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.

Device Description

OSTEOPAL® V is a PMMA bone cement for use in vertebroplasty. It is formed from powder and liquid by exothermic polymerization.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called OSTEOPAL® V, which is a polymethylmethacrylate (PMMA) bone cement. The purpose of the submission is to gain clearance for modifications to an existing device (K050085). Based on the provided text, the device itself is a material (bone cement), and thus the acceptance criteria and study described are for the performance of the material, not for an AI/software device. Therefore, many of the requested fields are not applicable.

Here's the information derived from the provided document regarding the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Mechanical Property Standards	The initially cleared acceptance criteria (likely referring to the mechanical properties outlined in ISO 5833 and ASTM F451 for PMMA bone cement) were fulfilled. The document states that the evaluation demonstrated that "no new risks were identified, and the existing risks were not significantly modified." This implies the mechanical performance remained within acceptable limits after the modifications.
Biocompatibility	The materials' biocompatibility remains unchanged, implying it meets established acceptance criteria for biocompatibility.
Physical and Chemical Characteristics	These characteristics demonstrate substantial equivalence to the predicate device, suggesting they meet the same acceptance criteria as the predicate.
Packaging Stability and Integrity	Stability testing was performed, and the initially cleared acceptance criteria were fulfilled, indicating the packaging maintains integrity and the product remains stable over its shelf-life.
Sterility / Shelf-life	Evaluation of changes regarding sterility/shelf-life demonstrated no new risks or significant modification of existing risks. Stability testing was performed and fulfilled initial acceptance criteria. This implies the device maintains sterility and efficacy over its stated shelf-life.
MR Safety (due to modifications)	The device is designated as "MR Safe." This means it poses "no known hazards in all MR environments" because it is composed of "electrically nonconductive, nonmetallic, and nonmagnetic" materials.
Labeling Changes (Contraindications, Adverse Events, Warnings, Precautions)	Assessed in clinical evaluation and 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." This suggests the updated labeling accurately reflects the device's safety profile and intended use.
Risk Profile	A risk-based assessment (per DIN EN ISO 14971) concluded that "no new risks were identified, and the existing risks were not significantly modified" due to the modifications. This indicates that the device's overall risk profile remains acceptable and within established limits.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily discusses non-clinical testing for material properties and risk assessments. There is no mention of a "test set" in the context of patient data or clinical imaging. The studies performed are mechanical testing, stability testing, and risk assessments. For these non-clinical tests, specific sample sizes are not provided in this summary. The data provenance is implied to be from Heraeus Medical GmbH in Germany, where the device is manufactured and where the tests would typically be performed. The tests are prospective in nature (i.e., new tests performed on the modified device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as there is no "test set" or "ground truth" related to expert opinions on medical images or diagnoses for this device. The evaluation is based on engineering standards, material science, and risk assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there is no "test set" requiring adjudication by experts.

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

This is not applicable. OSTEOPAL® V is a bone cement, not an AI/software device, and no MRMC study with human readers assisting with AI was performed or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. OSTEOPAL® V is a bone cement, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the non-clinical tests (mechanical, stability, material characterization), the "ground truth" is established by adherence to recognized international standards (e.g., ISO 5833, ASTM F451, DIN EN ISO 14971) and validated laboratory testing methodologies. For the MR safety assessment, the "ground truth" is based on the material properties and scientific rationale. For the labeling and risk assessments, the "ground truth" is derived from clinical evaluations of the device's performance in the field (implicitly from the predicate device's history and relevant medical literature), coupled with the risk assessment process. There is no specific "expert consensus" or "pathology" ground truth mentioned as would be relevant for a diagnostic device.

8. The sample size for the training set

This is not applicable as there is no "training set" for an AI/software model. The device is a physical product (bone cement).

9. How the ground truth for the training set was established

This is not applicable as there is no "training set."

Summary

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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"

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(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)

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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K241674 Traditional 510(k) Premarket Notification OSTEOPAL® V

510(k) Summary

I. SUBMITTER
Manufacturer:	Heraeus Medical GmbHPhilipp-Reis-Str. 8/1361273 WehrheimGermany
Contact Person:	Dr. Sarah KopischkeManager Regulatory AffairsPhone: +49 (6181) 959-259Email: 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

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.

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.”