(277 days)
Not Found
No
The summary describes a traditional bone cement with mechanical properties and does not mention any AI/ML components or functionalities.
No
The bone cement is used for fixation of prostheses to bone, which is a supportive role in a surgical procedure, not a direct therapeutic treatment itself. It does not exert a therapeutic effect on the body but rather provides mechanical support for an implant.
No
This device is a bone cement used for securing prostheses during surgical interventions, not for diagnosing medical conditions.
No
The device description clearly states it is a "self-curing, radiopaque, polymethyl methacrylate-based cement," which is a physical material, not software. The performance studies also focus on physical and mechanical properties of the cement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is a "self-curing, radiopaque, polymethyl methacrylate-based cements used for securing a metal or polymeric prothesis to living bone." This is a material used in surgery for mechanical fixation.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status. The device's function is purely mechanical support within the body.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This bone cement does not fit that description.
N/A
Intended Use / Indications for Use
Bone Cement - Normal Viscosity is indicated for. fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, traumatic arthrilis, osteoporosis, avascular.necrosis, collagen disease, severe secondary destruction of the iciner conditions and in the review of previous arthroplasty procedures.
Product codes (comma separated list FDA assigned to the subject device)
LOD
Device Description
The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
musculoskeletal orthopedic surgical interventions
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)
Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. Non-clinical performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and Application characteristics
- Chemical Composition
- Molecular weight
- Physical Properties
- Stability of Components
- Thermal Properties
- Mechanical properties
The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003.
Sterilization and Shelf Life: The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2.
Endotoxins: The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 Bacterial Endotoxins Test.
Biocompatibility: The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the "Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process", issued September 20202018."
No clinical data were included in this submission.
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
§ 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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text.
May 31, 2022
Biomecanica Indústria e Comérciode Produtos Ortopédicos LTDA % Graziela Brum Regulatory Affairs Specialist Passarini Regulatory Affairs/PR Servicos Regulatórios Administrativos Ltda ME Rua Alice Além Saadi, 855/2402 Ribeirão Preto, São Paulo 14096-570 Brazil
Re: K212729
Trade/Device Name: Bone Cement-Normal Viscosity Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD Dated: April 11, 2022 Received: April 20, 2022
Dear Graziela Brum:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212729
Device Name
Bone Cement - Normal Viscosity
Indications for Use (Describe)
Bone Cement - Normal Viscosity is indicated for. fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, traumatic arthrilis, osteoporosis, avascular.necrosis, collagen disease, severe secondary destruction of the iciner conditions and in the review of previous arthroplasty procedures.
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)
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3
510(k) Summary
ADMINISTRATIVE INFORMATION
| Sponsor/Manufacturer Name | Biomecanica Indústria e Comércio
de Produtos Ortopédicos Ltda.
Rua Luiz Pengo 145
Jaú, São Paulo, Brazil 17212-811
Telephone: +55 (14) 2104-7900 |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person and Preparer | Graziela Brum and Ana Carolina Carvalho
Regulatory Affairs Specialist
Passarini Regulatory Affairs
PR Serviços Regulatórios Administrativos Ltda
E-Mail: graziela@passarini.com.br
Telephone +55 (11) 98578-0200 |
30/May/2022 Date Prepared
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Bone Cement - Normal Viscosity |
|---|---|
| Common Name | Bone Cement |
| Classification Name | Polymethyl Methacrylate (PMMA) Bone Cement |
| Product Code | LOD |
| Classification Regulation | 21 CFR 888.3027; Class II |
| Classification Panel | Orthopedic |
PREDICATE DEVICE INFORMATION
K053003 - DePuy CMW 3 Bone Cements, DePuy Orthopedics, Predicate Device Inc.
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INDICATIONS FOR USE
Bone Cement - Normal Viscosity is indicated for fixation of prostheses to live bone in musculoskeletal orthopedic surgical interventions in cases of rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe secondary destruction of the joints after trauma or other conditions and in the review of previous arthroplasty procedures.
DEVICE DESCRIPTION
The Bone Cement - Normal Viscosity is a self-curing, radiopaque, polymethyl methacrylatebased cements used for securing a metal or polymeric prothesis to living bone in arthroplasty procedures. The bone cement has no intrinsic adhesive properties but rely instead on close mechanical interlock between the irregular bone surface and the prosthesis.
EQUIVALENCE TO MARKETED DEVICE
The Bone Cement – Normal Viscosity shares many of the same technological characteristics compared to the predicate DePuy CMW 1, 2 and 3 Bone Cements important considerations such as most materials. The subject device has similar technological characteristics as the predicate devices. Both predicates and subject device provide two separate, premeasured sterilized components which, when mixed, form a radiopaque rapidly setting bone cement. The subject device and the predicate devices are all polymethylmethacrylate (PMMA) bone cements.
| Characteristics | Subject Device | Predicate(K053003) Model: CMW3 | |
|---|---|---|---|
| Bone Cement Powder: | Radio pacifier | Barium Sulphate | Barium Sulphate |
| Polymer | Poly (methyl acrylate/methyl methacrylate) (PMMA) | Poly (methyl acrylate/methyl methacrylate) (PMMA) | |
| Initiator | Benzoyl Peroxide | Benzoyl Peroxide | |
| Colour additives | None | None | |
| Bone Cement Liquid: | Monomer | Methylmethacrylat e (MMA) stabilized with Hydroquinone | Methylmethacrylat e (MMA) stabilized with Hydroquinone |
| Activator | N, N-dimethyl-p toluidine | N, N-dimethyl-p toluidine |
Table 1: Comparison of the Technological Characteristics with the Predicate Devices
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| Colour
| Additives | None | None |
|---|---|---|
| --------------------- | ------ | ------ |
PERFORMANCE DATA
These 510(k) submissions provided performance data to establish the substantial equivalence of the new bone cements to the predicate bone cement. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylacrylate (PMMA) Bone Cement; Guidance for Industry and FDA" dated July 17, 2002. Non-clinical performance testing was performed to characterize the bone cements in accordance with special controls guidance document. This testing included the following:
- Mixing and Application characteristics
- Chemical Composition
- Molecular weight
- Physical Properties
- Stability of Components
- Thermal Properties
- Mechanical properties
The performance data demonstrate that the new device Bone Cement - Normal Viscosity substantially equivalent to the predicate device application K053003.
Sterilization and Shelf Life: The sterilization process, including the ethylene oxide method and the membrane filter sterilization has been validated and the sterility of the subject device has been verified according to ISO 11135 and ISO 13408-1/2.
Endotoxins: The assessment on the presence of endotoxins was carried out in accordance with USP 43 - NF 38, 2020 Bacterial Endotoxins Test.
Biocompatibility: The biological evaluation of subject device was performed in accordance with ISO 10993-1 in accordance with the "Biological evaluation of medical devices - Part 1: evaluation and testing within a risk management process", issued September 20202018."
No clinical data were included in this submission.
CONCLUSION
The documentation submitted in this premarket notification demonstrates that the subject device has comparable features and performance and, therefore, are substantially equivalent to the identified predicate device.