(123 days)
No
The device description and performance studies focus on mechanical delivery of bone graft material and do not mention any computational or analytical capabilities that would suggest the use of AI/ML. The "Mentions AI, DNN, or ML" section is also explicitly marked as "Not Found".
No
The device is described as an autograft delivery system, intended for the delivery of bone graft material to a surgical site, and it does not directly treat a disease or condition.
No
Explanation: The device is intended for the delivery of bone graft material to an orthopaedic surgical site, which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide information on medical conditions.
No
The device description clearly lists multiple hardware components (Graft Cartridge, Bone Loading Scoop, Bone Packer, Delivery Cannulas, Threaded Delivery Plunger) that are integral to the device's function of delivering bone graft material.
Based on the provided information, the Avitus® Precision Autograft Delivery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the delivery of bone graft material to an orthopaedic surgical site. This is a surgical procedure, not a diagnostic test performed in vitro (outside the body).
- Device Description: The device is a mechanical system for handling and delivering bone graft. It does not involve analyzing biological samples or providing diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in a biological sample, or provide any information about a patient's health status based on in vitro analysis.
- Testing: The testing described focuses on the mechanical performance and reliability of the device in delivering bone graft, not on its ability to perform a diagnostic test.
IVD devices are typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Avitus system's function is purely for the physical delivery of material during surgery.
N/A
Intended Use / Indications for Use
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.
Product codes
FMF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orthopaedic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
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
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); 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 by
Mark Trumbore -S |
|-------------|-----------------------------------------|
| Trumbore -S | Date: 2023.06.26
15:57:56 -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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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
4
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.
5
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
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.
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 Precision
Autograft Delivery System | Predicate Device -
Bi-Portal Bone Graft
Delivery Device
(K142661) |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Product Code | FMF; Syringe, Piston | FMF; Syringe, Piston |
| Classification
and Regulation | 880.5860 | 880.5860 |
| Indication for
Use | Intended to be used for the delivery of bone
autograft or hydrated allograft. | Intended to be used for
the delivery of bone
autograft or hydrated
allograft. |
| Materials | Biocompatible Polycarbonate (Graft Cartridge,
Cannula, Plunger, Pack tool, Bone Scoop
Accessory
Biocompatible Stainless Steel (Cannula and
Plunger) | Biocompatible Plastics
(Entire Device) |
| Mechanism of
Operation | Graft material dispersed from device tip by
depressing the plunger. Plunger is threaded and
is twisted clockwise to disperse graft material. | Graft material dispersed
from device tip by
depressing the plunger. |
| Recommended
Graft Volume | Approximately up to 0.5cc per Cartridge | Up to 4.0cc in Barrel |
| Bone Graft Exit
Hole
Configuration | Single cannula endhole; 3.4mm diameter | Two sideholes; 5.6mm x
14.8mm |
| Sterilization
Method | 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
7
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 (