(267 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No.
This device is for the delivery of allograft material, not for treating a condition or restoring function itself.
No
Explanation: The device is a delivery system for allograft material, not a diagnostic tool. Its intended use is for "delivery of hydrated allograft to an orthopedic surgical site," and its description focuses on the physical components for this delivery. There is no mention of it being used to identify or determine the nature of a disease or condition.
No
The device description explicitly details physical components (cannula, push rod) and the performance studies include testing of physical properties and functions (sterilization, biocompatibility, functional verification of physical components).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of hydrated allograft to an orthopedic surgical site." This describes a device used during a surgical procedure to physically deliver material to a patient's body.
- Device Description: The description details a physical device (cannula and push rod) designed for containing and expressing allograft material. It does not mention any components or functions related to testing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, providing diagnostic information, or any other activities typically associated with IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely for the physical delivery of material during surgery.
N/A
Intended Use / Indications for Use
The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula.
The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
Sterilization and Shelf-life:
Sterilization validation was conducted to confirm that the subject device reached 10℃ sterility assurance level and the performance of the device and packaging are in line with expectations after sterilization requirements per ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3: 2017 standards. The sterilization process has been successfully validated and the sterility tests are within satisfactory limits.
The shelf-life validation study was conducted under the accelerated aging condition according to ASTM F1980-21 to verify the packaging integrity as well as the physical properties of the Allograft Delivery Device are within pass limits both before and after the aging process. The results successfully demonstrate an up to 1 year shelf life.
Sterile barrier testing was conducted in compliance with the following FDA-recognized consensus standards:
Visual Inspection, F1886/F1886M-16
Bubble Leak, ASTM F2096-11
Seal Strength, ASTM F88/F88M-21
Biocompatibility Testing:
The biocompatibility evaluation for the Allograft Delivery Device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" issued on September 8, 2023, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were conducted:
Cytotoxicity
Pyrogenicity
Irritation
Acute Systemic Toxicity
Sensitization
All of the tests received passing results, demonstrating that the Allograft Delivery Device meets the applicable requirements outlined in the FDA guidance on ISO 10993-1.
Functional verification:
Cannula Buckling
Plunger Force
Cannula Connection Strength
No gross separation of fluids from allograft
Cannula Durability
Push Rod Function/Strength
Shipping/Transit:
Shipping/Transit testing was conducted as per ASTM D4169-22
Usability testing:
Usability testing was conducted as per IEC 62366-1 edition 1.1 2020-06
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate device.
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.
Not Found
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: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
June 25, 2024
Bioventus LLC Shanna Hu Sr. Manager RA, FES Technology 4721 Emperor Blvd., Suite 100 Durham, North Carolina 27703
Re: K233368
Trade/Device Name: Allograft Delivery Device (OFAC-C) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: May 24, 2024 Received: May 24, 2024
Dear Shanna Hu:
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 (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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 H. Chen =S Digitally signed by Long H. Chen-S
Date: 2024.06.25 15:21:19 -04'00'
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
indications for
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Allograft Delivery Device (OFAC-C)
Indications for Use (Describe)
The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft 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.
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3
Image /page/3/Picture/0 description: The image shows the logo for Bioventus. The logo consists of a circular, interwoven design in shades of purple and orange on the left. To the right of the design is the word "bioventus" in a sans-serif font, colored in purple.
Manufacturer:
510(k):
Bioventus 4721 Emperor Blvd., Suite 100 Durham, NC 27703 USA
K233368 510(k) Summary
510(k) Summary Allograft Delivery Device
| Submitter Information: | |
|---|---|
| Company: | Bioventus LLC |
| 4721 Emperor Boulevard | |
| Suite 100 | |
| Durham, NC 27703 | |
| Contact: | Shanna Hu |
| Senior Manager, Regulatory Affairs | |
| (661) 362-6694 | |
| shanna.hu@bioventus.com |
Kellie Stefaniak
Vice President, Regulatory Affairs
(919) 566-1224
kellie.stefaniak@bioventus.com |
| Date Prepared: | June 24, 2024 |
| Device Information: | |
| Trade Name: | Allograft Delivery Device |
| Common Name: | Graft Delivery Device |
| Regulation Name: | Piston Syringe |
| Regulation Number: | 21 CFR 880.5860 |
| Regulatory Classification: | Class II |
| Product Code: | FMF |
| Proposed Panel: | General Hospital |
| Predicate Device: | |
| Name: | Bi-Portal Bone Graft Delivery Device (KGM1 Graft Delivery Canula) |
Spinal Surgical Strategies, LLC (Kleiner Device Labs) K142661
4
Device Description:
The Allograft Delivery Device is a sterile, single-use, disposable allograft delivery device intended for the delivery of hydrated allograft bone graft material to an orthopedic surgical site. The delivery device consists of a cannula used for containing and delivering the allograft material to the surgical site and a push rod required for expressing the allograft material from the cannula.
The cannula component is an open bore tube with a male double-threaded lock interface that mates with a pre-existing allograft syringe. The cannula component may be used to dispense allograft to a patient orthopedic surgical site. When used as an ancillary device to orthopedic surgical procedures that require the placement of allograft Delivery Device can deliver a prepared amount of allograft material.
