(116 days)
PALACOS® R, K030902
No
The device description and performance studies focus on the material properties and mechanical performance of the bone cement, with no mention of AI or ML.
Yes
The device is a bone cement used for the treatment of pathological fractures, which directly provides a therapeutic effect by stabilizing vertebral bodies.
No.
The device is a bone cement used to treat pathological fractures of the vertebral body by filling and stabilizing them. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a bone cement, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of pathological fractures of the vertebral body using a vertebroplasty or balloon kyphoplasty procedure. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a bone cement used to fill and stabilize vertebral bodies. It is mixed and applied directly into the patient's body.
- Lack of In Vitro Activity: IVDs are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on bodily specimens.
The device is a medical device used in vivo (within the body) for a therapeutic purpose (stabilizing fractures).
N/A
Intended Use / Indications for Use
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.
Product codes
LOD, NDN
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vertebral body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests were discussed. The maximum temperature, setting time, compressive strength, bending modulus and bending strength of OSTEOPAL® plus was characterized per ISO 5833. Both the subject and predicate device disclose a higher curing time, with OSTEOPAL® plus displaying an even increased setting time. These prolonged working phases are needed because for augmentation of vertebral bodies longer setting times than described in ISO 5833 are necessary. Therefore, the later setting time is advantageous. In addition, impact and bending strength were measured according to Dynstat test method. EtO sterilization was validated per ISO 11135. Biocompatibility testing, including cytotoxicity, irritation, sensitization, acute systemic toxicity was performed per ISO 10993. As PALACOS® R, K030902 (the predicate device for polymerized OSTEOPAL® V) is made of the same material constituents as OSTEOPAL® plus and the performed tests regarding genotoxicity are very sensitive it is reasonable that the results are transferable. Thus it can be concluded that OSTEOPAL® plus is not genotoxic. No clinical data was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OSTEOPAL® V, K050085
Reference Device(s)
PALACOS® R, K030902
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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
1
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) |
|---|---|
| ------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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(AFIT) 1888 AG3 (AD3 MAO3
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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 GmbH |
| Philipp-Reis-Straße 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Device trade name | OSTEOPAL® plus |
| Common name | PMMA Bone Cement |
| Classification | PMMA Bone Cement : Class II special control per 21 CFR |
| 888.3027 | |
| 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 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 |
4
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 the |
| treatment of pathological fractures of the vertebral body | |
| due to osteoporosis, cancer, or benign lesions using a | |
| vertebroplasty or balloon kyphoplasty procedure. | |
| Comparison of technological | |
| characteristics | Bone cement is derived by mixing a powder component |
| and a monomer liquid. The only difference between the | |
| subject and predicate device is a change to the | |
| monomer liquid composition and therefore an extended | |
| setting time. | |
| Discussion of nonclinical tests | The maximum temperature, setting time, compressive |
| strength, bending modulus and bending strength of | |
| OSTEOPAL® plus was characterized per ISO 5833. | |
| Both the subject and predicate device disclose a higher | |
| curing time, with OSTEOPAL® plus displaying an even | |
| increased setting time. These prolonged working phases | |
| are needed because for augmentation of vertebral bodies | |
| longer setting times than described in ISO 5833 are | |
| necessary. Therefore, the later setting time is | |
| advantageous. In addition, impact and bending strength | |
| were measured according to Dynstat test method. EtO | |
| sterilization was validated per ISO 11135. | |
| Biocompatibility testing, including cytotoxicity, irritation, | |
| sensitization, acute systemic toxicity was performed per | |
| ISO 10993. | |
| AS PALACOS® R, K030902 (the predicate device for | |
| polymerized OSTEOPAL® V) is made of the same | |
| material constituents as OSTEOPAL® plus and the | |
| performed tests regarding genotoxicity are very | |
| sensitive it is reasonable that the results are | |
| Special 510(k) | 510(k) Summary |
| transferable. Thus it can be concluded that | |
| OSTEOPAL® plus is not genotoxic. | |
| Clinical performance data | No clinical data was provided. |
| Conclusions from nonclinical | |
| and clinical data | OSTEOPAL® plus is substantial equivalent to |
| OSTEOPAL® 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."