The CoAxial Applicator System is designed to facilitate pre-mixinq of allograft, autograft, or synthetic bone graft materials for application to an orthopedic surgical site, with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements.

In addition, the CoAxial Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other specific blood component(s), as deemed necessary by the surgeon's determination of the clinical use requirements to facilitate the preparation of soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

Device Description

The CoAxial™ Applicator System consists of the CoAxial™ Spray Kit and CoAxial™ Applicator Tips. Within the CoAxial™ Spray Kit is a sterile, single-use, syringe type device (CoAxial™ Applicator), connector and Spray Tip. The CoAxial™ Applicator is comprised of two separate chambers to facilitate pre-mixing of bone graft materials with blood or blood products.

The CoAxial™ Applicator is a dual-syringe system, similar to all three predicate devices. It is comprised of an inner, smaller syringe and an outer, larger syringe, instead of two separate syringes. While the design differs from the predicates, it is designed to function in the same manner. Two fluids can be held by separate syringes and all applicators allow for dispensing the two liquids simultaneously.

The dimensions of the two chambers that comprise the CoAxial™ Applicator are 12 ml (outer) and 1.2 ml (inner), which are similar to the 10 ml and 1 ml volumes held by the two syringes in both the Harvest SmartJet™ Bone Grafting Liquid Applicator predicates. The 10:1 ratio of dispelled fluids is the same for the SmartJet™ systems. The FibriJet® Applicator has a ratio of 1:1.

AI/ML Overview

Here's an analysis of the provided text regarding the CoAxial™ Applicator System, focusing on acceptance criteria and supporting studies:

I. Acceptance Criteria and Device Performance

The submission does not explicitly list quantified acceptance criteria with pass/fail thresholds for each test. Instead, it describes performance characteristics tested and states whether the results met general "acceptance criteria" or were deemed "acceptable."

Test Performed	Acceptance Criteria (Stated)	Reported Device Performance
Torque Testing	Acceptance criteria "set forth within the applicable standard" (details not provided)	Results "either met the acceptance criteria set forth within the applicable standard, or if there were no set acceptance criteria, the results were acceptable per the test protocol." (Specific values/ranges not given)
Volume Accuracy Testing	Acceptance criteria "set forth within the applicable standard" (details not provided)	Results "either met the acceptance criteria set forth within the applicable standard, or if there were no set acceptance criteria, the results were acceptable per the test protocol." The intended use is for application in a 10:1 ratio, and instructions define how to achieve this.
Assembly Time (Comparative)	Not explicitly stated as an "acceptance criterion" but compared to FibriJet®	CoAxial™ Applicator System "demonstrated ease of use advantage over the FibriJet® Applicator, with a three-fold decrease in assembly time." (Specific time values not given)
Mixing Thoroughness (Comparative)	Not explicitly stated as an "acceptance criterion" but compared to FibriJet®	"The results of the mixing analysis were comparable for the two devices." (Specific metrics/values not given)
Bone Graft Cohesive Strength (Ratio Effect)	No statistically significant differences expected between ratios	"No statistically significant differences between the groups [11:1, 10:1, and 9:1 ratio of PRP/PP to autologous serum] were observed." This suggests the 10:1 ratio (intended) performs comparably to slightly varied ratios concerning bone graft cohesive strength. (Specific strength values not given).
Overall Functionality	Device is functional within its intended use.	Non-clinical laboratory testing "indicated that the device was functional within its intended use."

II. Sample Size and Data Provenance for Test Set

Sample Size: The document does not specify the exact sample sizes used for each of the non-clinical tests (Torque testing, Volume Accuracy, Assembly Time, Mixing Thoroughness, Bone Graft Cohesive Strength). It mentions "groups" for the bone graft testing, but without numerical detail.
Data Provenance: The studies are described as "Non-Clinical Testing" and "Non-clinical laboratory testing." This indicates the data was generated in a laboratory setting. The country of origin is not explicitly stated, but the manufacturer (Biomet Biologics, LLC) is based in Warsaw, IN, USA, suggesting the testing was likely conducted in the USA. All studies appear to be prospective as they were conducted specifically for this submission.

III. Number and Qualifications of Experts for Ground Truth (Test Set)

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The submission refers to an "assembly test subject who was unfamiliar with either device assembly" for the comparative assembly time study. For other tests, the involvement or qualifications of experts in establishing ground truth are not detailed.

IV. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for establishing ground truth or evaluating test results, as the studies are described as non-clinical laboratory tests rather than expert-reviewed observational or clinical studies.

V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The studies described are non-clinical hardware performance tests and a comparative ease-of-use/mixing analysis against a predicate device, not clinical studies involving human readers and interpretations.

VI. Standalone (Algorithm Only) Performance Study

Not applicable. The CoAxial™ Applicator System is a physical medical device (piston syringe/applicator), not an algorithm or AI system. Therefore, a standalone algorithm performance study was not performed.

