The Avitus® Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

Device Description

The Avitus Precision Autograft Delivery System is designed to deliver bone autograft or hydrated allograft material to an orthopaedic surgical site. The device delivers approximately up to 0.5cc of bone graft material per reloadable cartridge. Each system comes with the following:

· 2 x Graft Cartridge Features a graft channel, latching lid, and connection points to the Delivery Cannula and Threaded Delivery Plunger.
· 1 x Bone Loading Scoop Accessory Used to add graft to the Graft Cartridge channel.
· 1 x Bone Packer Accessory Used to compress graft into the Graft Cartridge channel.
· 1 x Straight Delivery Cannula Features a hub, which connects to a loaded Graft Cartridge, and straight-tipped cannula, through which graft material is delivered to the orthopaedic surgical site.
· 1 x Angled Delivery Cannula Features a hub, which connects a loaded Graft Cartridge, and angle-tipped cannula, through which graft material is delivered laterally to the orthopaedic surgical site.
· 1 x Threaded Delivery Plunger Features a plunger rod, knob, and threads. During graft delivery, the rod is depressed into the Graft Cartridge until the Plunger's threads engage with the Cartridge. This action transfers graft material into the Cannula. With the threads engaged, the user twists the Plunger knob to deliver a controlled volume of graft to the orthopaedic surgical site.

AI/ML Overview

The provided text describes the Avitus Precision Autograft Delivery System, a medical device designed to deliver bone graft material. It includes a 510(k) summary for the device, comparing it to a predicate device and outlining non-clinical testing and biocompatibility assessments.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria or specific numerical performance metrics for the Avitus Precision Autograft Delivery System. However, it states the overall conclusion from non-clinical testing:

Acceptance Criteria Category	Reported Device Performance (Implied from the text)
Reliability of Delivery	Meets reliability requirements for successful delivery of cadaveric bone graft material.
Structural Integrity	Meets confidence requirements for structural integrity during normal use.
Biocompatibility	Demonstrated with identical materials and processes to the Avitus Orthopaedics, Inc. Bone Harvester devices, indicating no negative impact on product safety or effectiveness.
Functionality (Graft Delivery)	Effectively delivers graft material (demonstrated in performance testing).

2. Sample Size Used for the Test Set and Data Provenance

The text mentions "worst-case non-clinical testing" and the use of "cadaveric bone graft material." However, it does not specify the sample size used for this test set nor the specific provenance of the cadaveric bone graft material (e.g., country of origin). The testing described is retrospective in nature, as it's a verification of the device's performance post-design before market release.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the non-clinical performance testing. The "ground truth" for the device's performance appears to be established through engineering specifications and the observed functionality during testing with cadaveric material.

4. Adjudication Method for the Test Set

Since the document does not mention the use of experts or a formal ground truth establishment process involving multiple parties, there is no adjudication method described for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device described is a delivery system for bone graft material, not an imaging or diagnostic device that would typically involve human readers. The text confirms: "No clinical testing was performed in association with this submission."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The Avitus Precision Autograft Delivery System is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only)" performance does not apply to this device. The non-clinical testing described focused on the physical device's performance.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" was based on engineering specifications and observed physical performance of the device successfully delivering cadaveric bone graft material, and maintaining structural integrity. For biocompatibility, the ground truth was established by demonstrating material equivalence and identical processes to a previously cleared device (Avitus Bone Harvester) that had undergone standard biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity).

8. The Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning or AI algorithms. Since this is a physical medical device, there is no training set in that context. The development and design of the device would have involved iterative testing and refinement, but not a formal "training set" as understood in AI studies.

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

As there is no training set for an AI/algorithm, this question is not applicable. The "ground truth" for the device's design and functionality would have been established through engineering design principles, materials science, and physical prototyping, followed by verification and validation testing.

Summary

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June 26, 2023

Avitus Orthopaedics, Inc. % Robert Mclain Sr. Quality and Regulatory Affairs Consultant Keystone Regulatory Services, LLC 324 E. Main Street Leola, Pennsylvania 17540

Re: K230492

Trade/Device Name: Avitus® Precision Autograft Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: May 4, 2023 Received: May 4, 2023

Dear Robert Mclain:

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

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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); 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,

Mark	Digitally signed byMark Trumbore -S
Trumbore -S	Date: 2023.06.2615:57:56 -04'00'

Mark Trumbore, 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

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Indications for Use

510(k) Number (if known) K230492

Device Name Avitus® Precision Autograft Delivery System

Indications for Use (Describe)

The Avitus® Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

Type of Use (Select one or both, as applicable)
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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 - K230492

