(109 days)
Not Found
No
The description focuses on a mechanical mixing and delivery system for bone graft material and does not mention any computational or analytical capabilities that would suggest AI/ML.
No
The device is described as a "Mixing Syringe System" intended for the "delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site." While it is used in a surgical context, its function is solely for material delivery, not to directly treat or diagnose a disease or condition itself. It's a delivery tool, not a therapeutic agent or intervention.
No.
The "Intended Use" states that the device is for the "delivery of hydrated allograft, autograft, or synthetic bone graft material to an orthopedic surgical site," which is a treatment modality, not a diagnostic one.
No
The device description explicitly states it is comprised of physical components: a disposable medical piston syringe and a mixing system funnel. It is provided sterile and for single use, indicating a physical product, not software.
Based on the provided information, this device 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 during a surgical procedure to deliver material to a patient's body.
- Device Description: The device is a "Mixing Syringe System" comprised of a syringe and funnel. This is a tool for handling and delivering materials, not for testing samples in vitro (outside of the body).
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information about a patient's condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for the delivery of materials during surgery.
N/A
Intended Use / Indications for Use
The Mixing Syringe 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
EME, FMF
Device Description
The Mixing Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe 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
The Mixing Syringe System met all specified criteria and did not raise new safety or effectiveness questions.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K133021 Page 1 of 2
510(k) Summary
JAN 13 2014
ん
| Device Trade Name: | Mixing Syringe System |
|---|---|
| Manufacturer: | Zimmer Knee Creations, Inc. |
| 841 Springdale Dr. | |
| Exton, PA 19341 | |
| Contact: | Mr. Shaun Hanson |
| Associate Director of Development | |
| Phone: 484-753-5461 | |
| Fax: 202-552-5798 | |
| Prepared by: | Musculoskeletal Clinical & Regulatory Advisers, LLC |
| 1331 H Street NW, 12th Floor | |
| Washington, DC 20005 | |
| Phone: (202) 552-5800 | |
| Date Prepared: | December 5, 2013 |
| Common Name: | Piston Syringe |
| Classification: | 21 CFR 880.5860 |
| Class: | II |
| Product Code: | EME |
Indications For Use:
The Mixing Syringe 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 Mixing Syringe System is comprised of a commercially available disposable medical piston syringe (syringe barrel with female luer, plunger), and mixing system funnel. The Mixing Syringe System is provided sterile, for single use only.
Predicate Device:
The Mixing Syringe System has the same indications for use, design, function, materials, and is substantially equivalent to the Arthrex Mixing and Delivery System (K121124) and InFill graft Delivery System (K121476, K111632).
1
Performance Standards:
All necessary testing has been performed for the Mixing Syringe 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 Mixing Syringe System met all specified criteria and did not raise new safety or effectiveness questions. The indications, intended use, and fundamental scientific technology of the Mixing Syringe System are the same as those for the predicate device. Therefore, the Mixing Syringe System is substantially equivalent to the Arthrex Mixing and Delivery System (K121124) and InFill graft Delivery System (K121476, K111632).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Zimmer Knee Creations, Incorporated Mr. Shaun Hanson Associate Director of Development 841 Springdale Drive Exton, Pennsylvania 19341
January 13, 2014
Re: K133021
Trade/Device Name: Mixing Syringe System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: FMF Dated: December 6, 2013 Received: December 9, 2013
Dear Mr. Hanson:
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. Shaun Hanson
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.
For
Sincerely yours,
Joshua C. Nipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use 4.
K133021 510(k) Number (if known):
Device Name: Mixing Syringe System
The Mixing Syringe 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 4 (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)
Long H. Chen -A
for BSA
(Division Sign-Off) Division of Surgical Devices 510(k) Number: K133021
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