length with a diameter of .350 inches. The component is made up of medical grade polypropyle ne.
The graft syringe as demonstrated in Figure 2 is made up of:

The loading device, shown in Figure 2, also is a syringe style system. It has a large syringe tube that can be filled easily by the clinician with the intended graft material, a rotary-style plunger to express the material, and an end cap that attaches to both the filler graft tube and delivery graft tube for loading the delivery graft tube with graft material.

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## Figure 2

Image /page/5/Figure/3 description: The image shows a black and white drawing of a medical syringe. The syringe has a circular end with a design on it. The syringe has two levers on the side that can be pressed to administer the medication. The syringe is empty and ready to be used.

- Figure 2 The Graftgun loading device (Syringe Tube). Rotating the plunger causes it to advance down the length of the graft tube, forcing the graft material out and into the filler graft tube (not shown) by means of end cap, which attaches to both graft tubes. The large open bore of the loading syringe makes graft expression into the filler graft tube easier than if using a more standard Luer-type syringe. The syringe is 4.538 inches in length with a diameter of .716 inches. The component is made up of Polycarbonate material.
#### Technology and Characteristics Summary:

The device components called out in Figure 1 and Figure 2 provide the identical technological and characteristic use as the cleared device K170675.

#### Performance Data:

The following performance data was provided in support of the substantial equivalence determination:

The risk analysis method used was Failure Modes Effect Analysis (FMEA). The results of that analysis showed that after mitigation and characterization of each remaining risk's severity and probability, all remaining risks were ranked as Acceptable.

In accordance with design control procedures, design verification and validation testing of the modified device were performed based on the risk results of the risk analysis. Table 2 summarizes the identified risks for the modification and the applicable testing that was performed.

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| Potential Effects of Failure | Potential Cause | Action Taken |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The bone graft loaded by the Bone Graft<br>Manufacturer cannot be pushed through the<br>Graft tube | The bone graft loaded is too viscous to be<br>pushed through the tube. | Functionality Test -Specific material (GGDVT15 Rev A<br>performed on tubes after they have gone through the Bone<br>Graft manufacturer's entire process. - 12.5 |
| Device's physical properties are diminished<br>by the Bone Graft company's manufacturing<br>process (Ex: filling, freezing storage<br>temperatures, etc.) | Tube was weakened from Bone Graft<br>manufacturer's process and the user bending<br>the tube to reach desired graft dispensing<br>location. | Tube Bend Test (GGDVT05 Rev A) performed on tubes after<br>they have gone through the Bone Graft manufacturer's<br>entire process. - 12.3 |
| Marking on tube are rubbed off from bone<br>graft manufacturer's process. | Markings rubbed off during Bone Graft<br>manufacturer's process. | Ink scratchoff test (GGDVT01 Rev A) performed after they<br>have gone through the Bone Graft manufacturer's entire<br>process. - 12.1 |
| Marking on tube are rubbed off during use | Markings were affected during the Bone Graft<br>manufacturer's process so they can be rubbed<br>off easier. | Ink scratchoff test (GGDVT01 Rev A) performed after they<br>have gone through the Bone Graft manufacturer's entire<br>process. - 12.1 |
| Device's physical properties are diminished<br>by the Bone Graft company's manufacturing<br>process (Ex: filling, freezing, storage<br>temperatures, etc.). | Tube was weakened from Bone Graft<br>manufacturer's process so when the user<br>squeezes handle to dispense graft it breaks the<br>tube. | Tube burst test (GGDVT11 Rev A) and Functionality -<br>Specific Material test (GGDVT15 Rev A) performed on tubes<br>after they have gone through the Bone Graft manufacturer's<br>entire process. - 12.4 and 12.5 |
| Device's physical properties are diminished<br>by the Bone Graft company's manufacturing<br>process (Ex: filling, freezing, storage<br>temperatures, etc.). | Connection with tube was weakened from Bone<br>Graft manufacturer's process which allowed the<br>ring to fall off. | Ring Pull Off Test (GGDVT02 Rev A) performed on tubes<br>after they have gone through the Bone Graft manufacturer's<br>entire process. - 12.2 |
| Cracks. Breaks. Handles on syringe break. | The assembly was weakened from Bone Graft<br>manufacturer's process so the device breaks<br>before it can load the Graft Tube | Functionality Test-Specific material test (GGDVT16 Rev A)<br>performed on prototype and production validation. - 12.6 |
| Reduction of components in the kit causes a<br>reduction of sterility | Less components in the tray affects the way the<br>componentsare sterilized | The gamma sterilizer (Sterigenics) advised that removing<br>components at this scale is no issue for gamma sterilization.<br>Because the density was decreased and packaging<br>configuration did not change significantly, the validated<br>gamma sterilization process should not have affect on |

