The Allograft MIS Delivery System is a sterile, single-use, disposable graft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery system consists of: a cannula for containing and delivering the allograft material to the surgical site; a plunger to express the allograft material from the cannula; a dispenser to advance the plunger down the length of the cannula; and two end caps to retain the allograft material in the cannula prior to system assembly.

The cannula component is a 5 cc straight, open bore tube with a double threaded interface that mates with two end caps which are removed prior to cannula attachment to the dispenser. The dispenser is designed for single-hand, incremental delivery of graft materials and may be used to dispense multiple cannulas for a single patient.

AI/ML Overview

This FDA 510(k) summary is for a medical device (Allograft MIS Delivery System), not an AI algorithm. Therefore, many of the requested criteria related to AI performance, ground truth, experts, and training sets are not applicable.

However, I can extract the acceptance criteria and the study type conducted to demonstrate substantial equivalence for this device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Tests Conducted	Reported Device Performance
Safety & Biocompatibility	Biocompatibility	All specified acceptance criteria were met.
Dimensional Integrity	Dimensional and fit verification	All specified acceptance criteria were met.
Functional Performance	Functional verification: Mechanical extrusion	All specified acceptance criteria were met.
	Functional verification: Simulated use	All specified acceptance criteria were met.
Packaging & Stability	Package performance and stability	All specified acceptance criteria were met.

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

Sample Size: The document does not specify the exact sample sizes used for each of the performance tests. It generally states that "Testing was performed on samples that represented the finished device."
Data Provenance: Not applicable. This is a physical device, and the testing involves laboratory and simulated use rather than clinical data from a specific country or retrospective/prospective studies.

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):

Not applicable. This document describes the testing of a physical medical device. Ground truth as typically defined for AI algorithms (e.g., expert consensus on image interpretation) is not relevant here. The acceptance criteria are based on engineering and performance standards, likely evaluated by engineers, technicians, and quality control professionals.

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

Not applicable. Adjudication methods are typically relevant for human interpretation tasks or clinical trials, not for direct performance testing of a physical device against predefined engineering standards.

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 versus without AI assistance:

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

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

Ground Truth (for device performance): The "ground truth" in this context refers to established engineering specifications, regulatory standards, and intended functional outputs for the device. For example, the device must extrude material within certain force limits, fit together correctly, and maintain sterility. These are objective measures rather than subjective interpretations.

8. The sample size for the training set:

Not applicable. This is not an AI device, so there is no training set in the context of machine learning.

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

Not applicable. This is not an AI device.

Summary

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July 13, 2020

LifeNet Health Brittany Beasley Global Regulatory Affairs Program Manager 1864 Concert Drive Virginia Beach, Virginia 23453

Re: K201338

Trade/Device Name: Allograft MIS Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: May 19, 2020 Received: May 20, 2020

Dear Brittany Beasley:

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.

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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 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 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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201338

Device Name Allograft MIS Delivery System

Indications for Use (Describe)

The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft 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)

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510(k) Summary

Allograft MIS Delivery System

Submitter Information:
Name:	LifeNet Health
Address:	1864 Concert DriveVirginia Beach, Virginia 23453
Contact:	Brittany Beasley, RACGlobal Regulatory Affairs Program Manager
Phone:	(757) 609-4201
Email:	brittany_beasley@lifenethealth.org
Date Prepared:	July 10, 2020
Device Information:
Trade Name:	Allograft MIS Delivery System
Common Name:	Graft Delivery Device
Regulation Name:	Piston Syringe
Regulation Number:	21 CFR 880.5860
Regulatory Class:	Class II
Product Code:	FMF
Proposed Panel:	General Hospital
Predicate Device:
Name:	Graftgun Universal Graft Delivery System (K180937
Manufacturer:	SurGenTec LLC

Device Description:

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Indications for Use:

The Allograft MIS Delivery System is intended to be used for the delivery of hydrated allograft bone graft material to an orthopedic surgical site.

Comparison of Technological Characteristics to the Predicate:

		Graftgun Universal Graft DeliverySystem(predicate device)	Allograft MISDelivery System(subject device)
General	Applicant	SurGenTec	LifeNet Health
	Regulation No. &Name	21 CFR 880.5860,Piston Syringe	21 CFR 880.5860,Piston Syringe
	Procode	FMF	FMF
	510(K) Number	K180937	K201338
	Labeling	Indications for use	The Graftgun Universal GraftDelivery System is intended to beused for the delivery of hydratedallograft, autograft, or synthetic bonegraft material to an orthopedicsurgical site.
	Prescription /OTC Use	Prescription Use	Prescription Use
	Type of Use	Single, Disposable	Single, Disposable
Design	Mechanism ofoperation	Graft material expressed from grafttube via a plunger, operated by aratchet-actuated handle. Materialexpressed from graft tube directly tograft site.	Graft material expressed fromcannula via a plunger, operated by aratchet-actuated handle. Materialexpressed from graft cannuladirectly to graft site.
	Patient-contactmaterials	Graft tube - Medical gradepolypropyleneLoading Device/Syringe Tube -Medical grade polycarbonateRadiopaque ring marker - Medicalgrade stainless steel - 316L, 316F,304H, 304HC and ABS	Graft cannula - Medical gradepolypropylene
	GraftTube/Cannula	Option of having the 5cc graft tubeprovided clean to a graft facility,preloaded with graft, packaged,sterilized and shipped to the surgicalfacility prior to the surgicalprocedure.	Cannula provided sterile to a graftfacility, preloaded with graft,packaged, and shipped to thesurgical facility prior to the surgicalprocedure.
	Radiopaquemarker	Yes	No
	Volume capacity	Up to 5 cc	Up to 5 cc
	Volume markings	Yes	No
		Graftgun Universal Graft DeliverySystem(predicate device)	Allograft MISDelivery System(subject device)
Sterility	Sterility Claim /SAL	Sterile, SAL 1 x 10-6(see Note 1)	Sterile, SAL 1 x 10-6(see Note 2)
	SterilizationMethod	Gamma irradiation	Dispenser & Plunger:Gamma irradiationCannula & End caps:Ethylene Oxide
		Note 1: Graft tubes are provided to aregistered graft facility. Theirsterilization process is validated asper their internal accepted standardsprior to the prefilled tubes beingshipped.	Note 2: Cannulas and end caps areprovided to a registered graftfacility. Their manufacturing stepsconform to Current Good TissuePractice requirements under 21CFR 1271, Subpart D.

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Performance Data:

The following testing was performed on the subject device to demonstrate substantial equivalence:

Biocompatibility
트 Dimensional and fit verification
I Functional verification
- -Mechanical extrusion
- -Simulated use
트 Package performance and stability

Testing was performed on samples that represented the finished device and all specified acceptance criteria were met.

Conclusion:

The Allograft MIS Delivery System is substantially equivalent to the Graftgun dispensing unit of the Graftgun Universal Graft Delivery System in intended use, mechanism of operation, patientcontacting materials, and intent to supply the device to a registered graft facility prior to the surgical facility. The differences between the subject device and the predicate device are minor and do not impact the safety and effectiveness of the subject device as demonstrated by the provided performance testing.

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).