(167 days)
Not Found
No
The device description and performance studies indicate a manual delivery system for bone grafting materials, with no mention of AI or ML capabilities.
No.
The device is described as a delivery system for bone grafting materials, not a device that itself provides therapy.
No
The device is described as a "Graft Delivery Syringe" intended to "deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites." There is no mention of diagnostic functions or capabilities.
No
The device description clearly states it is a physical syringe with a barrel, plunger, and caps, designed to manually deliver bone grafting material. It is a hardware device.
Based on the provided information, the Biomet Graft Delivery Syringes are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites." This describes a device used during surgery to physically deliver material to a patient's body.
- Device Description: The description details a syringe and its components, designed for manual delivery of bone grafting material. This is a mechanical delivery system.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Biomet Graft Delivery Syringes do not perform any such analysis or testing of specimens.
The device is clearly intended for direct surgical use in delivering materials to a patient's body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The Biomet Graft Delivery Syringes provide the surgeon with a method to manually deliver bone grafting material such as allograft, autograft and synthetic bone grafting materials to all orthopedic surgical sites. The sterile syringes are available in three different sizes to hold different volumes of grafting materials. The graft delivery syringe consist of a syringe barrel with a plunger, a removable female luer cap and removable end cap and will be provided empty or pre-filled with commercially available bone grafting materials. The syringes will be available with and without an internal stainless steel strainer.
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
surgeon
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)
Simulated use testing was conducted to demonstrate the device functions as intended to deliver bone graft materials to an orthopedic surgical site. The testing verifies that the subject device is substantially equivalent to other graft delivery systems currently on the market for its intended use and does not raise any new issues regarding safety and effectiveness.
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.
K072330, K121124, K121476, K111632, K021071
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
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 4, 2014
Biomet Spine Ms. Kimberly McCoy Regulatory Affairs Project Manager 310 Interlocken Parkway, Suite 120 Broomfield, Colorado 80021
Re: K140710
Trade/Device Name: Biomet Graft Delivery Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: July 22, 2014 Received: July 24' 2014
Dear Ms. McCoy:
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
1
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/Resourcesfor You/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
Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140710
Device Name Biomet Graft Delivery Syringe
Indications for Use (Describe)
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image shows the logo for Biomet Spine. The word "BIOMET" is in a bold, sans-serif font, with each letter connected to the next. Below the word "BIOMET" is the word "SPINE" in a smaller, sans-serif font. The logo is black and white.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.92.
| Preparation Date: | July 22, 2014 |
|---|---|
| Applicant/Sponsor: | Biomet Spine |
| 310 Interlocken Parkway, Suite 120 | |
| Broomfield, CO 80021 | |
| Contact Person: | Kimberly McCoy MBA, RAC |
| Regulatory Affairs Project Manager | |
| Phone: 303.465.8923 | |
| Fax: 303.501.8444 | |
| Trade name: | Biomet Graft Delivery Syringes |
| Common Name: | Piston Syringe for grafting material |
| Device Class: | Class II |
| Classification Name: | |
| (Product Code): | Piston Syringe (FMF) |
| Device Panel - Regulation No.: | General Hospital - 21 CFR 880.5860 |
Device Description:
The Biomet Graft Delivery Syringes provide the surgeon with a method to manually deliver bone grafting material such as allograft, autograft and synthetic bone grafting materials to all orthopedic surgical sites. The sterile syringes are available in three different sizes to hold different volumes of grafting materials. The graft delivery syringe consist of a syringe barrel with a plunger, a removable female luer cap and removable end cap and will be provided empty or pre-filled with commercially available bone grafting materials. The syringes will be available with and without an internal stainless steel strainer.
Indications for Use:
The Biomet Graft Delivery Syringes are intended to deliver autograft, allograft or synthetic bone grafting materials to all orthopedic surgical sites.
Substantial Equivalence:
The Biomet Graft Delivery System is substantially equivalent to the CDO™ and Graft Preparation Systems (K072330), the Arthrex Mixing and Delivery System (K121124), the InFill™ Graft Delivery System (K121476 & K111632) and Biomet's Graft Delivery System (K021071). The technological characteristics of the subject Biomet Graft Delivery System is the same as, or similar to, the predicate devices in regards to intended use, indications for use, design, materials, fundamental technology, and operational principles.
Performance Data:
Simulated use testing was conducted to demonstrate the device functions as intended to deliver bone graft materials to an orthopedic surgical site. The testing verifies that the subject device is
4
substantially equivalent to other graft delivery systems currently on the market for its intended use and does not raise any new issues regarding safety and effectiveness.
Conclusion:
The Biomet Graft Delivery System is substantially equivalent to the predicate syringes as a graft delivery syringe in regards to intended use, indications for use, fundamental technology including design, materials, manufacturing methods, sterility, and operational principles. Furthermore, testing and other supporting information sufficiently demonstrate the substantial equivalence of the subject devices to the named predicate systems, which have been cleared for delivering graft material to orthopedic surgical sites. Based on this information, the subject devices do not raise any new issues regarding the safety or efficacy when compared to its predicates.