(101 days)
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 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.
This document is a 510(k) premarket notification for the "Bone Solutions Mixing and Delivery System." This notice is for a Class II medical device, specifically a piston syringe. The purpose of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it is as safe and effective as the predicate.
The provided text focuses on the substantial equivalence of the Bone Solutions Mixing and Delivery System to an existing device rather than presenting a study with specific acceptance criteria and performance metrics for a standalone device. In the context of a 510(k) for a device like a piston syringe, "acceptance criteria" and "device performance" are typically demonstrated through comparisons to a predicate device and verification of basic functional requirements, material safety, and sterility, rather than clinical efficacy studies with numerical targets.
Based on the provided text, here's an analysis of the information related to acceptance criteria and the "study" (in this case, the substantial equivalence justification):
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics like a clinical trial report would. Instead, it relies on demonstrating substantial equivalence to a predicate device.
The core "acceptance criteria" for this 510(k) is that the Bone Solutions Mixing and Delivery System is substantially equivalent to the ETEX Mixing and Delivery System (K141245) in terms of:
- Design
- Manufacturing materials
- Intended use
- Principles of operation
- Technical characteristics
- Safety and effectiveness (i.e., it raises no new issues of safety or effectiveness compared to the predicate).
The "reported device performance" is essentially the assertion that these equivalences hold true, as stated in the following phrases:
- "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."
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: This type of information (e.g., number of units tested for specific material properties or functional aspects) is not detailed in the provided summary. The 510(k) summary focuses on the justification of equivalence rather than presenting raw test data. Information about specific mechanical or material tests would typically be found in the full 510(k) submission's supporting documentation (e.g., engineering reports, biocompatibility reports), which is not part of this summary.
- Data Provenance: Not specified in this summary. The "study" here is a regulatory comparison rather than a data-driven clinical or performance study with provenance like country of origin or retrospective/prospective design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not present in the document. The "ground truth" for a substantial equivalence determination in a 510(k) for a device like this is the established safety and effectiveness of the predicate device, and the new device's compliance with general controls and recognized standards. Expert panels for establishing "ground truth" in terms of diagnoses or outcomes are not part of this type of submission.
4. Adjudication method for the test set:
- Not applicable. There is no "test set" in the sense of a clinical or image-based diagnostic study requiring adjudication. The FDA's review process itself involves regulatory experts evaluating the submitted documentation for compliance and equivalency.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI/diagnostic imaging device, and therefore, an MRMC study is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-based device. It is a physical medical device (piston syringe).
7. The type of ground truth used:
- The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (ETEX Mixing and Delivery System, K141245). The submission asserts that the new device shares fundamental technological characteristics and intended use with this predicate, and thus is equally safe and effective.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
In summary:
This document is a 510(k) summary for a relatively low-risk Class II device (piston syringe). The "study" presented is a demonstration of substantial equivalence to a predicate device, rather than a clinical trial or performance study with quantitative acceptance criteria and detailed test set sample sizes and ground truth establishment methods for diagnostic accuracy. The FDA's acceptance is based on the argument that the new device is fundamentally the same as a device already on the market, thereby implying it meets the same safety and effectiveness standards.
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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
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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
§ 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).