(103 days)
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is described as a "Mixing and Delivery System" for bone graft material, and its intended use is for the "delivery" of this material. It does not exert a therapeutic effect on the body itself; rather, it is a tool for applying a separate therapeutic agent (the bone graft material).
No
The device is described as a system for mixing and delivering bone graft materials to surgical sites, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly details physical components like a syringe, applicator tip, and pusher rod, and the performance studies focus on mechanical and material properties, indicating it is a hardware-based medical device.
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, autograft, or synthetic bone graft material to surgical sites." This describes a device used in vivo (within the body) for a surgical procedure, not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a system for mixing and delivering bone graft material. This aligns with a surgical tool, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the Bonus Therapeutics Mixing and Delivery System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bonus Therapeutics Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to surgical sites.
Product codes
FMF
Device Description
The Bonus Therapeutics Mixing and Delivery System comprises a sterile piston syringe with an end cap, a cannulated applicator tip and a pusher rod. The syringe consists of syringe barrel with a plunger and an integrated mixing rod to enable mixing of the grafting material prior to application.
The open bore barrel enables the loading of viscous grafting material by transferring it directly into the sterile syringe. The plunger sleeve is removable, and when removed it exposes the integrated mixing rod; a rotatable rod with four diagonal blades which allow mixing of the material as needed prior to injection, while maintained in the closed syringe barrel. When the plunger sleeve is attached, it operates as a simple piston to allow the extrusion of the material from the syringe.
The Cannula may be attached to the syringe via the Luer connection to facilitate the delivery of grafting material to the surgical site.
The Pusher may be used to release grafting material remaining in the Cannula.
The system is supplied sterile for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
surgical sites
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
All necessary testing has been performed for the Bonus Therapeutics Mixing and Delivery System to assure that the device performs as intended. Testing was performed on test units representative of the finished devices. The device design was qualified through tests including: simulated use, liquid leak tests, piston friction, performance limits, biocompatibility evaluation, stability over shelf life.
Biocompatibility evaluation was conducted in accordance with the FDA guidance document 'Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff', published June 16, 2016, and the International Standard ISO 10993-1:2009. The battery of biocompatibility tests included: Cytotoxicity study, Sensitization study - maximization, Irritation study intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity.
Sterility: The Bonus Therapeutics Mixing and Delivery System components are labeled as being sterile for single use, with a Sterility Assurance Level (SAL) of 10-6; sterilization is performed using Gamma radiation at 22.5 kGy. The sterilization process was validated according to AAMI ISO TIR 13004:2013 using the VDmax method, and a verification dose of 22.5 kGy.
Shelf life: The components of the Bonus Therapeutics Mixing and Delivery System have a validated shelf life of 3 years. The ability of the sterile packaging to maintain a sterile barrier and device performance for this shelf life has been validated according to ISO 11607-1 by means of: Verification of package integrity (visual inspection, peel test and dye penetration test) following maximum dose sterilization and accelerated aging based on ASTM F1980; Verification of package integrity (as above) after completion of real time aging; Verification of device performance following accelerated aging and real time aging, including: visual inspection and bench tests in compliance with device specifications (liquid leakage, piston friction, performance limits and mixing rod torque resistance).
Mechanical performance bench testing: The following tests were performed for the verification of the most important functional features of the devices on both newly manufactured devices and devices at different time points of their shelf life: Syringe tightness, Piston friction, Performance limit - cap closure, Performance limit clogged cannula attachment, Mixing rod torque resistance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Bonus Therapeutics Ltd. Nir Shtayer Head of Regulatory Affairs Matam Advanced Technology Park, Building 8B Haifa 3190501 Israel
Re: K190996
Trade/Device Name: Bonus Therapeutics Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: April 17, 2019 Received: April 30, 2019
Dear Nir Shtayer:
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,
Laurence D. Coyne, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K190996
Device Name
Bonus Therapeutics Mixing and Delivery System
Indications for Use (Describe)
The Bonus Therapeutics Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to surgical sites.
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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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:
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Date submitted: April 30, 2019 510(k) Number: K190996
Image /page/3/Picture/1 description: The image contains the logo for Bonus BioGroup. The logo consists of a stylized cross made of bone-like shapes in gold, blue, and green. To the right of the cross is the word "Bonus" in large, bold, blue font, with the word "BioGroup" underneath in a smaller, green font.
K190996 Page 1 of 4
510(k) Summary
This 510(k) summary information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Bonus Therapeutics Ltd.
Matam Advanced Technology Park,
P.O.B 15143,
Haifa, 3190501 ISRAEL |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | April 8th, 2019 |
| Contact: | Nir Shtayer
Head of Regulatory Affairs
Bonus Therapeutics Ltd
Matam Advanced Technology Park,
P.O.B 15143,
Haifa, 3190501 ISRAEL
Phone: 972-73-2067100
Fax: 972-73-2067111
Email: Nirsh@bonus-bio.com |
| Trade Name: | Bonus Therapeutics Mixing and Delivery
System |
| Common Name: | Piston Syringe |
| Classification Name: | Piston Syringe, 21 CFR 880.5860 |
| Regulatory Class: | II |
| Product Code: | FMF |
Predicate Device:
ETEX Mixing and Delivery System, K141245
This predicate has not been subject to a design-related recall.
