The 3D GraftRasp System is intended to be used in orthopedic procedures to rasp or decorticate bone from the transverse processes and/or facets, and for the delivery of hydrated allograft, 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, tools, 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 from transverse processes and/or facets. 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 text describes the 3D GraftRasp System, a medical device for orthopedic procedures, seeking 510(k) clearance from the FDA. It details device characteristics, indications for use, and a comparison to a predicate device (also the 3D GraftRasp System, K200431, from the same manufacturer).

However, the document does not contain specific acceptance criteria for a device performance study in the context of an AI/ML medical device, nor does it describe a study that proves the device meets such criteria for an AI/ML product. The performance data section focuses on non-clinical performance data for a mechanical medical device.

Therefore, I cannot extract the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI/ML device.

The performance data provided is for a mechanical physical device and includes:

Biocompatibility testing: Per ISO 10993-1:2018.
Sterilization validation: Per ISO 17665-1:2006/(R) 2013.
Bench Testing:
- Functionality Common Material Test: Tested extrusion of various graft materials through rasps using an acceptable hand force.
- Rasp Functionality Test: Tested the rasping surface on a bone block for decortication capability without failure of teeth or main body.
- Volume Dispensing Verification Test: Tested the Graftgun for accurate bone graft dispensing with each trigger squeeze.
Simulated Use Validation Testing: Seven studies conducted with physicians (intended users) on cadavers and/or sawbones models to simulate typical use. This aimed to gather feedback and validate the device, labeling, usability, human factors, and technique.

This information does not align with the typical requirements for describing the acceptance criteria and study proving an AI/ML device's performance.

Summary

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September 3, 2020

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

Re: K201900

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: July 6, 2020 Received: July 8, 2020

Dear Mr. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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) 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 (OS) 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 mediation-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,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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4.0 Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES	Form Approved: OMB No. 0910-0120
Food and Drug Administration	Expiration Date: 06/30/2020
Indications for Use	See PRA Statement below.

510(k) Number (if known) TBD K201900

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.

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FORM FDA 3881 (7/17)

Page 1 of 1

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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 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:	July 6th, 2020
5.2 Name of DeviceDevice 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

5.3 Legally Marketed Predicate Device

Predicate: 3D GraftRasp System Surgentec, LLC. Class II Device (K200431)

5.4 Device Description

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5.5 Indication for Use

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

	Technological Characteristics and SubstantialEquivalence	3D GraftRasp System	3D GraftRasp System
	Topic
	510(k)	TBD	K200431
	Regulation	21 CFR 880.5860	21 CFR 880.5860
	Description
	Device Name	3D GraftRasp System	3D GraftRasp System
	Product Code	FMF, HTR	FMF, HTR
	Classification	Class II	Class II
	Indications forUse	The 3D GraftRasp System is intendedto be used in orthopedic procedures torasp or decorticate bone from thetransverse processes and/or facets,and for the delivery of hydratedallograft, autograft, or synthetic bonegraft material to an orthopedicsurgical site.	The 3D GraftRasp System is intendedto be used in orthopedic procedures torasp or decorticate bone and for thedelivery of hydrated allograft,autograft, or synthetic bone graftmaterial to an orthopedic surgical site.
	Single Use	Yes / No*	Yes / No*
	Sterility	Steam Sterilization	Steam Sterilization
	Patient ContactMaterial	Medical Grade:Stainless Steel – 316L, 304per ASTM F899-12b,passivated per ASTM A967-13Nitinol Superelastic perASTM F2063, passivated perASTM A967-13Ti64 per ASTM F136-13,passivated per ASTMA967-13.	Medical Grade:Stainless Steel – 316L, 304per ASTM F899-12b,passivated per ASTM A967-13Nitinol Superelastic perASTM F2063, passivated perASTM A967-13
	Packaging	Packaged in sterilization tray,sterilized and cleaned prior to eachuse via autoclave.Replacement parts shipped innonsterile packaging includinglabeling, IFU, and cleaninginstructions. Need to be assembled,cleaned and sterilized prior to use.	Packaged in sterilization tray,sterilized and cleaned prior to eachuse via autoclave.Replacement parts shipped innonsterile packaging includinglabeling, IFU, and cleaninginstructions. Need to be assembled,cleaned and sterilized prior to use.
	OperatingPrinciple	The user can dilate tissue for easieraccess to the surgical site. Thedecortication rasp is then used toremove cortical bone by manuallyscraping the bony anatomy. Once thebony anatomy is prepared, graft isapplied using the Groftoun Universal	The user can dilate tissue for easieraccess to the surgical site. Thedecortication rasp is then used toremove cortical bone by manuallyscraping the bony anatomy. Once thebony anatomy is prepared, graft isapplied using the Groftoun Universal
	Graft Delivery Device. It's inserted	Graft Delivery Device. It's inserted
	into the rasp and delivers graft	into the rasp and delivers graft
	through the rasp lumen directly to the	through the rasp lumen directly to the
	prepared surgical site. The shape of	prepared surgical site. The shape of
	the rasp allows to access to adjacent	the rasp allows to access to adjacent
	transverse processes and/or facets	vertebral bodies or other bony
	during decortication and graft	anatomy during decortication and
	delivery.	graft delivery.
Components	Orthopedic Rasp, Dilators, Pushers, Graft Funnel, Tools	Orthopedic Rasp, Dilators, Pushers, Graft Funnel

Technological Characteristics and Substantial Equivalence 5.6

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*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
  - l 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.
- Rasp Functionality Test o
  - 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.
- o Volume Dispensing Verification Test
  - 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 the acceptance criteria
- Simulated Use Validation Testing O
  - Seven simulated use validation studies were conducted with ■ physician who are considered intended users. The validations were completed on cadavers and/or sawbones models to simulates typical use of the system in an operating room environment. These validations were designed to get feedback from a potential user and to validate the devices, labeling, usability, human factors, and technique. The user is supplied with a complete the appropriate labeling and Surgical

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Technique. The validations demonstrated that the GraftRasp System was able to be effectively used in orthopedic procedures to rasp or decorticate bone from transverse processes and/or facets, and for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. It also evaluated multiple physicians' feedback on the safety and efficacy of the device, labeling and training.

5.8 Conclusion

The design characteristics of the 3D GraftRasp System do not raise different questions of safety and effectiveness. 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).