(106 days)
Cobalt™ MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck and of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Cobalt™ MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic bone cement with a medium viscosity. Cobalt™ MV Bone Cement provides two separate, premeasured sterilized components that when mixed form fast-setting radiopaque bone cement for use in orthopedic surgery.
The provided text describes a 510(k) summary for a medical device, "Cobalt™ MV Bone Cement," and its subsequent FDA clearance. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics like sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical trials for diagnostic or AI-powered devices.
This document specifically states: "Clinical Testing: None provided as a basis for substantial equivalence."
Instead, the submission for Cobalt™ MV Bone Cement relies on "Non-Clinical Testing" which "was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This means the substantial equivalence was based on demonstrating that the new device has similar technological characteristics and performance (likely mechanical, chemical, and biological) to previously cleared predicate devices, rather than a clinical study establishing specific performance metrics against a defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's what can be stated based on the document:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a clinical study. The acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states that "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." No specific performance values (e.g., strength, setting time, biocompatibility results) are provided in this summary document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical test set was used to establish performance for substantial equivalence. Non-clinical testing would have involved laboratory samples, not human data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no clinical test set with human data requiring expert ground truth was used.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set with human data was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable as this is a bone cement, not an AI-powered diagnostic device, and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a bone cement, not an AI-powered algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For non-clinical testing, the "ground truth" would likely be established by validated physicochemical test methods and relevant ISO standards, not expert consensus or pathology in a clinical sense.
8. The sample size for the training set
- Not applicable as this is a bone cement, not a machine learning model, and no clinical study was performed.
9. How the ground truth for the training set was established
- Not applicable as this is a bone cement, not a machine learning model.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The characters appear to be a combination of letters and numbers. The string reads 'K091608'. The handwriting is somewhat stylized, with rounded shapes and connected strokes.
Image /page/0/Picture/2 description: The image shows the logo for BIOMET MANUFACTURING CORP. The word "BIOMET" is in a stylized font with each letter connected to the next. Below the logo, the words "MANUFACTURING CORP." are printed in a simple, sans-serif font.
510(k) Summarv
| Preparation Date: | May 29, 2009 |
|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corp. |
| Contact Person: | Susan Alexander |
| Proprietary Name: | Cobalt™ MV Bone Cement |
| Common Name: | Bone Cement |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement (21 CFR §888.3027) |
| Product Code: | LOD |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed:
Cobalt™ HV Bone Cement K051496 Biomet Manufacturing Corp. Simplex® P Radiopaque Bone Cement N17004* Stryker Howmedica Osteonics
Device Description: Cobalt™ MV Bone Cement is a methyl methacrylate-styrene copolymer based acrylic bone cement with a medium viscosity. Cobalt™ MV Bone Cement provides two separate, premeasured sterilized components that when mixed form fast-setting radiopaque bone cement for use in orthopedic surgery.
Intended Use: Cobalt™ MV Bone Cement is an acrylic cement-like substance which allows seating and fixation of the prosthesis to the bone. After complete polymerization, the cement acts as a buffer for even weight distribution and other stresses between the prosthesis and the bone.
Indications for Use: Cobalt™ MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, theumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck and of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Summary of Technologies: The technological characteristics of Cobalt™ MV Bone Cement are similar or identical to the predicate devices.
Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.
Clinical Testing: None provided as a basis for substantial equivalence.
*Approved prior to the downdassification of PMMA bone cements.
All trademarks are property of Biomet, Inc., unless otherwise noted. Simplex® is a registered trademark of Stryker Howmedica Osteonics.
Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800 348 9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomet.com
Shipping Address: 56 East Bell Drive Warsaw, IN 46582
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a human figure with outstretched arms. The symbol is composed of three curved lines that form the body and arms of the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 2009
Biomet Manufacturing Corporation % Ms. Susan Alexander Regulatory Affairs Specialist P.O. Box 587 Warsaw, Indiana 46581-0587
Re: K091608
Trade/Device Name: Cobalt™ MV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD Dated: September 1, 2009 Received: September 2, 2009
Dear Ms. Alexander:
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.
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
{2}------------------------------------------------
Page 2 - Ms. Susan Alexander
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sincerely yours,
Chavare Bnehus
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known):
Device Name: Cobalt™ MV Bone Cement
Indications For Use:
Cobalt™ MV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck and of the femur, sickle cell anemia osteoporosis, secondary severe joint destruction following trauma or other conditions (also for fixation of unstable fractures in metastatic malignancies), and revision of previous arthroplasty procedures.
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K091608
Page 1 of 1
§ 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.”