(90 days)
The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. KYPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.
This document is a marketing clearance (510(k)) for a medical device, KYPHON™ VuE™ Bone Cement, and as such, it primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than providing detailed acceptance criteria and performance data in the format typically seen for an AI/ML medical device.
Key takeaway: This document describes a PMMA bone cement, not an AI/ML device. Therefore, the specific types of acceptance criteria and study designs (e.g., MRMC studies, ground truth establishment with experts, data provenance for test/training sets) that are applicable to AI/ML devices are not relevant to this 510(k) submission and are not present in the provided text.
The document discusses acceptance criteria and performance data related to the physical and chemical properties of the bone cement, its biocompatibility, sterility, and shelf life, comparing it to existing predicate devices.
However, to answer your request using the information available and adapting it to the framework you provided (even though it's designed for AI/ML), I will interpret "acceptance criteria" and "device performance" in the context of this traditional medical device.
Acceptance Criteria and Device Performance for KYPHON™ VuE™ Bone Cement
The acceptance criteria for KYPHON™ VuE™ Bone Cement, as described in this 510(k) submission, are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, particularly KYPHON® Xpede™ Bone Cement and Spineplex™ Bone Cement. This equivalence is established through various performance tests that ensure the new device meets established standards for bone cements.
1. Table of Acceptance Criteria and the Reported Device Performance (Adapted for a Non-AI/ML Device):
| Acceptance Criteria Category | Specific Criteria/Standard (Implicit) | Reported Device Performance (Summary) |
|---|---|---|
| Components | Composition should be safe and functionally equivalent (PMMA, MMA, Barium Sulfate, etc.) | Main Components: Polymethylmethacrylate (PMMA), Methylmethacrylate (MMA) - Same as predicates.Radiopacity Agent: Barium Sulfate (powder and granules) - Different from predicates (predicates used powder only), with the modification intended to improve visualization.Other Significant Components: Benzoyl peroxide, N,N-Dimethyl-p-toluidine, Hydroquinone - Same as predicates. |
| Mixing/Application | Manual mixing and application characteristics should be comparable. | Mixing/Application: Manual - Same as predicates. |
| Sterilization | Sterilization method and Sterility Assurance Level (SAL) must meet defined standards. | Powder Sterilization Method: Gamma-ray irradiation - Same as predicates.Powder SAL: 10⁻⁶ - Same as predicates.Liquid Sterilization Method: Filtration - Same as predicates.Liquid SAL: 10⁻³ - Same as predicates.Overall: Sterilization cycles validated following international standards. Shelf life of 2 years established. Bacterial endotoxin testing met limits (<20 EU/device). |
| Biocompatibility | Device materials must be safe and biocompatible, meeting ISO 10993 standards. | Results: Not cytotoxic, Not sensitizing, No signs of erythema/eschar/edema (intracutaneous reactivity), Non-toxic (acute systemic toxicity), Absence of pyrogens (material-mediated pyrogenicity), Non-mutagenic (Genotoxicity - Ames test & Mouse Lymphoma), No local and systemic effects (Implantation 13W). All tests met their respective pass criteria. |
| Performance Testing | Physical, chemical, and mechanical properties (e.g., dough time, setting time, polymerization temperature, strength) must meet relevant ASTM and ISO standards for PMMA bone cements. Sacroplasty testing (extravasation rate) must be acceptable. | Results: "Results show comparable performances to the predicate devices and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20." This statement indicates that the device met the performance requirements specified by these standards for various properties including mixing/application characteristics, chemical composition, thermal properties, mechanical properties, and extravasation rate. |
| Indications for Use | Must be consistent with predicate devices or justifiable. | Indications for Use: Same as predicates (treatment of pathological fractures of vertebral body due to osteoporosis, cancer, or benign lesions using cementoplasty; fixation of sacral vertebral body/ala using sacral vertebroplasty or sacroplasty). |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify exact sample sizes for each performance test (e.g., number of cement samples tested for mechanical properties, or biological replicates for biocompatibility). It generally states that "Performance testing was performed to characterize the bone cement." The data provenance is laboratory testing conducted by the manufacturer, Tecres S.p.A., with no specific mention of the country of origin for the test data for the performance studies described, although the manufacturer is based in Italy. These were likely prospective lab tests performed specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable as this is not an AI/ML device that requires human expert ground truth for imaging interpretation. The "ground truth" for this device's performance is established by its physical, chemical, and biological properties, measured against established engineering and biological standards (ASTM, ISO, Pharmacopoeia).