Table 2 - Summary of Identified Risk and Verification Testing for Modification

#### Subs tantial Equivalence :

The Graftgun Universal Graft Delivery system that is the subject of this 510(k) is substantially equivalent to the previously cleared device in K170675. The only modification to the device is that the previously cleared version was demonstrating a 5cc graft or syringe tube that was loaded in the surgical facility prior to the surgical procedure. The current version that is the subject of this 510(k) is the option of having the 5cc graft or syringe tubes supplied to a registered graft facility, preloaded with graft, packaged, sterilized and shipped to the surgical facility prior to the surgical procedure. The device comparison table is provided in Table 1.

| Substantial<br>Equivalence Topic | Graftgun Universal Graft<br>Delivery System | Graftgun Universal Graft<br>Delivery System |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | To Be Determined | K170675 |
| Regulation Description | 21 CFR 880.5860 | 21 CFR 880.5860 |
| Device Name | Graftgun Universal Graft<br>Delivery System | Graftgun Universal Graft<br>Delivery System |
| Product Code | FMF | FMF |
| Classification | Class II | Class II |
| Indications for Use | The Graft tube is intended to be<br>used for the delivery of<br>hydrated allograft, autograft, or<br>synthetic bone graft material to<br>an orthopedic surgical site. | The Graft tube is intended to be<br>used for the delivery of<br>hydrated allograft, autograft, or<br>synthetic bone graft material to<br>an orthopedic surgical site. |
| Single Use | Yes | Yes |

| | Table | 1: | |
|--|-------|----|--|
| | | | |

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| Sterility | Gamma irradiation to SALof<br>10-6 See Note 1 | Gamma irradiation to a SALof<br>10-6 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Patient Contact Material | Medical Grade:<br>Polycarbonte Polypropylene Stainless Steel – 316L, 316F, 304H, 304HC and ABS | Medical Grade:<br>Polycarbonte Polypropylene Stainless Steel – 316L, 316F, 304H, 304HC and ABS |
| 5cc Graft Tube | Option of having the 5cc<br>graft tube provided clean<br>to a graft facility,<br>preloaded with graft,<br>packaged, sterilized and<br>shipped to the surgical<br>facility prior to the surgical<br>procedure. | Loaded in the surgical facility<br>and made ready for use. |
| Syringe Tube | Option of having the<br>Syringe Tube provided<br>clean to a graft facility,<br>preloaded with graft,<br>packaged, sterilized and<br>shipped to the surgical<br>facility prior to the surgical<br>procedure. | Loaded in the surgical facility<br>and made ready for use. |
| Packaging | Device tray containing the<br>required components to action<br>the device less those used for<br>graft loading. Add separate<br>packaging for both | Device tray containing the<br>required components to action<br>the device which includes<br>those used for graft loading |

# Bold – Identifies differences

Note 1 - Graft tubes are provided to a registered graft facility. Their sterilization process is validated as per their internal accepted standards prior to the prefilled tubes being shipped.

#### Summary:

The modification of the Graftgun Universal Graft Delivery System to provide the 5cc graft or syringe tube pre-loaded with graft, packaged, sterilized then shipped for use in the Graftgun Universal Graft Delivery System prior to the surgical procedure does not change the device functionality or the intended use of the device. The performance data support the safety of the device. Based on the device modification and indications for use, the modified device is substantially equivalent to the previous cleared Graftgun Universal Graft Delivery System in K170675.