(101 days)
Not Found
No
The summary describes a simple mechanical mixing and delivery system (syringe and funnel) with no mention of AI/ML terms, image processing, or performance studies related to algorithmic analysis.
No
The device is described as a system for mixing and delivering bone graft materials to a surgical site, which is a supportive function during therapy, not a therapeutic action itself. It does not directly treat or prevent a disease or condition.
No
Explanation: The device is described as a "Mixing and Delivery System" for bone graft material and its intended use is for delivery, not for diagnosing medical conditions.
No
The device description explicitly states it is a disposable medical piston syringe and funnel, which are physical hardware 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, autograft, or synthetic bone graft material to an orthopedic surgical site." This describes a surgical tool used in vivo (within the body) to deliver material, not a device used in vitro (outside the body) to test samples like blood, urine, or tissue for diagnostic purposes.
- Device Description: The description details a syringe and funnel system for mixing and delivering bone graft material. This aligns with a surgical delivery system, not an IVD which would typically involve reagents, test strips, or analytical components.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting markers, or providing diagnostic information.
Therefore, the Bone Solutions Mixing and Delivery System is a surgical delivery device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Bone Solutions Mixing and Delivery System is commercially available disposable medical piston syringe (syringe barrel with female luer, plunger) to facilitate mixing and a funnel to facilitate filling of the syringe barrel. The system with a 14 mL syringe barrel and will be provided empty.
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
qualified medical personnel in a controlled operating room environment
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)
Not Found
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a cascading manner, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2016
Bone Solutions, Inc. Mr. Drew Diaz President - CEO 5712 Colleyville Blvd. Suite 210 Collevville. Texas 76034
Re: K161568
Trade/Device Name: Bone Solutions Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: August 31, 2016 Received: September 2, 2016
Dear Mr. Diaz:
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth
1
in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christopher J. Ronk-S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K161568
Device Name
Bone Solutions Mixing and Delivery System
Indications for Use (Describe)
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.
| 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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5 510(k) Summary
In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Bone Solutions, Inc. is hereby submitting this 510(k) summary.
Submitter [510(k) owner]
Bone Solutions, Inc.
5712 Colleyville Blvd., Suite 210
Colleyville, TX 76034
Company Contact
Drew Diaz President-CEO P 817.809.8850 diaz@bonesolutions.net
Submitted Device Information
Trade Name: Bone Solutions Mixing and Delivery System Common Name: Piston Syringe Classification Name: Syringe, Piston, General Hospital
Classification Information
Classification: Class II Classification Regulation: 21 CFR 880.5860 Classification Product Code: FMF
Legally Marketed Predicate Devices
The Bone Solutions Mixing and Delivery System manufactured by Bone Solutions, Inc. (BSI) is substantially equivalent to the following device currently in commercial use:
| Device: | ETEX Mixing and Delivery System |
|---|---|
| Manufacturer: | ETEX Corporation |
| Address: | 675 Massachusetts Ave., 12th Floor, Cambridge, MA 02139 |
| 510(k) number: | K141245 |
Submitted Device Description
The Bone Solutions Mixing and Delivery System is commercially available disposable medical piston syringe (syringe barrel with female luer, plunger) to facilitate mixing and a funnel to facilitate filling of the syringe barrel. The system with a 14 mL syringe barrel and will be provided empty.
Intended Use
The Bone Solutions Mixing and Delivery System, like the predicate, is intended to provide the surgeons with a means to mix and deliver graft material to an orthopedic surgical site.
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The Bone Solutions Mixing and Delivery System is intended to be used in a controlled operating room environment with compatible devices by qualified medical personnel. The device is sterile, single use, with a 3 year expected shelf life.
Indications for Use:
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.
Substantial Equivalence
The Bone Solutions Mixing and Delivery System is substantially equivalent to the predicate device, in which the basic features and intended uses are the same. The identical mixing syringes, made of identical materials, have been provided to both manufacturers by the same qualified supplier, as verified in the design history file. The lack of gradation markings on the BSI syringe does not change the performance or biocompatibility compared to the predicate Additions from the accessory tray are considered minor and do not raise questions concerning safety and effectiveness.
The Bone Solutions Mixing and Delivery System is substantially equivalent in design, manufacturing materials, intended use, principles of operation, and technical characteristics to the ETEX Mixing and Delivery System, and raises no new issues of safety or effectiveness.
Drew Diaz President-CEO 5712 Colleyville Blvd., Suite 210 Colleyville, TX 76034 P 817.809.8850
Date: August 31, 2016