(331 days)
Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
The provided text focuses on the 510(k) summary for Cobalt™ V Radiopaque Vertebroplasty Bone Cement and does not contain detailed information about specific acceptance criteria, device performance metrics, or a formal study design with corresponding results.
Therefore, many of the requested fields cannot be filled. Based on the provided text, here's what can be extracted:
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A table of acceptance criteria and the reported device performance:
The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, it does not provide specific acceptance criteria (e.g., tensile strength, setting time ranges) or numerical performance metrics. -
Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
No information is provided regarding sample sizes, data provenance, or the nature of the test set for any performance evaluation. The testing described is "non-clinical laboratory testing." -
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. The document refers to non-clinical laboratory testing of a bone cement, not diagnostic image interpretation where expert ground truth would be established. -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as this refers to a medical device's performance in evaluating diagnostic results, which is not the case here. -
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. This device is a bone cement, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is a bone cement, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The testing was non-clinical laboratory testing of material properties, not an evaluation against a medical ground truth like pathology for a diagnostic device. -
The sample size for the training set:
Not applicable. This device is a bone cement, not a machine learning model that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for a bone cement device.
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Image /page/0/Picture/0 description: The image shows the word "BIOMET" in a stylized, blocky font. Each letter is outlined in black, giving it a bold and distinct appearance. The letters are connected, forming a single, unified wordmark.
510(k) Summary
| Preparation Date: | December 22, 2006 | NOV 3 0 2007 |
|---|---|---|
| Applicant/Sponsor: | Biomet Manufacturing Corporation | |
| Contact Person: | Gary E. Baker | |
| Proprietary Name: | CobaltTM V Radiopaque Vertebroplasty Bone Cement | |
| Common Name: | PMMA Bone Cement | |
| Classification Name: | Polymethylmethacrylate (PMMA) Bone Cement (§ 888.3027) |
Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Osteopal® V - Heraeus Kulzer GMBH (K050085) Spineplex™ Radiopaque Bone Cement -- Stryker (K032945) Cobalt" HV Bone Cement - Biomet Inc. (K051496)
Device Description: Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
Intended Use: Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Summary of Technologies: Cobalt™ V Radiopaque Vertebroplasty Bone Cement has the same indications for use and technology as the predicate devices. Cobalt" V Radiopaque Vertebroplasty Bone Cement is made of the same components as the predicate Cobalt™ HV Bone Cement. The ratio of ingredients has been modified to meet specific customer needs for vertebroplasty and kyphoplasty applications.
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.
All trademarks are property of Biomet, Inc. except for Osteopal® V and Spineplex
5-1
MAHING ADDRESS SHIPPING ADDRESS P.O. Box 587 Warsaw, IN 46581 0587 ()ドFFICE PAX 그
574.267-66.41)
574.267.8137
56 E. Rell Drive Warsaw, IN 46582
.
E-MAII biomet@biomet.com
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2007
Biomet Manufacturing Corporation %Gary E. Baker Regulatory Specialist PO Box 587 Warsaw, Indiana 46581
Re: K070015
Trade/Device Name: Cobalt V Radiopaque Vertebroplasty Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, NDN Dated: October 30, 2007 Received: November 02, 2007
Dear Mr. Baker:
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 such 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); good manufacturing practice requirements as set 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.
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Page 2 - Mr. Gary E. Baker
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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,
Mark N. Mcllheran
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):_
Device Name: _____ Cobalt™ V Radiopaque Vertebroplasty Bone Cement
Indications For Use:
Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.
Prescription Use X (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
(Division S 10-3-011 Division of General, Restoration and Neurological Devices
510(k) Number: 10700015
§ 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.”