The ETEX 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.

Device Description

The ETEX Mixing and Delivery System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger). The ETEX Mixing and Delivery System is provided sterile, for single use only.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ETEX Mixing and Delivery System, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Device Design Qualification	Simulated Use Testing	Met all specified criteria
Device Design Qualification	Volume Verification	Met all specified criteria
Device Design Qualification	Separation Force Testing	Met all specified criteria
Device Design Qualification	Liquid Leak Testing	Met all specified criteria
Biocompatibility Assessment	Biocompatibility Evaluation	Met all specified criteria

Study Details

Sample Size for Test Set and Data Provenance: The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact number of units tested for each criterion, nor does it provide information on data provenance (e.g., country of origin, retrospective/prospective).
Number of Experts for Ground Truth and Qualifications: Not applicable. This device is a piston syringe, and the testing performed relates to its physical performance rather than diagnostic accuracy or human interpretation. Therefore, expert ground truth as typically defined for medical image analysis or similar tasks is not relevant here.
Adjudication Method for Test Set: Not applicable. The tests performed are engineering performance tests, not studies requiring expert adjudication.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No. This type of study is typically conducted for diagnostic devices or AI systems where human reader performance is being evaluated, often with and without AI assistance. This device is a mechanical delivery system.
Standalone (Algorithm Only) Performance Study: Not applicable. This device is a physical, mechanical system, not an algorithm.
Type of Ground Truth Used: The "ground truth" for the tests performed would be defined by the pre-specified limits or requirements for each performance characteristic (e.g., a specific volume range for "Volume Verification," a minimum force for "Separation Force Testing," or absence of leaks for "Liquid Leak Testing"). These are engineering specifications.
Sample Size for Training Set: Not applicable. This device is a physical product and does not involve machine learning or an "algorithm" in the sense that would require a training set.
How Ground Truth for Training Set was Established: Not applicable, as no training set was used.

Summary

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510(k) Summary

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K141245

JUL 0 9 2014

Device Trade Name: ETEX Mixing and Delivery System

Manufacturer:

ETEX Corporation 675 Massachusetts Ave, 12th Floor Cambridge, MA 02139

Contact: Andy Soman Regulatory Affairs Phone: 617-871-6342

617-577-7170 Fax:

21 CFR 880.5860

Date Prepared: July 7, 2014

Common Name: Piston Syringe

Classification:

Class:

FMF Product Code:

Indications For Use:

The ETEX 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.

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K141245

Device Description:

・

Predicate Device:

The ETEX Mixing and Delivery System has the same indications for use, design, function, materials, and is substantially equivalent to the Zimmer Knee Creations Inc. Mixing Syringe System (K133021) and the Arthrex Mixing and Delivery System (K121124)

Performance Standards:

All necessary testing has been performed for the ETEX Mixing and Delivery System to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device design was qualified through the following tests:

Simulated Use Testing ●
. Volume Verification
Separation Force Testing .
Liquid Leak Testing .
Biocompatibility Evaluation .

Conclusion:

The ETEX Mixing and Delivery System met all specified criteria and did not raise new safety or effectiveness questions. The indications, intended use, and fundamental scientific technology of the ETEX Mixing and Delivery System are the same as those for the predicate devices. Therefore, the ETEX Mixing and Delivery System is substantially equivalent to the Zimmer Knee Creations Inc. Mixing Syringe System (K133021) and the Arthrex Mixing & Delivery System (K121124).

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines forming its body and wings. The eagle is enclosed within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G669 Silver Spring, MD 20993-0002

July 9, 2014

ETEX Corporation Mr. Andy Soman Regulatory Affairs 675 Massachusetts Avenue, 12" Floor Cambridge. Massachusetts 02139

Re: K141245

Trade/Device Name: ETEX Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: May 12, 2014 Received: May 14, 2014

Dear Mr. Soman:

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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Page 2 - Mr. Andy Soman

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/ResourcesforYou/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

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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1. Indications for Use

510(k) Number (if known): K141245

Device Name: ETEX Mixing and Delivery System

The ETEX 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.

Prescription Use ___ マ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ua C-Nip er -S

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).