The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.

Device Description

The Biomet Graft Delivery Syringes provide the surgeon with a method to manually deliver bone grafting material such as allograft, autograft and synthetic bone grafting materials to all orthopedic surgical sites. The sterile syringes are available in three different sizes to hold different volumes of grafting materials. The graft delivery syringe consist of a syringe barrel with a plunger, a removable female luer cap and removable end cap and will be provided empty or pre-filled with commercially available bone grafting materials. The syringes will be available with and without an internal stainless steel strainer.

AI/ML Overview

This is a 510(k) premarket notification for the Biomet Graft Delivery Syringes. The document indicates that the device is substantially equivalent to legally marketed predicate devices, and therefore does not provide the detailed acceptance criteria and study data typically found in a clinical trial report or a performance study summary for novel devices.

However, based on the provided text, here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Functional Performance	"device functions as intended to deliver bone graft materials to an orthopedic surgical site."
Substantial Equivalence	"The Biomet Graft Delivery System is substantially equivalent to the predicate syringes as a graft delivery syringe in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles."
Safety & Effectiveness	"does not raise any new issues regarding safety and effectiveness."

Missing Information: Specific quantitative acceptance criteria (e.g., maximum force to deliver graft, leakage rates, specific flow rates) and the precise quantitative performance results are not detailed in this summary. The performance is stated in qualitative terms (e.g., "functions as intended," "substantially equivalent").

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for the "simulated use testing."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing is described as "simulated use testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the study described is a "simulated use testing" focused on device function, not on clinical interpretation or an evaluation requiring expert ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not provided and is not applicable given the nature of the described "simulated use testing."

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:

No, an MRMC comparative effectiveness study was not done. This device is a medical instrument (syringe) and not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone algorithm performance study was not done. This device is a physical instrument, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the simulated use testing would likely be based on engineering specifications and functional requirements for the device (e.g., successful delivery of graft material without clogging, leakage, or structural failure). It is not based on expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. The sample size for the training set:

Not applicable. This device is hardware; there is no "training set" in the context of machine learning or AI.

9. How the ground truth for the training set was established:

Not applicable. See point 8.

Summary of Study:

The document describes "Simulated use testing" which was conducted to demonstrate that the Biomet Graft Delivery Syringes function as intended to deliver bone graft materials. The purpose of this testing was to support the claim of substantial equivalence to predicate devices, ensuring that the new device does not raise new safety or effectiveness concerns. The details of this simulated use testing (e.g., protocols, specific pass/fail criteria, actual quantitative results, sample size) are not provided in this 510(k) summary, only the conclusion that it successfully demonstrated the device functions as intended.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2014

Biomet Spine Ms. Kimberly McCoy Regulatory Affairs Project Manager 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021

Re: K140710

Trade/Device Name: Biomet Graft Delivery Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 22, 2014 Received: July 24' 2014

Dear Ms. McCoy:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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) K140710

Device Name Biomet Graft Delivery Syringe

Indications for Use (Describe)

The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.

Preparation Date:	July 22, 2014
Applicant/Sponsor:	Biomet Spine310 Interlocken Parkway, Suite 120Broomfield, CO 80021
Contact Person:	Kimberly McCoy MBA, RACRegulatory Affairs Project ManagerPhone: 303.465.8923Fax: 303.501.8444
Trade name:	Biomet Graft Delivery Syringes
Common Name:	Piston Syringe for grafting material
Device Class:	Class II
Classification Name:(Product Code):	Piston Syringe (FMF)
Device Panel - Regulation No.:	General Hospital - 21 CFR 880.5860

Device Description:

Indications for Use:

The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.

Substantial Equivalence:

The Biomet Graft Delivery System is substantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet's Graft Delivery System (K021071). The technological characteristics of the subject Biomet Graft Delivery System is the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, materials, fundamental technology, and operational principles.

Performance Data:

Simulated use testing was conducted to demonstrate the device functions as intended to deliver bone graft materials to an orthopedic surgical site. The testing verifies that the subject device is

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substantially equivalent to other graft delivery systems currently on the market for its intended use and does not raise any new issues regarding safety and effectiveness.

Conclusion:

The Biomet Graft Delivery System is substantially equivalent to the predicate syringes as a graft delivery syringe in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject devices to the named predicate systems, which have been cleared for delivering graft material to orthopedic surgical sites. Based on this information, the subject devices do not raise any new issues regarding the safety or efficacy when compared to its predicates.

Regulation Number and Section

§ 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).