(177 days)
Not Found
No
The document describes a bone cement and its physical properties and testing, with no mention of AI or ML.
Yes
The device is indicated for the treatment of pathological fractures of the vertebral body, which is a therapeutic purpose.
No
The device description indicates OSTEOPAL® V is a PMMA bone cement used in vertebroplasty, a procedure for treating pathological fractures. Its function is to solidify and stabilize fractured vertebral bodies, not to diagnose a condition.
No
The device description clearly states it is a PMMA bone cement, which is a physical material used in a surgical procedure, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for treating pathological fractures of the vertebral body using surgical procedures (vertebroplasty or balloon kyphoplasty). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used to fill and stabilize bone fractures.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
OSTEOPAL® V 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 (comma separated list FDA assigned to the subject device)
LOD, NDN
Device Description
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing OSTEOPAL® V polymethylmethacrylate (PMMA) bone cement previously cleared in K050085.
The modifications include the cumulative effect of changes regarding sterility, shelf-life and manufacturing as well as the addition of MR safety information, the specification of benzoyl peroxide and labeling changes.
OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.
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)
Summary of non-clinical tests
A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications regarding sterility, shelf-life and manufacturing as well as the specification extension of benzoyl peroxide on the device. The evaluation demonstrated that no new risks were identified, and the existing risks were not significantly modified. Subsequent mechanical testing (as per ISO 5833 and ASTM F451) and stability testing were performed and the initially cleared acceptance criteria were fulfilled. It has been indicated that the subject device is as safe and effective as the predicate device.
Furthermore, a scientifically based rationale has been prepared to designate the bone cement as "MR Safe". OSTEOPAL® V is composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic and pose no known hazards in all MR environments.
The labeling changes regarding contraindications, adverse events and residual risks, warnings, and precautions were assessed in the clinical evaluation and a risk-based assessment. It has been demonstrated that OSTEOPAL® V performs as intended if used as intended by the manufacturer and no unknown complications that have not yet been described in the instructions for use were found.
Summary of clinical tests
No clinical tests were performed to demonstrate substantial equivalence.
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.
OSTEOPAL V (K050085)
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.”
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 5, 2024
Heraeus Medical GmbH Sarah Kopischke Manager Regulatory Affairs Philipp-Reis-Str. 8/13 Wehrheim, Hessen 61273 Germany
Re: K241674
Trade/Device Name: Osteopal® V Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: LOD, NDN Dated: June 11, 2024 Received: June 11, 2024
Dear Sarah Kopischke:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Digitally signed by JESSE JESSE MUIR -S MUIR -S Date: 2024.12.05 12:09:20 -05'00'
Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair & Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
K241674
Device Name
OSTEOPAL® V
Indications for Use (Describe)
OSTEOPAL® V 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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Image /page/4/Picture/0 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font in gray. Below it, in a smaller, black, sans-serif font, are the words "Heraeus Medical GmbH."
K241674 Traditional 510(k) Premarket Notification OSTEOPAL® V
510(k) Summary
| I. SUBMITTER | |
|---|---|
| Manufacturer: | Heraeus Medical GmbH |
| Philipp-Reis-Str. 8/13 | |
| 61273 Wehrheim | |
| Germany | |
| Contact Person: | Dr. Sarah Kopischke |
| Manager Regulatory Affairs | |
| Phone: +49 (6181) 959-259 | |
| Email: Sarah.kopischke@heraeus.com | |
| Date Prepared: | December 4, 2024 |
II. DEVICES
| Name of Device(s): | OSTEOPAL® V |
|---|---|
| Device Common Name: | Polymethylmethacrylate (PMMA) bone cement |
| Regulation Number: | 21CFR 888.3027 |
| Device Class: | Class 2 |
| Primary Product Code: | LOD |
| Associated Product Code(s): | NDN |
PREDICATE DEVICES lll.
| Primary Predicate: | OSTEOPAL V (K050085) |
|---|---|
| -------------------- | ----------------------------------- |
IV. DEVICE DESCRIPTION
A Traditional 510(k) submission is being supplied to the U.S. FDA to gain clearance for modifications to the existing OSTEOPAL® V polymethylmethacrylate (PMMA) bone cement previously cleared in K050085.
The modifications include the cumulative effect of changes regarding sterility, shelf-life and manufacturing as well as the addition of MR safety information, the specification of benzoyl peroxide and labeling changes.
OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.
> INDICATIONS FOR USE
OSTEOPAL® V 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.
The subject device (OSTEOPAL® V) has the same intended use and indications for use in comparison to the predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for Heraeus Medical GmbH. The word "Heraeus" is in a large, bold, sans-serif font, and it is gray. Below the word "Heraeus" is the text "Heraeus Medical GmbH" in a smaller, bold, sans-serif font, and it is black.
OSTEOPAL® V
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.
Device comparison demonstrated that OSTEOPAL® V is substantial equivalent to the cited predicate device in terms of operating principle and technological characteristics (design features, material, and performance). At a high level, the subject device and predicate device are based on the following same technological elements:
- . PMMA bone cements,
- . Same raw materials.
- . Biocompatibility of materials,
- Physical and chemical characterization, ●
- Mechanical performance characteristics,
- Packaging including stability and integrity,
- Sterilized with an established method (ethylene oxide) and .
- Designed for use in vertebroplasty or kyphoplasty procedures. .
The following technological differences exist between the subject and predicate devices:
- . Cumulative effect of changes regarding sterility / shelf-life and manufacturing,
- . Specification extension of benzoyl peroxide,
- Addition of MR safety information, and ●
- . Labeling changes.
PERFORMANCE DATA VII.
Summary of non-clinical tests
A risk-based assessment was performed as per DIN EN ISO 14971 to evaluate the impact of the modifications regarding sterility, shelf-life and manufacturing as well as the specification extension of benzoyl peroxide on the device. The evaluation demonstrated that no new risks were identified, and the existing risks were not significantly modified. Subsequent mechanical testing (as per ISO 5833 and ASTM F451) and stability testing were performed and the initially cleared acceptance criteria were fulfilled. It has been indicated that the subject device is as safe and effective as the predicate device.
Furthermore, a scientifically based rationale has been prepared to designate the bone cement as "MR Safe". OSTEOPAL® V is composed of materials that are electrically nonconductive, nonmetallic, and nonmagnetic and pose no known hazards in all MR environments.
The labeling changes regarding contraindications, adverse events and residual risks, warnings, and precautions were assessed in the clinical evaluation and a risk-based assessment. It has been demonstrated that OSTEOPAL® V performs as intended if used as intended by the manufacturer and no unknown complications that have not yet been described in the instructions for use were found.
Summary of clinical tests
No clinical tests were performed to demonstrate substantial equivalence.
VIII. CONCLUSION
OSTEOPAL® V is substantially equivalent to the predicate device (OSTEOPAL® V (K050085)) identified in this premarket notification.