4. Adjudication Method for the Test Set:
This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of data, typically for AI/ML devices; they are not relevant for the objective physical, chemical, and biological tests performed on bone cement.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed to evaluate the impact of an AI algorithm on human reader performance, usually in diagnostics. This device is a bone cement, not a diagnostic AI tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done:
No, this is not applicable. This is not an algorithm. The "standalone performance" of the bone cement refers to its physical and chemical properties as measured in a lab, which are summarized under "Performance Testing" in section 8 of the 510(k) summary.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by:
- Compliance with international standards (e.g., ASTM F451-16, ISO 5833:2002, ISO 10993 series for biocompatibility).
- Objective laboratory measurements of its physical (e.g., mechanical strength, setting time), chemical (e.g., composition, residuals), and biological (e.g., cytotoxicity, endotoxin levels) properties.
- Comparison to predicate device performance, demonstrating "comparable performances."
8. The Sample Size for the Training Set:
This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this device would be its formulation and manufacturing process, optimized through R&D.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" in the development of the bone cement would relate to established material science principles, biocompatibility requirements, and clinical needs for bone cements, which guide its formulation and testing.
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April 18, 2022
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Tecres S.p.A. % Christine L. Brauer, PhD Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850
Re: K220131
Trade/Device Name: KYPHONTM VuE™ Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: January 14, 2022 Received: January 18, 2022
Dear Christine Brauer:
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. 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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
For:
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and 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
510(k) Number (if known) K220131
Device Name KYPHONTM VuE™ Bone Cement
Indications for Use (Describe)
The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
| 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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510(k) SUMMARY
GENERAL INFORMATION 1
1.1 Submitter and Owner of the 510(k)
Tecres S.p.A. Via A. Doria 6 37066 Sommacampagna Verona – Italy
1.2 Official Correspondent
Christine L. Brauer, PhD Regulatory Affairs Consultant 7 Trail House Court Rockville, Maryland 20850 Telephone: (301) 545-1990 E-mail: chris.brauer@comcast.net
Devices Subject of this 510(k) 1.3
KYPHON™ VuE™ Bone Cement
1.4 Date of Preparation
March 16, 2022
1.5 510(k) Number
2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION
2.1 Trade/Proprietary Name
KYPHON™ VuE™ Bone Cement
2.2 Common/Usual Name
Acrylic resin for vertebroplasty/kyphoplasty
2.3 Classification Information
| Classification Name: | Polymethylmethacrylate (PMMA) bone cement |
|---|---|
| Classification Regulation: | 21 CFR 888.3027 |
| Class: | II |
| Product Code(s): | NDN – Cement, Bone, Vertebroplasty |
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| Panel: | Orthopaedic |
|---|---|
| -------- | ------------- |
3 PREDICATE DEVICE
The predicate devices are identified as follows:
- KYPHON® Xpede™ Bone Cement which was cleared originally through 510(k) . application K102397 and subsequently cleared in K151227, K163032, K171938 and K191148.
- Spineplex™ Bone Cement by Stryker which was originally cleared through 510(k) ● notification K032945.
DEVICE DESCRIPTION ব
KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures.
K YPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy.
KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use.
ഗ INDICATIONS FOR USE
Below is the indication for use.
The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
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6 COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE
The KYPHON™ VuE™ Bone Cement and the predicate devices, the KYPHON® Xpede™ Bone Cement and the Spineplex™ Bone Cement, are intended to be used in the same surgical procedure (kyphoplasty, vertebroplasty or sacroplasty procedure) in the same target patient population and have the same primary function of treatment of pathological fractures of the vertebral body. Thus, the KYPHON™ VuE™ Bone Cement has the same intended use as the predicate devices.
