Cobalt™ HV 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 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.

Device Description

Cobalt™ Bone Cement provides two separate, pre-measured sterilized components which when mixed form radiopaque rapidly setting bone cement.

AI/ML Overview

The provided text describes the 510(k) premarket notification for Cobalt™ HV Bone Cement. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of diagnostic device performance. Therefore, many of the requested categories regarding acceptance criteria derivation and study design for diagnostic devices are not applicable.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

For medical devices like bone cement, acceptance criteria are typically based on in-vitro mechanical, chemical, physical, and handling properties. The "performance" isn't a diagnostic accuracy metric but rather meeting specified ranges for these properties.

Acceptance Criteria Category	Reported Device Performance (Cobalt™ HV Bone Cement)
Mechanical Properties	Demonstrated substantial equivalence to Palacos® R Bone Cement, indicating comparable mechanical performance. (Specific numerical values not provided in this summary.)
Chemical Properties	Demonstrated substantial equivalence to Palacos® R Bone Cement, indicating comparable chemical characteristics. (Specific numerical values not provided in this summary.)
Physical Properties	Demonstrated substantial equivalence to Palacos® R Bone Cement, indicating comparable physical characteristics. (Specific numerical values not provided in this summary.)
Handling Properties	Demonstrated substantial equivalence to Palacos® R Bone Cement, indicating comparable mixing, working, and setting characteristics. (Specific numerical values not provided.)
Material Composition Equivalence	Composed of similar materials (methylmethacrylate-methylacrylate copolymer, benzoyl peroxide, zirconium dioxide, methylmethacrylate, N,N-dimethyl-p-toluidine, hydroquinone) to predicate, supporting claim of equivalence.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify the exact sample sizes (e.g., number of test batches, number of samples per test) used for the in-vitro testing. It refers generally to "extensive in-vitro testing."
Data Provenance: The data is from "in-vitro testing" conducted by the manufacturer, Biomet Manufacturing Corp. It is not patient or clinical data, so terms like "country of origin" or "retrospective/prospective" in the clinical sense are not applicable.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This question is not applicable. For material performance testing, "ground truth" is established by validated laboratory testing methods rather than expert consensus on clinical cases. The tests themselves provide the "ground truth" data for the material properties.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication typically refers to resolving disagreements among human reviewers (e.g., radiologists) in diagnostic studies. For in-vitro material testing, results are quantitative and subject to standard laboratory quality control.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was performed or is mentioned. This type of study is relevant for diagnostic imaging devices where human readers interpret results. The Cobalt™ HV Bone Cement is a bone cement, not an imaging device. The document explicitly states: "No clinical testing was performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. "Standalone performance" refers to the performance of a diagnostic algorithm without human intervention. This device is a medical material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on standardized in-vitro test methods for material properties (mechanical, chemical, physical, handling). These tests are designed to objectively measure properties relevant to the function and safety of bone cement, often following international standards or specific guidance documents (e.g., Class II Special Controls Guidance: Polymethylmethacrylate (PMMA) Bone Cement: Guidance for Industry & FDA-July 17, 2002, mentioned in the document).

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product (bone cement), not an AI algorithm that requires a "training set." The materials and manufacturing processes are developed through research and engineering, not machine learning.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reasons as #8.

Summary

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K051496

AUG 4 - 2005

510(k) Summary

Cobalt™ HV Bone Cement

Applicant/Sponsor: Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person: Lonnie Witham Telephone: (574) 267-6639 Fax: (574) 372-1683

Proprietary Name: Cobalt™ HV Bone Cement

Common Name: Bone Cement

Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

Device: Palacos® R Bone Cement Approved by: PMA (P810020, S001, S002, S003, S004) reclassified into Class II Manufacturer: Biomet Inc.; 56 East Bell Drive; Warsaw, IN 46582

Predicate Device: Generation 4® Bone Cement Cleared by: 510(k) Notification (K993836) Manufacturer: Biomet Inc.; 56 East Bell Drive; Warsaw, IN 46582 (Relevant to packaging and sterilization processes cleared for this device)

Device Description:

Cobalt™ Bone Cement provides two separate, pre-measured sterilized components which when mixed form radiopaque rapidly setting bone cement.

Materials used:

40 g powder component (copolymer):

Methylmethacrylate-methylacrylate copolymer containing FD&C Blue No. 2 . Aluminum Lake
Benzoyl peroxide, hydrous 75% .
Zirconium dioxide .

20 ml of liquid component (monomer):

Methylmethacrylate (stabilized with hydroquinone) .
. N.N-dimethyl-p-toluidine

Methymethacrylate monomer is the primary constituent of the liquid component. In much smaller quantities are the accelerator, N, N-dimethyl-p-toluidine, and the stabilizer, hydroquinone, both are typical constituents of PMMA bone cement.

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When the powder and liquid components are mixed, the accelerator speeds the generation of free radicals and the stabilizer in the liquid reacts with many of the early free radicals, but is soon consumed. Free radicals can then initiate formation of polymer chains.

Polymerization proceeds slowly over the first few minutes. Polymer chains at the surface of the powder beads mingle with monomer and newly formed polymer chains, while smaller beads may dissolve completely. The cement temperature rises as set time of the cement approaches. Polymerization is essentially complete and the bone cement is hard within 15 minutes.

Intended Use / Indications for Use:

Cobalt™ 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 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 the Technological Characteristics:

Extensive in-vitro testing was performed in accordance with Class II Special Controls Guidance: Polymethylmethacrvlate (PMMA) Bone Cement: Guidance for Industry & FDA-July 17, 2002 to demonstrate the equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement. Test results showed that the technological characteristics (mechanical, chemical, physical & handling properties) of the two cements are substantially the same.

Non-Clinical:

The substantial equivalence of Cobalt™ Bone Cement to Palacos® R Bone Cement was determined by performing comparative in vitro testing and then comparing the results. The results showed that Cobalt™ Bone Cement possesses mechanical, chemical, physical and handling characteristics necessary to fulfill its intended use. In summary, Cobalt™ Bone Cement is substantially equivalent to Palacos® R Bone Cement for its primary intended use of fixation of prosthetic components as described in the device labeling. No clinical testing was performed.

Clinical Testing: No clinical testing was required.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

9200 Corpor
Rockville M

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lonnie Witham Biomet Manufacturing Corp. P.O. Box 587 Warsaw, Indiana 6581-0587

Re: K051496

Trade/Device Name: Cobalt™ HV Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 3, 2005 Received: June 6, 2005

Dear Mr. Witham:

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.

AUG 4 - 2005

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. Lonnie Witham

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 Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Stupt Rhodes

Mark Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

510(k) Number

Device Name: Cobalt™ HV Bone Cement

Indications for Use:

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hyst Rurda
(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.”