Reference Device:
InFill™ Graft Delivery System, K143488 is the reference device for the Cannula component of the Bonus Therapeutics Mixing and Delivery System.
This reference device has not been subject to a design-related recall.
Device Description:
The Bonus Therapeutics Mixing and Delivery System comprises a sterile piston syringe with an end cap, a cannulated applicator tip and a pusher rod. The syringe consists of syringe barrel with a plunger and an integrated mixing rod to enable mixing of the grafting material prior to application.
4
K190996 Page 2 of 4
Image /page/4/Picture/1 description: The image shows the logo for Bonus BioGroup. The logo features a stylized cross shape made up of four bone-like elements, each with a gold base, a green center, and a blue tip. To the right of the cross is the word "Bonus" in a bold, dark blue font, with the word "BioGroup" underneath in a smaller, dark green font.
510(k) Summary
The open bore barrel enables the loading of viscous grafting material by transferring it directly into the sterile syringe. The plunger sleeve is removable, and when removed it exposes the integrated mixing rod; a rotatable rod with four diagonal blades which allow mixing of the material as needed prior to injection, while maintained in the closed syringe barrel. When the plunger sleeve is attached, it operates as a simple piston to allow the extrusion of the material from the syringe.
The Cannula may be attached to the syringe via the Luer connection to facilitate the delivery of grafting material to the surgical site.
The Pusher may be used to release grafting material remaining in the Cannula.
The system is supplied sterile for single use.
Indications for Use:
The Bonus Therapeutics Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to surgical sites.
This Indications for Use Statement for The Bonus Therapeutics Mixing and Delivery System is equivalent to the predicate device, as well as to the reference device.
Comparison of Technological Characteristics with the Predicate Device and the Reference Device:
The subject device has the same technological characteristics as the predicate and reference devices. The predicate device, as well as the reference device, use the same or very similar components as the subject device, and all are purchased by the 510(k) holders from the same supplier.
The differences that exist are limited to the cannula length and the presence of a pusher.
These differences have no significant effect on the performance, safety or effectiveness of the subject device.
Performance Data:
All necessary testing has been performed for the Bonus Therapeutics Mixing and Delivery System to assure that the device performs as intended.
Testing was performed on test units representative of the finished devices.
The device design was qualified through tests including:
- simulated use, ●
- liquid leak tests, ●
- piston friction, ●
- performance limits,
- biocompatibility evaluation, ●
- stability over shelf life.
5
K190996 Page 3 of 4
Image /page/5/Picture/1 description: The image contains the logo for Bonus BioGroup. The logo features a stylized cross shape made of bone-like structures in gold, with green and blue accents at the ends. To the right of the cross is the word "Bonus" in a bold, dark blue font, and below that is the word "BioGroup" in a smaller, green font.
510(k) Summary
The following performance data were provided in support of the substantial equivalence determination:
Biocompatibility:
The biocompatibility evaluation for the Bonus Therapeutics Mixing and Delivery System was conducted in accordance with the FDA guidance document 'Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process": Guidance for Industry and Food and Drug Administration Staff', published June 16, 2016, and the International Standard ISO 10993-1:2009, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', as recognized by FDA.
The battery of biocompatibility tests included:
- . Cytotoxicity study
- Sensitization study - maximization
- Irritation study intracutaneous reactivity ●
- . Acute systemic toxicity
- . Material-mediated pyrogenicity
Sterility:
The Bonus Therapeutics Mixing and Delivery System components are labeled as being sterile for single use, with a Sterility Assurance Level (SAL) of 10-6; sterilization is performed using Gamma radiation at 22.5 kGy. The sterilization process was validated according to AAMI ISO TIR 13004:2013 using the VDmax method, and a verification dose of 22.5 kGy.
Shelf life:
The components of the Bonus Therapeutics Mixing and Delivery System have a validated shelf life of 3 years. The ability of the sterile packaging to maintain a sterile barrier and device performance for this shelf life has been validated according to ISO 11607-1 by means of:
- . Verification of package integrity (visual inspection, peel test and dye penetration test) following maximum dose sterilization and accelerated aging based on ASTM F1980.
- Verification of package integrity (as above) after completion of real time aging.
- . Verification of device performance following accelerated aging and real time aging, including: visual inspection and bench tests in compliance with device specifications (liquid leakage, piston friction, performance limits and mixing rod torque resistance).
Mechanical performance bench testing:
The following tests were performed for the verification of the most important functional features of the devices on both newly manufactured devices and devices at different time points of their shelf life:
- . Syringe tightness
6
Image /page/6/Picture/0 description: The image shows the logo for Bonus BioGroup. The logo features a stylized four-pointed star shape in the upper left corner, with each point resembling a bone joint in gold, green, and blue. To the right of the star is the company name, "Bonus" in bold navy blue, with "BioGroup" in green underneath. The overall design is clean and professional, suggesting a focus on bone-related medical or biological products.
K190996 Page 4 of 4
510(k) Summary
- Piston friction ●
- Performance limit -cap closure .
- Performance limit clogged cannula attachment ●
- Mixing rod torque resistance ●
Conclusion:
The Bonus Therapeutics Mixing and Delivery System is substantially equivalent to the predicate device with regard to intended use, indications for use, and fundamental technology, including design, materials, sterility, and operational principles. Based on this information, the subject device does not raise any new issues regarding safety or efficacy when compared to the predicate device.