(107 days)
No
The device description and performance studies focus on the material properties and mechanical performance of the bone cement, with no mention of AI or ML technologies.
No
The device is a bone cement used to fix prosthetic parts to bone, which is a structural and anchoring function rather than directly treating a disease or condition. While it contains an antibiotic, its primary indicated use is mechanical fixation.
No
The device is a bone cement used to fix prosthetic parts to living bone in arthroplasty procedures. It is not used to diagnose a medical condition.
No
The device description clearly indicates it is a physical bone cement composed of powder and liquid components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Refobacin® Bone Cement R is used in arthroplasty procedures to fix prosthetic parts to bone. This is a surgical procedure performed on the patient's body.
- Device Description: The description details a two-component system that is mixed to form a paste for anchoring prostheses. This is a material used during surgery.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (like blood, urine, or tissue) outside of the body to provide diagnostic information about a patient's health status.
IVD devices are used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. Refobacin® Bone Cement R is a surgical implant material, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
Product codes (comma separated list FDA assigned to the subject device)
LOD, MBB, KIH, JDZ
Device Description
Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hip, knee, and other joints
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)
Non-Clinical Tests
o Comparative in-vitro testing was performed and the results for Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R were compared to that of the predicate, Palacos® G. The results showed that Refobacin® Bone Cement R and Refopac® Refobacin® Bone Cement R as packaged in the Optipac® possess mechanical, chemical, physical and handling characteristics necessary to fulfill their intended use. Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R are substantially equivalent to Palacos® G for their primary intended use of fixation of prosthetic components as described in the device labeling.
Clinical Tests
o Clinical data was not required to establish substantial equivalence between the subject Biomet Refobacin® Bone Cement R and the predicate device.
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.
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
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”
0
Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing right, layered on top of each other. The profiles are black and are connected by a flowing line. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 20, 2015
Biomet Incorporated Carmen Albany, DVM Senior Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K150850
Trade/Device Name: Refobacin Bone Cement R Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, MBB, KIH, JDZ Dated: June 19, 2015 Received: June 22, 2015
Dear Dr. Albany:
This letter corrects our substantially equivalent letter of July 16, 2015.
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
1
Page 2 - Carmen Albany, DVM
(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below
510(k) Number (if known) K150850
Device Name Refobacin Bone Cement R
Indications for Use (Describe)
Refobacin Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage revision for total joint arthroplasty after the initial infection has been cleared.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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
"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
BIOMET
510(k) Summary
In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the Refobacin® Bone Cement R 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.
| Sponsor: | Biomet Inc.
56 East Bell Drive
PO Box 587
Warsaw, IN 46581
Establishment Registration Number: 1825034 |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Carmen Albany, DVM
Sr. Regulatory Affairs Specialist, US
Phone: 574-371-3024
Fax: 574-372-1683 |
| Date: | March 25, 2015 |
| Subject Device: | Trade Name: Refobacin® Bone Cement R
Classification Name:
• MBB, LOD- Refobacin® Bone Cement R (21 CFR 888.3027) |
| | Alternative Packaging Configuration Classification Name:
• MBB, LOD-Optipac®- Refobacin® Bone Cement R (21 CFR 888.3027)
• JDZ- Optipac®- Refobacin® Bone Cement R (21 CFR 888.4210)
• KIH- Optipac®- Refobacin® Bone Cement R (21 CFR 888.4200) |
| | Legally marketed devices to which substantial equivalence is claimed: |
- PALACOS®G Bone Cement (K031673)* ● *The product obtained for testing and labeling comparison is labeled as Palacos® R+G
Reference Device
- . PALACOS®R + G pro (K142157)
Device Description
Refobacin® Bone Cement R is a fast setting polymer containing gentamicin, for use in bone surgery. Mixing of the two component system, consisting of a powder and a liquid, produces a paste, which is used to anchor the prosthesis to the bone. The hardened bone cement allows stable fixation of the prosthesis and transfers all stresses produced in a movement to the bone via the large interface. Insoluble zirconium dioxide is included in the cement powder as an X ray contrast medium. The chlorophyll additive in the liquid component serves as optical marking of the bone cement at the site of the operation.
4
BIOMET
510(k) Summarv Refobacin Bone Cement R | Traditional 510(k)
Indications for Use
Refobacin® Bone Cement R is indicated for use as bone cement in arthroplasty procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of revision of previous arthroplasty procedures due to joint infection. The cement is indicated for use in the second stage of a two stage revision for total ioint arthroplasty after the initial infection has been cleared.
Summary of Technological Characteristics
The intended use, indications for use, materials, sterilization methods, cement design, and principle of operation of the subject device are the same as the predicate device. Differences in size offerings, packaging configurations, and shelf life do not introduce any new risks of safety and efficacy. Refobacin® Bone Cement R is substantially equivalent to Palacos® G for the primary intended use of fixation of prosthetic components as described in the device labeling.
Summary of Performance Data (Nonclinical and/or Clinical)
- . Non-Clinical Tests
- o Comparative in-vitro testing was performed and the results for Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R were compared to that of the predicate, Palacos® G. The results showed that Refobacin® Bone Cement R and Refobacin® Bone Cement R as packaged in the Optipac® possess mechanical, chemical, physical and handling characteristics necessary to fulfill their intended use. Refobacin® Bone Cement R and Optipac® Refobacin® Bone Cement R are substantially equivalent to Palacos® G for their primary intended use of fixation of prosthetic components as described in the device labeling.
- Clinical Tests .
- Clinical data was not required to establish substantial equivalence between the o subject Biomet Refobacin® Bone Cement R and the predicate device.
Substantial Equivalence Conclusion
Based on the similarities in design, function, indications for use and fundamental scientific technology, the devices that are the subject of this submission are similar to the predicate devices and do not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject device is substantially equivalent to the predicate device.