Indications for Use:
The Allograft Delivery Device is intended to be used for the delivery of hydrated allograft to an orthopedic surgical site.
Substantial Equivalence:
The Allograft Delivery Device was evaluated to verify substantial equivalence. The indication for use of the subject device is the same as the predicate device. The comparison table provides an overview of the indications, key features, and technological comparison of the device to the predicate device. These comparisons support substantial equivalence for the intended use, technology, function, and mechanism of action to the predicate. The Allograft Delivery Device does not introduce any new issues of safety or efficacy relative to the predicate device.
Comparison Table:
| Attributes | Allograft Delivery Device
(Subject Device) | Bi-Portal Bone Graft
Delivery Device
(Predicate Device) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Bioventus LLC | Spinal Surgical Strategies,
LLC (Kleiner Device Labs) |
| Regulation No. & | 21 CFR 880.5860, Piston | 21 CFR 880.5860, Piston |
| Name | Syringe | Syringe |
| Product Code | FMF | FMF |
| 510(k) Number | K233368 | K142661 |
| Indications for Use | The Allograft Delivery
Device is intended to be
used for the delivery of
hydrated allograft to an
orthopedic surgical site. | The Bi-Portal Bone Graft
Delivery Device is
intended to be used for the
delivery of hydrated
allograft or autograft to an
orthopedic surgical site. |
5
| Prescription / OTC Use | Prescription Use | Prescription Use |
|---|---|---|
| Type of Use | Single-Use, Disposable | Single-Use, Disposable |
| Mechanism of | ||
| Operation | Graft dispersed from device | |
| tip by depressing syringe | ||
| plunger and by the action of | ||
| a push rod. | Graft dispersed from | |
| device tip by depressing | ||
| plunger | ||
| Graft Injection | Single distal hole delivery | |
| into surgical space | Bilateral sidehole delivery | |
| into surgical space | ||
| Device Materials | Biocompatible Medical | |
| grade polypropylene | Biocompatible Medical | |
| Grade Plastics | ||
| Device Components | Cannula Barrel and Push | |
| Rod | Barrel, Plunger and Funnel | |
| Bone Graft Exit Hole | ||
| Diameter | Single distal hole | |
| 5.5 mm | Two sideholes: | |
| 5.6 mm x 14.8mm | ||
| Barrel Shape | Round, Curved | Rectangular, Straight |
| Volume Capacity | Up to 4.6 cc in Cannula | |
| Barrel | Up to 4.0 cc in Barrel | |
| Sterility Claim / | ||
| Sterility Assurance | ||
| Level (SAL) | Sterile, SAL 1 x 10-6 | Sterile, SAL 1 x 10-6 |
| Sterilization Method | Gamma irradiation | Ethylene Oxide gas |
Performance Data:
The following performance data were provided in support of the substantial equivalence determination:
Sterilization and Shelf-life
Sterilization validation was conducted to confirm that the subject device reached 10℃ sterility assurance level and the performance of the device and packaging are in line with expectations after sterilization requirements per ISO 11137-1:2006, ISO 11137-2:2013, and ISO 11137-3: 2017 standards. The sterilization process has been successfully validated and the sterility tests are within satisfactory limits.
The shelf-life validation study was conducted under the accelerated aging condition according to ASTM F1980-21 to verify the packaging integrity as well as the physical properties of the Allograft Delivery Device are within pass limits both before and after the aging process. The results successfully demonstrate an up to 1 year shelf life.
6
Sterile barrier testing was conducted in compliance with the following FDA-recognized consensus standards:
- . Visual Inspection, F1886/F1886M-16
- Bubble Leak, ASTM F2096-11
- Seal Strength, ASTM F88/F88M-21
Biocompatibility Testing
The biocompatibility evaluation for the Allograft Delivery Device was conducted in accordance with the FDA guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"" issued on September 8, 2023, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The following tests were conducted:
- Cytotoxicity
- Pyrogenicity
- Irritation
- Acute Systemic Toxicity ●
- Sensitization ●
All of the tests received passing results, demonstrating that the Allograft Delivery Device meets the applicable requirements outlined in the FDA guidance on ISO 10993-1.
Functional verification
- о Cannula Buckling
- o Plunger Force
- Cannula Connection Strength o
- No gross separation of fluids from allograft
- Cannula Durability o
- o Push Rod Function/Strength
Shipping/Transit
Shipping/Transit testing was conducted as per ASTM D4169-22
Usability testing
Usability testing was conducted as per IEC 62366-1 edition 1.1 2020-06
The conclusions drawn from the performance tests demonstrate that the device is performing as intended, and is substantially equivalent to the predicate device.
7
Conclusion:
The Allograft Delivery Device is substantially equivalent to the Bi-Portal Bone Graft Delivery Device in intended use, mechanism of operation, and patient-contacting materials. Performance testing has been conducted to demonstrate the subject device and predicate device technological characteristics are equivalent and that the subject device is as safe and as effective as the predicate device.