Avitus Orthopaedics, Inc. Avitus Precision Autograft Delivery System

Robert McLain Sr. Quality and Regulatory Affairs Consultant Keystone Regulatory Services, LLC 717-656-9656 rob.mclain@keystoneregulatory.com

June 12, 2023

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Section 1 510(k) Summary

Submission Owner and Correspondent 1.1

Submission Owner

Avitus Orthopaedics, Inc. 6 Armstrong Rd., Suite 107 Shelton, CT 06484 USA Contact: Maxim Budyansky Phone: 860-372-7213 Email: maxim@avitusortho.com

Submission Correspondent

Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, PA 17540 Contact: Robert McLain Phone: 717-656-9656 E-Mail: rob.mclain@keystoneregulatory.com

1.2 Date Summary Prepared

June 12, 2023

Device Trade Name 1.3

Avitus Precision Autograft Delivery System

1.4 Device Common Name

Piston syringe.

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Device Classification Name 1.5

Syringe, Piston Classified as Class 2 at 21 CFR 880.5860, product code FMF.

1.6 Predicate Device

The Spinal Surgical Strategies, LLC Bi-Portal Bone Graft Delivery Device cleared under K142661.

1.7 Description of the Device

· 2 x Graft Cartridge Features a graft channel, latching lid, and connection points to the Delivery Cannula and Threaded Delivery Plunger.
· 1 x Bone Loading Scoop Accessory Used to add graft to the Graft Cartridge channel.
· 1 x Bone Packer Accessory Used to compress graft into the Graft Cartridge channel.
· 1 x Straight Delivery Cannula Features a hub, which connects to a loaded Graft Cartridge, and straight-tipped cannula, through which graft material is delivered to the orthopaedic surgical site.
· 1 x Angled Delivery Cannula Features a hub, which connects a loaded Graft Cartridge, and angle-tipped cannula, through which graft material is delivered laterally to the orthopaedic surgical site.
· 1 x Threaded Delivery Plunger Features a plunger rod, knob, and threads. During graft delivery, the rod is depressed into the Graft Cartridge until the Plunger's threads engage with the Cartridge. This action transfers graft material into the Cannula. With the threads engaged, the user twists the Plunger knob to deliver a controlled volume of graft to the orthopaedic surgical site.

Indications for Use 1.8

The Avitus Precision Autograft Delivery System is intended to be used for the delivery of autograft or hydrated allograft bone graft material to an orthopaedic surgical site.

1.9 Technological Characteristics

Table 1.1 compares the technological characteristics of the proposed Avitus Precision Autograft Delivery System and the predicate Bi-Portal Bone Graft Delivery Device.

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Feature	Proposed Device - Avitus PrecisionAutograft Delivery System	Predicate Device -Bi-Portal Bone GraftDelivery Device(K142661)
Product Code	FMF; Syringe, Piston	FMF; Syringe, Piston
Classificationand Regulation	880.5860	880.5860
Indication forUse	Intended to be used for the delivery of boneautograft or hydrated allograft.	Intended to be used forthe delivery of boneautograft or hydratedallograft.
Materials	Biocompatible Polycarbonate (Graft Cartridge,Cannula, Plunger, Pack tool, Bone ScoopAccessoryBiocompatible Stainless Steel (Cannula andPlunger)	Biocompatible Plastics(Entire Device)
Mechanism ofOperation	Graft material dispersed from device tip bydepressing the plunger. Plunger is threaded andis twisted clockwise to disperse graft material.	Graft material dispersedfrom device tip bydepressing the plunger.
RecommendedGraft Volume	Approximately up to 0.5cc per Cartridge	Up to 4.0cc in Barrel
Bone Graft ExitHoleConfiguration	Single cannula endhole; 3.4mm diameter	Two sideholes; 5.6mm x14.8mm
SterilizationMethod	Ethylene Oxide	Ethylene Oxide

Table 1.1: Device Comparison

This section contains a comparison of technological characteristics of the Avitus Precision Autograft Delivery System and the predicate Bi-Portal Bone Graft Delivery Device and, where there are differences, provides an explanation of why there is no negative impact on substantial equivalence.

