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 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.

AI/ML Overview

This document describes the FDA's 510(k) premarket notification for the SurGenTec Graftgun Universal Graft Delivery System (K180937). The submission seeks to prove substantial equivalence to a previously cleared device (K170675), with the only modification being that the 5cc graft or syringe tubes can now be supplied preloaded with graft material by a registered graft facility, packaged, sterilized, and shipped to the surgical facility.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of acceptance criteria and the reported device performance:

The document details a series of potential failure modes and the corresponding tests performed to ensure the device's functionality and integrity are not compromised by the new pre-loading and sterilization process. While explicit numerical acceptance criteria are not presented in a table format, the "Action Taken" column describes the tests conducted and implies that the device passed these tests, thus meeting implicitly defined acceptance criteria. The document states that 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."

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

2. Sample size used for the test set and the data provenance:

Sample Size: The document provides test identification numbers (e.g., GGDVT15 Rev A, GGDVT05 Rev A) but does not specify the sample size used for each test. The number "12.5" which appears after some tests codes is not clearly defined but could potentially be a sample size (e.g., 12.5 units or batches). This is not explicitly stated.
Data Provenance: The tests were performed on "tubes after they have gone through the Bone Graft manufacturer's entire process." This indicates the tests were conducted prospectively on devices subjected to the new pre-loading and sterilization conditions. The document does not specify the country of origin of the data, but the context implies it relates to the US FDA submission process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

The provided text does not mention the use of experts to establish ground truth for the device's functional and physical property tests. These are engineering and performance validation tests, not diagnostic or clinical interpretation tasks.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

As the tests are focused on physical and functional properties and not on subjective interpretation, an adjudication method like 2+1 or 3+1 is not applicable and not mentioned in the document. The tests seem to have pass/fail criteria based on objective measurements or observations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is a device for delivering bone graft material, not a diagnostic imaging or AI-assisted device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not an algorithm-only device. It is a physical medical device. Therefore, a standalone algorithm performance study is not applicable and was not performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance tests appears to be based on engineering specifications and established functional requirements for a graft delivery system. For example, for the "Ink scratchoff test," the ground truth would be that the markings must remain legible, and for the "Tube burst test," the tube must not burst under anticipated stress. For sterility, the ground truth is a sterility assurance level (SAL) of 10-6, which is an industry standard.

8. The sample size for the training set:

This is a physical medical device, not an AI/Machine Learning algorithm. Therefore, the concept of a "training set" in the context of data for model training is not applicable and no such sample size is mentioned.

9. How the ground truth for the training set was established:

As above, this is not an AI/ML device, so the concept of a training set and its ground truth establishment is not applicable.

Summary

{0}------------------------------------------------

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);

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

vices

PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (101) 443-6700 EF

{3}------------------------------------------------

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 DeliverySystem
Submitter:	SurGenTec, LLC7601 N Federal Hwy #150ABoca Raton, FL 33487Telephone: 561-990-7882
Contact:	Stephen W IngleseCEO, FounderQuality Solutions and Support, LLCPhone: 561-251-0876Email: swi@qss-llc.com
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 DeviceThis predicate has not been subject to adesign related recall.

De vice Description:

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.

{4}------------------------------------------------

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.

{5}------------------------------------------------

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.

