(116 days)
OSTEOPAL® plus bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
OSTEOPAL® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833.
This document describes the FDA's clearance of OSTEOPAL® plus, a polymethylmethacrylate (PMMA) bone cement, based on its substantial equivalence to a predicate device (OSTEOPAL® V). The information provided does not detail an AI-powered device or a study involving AI performance. Instead, it focuses on the materials science and biocompatibility of the bone cement.
Therefore, many of the requested fields related to AI device performance are not applicable based on the provided text.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-Clinical Standards) | Reported Device Performance (OSTEOPAL® plus) |
|---|---|
| Maximum temperature (per ISO 5833) | Characterized (Specific values not provided in summary) |
| Setting time (per ISO 5833) | Characterized, displaying an even increased setting time compared to predicate. These prolonged working phases are needed for augmentation of vertebral bodies. |
| Compressive strength (per ISO 5833) | Characterized (Specific values not provided in summary) |
| Bending modulus (per ISO 5833) | Characterized (Specific values not provided in summary) |
| Bending strength (per ISO 5833) | Characterized (Specific values not provided in summary) |
| Impact strength (per Dynstat test method) | Measured (Specific values not provided in summary) |
| Bending strength (per Dynstat test method) | Measured (Specific values not provided in summary) |
| EtO sterilization (per ISO 11135) | Validated |
| Biocompatibility (cytotoxicity, irritation, sensitization, acute systemic toxicity per ISO 10993) | Performed (Specific results not provided in summary, but concluded to be not genotoxic based on predicate device's material constituents and sensitive tests). |
| Genotoxicity | Concluded to be not genotoxic (based on the same material constituents as a predicate device for which genotoxicity tests were performed and results are transferable). |
2. Sample size used for the test set and the data provenance:
- Sample size: Not applicable/Not provided. The document describes non-clinical laboratory testing of material properties, not a clinical study with human subjects or a test set for an AI algorithm.
- Data provenance: Not applicable/Not provided in terms of country of origin for a "test set." The testing was conducted by Heraeus Medical GmbH in Germany. The data is from laboratory testing of the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is not an AI algorithm and does not rely on expert-established ground truth for its performance assessment in this document. Its performance is assessed against material standards.
4. Adjudication method for the test set:
- Not applicable. This device is not an AI algorithm and does not involve adjudication of a test set.
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:
- No. This is not an AI-powered device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI-powered device.
7. The type of ground truth used:
- Material Standards & Benchmarking: The "ground truth" for this device's performance is established by recognized international standards (ISO 5833 for bone cement properties, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and comparison to a legally marketed predicate device (OSTEOPAL® V). For genotoxicity, it was based on the transferability of results from a predicate's predicate (PALACOS® R) due to shared material constituents.
8. The sample size for the training set:
- Not applicable. This is not an AI-powered device and therefore does not have a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI-powered device and therefore does not have a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized human figure with three faces in profile, representing the department's focus on health and well-being. The logo is simple, clean, and easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 22, 2016
Heraeus Medical GmbH % Mr. Gordon MacFarlane Senior Manager Regulatory Affairs ICON plc 62 Forest Street Marlborough, Massachusetts 01752
Re: K153737
Trade/Device Name: OSTEOPAL® plus Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: LOD, NDN Dated: March 15, 2016 Received: March 24, 2016
Dear Mr. MacFarlane:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/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 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 yours,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
|---|
| --------------------- |
| Form Approved: OMB No. 0910-0120 |
|---|
| Expiration Date: January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K153737 |
|---|---|
| -------------------------- | --------- |
