(57 days)
Biomet® 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.
Biomet® Bone Cement R is a fast setting acrylic cement, 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 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.
The Biomet Bone Cement R device 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.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance (Biomet® Bone Cement R) |
|---|---|---|
| Non-Clinical Testing | Mechanical Characteristics | Met acceptance criteria (comparable to predicate) |
| Chemical Characteristics | Met acceptance criteria (comparable to predicate) | |
| Physical Characteristics | Met acceptance criteria (comparable to predicate) | |
| Handling Characteristics | Met acceptance criteria (comparable to predicate) | |
| Bacterial Endotoxin Limit | Met pyrogen limit specifications | |
| Cytotoxicity | Met acceptance criteria |
2. Sample Size and Data Provenance
- Test Set Sample Size: No specific numerical sample sizes are provided for the non-clinical tests. The tests were performed in-vitro.
- Data Provenance: The data appears to be from non-clinical laboratory testing (in-vitro). The country of origin for the data is not explicitly stated, but the sponsor, Biomet Inc., is located in Warsaw, Indiana, USA, suggesting the testing was likely conducted in the US or by a lab associated with the company. The data is prospective, generated specifically for this submission.
3. Number of Experts and Qualifications (Ground Truth for Test Set)
- Number of Experts: Not applicable. The ground truth for the non-clinical tests is established by laboratory measurements against defined specifications, not by expert consensus in the same way clinical ground truth is.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (Test Set)
- Adjudication Method: Not applicable. For non-clinical tests, results are typically determined by adherence to standardized protocols and measurement against pre-defined specifications. There's no mention of an adjudication process by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. This device is a bone cement, and the evaluation for substantial equivalence was based on non-clinical (in-vitro) performance data compared to a predicate device, not on human reader performance.
6. Standalone Performance Study
- Standalone Performance Study: Yes, in the sense that the device's technical characteristics (mechanical, chemical, physical, handling) were assessed independently, and its biocompatibility (cytotoxicity, bacterial endotoxin) was also tested as an algorithm for its own performance. The non-clinical tests conducted evaluated the device's inherent properties. However, this is not a "standalone algorithm performance" in the context of AI/software, but rather standalone laboratory performance for a physical medical device.
7. Type of Ground Truth Used
- Ground Truth: For the non-clinical tests, the ground truth was based on:
- Defined specifications/standards: For mechanical, chemical, physical, and handling characteristics, the performance was compared to that of the predicate device (PALACOS® R), implying adherence to or equivalence with established performance profiles for bone cements.
- International standards: Bacterial Endotoxin Testing (BET) met "pyrogen limit specifications" (implying adherence to an accepted standard). Cytotoxicity testing was conducted "in accordance with ISO 10993-5," which establishes the ground truth for biocompatibility.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This submission is for a physical medical device (bone cement), not an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a physical device.
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October 5, 2017
Biomet Inc. Ms. Heidi Busz Regulatory Affairs Specialist 56 East Bell Drive Warsaw, Indiana 46581
Re: K172408
Trade/Device Name: Biomet Bone Cement R Regulation Number: 21 CFR 888,3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: August 7, 2017 Received: August 9, 2017
Dear Ms. Busz:
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 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.
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 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 (DICE) 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,
Vincent J. Devlin -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| Form Approved: OMB No. 0910-0120 | |
|---|---|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. |
| 510(k) Number (if known) | K172408 |
|---|---|
| Device Name | Biomet Bone Cement R |
| Indications for Use (Describe) | Biomet 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. |
| 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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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 Biomet® 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 DrivePO Box 587Warsaw, IN 46581Establishment Registration Number: 1825034 |
|---|---|
| Contact Person: | Heidi BuszRegulatory Affairs SpecialistTelephone: (574-372-4249)Fax: (574-372-4710) |
| Date: | October 2, 2017 |
| Subject Device: | Trade Name: Biomet® Bone Cement R (K172408)Common Name: Bone Cement |
| Classification Name:• LOD-Biomet® Bone Cement R (21 CFR 888.3027) | |
| Predicate Device(s): | K030902 PALACOS® R Bone Heraeus KulzerCement GmbH & Co. |
| Device Description: | Biomet® Bone Cement R is a fast setting acrylic cement,for use in bone surgery. Mixing of the two componentsystem, consisting of a powder and a liquid, produces apaste, which is used to anchor the prosthesis to the bone.The hardened bone cement allows stable fixation of theprosthesis and transfers stresses produced in amovement to the bone via the large interface. Insolublezirconium dioxide is included in the cement powder as anX-ray contrast medium. The chlorophyll additive in theliquid component serves as optical marking of the bonecement at the site of the operation. |
| Indications for Use: | Biomet® Bone Cement R is indicated for use as bonecement in arthroplasty procedures of the hip, knee, andother joints to fix plastic and metal prosthetic parts toliving bone. |
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Summary of Technological Characteristics:
The intended use, indications for use, materials, sterilization methods, cement design, and principle of operation of the subiect device are the same as the predicate device. Differences in pack size offerings and shelf life do not introduce any new risks of safety and efficacy. Biomet® Bone Cement R is substantially equivalent to PALACOS® R 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: .
- Comparative in-vitro testing was performed and the o results for Biomet® Bone Cement R were compared to that of the predicate, PALACOS® R. The results showed that Biomet® Bone Cement R possesses mechanical, chemical, physical and handling characteristics necessary to fulfill the intended use. Biomet® Bone Cement R is substantially equivalent to PALACOS® R for the primary intended use of fixation of prosthetic components as described in the device labeling.
- Bacterial Endotoxin Testing (BET) o
- . BET demonstrated the pyrogen limit specifications have been met.
- Cytotoxicity Testing O
- The biocompatibility evaluation of Biomet® ● Bone Cement R was conducted in accordance with ISO 10993-5. Cytotoxicity tests demonstrated that the acceptance criteria have been met.
- Clinical Tests: ●
- o Clinical data was not required to establish substantial equivalence between the subject Biomet® 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 subject device is similar to the predicate device and does not introduce any new risks of safety or efficacy. Therefore, Biomet concludes that the subject device is substantially equivalent to the predicate device.
§ 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.”