{6}------------------------------------------------

Potential Effects of Failure	Potential Cause	Action Taken
The bone graft loaded by the Bone GraftManufacturer cannot be pushed through theGraft tube	The bone graft loaded is too viscous to bepushed through the tube.	Functionality Test -Specific material (GGDVT15 Rev Aperformed on tubes after they have gone through the BoneGraft manufacturer's entire process. - 12.5
Device's physical properties are diminishedby the Bone Graft company's manufacturingprocess (Ex: filling, freezing storagetemperatures, etc.)	Tube was weakened from Bone Graftmanufacturer's process and the user bendingthe tube to reach desired graft dispensinglocation.	Tube Bend Test (GGDVT05 Rev A) performed on tubes afterthey have gone through the Bone Graft manufacturer'sentire process. - 12.3
Marking on tube are rubbed off from bonegraft manufacturer's process.	Markings rubbed off during Bone Graftmanufacturer's process.	Ink scratchoff test (GGDVT01 Rev A) performed after theyhave gone through the Bone Graft manufacturer's entireprocess. - 12.1
Marking on tube are rubbed off during use	Markings were affected during the Bone Graftmanufacturer's process so they can be rubbedoff easier.	Ink scratchoff test (GGDVT01 Rev A) performed after theyhave gone through the Bone Graft manufacturer's entireprocess. - 12.1
Device's physical properties are diminishedby the Bone Graft company's manufacturingprocess (Ex: filling, freezing, storagetemperatures, etc.).	Tube was weakened from Bone Graftmanufacturer's process so when the usersqueezes handle to dispense graft it breaks thetube.	Tube burst test (GGDVT11 Rev A) and Functionality -Specific Material test (GGDVT15 Rev A) performed on tubesafter they have gone through the Bone Graft manufacturer'sentire process. - 12.4 and 12.5
Device's physical properties are diminishedby the Bone Graft company's manufacturingprocess (Ex: filling, freezing, storagetemperatures, etc.).	Connection with tube was weakened from BoneGraft manufacturer's process which allowed thering to fall off.	Ring Pull Off Test (GGDVT02 Rev A) performed on tubesafter they have gone through the Bone Graft manufacturer'sentire process. - 12.2
Cracks. Breaks. Handles on syringe break.	The assembly was weakened from Bone Graftmanufacturer's process so the device breaksbefore it can load the Graft Tube	Functionality Test-Specific material test (GGDVT16 Rev A)performed on prototype and production validation. - 12.6
Reduction of components in the kit causes areduction of sterility	Less components in the tray affects the way thecomponentsare sterilized	The gamma sterilizer (Sterigenics) advised that removingcomponents at this scale is no issue for gamma sterilization.Because the density was decreased and packagingconfiguration did not change significantly, the validatedgamma 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.

SubstantialEquivalence Topic	Graftgun Universal GraftDelivery System	Graftgun Universal GraftDelivery System
510(k)	To Be Determined	K170675
Regulation Description	21 CFR 880.5860	21 CFR 880.5860
Device Name	Graftgun Universal GraftDelivery System	Graftgun Universal GraftDelivery System
Product Code	FMF	FMF
Classification	Class II	Class II
Indications for Use	The Graft tube is intended to beused for the delivery ofhydrated allograft, autograft, orsynthetic bone graft material toan orthopedic surgical site.	The Graft tube is intended to beused for the delivery ofhydrated allograft, autograft, orsynthetic bone graft material toan orthopedic surgical site.
Single Use	Yes	Yes

	Table	1:

{7}------------------------------------------------

Sterility	Gamma irradiation to SALof10-6 See Note 1	Gamma irradiation to a SALof10-6
Patient Contact Material	Medical Grade:Polycarbonte Polypropylene Stainless Steel – 316L, 316F, 304H, 304HC and ABS	Medical Grade:Polycarbonte Polypropylene Stainless Steel – 316L, 316F, 304H, 304HC and ABS
5cc Graft Tube	Option of having the 5ccgraft tube provided cleanto a graft facility,preloaded with graft,packaged, sterilized andshipped to the surgicalfacility prior to the surgicalprocedure.	Loaded in the surgical facilityand made ready for use.
Syringe Tube	Option of having theSyringe Tube providedclean to a graft facility,preloaded with graft,packaged, sterilized andshipped to the surgicalfacility prior to the surgicalprocedure.	Loaded in the surgical facilityand made ready for use.
Packaging	Device tray containing therequired components to actionthe device less those used forgraft loading. Add separatepackaging for both	Device tray containing therequired components to actionthe device which includesthose 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.

Regulation Number and Section

§ 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).