The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Device Description

The InstaFill™ Graft Delivery System consists of a delivery device with an actuating handle, loading plunger, conical tip, and empty and pre-filled cartridges, designed to deliver graft material to an orthopedic surqical site. Cartidges are pre-filled with DBM or SIGNIFY® Gel. The delivery device and associated instruments are reusable, and the cartridges are provided sterile for single use. InstaFill™ components are manufactured from stainless steel, aluminum and PEEK, with polypropylene cartridges.

AI/ML Overview

The InstaFill™ Graft Delivery System is intended for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Here's an analysis of the acceptance criteria and the study performed:

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Usability testing in a cadaver	All specified acceptance criteria were met.
Axial pull-off testing	All specified acceptance criteria were met.
Axial force testing	All specified acceptance criteria were met.
Burst testing	All specified acceptance criteria were met.
Bacterial Endotoxin Testing (BET)	Conducted on prefilled cartridges in accordance with ANSI/AAMI ST-72:2011. (Implied: results met the acceptance criteria as part of "All specified acceptance criteria were met.")
Biocompatibility of patient-contacting materials	Demonstrated by using materials that meet applicable standards or are used in 510(k)-cleared devices.

2. Sample Size and Data Provenance

The document does not explicitly state the sample sizes for the specific tests (e.g., number of cadavers for usability, number of devices for axial pull-off, axial force, and burst testing).
The data provenance is not specified. However, the testing was conducted in-house by the manufacturer (Globus Medical Inc.) to confirm the device's performance.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This device is a delivery system for bone graft material and the testing described is primarily mechanical and functional verification, not an AI or diagnostic device that requires expert-established ground truth on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. The testing described focuses on mechanical and functional performance, not diagnostic classification requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI or diagnostic device that would typically undergo an MRMC study.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering specifications, material standards, and functional requirements inherent in its design and intended use. For example:

Usability: Successful delivery of graft material in a cadaveric setting.
Axial Pull-Off, Axial Force, Burst: Measurement against predefined mechanical thresholds.
BET: Compliance with the ANSI/AAMI ST-72:2011 standard for endotoxin levels.
Biocompatibility: Conformance to established standards for medical device materials or prior FDA clearance of the materials.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

August 11, 2022

Globus Medical Inc. Dr. Jennifer Antonacci Group Manager, Regulatory Affairs 2560 General Armistead Ave. Audubon, Pennsylvania 19403

Re: K221737

Trade/Device Name: InstaFill Graft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: June 14, 2022 Received: June 15, 2022

Dear Dr. Antonacci:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

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 (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 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,

for

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) K221737

Device Name InstaFillTM Graft Delivery System

Indications for Use (Describe)

The InstaFill™ Craft Delivery System is intended to be used for the delivery of allograft, 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:

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."

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

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

510(k) Summary: InstaFillTM Graft Delivery System

Company:	Globus Medical Inc.2560 General Armistead Ave.Audubon, PA 19403610-930-1800
Contact:	Jennifer Antonacci, Ph.D.Group Manager, Regulatory Affairs
Date Prepared:	August 10, 2022
Device Name:	InstaFillTM Graft Delivery System
Common Name:	Graft Delivery Device
Classification:	Per 21 CFR as follows:§880.5860 Piston SyringeProduct Code: FMFRegulatory Class: II, Panel Code: 80 & 87
Predicates:PrimaryAdditional	Graftgun Universal Graft Delivery System (K180937)Graftgun Universal Graft Delivery System (K170675)SIGNIFY® Bioactive (K130977)

Purpose:

The purpose of this submission is to request clearance for the InstaFill™ Graft Delivery System and cartridges pre-filled with SIGNIFY® Bioactive Gel or demineralized bone matrix (DBM).

Device Description:

Indications for Use:

The InstaFill™ Graft Delivery System is intended to be used for the delivery of allograft, autograft, or synthetic bone graft material to an orthopedic surgical site.

Performance Data:

Testing was conducted on the InstaFill™ Graft Delivery System to confirm the device performs as intended and to demonstrate substantial equivalence to the predicate.

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

Testing included usability testing in a cadaver and functional verification, including axial pull-off, axial force, and burst testing. All specified acceptance criteria were met. Bacterial endotoxin testing (BET) was conducted on prefilled cartridges in accordance with ANSI/AAMI ST-72:2011. Biocompatibility of patient-contacting materials was demonstrated by using materials that meet applicable standards or are used in 510(k) cleared devices.

Technological Characteristics:

The subject InstaFill™ system components and pre-filled cartridges have similar technological characteristics as the predicate devices including design, intended use, material composition, and function. The table below compares technological characteristics of the subject device to the predicate.

Feature	SubjectInstaFill Graft Delivery System	PredicateGraftgunUniversal Graft Delivery System(K170675, K180937)
Regulation	21 CFR 880.5860	21 CFR 880.5860
Product Code	FMF	FMF
Materials	Delivery Device: Stainless steel, aluminum, PEEK	Delivery Device: Stainless steel, acrylonitrile butadiene styrene
Mechanism of Operation	Graft Cartridges: PolypropyleneGraft material expressed from graft tube via a plunger, operated by a spring-loaded actuating trigger.	Graft Tubes: PolypropyleneGraft material expressed from graft tube via a plunger, operated by a ratchet-actuated handle.
	Material expressed from graft tube directly to graft site.	Material expressed from graft tube directly to graft site.
Graft Volume Capacity	5.0cc (empty & prefilled)	5.0cc (empty & prefilled),7.5cc (empty)
Empty Graft Tube	Yes	Yes
Prefilled Graft Tube	Yes	Yes
Sterility	Cartridges & Conical Tip:Single Use, Sterile(Gamma irradiation)	Delivery Device & Cannulae:Single Use, Sterile(Gamma irradiation)
	Delivery Device: Reusable, Nonsterile(Steam sterilized)

Comparison of Technological Characteristics

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

Basis of Substantial Equivalence and Conclusion:

The subject InstaFill™ Graft Delivery System is similar to the predicate devices with respect to technological characteristics, performance, design, and intended use. The differences in plunger actuation and method of sterilization for the delivery device are minor and do not raise any new concerns of safety or effectiveness for the InstaFill™ device for its intended indications. The information provided within this premarket notification supports substantial equivalence to the predicate devices.

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).