Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical components and their functionality in bone decortication and graft delivery, with no mention of AI or ML.

Therapeutic

No
The device is described as an orthopedic surgical tool for bone preparation (rasping/decorticating) and delivery of bone graft materials, which are procedural steps rather than direct therapeutic actions to treat a disease or condition.

Diagnostic

No

The device is described as a surgical tool used for rasping or decorticating bone and for delivering bone graft material. Its intended use is to perform a surgical procedure, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components such as decortication rasps, graft pushers, a bone funnel, and dilators, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for orthopedic procedures to rasp/decorticate bone and deliver bone graft material to a surgical site. This is a surgical tool used directly on the patient's body.
Device Description: The components (rasps, pushers, funnel, dilators) are all instruments used in a surgical setting for physical manipulation of bone and delivery of material.
Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) outside of the body to provide diagnostic information about a patient's health.
Performance Studies: The performance studies focus on the mechanical functionality of the device (extruding graft, decorticating bone, volume dispensing accuracy) and biocompatibility and sterilization, which are typical for surgical instruments. There are no studies related to diagnostic accuracy or performance with biological samples.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

FMF, HTR

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.

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

Not Found

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

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
- 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.
- 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: 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 of accuracy.

Key Metrics

Not Found

Predicate Device(s)

K170675

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

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)

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.

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, LLC
911 Clint Moore Rd
Boca Raton, FL 33487
Telephone: (561) 990-7882 |
|----------------------------|-------------------------------------------------------------------------------------------|
| Contact: | Andrew Shoup
COO
Phone 561-990-7882
Email: 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

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

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

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.

	5.6 Technological Characteristics and Substantial Equivalence
Substantial
Equivalence
Topic	3D GraftRasp System	Graftgun Universal
Graft Delivery System	Millennium Surgical
Bone Rasp
510(k)	K200431	K170675	N/A – Class I Device
Regulation
Description	21 CFR 880.5860	21 CFR 880.5860	21 CFR 878.4800
Device Name	3D GraftRasp System	Graftgun Universal Graft
Delivery System	Bone Rasp No64 7 inches
3mm/4mm
Product Code	FMF, HTR	FMF	HTR
Classification	Class II	Class II	Class I
Indications for
Use	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.	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.	Millennium Surgical
Orthopedic Rasps are
coarse files used in
orthopedic procedures to
sculpt bone.
Single Use	Yes / No*	Yes	No
Sterility	Steam Sterilization	Gamma irradiation to a
SAL of 10-6	Steam Sterilization
Patient Contact
Material	Medical Grade:
Stainless Steel –
316L, 304 per
ASTM F899-12b,
passivated per
ASTM A967-13Nitinol Superelastic
per ASTM F2063,
passivated per
ASTM A967-13	Medical Grade:
PolycarbonatePolypropyleneStainless Steel –
316L, 316F,
304H, 304HC per
ASTM F899-12b,
passivated per
ASTM A967-13
ABS	Medical Grade:
Surgical Grade
Stainless Steel –
420 per ASTM
F899-12b
passivated per
ASTM A967-13
Packaging	Packaged in sterilization
tray, sterilized and cleaned
prior to each use via
autoclave.
Replacement parts shipped in
nonsterile packaging
including labeling, IFU, and
cleaning instructions. Need
to be assembled, cleaned and
sterilized prior to use.	Device tray containing the
required components to
action the device	Packaged in sterilization
tray, sterilized and cleaned
prior to each use via
autoclave.
Operating
Principle	The user can dilate tissue for
easier access to the surgical
site. The decortication rasp is
then used to remove cortical
bone by manually scraping
the bony anatomy. Once the
bony anatomy is prepared.
graft is applied using the
Graftgun Universal Graft
Delivery Device. It's inserted
into the rasp and delivers
graft through the rasp lumen
directly to the prepared
surgical site. The shape of
the rasp allows to access to
adjacent vertebral bodies or
other bony anatomy during
decortication and graft
delivery.	The user can apply a wide
variety of autograft,
allograft, and synthetic
bone grafts directly to a
surgical site using the
GraftGun using a
percutaneous approach.
The device comprises a
trigger which is manually
squeezed to dispense bone
graft.	The device is manually
maneuvered and scraped
across the bone to shape
and decorticate bony
anatomy.
Components	Orthopedic Rasp, Dilators,
Pushers, Graft Funnel	Graftgun, Graft Tubes,
Loading Device, Funnel
and 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.