(56 days)
Not Found
No
The 510(k) summary describes a simple mechanical mixing and delivery system for bone graft material and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No
The device is a system for mixing and delivering bone graft material to a surgical site, which is a delivery mechanism, not a therapeutic agent itself.
No
The device is described as a system for the delivery of bone graft material, not for identifying or investigating diseases or conditions.
No
The device description explicitly states it is comprised of a commercially available disposable medical piston syringe, which is a hardware component. The performance studies also focus on physical characteristics and functionality of the syringe.
Based on the provided information, the ETEX Mixing and Delivery System 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 device used in vivo (within the body) during a surgical procedure, not a device used in vitro (outside the body) to examine specimens like blood, tissue, or urine for diagnostic purposes.
- Device Description: The description details a syringe system for mixing and delivering materials, consistent with a surgical tool.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, diagnostic testing, or any of the typical characteristics of an IVD device.
Therefore, the ETEX Mixing and Delivery System is a surgical delivery system, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FMF
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.
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
Not Found
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)
The device design was qualified through the following tests:
- Simulated Use Testing
- Volume Verification
- Separation Force Testing
- Liquid Leak Testing
- Biocompatibility Evaluation
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).
0
510(k) Summary
page 1 of 2
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
ll
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.
1
1
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.
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).
2
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
3
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
4
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