Materials

Both the Avitus Precision Autograft Delivery System and the predicate K142661 Bi-Portal Bone Graft Delivery Device are made of biocompatible plastic materials. All elements of the Avitus Precision Autograft Delivery System are composed of polycarbonate with the sole exception of the cannula and plunger components, which contain biocompatible stainless steel in addition to polycarbonate. The polycarbonate and stainless steel materials which make up the Avitus Precision Autograft Delivery System are identical to the polycarbonate and stainless steel materials which make up the Avitus Orthopaedics, Inc. Bone Harvester devices (K152474). Similarities in Avitus Precision Autograft Delivery System and Avitus Bone Harvester device scale, manufacturing methods, and intended clinical use environment indicate that materials will not negatively impact the overall use and function of the new device. Biocompatibility has been demonstrated with the uti

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lization of identical materials and processes to the materials found in the Avitus Orthopaedics. Inc. Bone Harvester devices, there is no negative impact on product safety or effectiveness.

Mechanism of Operation

The predicate K142661 Bi-Portal Bone Graft Delivery Device deploys bone autograft or hydrated allograft when the user depresses the Threaded Delivery Plunger into the Cannula. The Avitus Precision Autograft Delivery System deploys bone autograft or hydrated allograft using a two stage deployment process. First, user depresses the Threaded Delivery Plunger into the Graft Cartridge until the Plunger's back-end threads engage with the Graft Cartridge, moving bone graft material into the Cannula. Next, the user turns the Threaded Delivery Plunger to deploy the desired volume of bone graft material from the Cannula. Despite this additional feature, which provides the user with precise control over the deployed volume of bone graft, the Avitus Precision Autograft Delivery System and the predicate K142661 Bi-Portal Bone Graft Delivery Device share basic mechanism of action. The addition of the threaded mechanism in the Avitus Precision Autograft Delivery System does not negatively impact product safety or effectiveness.

Recommended Graft Volume

The predicate K142661 Bi-Portal Bone Graft Delivery Device can accommodate up to 4.0 cc of hydrated allograft or autograft material in its syringe barrel. The Avitus Precision Autograft Delivery System can accommodate approximately up to 0.5 cc of hydrated allograft or autograft material in each reloadable Graft Cartridge. If more graft is required at the delivery site, the user replaces the Graft Cartridge with another loaded Graft Cartridge. This is repeated as many times as needed by opening the lid of the Graft Cartridge and reloading it after bone delivery. The Avitus Precision Autograft Delivery System and the predicate K142661 Bi-Portal Bone Graft Delivery Device are intended to deliver different volumes of graft. There is no negative impact of recommended graft volume on product safety or effectiveness because the Avitus Precision Autograft Delivery System will be utilized by clinicians who want to deliver smaller, precise volumes of graft.

Bone Graft Exit Hole Configuration

The predicate K142661 Bi-Portal Bone Graft Delivery Device deploys bone autograft or hydrated allograft through bilateral sideholes. Each sidehole measures 14.8 mm x 5.6 mm. The Avitus Precision Autograft Delivery System deploys bone autograft through a single endhole in the case of the Straight Delivery Cannula and through a single sidehole in the case of the Angled Delivery Cannula. Both Straight and Angled Delivery Cannulas have an exit hole diameter of 3.4 mm. This difference, combined with the difference in recommended graft volume, indicates that the devices are designed to deliver different volumes of graft material, however, there is no difference between the proposed and predicate devices in terms of function and intended purpose. The Avitus Precision Autograft Delivery System effectively delivers graft material. This has been demonstrated in performance testing. There is no negative impact of the difference in bone graft exit hole configuration on product safety or effectiveness.

1.10 Non-Clinical Testing

Avitus Orthopaedics, Inc. performed worst-case non-clinical testing in which the Avitus Precision Autograft Delivery System was used to deliver cadaveric bone graft material. Testing found that the Avitus Precision Autograft Delivery System meets the reliability and confidence requirements for successful delivery and for structural integrity during normal use.

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1.11 Biocompatibility

The previously-cleared Avitus Bone Harvester and the Avitus Precision Autograft Delivery System are both external communicating devices with limited tissue/bone/dentin contact (<24 hours). Per ISO 10993-1:2018 and FDA Guidance Use of International Standard ISO 10993-1, the following biocompatibility endpoints are appropriate for both devices:

· Cytotoxicity
· Sensitization
· Irritation
· Acute Systemic Toxicity
· Material-Mediated Pyrogenicity

Per Attachment D of the aforementioned FDA guidance, the results of biocompatibility testing of the Avitus Bone Harvester may be applied to the subject device, considering that the material formulation, body contact, and sterilization of direct and indirect contacting components are identical and that the geometry and manufacturing processes (noting that no new plasticizers, fillers, additives, cleaning agents, mold release agents have been added to the subject device manufacturing process) of the Avitus Bone Harvester represent worst-case biocompatibility conditions.

Clinical Testing 1.12

No clinical testing was performed in association with this submission.

1.13 Conclusions

The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed 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).