Who is the manufacturer of Mixing and Delivery System?

Bone Solutions, Inc. filed the 510(k) submission for Mixing and Delivery System (K192674).

What is the FDA product code for Mixing and Delivery System?

FMF. It is classified under 21 CFR 880.5860 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Mixing and Delivery System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Mixing and Delivery System?

Bone Solutions Mixing and Delivery System (K161568).

Who can help prepare an FDA 510(k) submission like Mixing and Delivery System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mixing and Delivery System

K192674 · Bone Solutions, Inc. · FMF · Feb 18, 2020 · General Hospital

Device Facts

Record ID	K192674
Device Name	Mixing and Delivery System
Applicant	Bone Solutions, Inc.
Product Code	FMF · General Hospital
Decision Date	Feb 18, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5860
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site.

Device Story

Device is a piston syringe system used to mix and deliver bone graft materials (allograft, autograft, or synthetic) to orthopedic surgical sites. System includes a mixing/delivery syringe, threaded spindle with nut, open bore luer cap, pusher, and cannulae. Operated by clinicians in surgical settings; provides manual delivery methods for graft material. Device facilitates controlled placement of bone graft into surgical sites, aiding orthopedic procedures. Output is the physical delivery of graft material; healthcare providers use the system to ensure precise graft placement.

Clinical Evidence

Bench testing only. Performance testing included liquid and air leak testing, separation from axial load testing, disconnection torsional testing, and sterility/packaging validation. Results confirmed the device met all specified criteria.

Technological Characteristics

Piston syringe system; 14cc volume; medical grade polymers; manual operation via axial push or helical screw; luer and open bore threaded tips; cannulae lengths 100/150mm and diameters 4.3/8.0mm. Sterile, single-use.

Indications for Use

Indicated for delivery of hydrated allograft, autograft, or synthetic bone graft material to orthopedic surgical sites.

Regulatory Classification

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.

Predicate Devices

Bone Solutions Mixing and Delivery System (K161568)

Reference Devices

InFill™ Graft Delivery System (K143488)
ETEX Mixing and Delivery System (K141245)

Related Devices

K062986 — MEDTRONIC GRAFT DELIVERY SYRINGE · Medtronic Sofamor Danek USA, Inc. · Dec 8, 2006
K173385 — Graft Delivery, DePuy Synthes · Micromedics, Inc. (D/B/A Nordson Medical) · Nov 30, 2017
K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS) · Depuyacromed · Nov 14, 2001
K161568 — Bone Solutions Mixing and Delivery System · Bone Solutions, Inc. · Sep 16, 2016
K022246 — MODIFICATION TO SYMPHONY GRAFT DELIVERY SYSTEM · Depuyacromed · Aug 2, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 18, 2020 Bone Solutions, Inc. % Karen E. Warden, Ph.D. President BackRoads Consulting Incorporation Po Box 566 12520 Heath Road Chesterland, Ohio 44026 Re: K192674 Trade/Device Name: Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: January 21, 2020 Received: January 23, 2020 Dear Dr. Warden: 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. {1}------------------------------------------------ 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 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192674 Device Name Mixing and Delivery System #### Indications for Use (Describe) The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, or synthetic bone graft material to an orthopedic surgical site. Type of Use (Select one or both, as applicable) | <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | |----------------------------------------------------------------------------------|----------------------------------------------------------------------| |----------------------------------------------------------------------------------|----------------------------------------------------------------------| ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary | Date: | 11 February 2020 | |---------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sponsor: | Bone Solutions, Inc. 5712 Colleyville Blvd, STE 210 Colleyville, TX 76034 | | Sponsor Contact: | Drew Diaz, CEO Office: 817.809.8850 customerservice@bonesolutions.net | | 510(k) Contact: | Karen E. Warden, PhD President, BackRoads Consulting Inc. PO Box 566 Chesterland, OH 44026 Office: 440.729.8457 info@followbackroads.com | | Proposed Trade Name: | Mixing and Delivery System | | Common Name: | Piston syringe | | Device Classification: | Class II | | Regulation Name, Regulation Number, Product Code: | Piston syringe, 880.5860, FMF | | Submission Purpose: | To add auxiliary components to the cleared Bone Solutions Mixing and Delivery System components. | | Device Description: | The Mixing and Delivery System is used to mix graft material such that it can be delivered to the patient. The system is comprised of the mixing/delivery syringe and auxiliary components including a threaded spindle with nut, open bore luer cap, pusher and cannulae which provide alternative methods of delivery for the mixed material. | | Indications for Use: | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | | Primary Predicate: | Bone Solutions Mixing and Delivery System (Bone Solutions, Inc. - K161568) | | Reference Devices: | InFill™ Graft Delivery System (Pinnacle Spine Group - K143488), ETEX Mixing and Delivery System (ETEX Corporation - K141245) | | Performance Data: | The following non-clinical performance testing was performed to demonstrate the device performs as intended: Liquid and Air Leak Testing Separation from Axial Load Testing Disconnection Torsional Testing Sterility Validation Testing and Packaging Validation Testing The Mixing and Delivery System met all specified criteria and did not raise new safety or performance questions. | | Substantial Equivalence Comparison: | The subject Mixing and Delivery System components possess the same indications for use and technological characteristics as the predicate devices and/or reference devices as shown below. | {4}------------------------------------------------ | System → Features↓ | Subject device: Bone Solutions Mixing and Delivery System K192674 | Primary predicate: Bone Solutions Mixing and Delivery System K161568 | Reference device: InFill™ Graft Delivery System K143488 | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use: | The Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | The Bone Solutions Mixing and Delivery System is intended to be used for the delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site. | The InFill™ Graft Delivery System is intended to be used for the delivery of hydrated allograft, autograft or synthetic bone graft material to an orthopedic surgical site | | Basic design | Piston syringe with auxiliary components | Piston syringe with auxiliary components | Piston syringe with auxiliary components | | Material | Medical grade polymers | Medical grade polymers | Medical grade polymers | | Principle of operation | Mix and deliver graft material | Mix and deliver graft material | Mix and deliver graft material | | How supplied | Sterile, single use only | Sterile, single use only | Sterile, single use only | | Syringe | Piston | Piston | Piston | | Plunger | Axial push or helical screw | Axial push | Helical screw | | Tip | Luer | Luer | Luer | | Volume | 14cc | 14cc | 14cc | | Cannula | Luer & open bore threaded | Luer & open bore threaded | Luer & open bore threaded | | Length | 100 & 150mm | -- NA -- | 150, 275 & 300mm | | Diameter | 4.3 & 8.0mm | 4.3 & 8.0mm | 3.5, 4.8 & 8.0mm | | Accessories | Mixing plunger, funnel | Mixing plunger, funnel | Mixing plunger, funnel | Substantial Equivalence Conclusion: Bone Solutions has demonstrated that the Mixing and Delivery System possesses the same intended use and technological characteristics as the predicate devices. Therefore the Mixing and Delivery System is substantially equivalent for its intended use.