(33 days)
Not Found
No
The device description and intended use focus on mechanical mixing and delivery of bone graft materials, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a system for mixing and delivering bone graft materials, not for treating a disease or condition itself. While it facilitates a surgical procedure, it does not directly exert a therapeutic effect on the body. Its function is to prepare and deliver substances that may be therapeutic.
No
Explanation: The device is indicated for the delivery and mixing of bone graft materials, not for diagnosing any medical condition.
No
The device description explicitly lists physical components such as syringes, needles, obturators, luer connectors, and a funnel, indicating it is a hardware-based medical device.
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 and mixing of bone graft materials for orthopedic surgical sites. This is a surgical tool used in vivo (within the body) during a procedure.
- Device Description: The device components (syringe, needles, connectors, funnel) are consistent with a system for preparing and delivering materials directly to a surgical site.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples (blood, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. This device's function is purely for the preparation and delivery of materials during surgery.
N/A
Intended Use / Indications for Use
The Arthrex Mixing and Delivery System, like the predicates, is intended to provide the surgeons with a means to mix and deliver graft material to an orthopedic surgical site.
Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Arthrex Mixing and Delivery System consists of a piston syringe with a movable plunger and cap to facilitate mixing and delivery; straight and curved (tuohy) delivery needles; a mating obturator for delivery needles; luer connectors; and a funnel to facilitate filling of the syringe barrel. The system will be offered with either a 3mL or 14 mL syringe barrel and may be provided either empty or pre-filled with allograft, autograft, or synthetic bone graft materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all orthopedic surgical sites
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgeons
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)
Based on the biocompatibility and mechanical testing performed, Arthrex, Inc. has determined that the Arthrex Mixing and Delivery System is substantially equivalent to the marketed predicate devices.
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.
K062986 Medtronic Graft Delivery Syringe, K012738, DePuy Symphony Graft Delivery System, K062365 Arthrex Aspirate Kit
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
Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
3 510(k) Summary of Safety and Effectiveness
| Date Summary Prepared | April 11, 2012 |
|---|---|
| Manufacturer/Distributor/Sponsor | Arthrex, Inc. |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| 510(k) Contact | Christina Flores |
| Regulatory Affairs Specialist | |
| Arthrex, Inc. | |
| 1370 Creekside Boulevard | |
| Naples, FL 34108-1945 USA | |
| Telephone: 239/643.5553, ext. 1819 | |
| Fax: 239/598.5508 | |
| Email: Christina.flores@arthrex.com | |
| Trade Name | Arthrex Mixing and Delivery System |
| Common Name | Piston Syringe |
| Product Code -Classification | |
| Name | |
| CFR | Syringe, Piston |
| FMF | |
| 21 CFR 880.5860 | |
| Predicate Device | K062986 Medtronic Graft Delivery Syringe |
| K012738, DePuy Symphony Graft Delivery System | |
| K062365 Arthrex Aspirate Kit | |
| Purpose of Submission | This Traditional 510(k) premarket notification is |
| submitted to obtain clearance for the Arthrex Mixing and | |
| Delivery System. | |
| Device Description and Intended | |
| Use | The Arthrex Mixing and Delivery System consists of a |
| piston syringe with a movable plunger and cap to facilitate | |
| mixing and delivery; straight and curved (tuohy) delivery | |
| needles; a mating obturator for delivery needles; luer | |
| connectors; and a funnel to facilitate filling of the syringe | |
| barrel. The system will be offered with either a 3mL or 14 | |
| mL syringe barrel and may be provided either empty or | |
| pre-filled with allograft, autograft, or synthetic bone graft | |
| materials. | |
| The Arthrex Mixing and Delivery System, like the | |
| predicates, is intended to provide the surgeons with a | |
| means to mix and deliver graft material to an orthopedic | |
| surgical site. | |
| Arthrex Mixing and Delivery System is indicated for the | |
| delivery of allograft, autograft, or synthetic bone graft | |
| materials to all orthopedic surgical sites. In addition, it is | |
| designed to facilitate pre-mixing of allograft, autograft, or | |
| synthetic bone graft materials with I.V. fluids, blood, | |
| plasma, platelet rich plasma, bone marrow or other specific | |
| blood component(s) as deemed necessary by the clinical | |
| use requirements. | |
| Substantial Equivalence | |
| Summary | The Arthrex Mixing and Delivery System is substantially |
| equivalent to the predicate devices, in which the basic | |
| features and intended uses are the same. Any differences | |
| between the Arthrex Mixing and Delivery System and the | |
| predicates are considered minor and do not raise questions | |
| concerning safety and effectiveness. | |
| Based on the biocompatibility and mechanical testing | |
| performed, Arthrex, Inc. has determined that the Arthrex | |
| Mixing and Delivery System is substantially equivalent to the marketed predicate devices. |
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • - Arthrex Hier - 1970 - 210cables - Fax: 239-430-3490 • website: www.arthrex.com
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Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: 800-933-7001 or 239-643-5553 • Fax: 239-430-3490 • website: www.arthrex.com
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Arthrex, Incorporated % Ms. Christina Flores Regulatory Affairs Specialist 1370 Creekside Boulevard Naples, Florida 34108
MAY 1 6 2012
Re: K121124
Trade/Device Name: Arthrex Mixing and Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: II Product Code: FMF Dated: May 7, 2012 Received: May 8, 2012
Dear Ms. Flores:
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 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.
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Page 2 - Ms. Christina Flores
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 yours,
Mark N. Melkerson Director .
Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Arthrex TRADITIONAL 510(k): Arthrex Mixing and Delivery System
2 Indications for Use Form
510(k) Number:
Device Name:
Arthrex Mixing and Delivery System
The Arthrex Mixing and Delivery System is indicated for the delivery of allograft, autograft, or synthetic bone graft materials to all orthopedic surgical sites. In addition, it is designed to facilitate pre-mixing of allograft, autograft, or synthetic bone graft materials with I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements.
Prescription Use_X_AND/OR Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(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)
l of 1
Neil R. Orden for mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121124
Arthrex Inc. • 1370 Creekside Boulevard • Naples, Florida 34108-1945 USA • Tel: 800-933-7001 or 239-643-5553 • Fax: 239-430-3490 • website: www.arthrex.com
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