(114 days)
Not Found
No
The description focuses on the chemical composition and physical properties of a bone cement, with no mention of AI or ML technologies.
Yes
The device is a bone cement used for the fixation of pathological fractures of the vertebral body, which is a therapeutic intervention aimed at stabilizing and alleviating pain from vertebral compression fractures.
No
Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body. It is a treatment device, not a diagnostic one.
No
The device description clearly states it is a radio-opaque, injectable acrylic 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 fixation of pathological fractures of the vertebral body using surgical procedures (Vertebroplasty or Kyphoplasty). This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The device is a bone cement that is mixed and injected into the vertebral body to stabilize fractures. It is a material used in vivo (within the body) for structural support.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (blood, tissue, etc.) to provide diagnostic information about a disease or condition. IVDs are designed to perform tests on these types of samples.
The device is a medical device used in a surgical procedure for treatment, not for diagnosis.
N/A
Intended Use / Indications for Use
The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Product codes (comma separated list FDA assigned to the subject device)
LOD, NDN, MDN
Device Description
Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.
The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.
Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.
The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included.
The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.
When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D.
As a result, a viscous injectable paste is obtained which can be introduced into a vertebral body using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing the bone cement is able to stabilize the vertebral lesions and vertebral compression fractures. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.
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)
The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.”
0
| aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
| Germany | Vertecem II Mixing Kit | K121876 |
|---|---|---|
| 5. 510(k) Summary | 164-0008-01 | |
| Date of issue: | ||
| 2 2. Juni 2012 | ||
| 510(k) Premarket Notification PO-32 | page 1 of 3 |
.
5. 510(k) summary
:
OCT 1 9 2012
:
:
| Preparation date: | June 22, 2012 |
|---|---|
| Submitter: | aap Biomaterials GmbH |
| Lagerstraße 11-15 | |
| 64807 Dieburg | |
| Germany | |
| Phone: +49 6071 / 929-0 | |
| Fax: +49 6071 / 929-100 | |
| Contact person: | Volker Stirnal |
| Trade name: | Vertecem II Mixing Kit |
| Common name: | PMMA Bone Cement (For Vertebroplasty) |
| Classification: | Polymethylmethacrylate (PMMA) Bone Cement |
| 21 CFR 888.3027, Class II | |
| Product Code: | LOD, NDN |
| Panel: | Orthopedics |
Predicate device to which substantial equivalence is claimed:
| Manufacturer | Device Name | 510(k) # |
|---|---|---|
| Teknimed S.A.S. | Vertecem | (K090435) |
| Manufacturer | Device Name | 510(k) # |
| aap Biomaterials | BonOs Inject | (K090460) |
1
| K 121876 | ||
|---|---|---|
| aap Biomaterials GmbH | ||
| Lagerstraße 11 – 15 | ||
| 64807 Dieburg | ||
| Germany | Vertecem II Mixing Kit |
- 510(k) Summary
510(k) Premarket Notification PO-32 | 164-0008-01
Date of issue: - Juni 2012
page 2 of 3 |
Device description:
Vertecem II is a radio-opaque, injectable acrylic bone cement used for the treatment of pathological fractures of the vertebral body using a Vertebroplasty or Kyphoplasty procedure.
The Vertecem II Mixing Kit consists of sterile packed components. When the cement components are mixed together, they become a self hardening, radioopaque bone cement.
Scientific concepts, significant physical and performance characteristics:
Bone cements in general are self-polymerizing two-component systems comprising a powder and a liquid which polymerize at room temperature immediately after they are mixed together.
The major powder component is polymethyl methacrylate / acrylate. Furthermore a radio-opacifier and benzoyl peroxide as initiator is included.
The liquid mainly consists of methyl methacrylate. It is furthermore comprised of an activator and a stabilizer to prevent premature polymerization.
When the powder and liquid components are mixed together, the activator DmpT, contained in the liquid activates the initiator in the powder component. This reaction starts the polymerization of the MMA, which is bonded with the polymer powder during ongoing polymerization. A description of polymerization technology is depictured in section 10- Executive summary, annex 10 - D.
As a result, a viscous injectable paste is obtained which can be introduced into a vertebral body using a suitable application system. Heat is generated during setting as a result of the progressive polymerization and exothermic reaction respectively. After curing the bone cement is able to stabilize the vertebral lesions and vertebral compression fractures. The setting or curing time is greatly influenced by the temperature of the components and environment, which is common for all acrylic bone cements.
Statement of the intended use:
The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
2
| aap Biomaterials GmbH
Lagerstraße 11 – 15
64807 Dieburg
Germany | Vertecem II Mixing Kit
- 510(k) Summary
510(k) Premarket Notification PO-32 | 164-0008-01
Date of issue:
2 2. Juni 2012
page 3 of 3 |
| -------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------- | -------------------------------------------------------------------- |
|---|
VI91471
Summary of technological characteristics of the new device in comparison to the predicate devices:
Vertecem II bone cement comprises the same materials, mechanical safety and performance as the legally marketed devices BonOs Inject and Vertecem.
| Trade Name | Vertecem II Mixing Kit | Vertecem | BonOs Inject |
|---|---|---|---|
| Common name | PMMA Bone | ||
| Cement | PMMA Bone | ||
| Cement | PMMA Bone | ||
| Cement | |||
| Responsible | |||
| manufacturer | aap Biomaterials | Teknimed S.A.S. | aap Biomaterials |
| 510(k) Number | - | K090435 | K090460 |
| Device | |||
| Classification | |||
| Name | Cement, Bone, | ||
| Vertebroplasty | Cement, Bone, | ||
| Vertebroplasty | Cement, Bone, | ||
| Vertebroplasty | |||
| Product Code | NDN | NDN | NDN |
| Classification | Class II | Class II | Class II |
| Regulation no. | 21 CFR 888.3027 | 21 CFR 888.3027 | 21 CFR 888.3027 |
The effectiveness and substantial equivalence of Vertecem II Bone Cement was determined by physical, chemical and mechanical comparative tests to Vertecem and BonOs Inject by comparing the results of the relevant data.
In summary, Vertecem II Bone Cement is as safe and effective for the declared indications as the predicate devices BonOs Inject and Vertecem.
In conclusion substantially equivalence has been demonstrated for Vertecem II Mixing Kit in comparison to Vertecem (K090435) and BonOs Inject (K090460).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
aap Biomaterials GmbH % Mr. Volker Stirnal Director, Quality Assurance and Regulatory Affairs Lagerstrasse 11-15 Dieburg, Germany D-64807
Re: K121876
Trade/Device Name: Vertecem II Mixing Kit Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: MDN, LOD Dated: October 15, 2012 Received: October 16, 2012
Dear Mr. Stirnal:
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
OCT 1 9 2012
4
Page 2 - Mr. Volker Stirnal
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.htm 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/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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Sincerely yours,
for
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
| aap Biomaterials GmbH
| Lagerstraße 11 – 15 | Vertecem II Mixing Kit | 164-0007-01 |
|---|---|---|
| 64807 Dieburg | ||
| Germany | 4. Indications for Use Statement | Date of issue: |
- Juni 2012 |
| | 510(k) Premarket Notification PO-32 | |
4. Indications for Use
510(k) Number:
Device Name:
Vertecem II Mixing Kit
Indications for Use:
The Vertecem II Bone Cement is used for the fixation of pathological fractures of the vertebral body using Vertebroplasty or Kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Samuel D. Payne
(Division Sign-Off) (Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121876
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)