The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Description

The 3D GraftRasp system contains various decortication rasps, graft pushers, a bone funnel, and dilators. The 3D GraftRasp system is compatible with the Graftgun Universal Graft Delivery System for graft delivery to the surgical site. The decortication rasps can be used to rasp or decorticate bone. After rasping, a 5cc or 7.5cc graft tube can be inserted into the rasp lumen to extrude graft from the tip of the rasp. A set of optional sequential dilators and rasp pushers may also be provided to aid in the use of the decortication rasp. A bone funnel may optionally be used to extrude graft through the rasps instead of the graftgun.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device called the "3D GraftRasp System." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML powered device.

The document discusses the substantial equivalence of the 3D GraftRasp System to predicate devices based on technological characteristics and non-clinical performance data (biocompatibility, sterilization validation, and bench testing). The bench testing includes:

Functionality Common Material Test: Verifies the Graftgun can successfully extrude various graft materials through the different rasps of the 3D GraftRasp System.
Rasp Functionality Test: Confirms the rasping surface can decorticate a bone block without failure.
Volume Dispensing Verification Test: Ensures the Graftgun dispenses an accurate amount of bone graft.

However, the nature of the device (a piston syringe and bone rasp) and the tests described align with a traditional medical device submission, not an AI/ML-powered device. Therefore, the specific information requested, such as sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, is not applicable or present in this document.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 18, 2020

SurGenTec. LLC. Andrew Shoup, COO 911 Clint Moore Rd Boca Raton, Florida 33847

Re: K200431

Trade/Device Name: 3D GraftRasp System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, HTR Dated: February 21, 2020 Received: February 21, 2020

Dear Andrew Shoup:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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

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

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K200431

Device Name 3D GraftRasp System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X 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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff 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."

{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 3D GraftRasp System is provided below.

5.1 Submitter Information:

Submitter:	SurGenTec, LLC911 Clint Moore RdBoca Raton, FL 33487Telephone: (561) 990-7882
Contact:	Andrew ShoupCOOPhone 561-990-7882Email: ashoup@surgentec.com
Date Prepared:	May 15, 2020
5.2 Name of Device
Device Proprietary Name:	3D GraftRasp System
Device Common Name:	Piston Syringe and Bone Rasp
Classification Regulation:	21 CFR 880.5860 Class II
Classification name:	Piston Syringe
Panel:	General & Plastic Surgery
Product Code:	FMF, HTR

Legally Marketed Predicate Device 5.3

Predicate(s): Graftgun Universal Graft Delivery System Surgentec, LLC. Class II Device (K170675)

Bone Rasp No64 7 inches 3mm/4mm Millennium Surgical Class I Exempt

5.4 Device Description

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

aid in the use of the decortication rasp. A bone funnel may optionally be used to extrude graft through the rasps instead of the graftgun.

Indication for Use ર્સ રાજ્યના સાથે જિલ્લાના પાકની ખેતી કરવામાં આવે છે. આ ગામનાં મુખ્યત્વે ખેત-ઉત્પત્તમજૂરી તેમ જ દૂધની ડેરી જેવી સવલતો પ્રાપ્ય થયેલી છે. આ ગામનાં મુખ્યત્વે આવેલું એક ગામના લોક