VII. Type of Ground Truth Used

The ground truth for the non-clinical tests appears to be based on:

Engineering/Performance Standards: For torque and volume accuracy, the ground truth is against "applicable standard" or "test protocol" acceptance criteria.
Direct Measurement/Observation: For assembly time and mixing thoroughness, the ground truth is derived from direct measurements and visual/analytical comparisons.
Statistical Analysis of Experimental Data: For bone graft cohesive strength, the ground truth is based on the statistical analysis of experimental data comparing different ratios.

VIII. Sample Size for the Training Set

Not applicable. As this is a physical medical device (syringe/applicator) and not an AI system, there is no "training set" in the machine learning sense. The device's design and engineering would be based on design specifications and general engineering principles.

IX. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of device. The device's design and manufacturing processes are likely guided by established engineering best practices, prior device experience, and applicable industry or regulatory standards for medical devices.

Summary

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K0917222

MAR ] 2 2010

510(k) Summary

Applicant/Sponsor: Biomet Biologics, LLC 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581 Phone: 800-348-9500 www.biomet.com

Contact Person: Lonnie Witham Summary Preparation Date: March 11, 2010

Device Trade Name: CoAxial™ Applicator System Common Name: Piston Syringe

Classification Name: Piston Syringe FMF (21 CFR 880.5860)

510(k) Number	Predicate Device	Manufacturer
K011032	SmartJet™ Bone Grafting Liquid Applicator	Harvest Technologies Corp.Plymouth, MA 02360
K020252	SmartJet™ Liquid Grafting Applicator	Harvest Technologies Corp.Plymouth, MA 02360
K883338	Surgical Sealant Applicator (FibriJet®)	Micromedics, Inc.St. Paul, MN 55107

Legally Marketed Predicate Devices To Which Substantial Equivalence Is Claimed:

Device Description:

Statement of Intended Use:

The CoAxial™ Applicator System is designed to facilitate pre-mixing of allograft, or synthetic bone graft materials for application to an orthopedic surgical site, with autologous blood, plasma, platelet-rich plasma, or other specific blood component(s) as deemed necessary by the clinical use requirements

In addition, the CoAxial™ Applicator System is intended for the application of autologous blood, plasma, platelet-rich plasma, or other specific blood component(s), as deemed necessary by the surgeon's determination of the clinical use requirements to facilitate the preparation of

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soft tissue autograft or allograft material prior to the application of the graft material to a repair site.

Summary of Technological Characteristics:

Summary of Performance Data:

Torque testing (separation force, unscrewing torque, ease of assembly, resistance of overriding, stress cracking) and volume accuracy testing was performed on the CoAxial™ Applicator. Results either met the acceptance criteria set forth within the applicable standard, or if there were no set acceptance criteria, the results were acceptable per the test protocol.

Assembly time and mixing thoroughness were evaluated against the FibriJet® Applicator, manufactured by Micromedics. The CoAxial™ Applicator System demonstrated ease of use advantage over the FibriJet® Applicator, with a three-fold decrease in assembly time using an assembly test subject who was unfamiliar with either device assembly. The results of the mixing analysis were comparable for the two devices.

The CoAxial™ Applicator System is intended to be used for the application of liquids in a 10:1 ratio, and the instructions for use clearly define how to achieve this application. Bone graft handling testing was performed to compare the effect that an 11:1, 10:1, and 9:1 ratio of PRP/PP to autologous serum has on bone graft cohesive strength. No statistically significant differences between the groups were observed.

Non-Clinical Testing:

Non-clinical laboratory testing was performed to determine substantial equivalence. Testing indicated that the Fat Concentration System is substantially equivalent to currently marketed predicate devices. The results indicated that the device was functional within its intended use.

Clinical Testing:

None provided as a basis for substantial equivalence.

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Adverse Events:

A search of FDA's MAUDE database for the period of Jan. 1, 2008 thru Jan. 31, 2010 revealed that no adverse events were reported under K011032, K020252, and K883338.

Substantial Equivalence:

The CoAxial™ Applicator System is shown to be substantially equivalent to the previously cleared devices, the Harvest SmartJet™ Bone Grafting Liquid Applicator- K011032, SmartJer™ Liquid Grafting Applicator - K020252, and the Micromedics FibriJet® Applicator - K883338. The design, sizes, and materials are similar to the aforementioned predicates and there are no new performance characteristics that introduce new safety and/or effectiveness issues.

All trademarks are property of Biomet, Inc.

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Image /page/3/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Mr. Lonnie Witham Regulatory Affairs Consultant Biomet, Biologics, LLC 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587

MAR 1 2 2010

Re: K091722

Trade/Device Name: CoAxial Applicator System Regulation Number: 21CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: March 3, 2010 Received: March 4, 2010

Dear Mr. Witham:

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.

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Page 2 Mr. Witham

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): NA _________________________________________________________________________________________________________________________________________________

Device Name: CoAxial Applicator System

Indications for Use:

Prescription Use YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CBER, Office of Blood Research and Review

Division Sign-Off) vision of Anesthesiology, General Hospital ection Control, Dental Devices

10(k) Number:

Page 1 of 1

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).