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OSTEDPAL® plus
OSTEOPAL® plus
| Indications for Use (Describe) | OSTEOPAL® plus bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure. |
|---|---|
| -------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| 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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Heraeus Heraeus Medical GmbH 61273 Wehrheim, Germany
OSTEOPAL® plus
Radiopaque bone cement for augmentation
of vertebral bodies
Special 510(k)
510(k) Summary
| Date of summary | March 15th, 2016 |
|---|---|
| Applicant's name and address | Heraeus Medical GmbHPhilipp-Reis-Straße 8/1361273 WehrheimGermany |
| Device trade name | OSTEOPAL® plus |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement : Class II special control per 21 CFR888.3027 |
| Classification name | Polymethylmethacrylate (PMMA) bone cement |
| Product code | LOD, NDN |
| Identification of the marketed device to which equivalence is claimed | OSTEOPAL® V, K050085 |
| Description of the device | OSTEOPAL® plus is a radiopaque, low-viscosity bonecement, based on polymethyl methacrylate with anextended application phase, used to fill and stabilizevertebral bodies. OSTEOPAL® plus contains zirconiumdioxide as an X-ray contrast agent. OSTEOPAL® pluscontains the coloring agent chlorophyll VIII (E141) toimprove visibility in the surgical field. The bone cementis prepared immediately prior to use by mixing thepolymer powder component and the liquid monomercomponent. A low viscosity paste is applied with theuse of application system, placed in the vertebralbody, where it cures. OSTEOPAL® plus conforms to |
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OSTEOPAL® plus
Image /page/4/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The logo consists of the word "Heraeus" in a bold, sans-serif font, with the words "Heraeus Medical GmbH" printed below it. The address "61273 Wehrheim, Germany" is printed below the company name. The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.
Radiopaque bone cement for augmentation of vertebral bodies
| Special 510(k) | 510(k) Summary |
|---|---|
| Intended use | OSTEOPAL® plus bone cement is indicated for thetreatment of pathological fractures of the vertebral bodydue to osteoporosis, cancer, or benign lesions using avertebroplasty or balloon kyphoplasty procedure. |
| Comparison of technologicalcharacteristics | Bone cement is derived by mixing a powder componentand a monomer liquid. The only difference between thesubject and predicate device is a change to themonomer liquid composition and therefore an extendedsetting time. |
| Discussion of nonclinical tests | The maximum temperature, setting time, compressivestrength, bending modulus and bending strength ofOSTEOPAL® plus was characterized per ISO 5833.Both the subject and predicate device disclose a highercuring time, with OSTEOPAL® plus displaying an evenincreased setting time. These prolonged working phasesare needed because for augmentation of vertebral bodieslonger setting times than described in ISO 5833 arenecessary. Therefore, the later setting time isadvantageous. In addition, impact and bending strengthwere measured according to Dynstat test method. EtOsterilization was validated per ISO 11135.Biocompatibility testing, including cytotoxicity, irritation,sensitization, acute systemic toxicity was performed perISO 10993.AS PALACOS® R, K030902 (the predicate device forpolymerized OSTEOPAL® V) is made of the samematerial constituents as OSTEOPAL® plus and theperformed tests regarding genotoxicity are verysensitive it is reasonable that the results are |
| Special 510(k) | 510(k) Summary |
| transferable. Thus it can be concluded thatOSTEOPAL® plus is not genotoxic. | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from nonclinicaland clinical data | OSTEOPAL® plus is substantial equivalent toOSTEOPAL® V. |
| Submitted by | Dr. Astrid Marx |
| Phone: + 49 (0) 6181.35-2963 | |
| Fax: + 49 (0) 6181.35-2916 | |
| astrid.marx@heraeus.com | |
| US contact information | ICON plc, |
| Gordon MacFarlane, | |
| 62 Forest Street Suite 300, Marlborough, MA 01752 | |
| Tel: +1.919.873.8962 | |
| gordon.macfarlane@iconplc.com |
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OSTEOPAL® plus
Image /page/5/Picture/1 description: The image shows the logo and address of Heraeus Medical GmbH. The logo is a stylized wordmark with the company name "Heraeus" in a bold, sans-serif font. Below the logo is the company's name and address, which is "Heraeus Medical GmbH, 61273 Wehrheim, Germany."
Radiopaque bone cement for augmentation of vertebral bodies
§ 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.”