	5.6 Technological Characteristics and Substantial Equivalence
SubstantialEquivalenceTopic	3D GraftRasp System	Graftgun UniversalGraft Delivery System	Millennium SurgicalBone Rasp
510(k)	K200431	K170675	N/A – Class I Device
RegulationDescription	21 CFR 880.5860	21 CFR 880.5860	21 CFR 878.4800
Device Name	3D GraftRasp System	Graftgun Universal GraftDelivery System	Bone Rasp No64 7 inches3mm/4mm
Product Code	FMF, HTR	FMF	HTR
Classification	Class II	Class II	Class I
Indications forUse	The 3D GraftRasp System isintended to be used inorthopedic procedures to raspor decorticate bone and forthe delivery of hydratedallograft, autograft, orsynthetic bone graft materialto an orthopedic surgical site.	The Graftgun UniversalGraft Delivery System isintended to be used for thedelivery of hydratedallograft, autograft, orsynthetic bone graftmaterial to an orthopedicsurgical site.	Millennium SurgicalOrthopedic Rasps arecoarse files used inorthopedic procedures tosculpt bone.
Single Use	Yes / No*	Yes	No
Sterility	Steam Sterilization	Gamma irradiation to aSAL of 10-6	Steam Sterilization
Patient ContactMaterial	Medical Grade:Stainless Steel –316L, 304 perASTM F899-12b,passivated perASTM A967-13Nitinol Superelasticper ASTM F2063,passivated perASTM A967-13	Medical Grade:PolycarbonatePolypropyleneStainless Steel –316L, 316F,304H, 304HC perASTM F899-12b,passivated perASTM A967-13ABS	Medical Grade:Surgical GradeStainless Steel –420 per ASTMF899-12bpassivated perASTM A967-13
Packaging	Packaged in sterilizationtray, sterilized and cleanedprior to each use viaautoclave.Replacement parts shipped innonsterile packagingincluding labeling, IFU, andcleaning instructions. Needto be assembled, cleaned andsterilized prior to use.	Device tray containing therequired components toaction the device	Packaged in sterilizationtray, sterilized and cleanedprior to each use viaautoclave.
OperatingPrinciple	The user can dilate tissue foreasier access to the surgicalsite. The decortication rasp isthen used to remove corticalbone by manually scrapingthe bony anatomy. Once thebony anatomy is prepared.graft is applied using theGraftgun Universal GraftDelivery Device. It's insertedinto the rasp and deliversgraft through the rasp lumendirectly to the preparedsurgical site. The shape ofthe rasp allows to access toadjacent vertebral bodies orother bony anatomy duringdecortication and graftdelivery.	The user can apply a widevariety of autograft,allograft, and syntheticbone grafts directly to asurgical site using theGraftGun using apercutaneous approach.The device comprises atrigger which is manuallysqueezed to dispense bonegraft.	The device is manuallymaneuvered and scrapedacross the bone to shapeand decorticate bonyanatomy.
Components	Orthopedic Rasp, Dilators,Pushers, Graft Funnel	Graftgun, Graft Tubes,Loading Device, Funneland Pusher, Plunger Rods	Orthopedic Rasp

Technological Characteristics and Substantial Equivalence 5 6

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

SurGenTec. LLC

*Some components of the GraftRasp System are designed to be reusable while others are single use such as the replaceable rasp teeth and the flexible tip of the rasp pusher.

5.7 Performance Data

The following non-clinical performance data were provided to demonstrate substantial equivalence of the subject device to the predicate.

Biocompatibility per ISO 10993-1:2018 ●
Sterilization validation per ISO 17665-1:2006/(R) 2013 ●
Bench Testing ●
- o Functionality Common Material Test
  - Various graft materials were tested to ensure the Graftgun can ■ successfully extrude them through the various rasps of the 3D GraftRasp System. For each rasp, the Graftgun was able to successfully extrude the graft materials using an acceptable hand force.
- o Rasp Functionality Test
  - The rasping surface of the rasp was tested on a sample bone ■ block to ensure the worst case scenario rasp of the 3D GraftRasp System is capable of bone decortication without failure. The rasp was able to successfully decorticate a portion of the bone block without failure of either the teeth of the rasping surface or of the main rasp body.
- Volume Dispensing Verification Test o
  - The Graftgun Universal Graft Delivery system was tested to ensure an accurate amount of bone graft was dispensed with every squeeze of the trigger. It was justified that using the Graftgun along with either rasp and the accompanying graft pusher of the 3D GraftRasp System was adequate to maintain

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

SurGenTec, LLC

the acceptance criteria of accuracy.

5.8 Conclusion

The design characteristics of the 3D GraftRasp System do not raise different questions of safety and effectiveness. Non-clinical study data supports that the device is safe and effective. This data supports that the 3D GraftRasp System is substantially equivalent to the predicate device.

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).