7 COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
VuE™ -KYPHON™ Bone Cement shares many of the same technological characteristics compared to the predicate KYPHON® Xpede" Bone Cement (see Table 1) and to the predicate Spineplex™ Bone Cement (see Table 2).
| Characteristics | KYPHON™ VuE™Bone Cement(Subject Device) | KYPHON® Xpede™ BoneCement(Predicate Device,K102397, K151227,K163032, K171938 andK191148) | Comparison |
|---|---|---|---|
| Main Components | Polymethylmethacrylate(PMMA)Methylmethacrylate(MMA) | Polymethylmethacrylate(PMMA)Methylmethacrylate(MMA) | Same |
| Main Components | Barium Sulfate(powder and granules) | Barium Sulfate(powder only) | Different |
| Other SignificantComponents | Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone | Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone | Same |
| Mixing/Application | Manual | Manual | Same |
| Powder SterilizationMethod | Gamma-ray irradiation | Gamma-ray irradiation | Same |
| Sterility Assurance Level(SAL) - Powder | 10-6 | 10-6 | Same |
| Liquid SterilizationMethod | Filtration | Filtration | Same |
| SAL - Liquid | 10-3 | 10-3 | Same |
Table 1: Summary of Technological Characteristics between the KYPHON VuE™ Bone Cement and the Predicate Device, the KYPHON® Xpede™ Bone Cement
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| Characteristics | KYPHON™ VuE™Bone Cement(Subject Device) | Spineplex Bone Cement(Predicate Device,K032945) | Comparison |
|---|---|---|---|
| Main Components | Polymethylmethacrylate(PMMA)Methylmethacrylate(MMA)Barium Sulfate(powder and granules) | Polymethylmethacrylate(PMMA)Methylmethacrylate(MMA)Barium Sulfate(powder only) | SameDifferent |
| Other SignificantComponents | Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone | Benzoyl peroxideN,N-Dimethyl-p-toluidineHydroquinone | Same |
| Mixing/Application | Manual | Manual | Same |
| Powder SterilizationMethod | Gamma-ray irradiation | Irradiation | Same |
| Sterility AssuranceLevel (SAL) – Powder | 10-6 | 10-6 | Same |
| Liquid SterilizationMethod | Filtration | Filtration | Same |
| SAL - Liquid | 10-3 | 10-3 | Same |
Table 2: Summary of Technological Characteristics between the KYPHON™ VuE™ Bone Cement and the Predicate Device, the Spineplex™ Bone Cement
8 PERFORMANCE DATA
This 510(k) notification provided performance data to establish the substantial equivalence of the KYPHON™ VuE™ Bone Cement to the predicate device. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement: Guidance for Industry and FDA " dated July 17, 2002. The following is a summary of the performance data.
Sterilization and Shelf Life: The device is sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of 2 years has been established in stability studies in that evaluated both device functionality and sterility. Bacterial endotoxin testing was performed using the LAL test (gel clot) method, following the current edition of the European Pharmacopoeia (EP) Standard 2.6.14. Bacterial Endotoxins and met the limits (<20 EU/device). The analytical procedures described in the official pharmacopoeial texts, European Pharmacopoeia (Ph. Eur.): 2.6.14. Bacterial Endotoxins, Japanese Pharmacopoeia (JP): 4.01 Bacterial Endotoxins Test, and United States Pharmacopeia (USP) General Chapter Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions (Guidance for Industry O4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 14 Bacterial Endotoxins Test General Chapter, October 2013).
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Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible, and suitable for their intended use. FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was taken into account to evaluate the biocompatibility of the device materials and the following biocompatibility studies were completed.
| Biocompatibility Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | ISO 10993-5 | Not cytotoxic |
| Sensitization | ISO 10993-10 | Not sensitizing |
| Intracutaneous reactivity | ISO 10993-10 | No signs of erythema, eschar or edema |
| Systemic toxicity (acute) | ISO 10993-11 | Non-toxic |
| Material-mediated pyrogenicity | USP 42 <151>ISO 10993-11 | Absence of pyrogens |
| Genotoxicity (Ames test) | ISO 10993-3 | Non-mutagenic |
| Genotoxicity (MouseLymphoma) | ISO 10993-3ISO/TR 10993-33 | Non-mutagenic |
| Implantation 13W | ISO 10993-6 | No local and systemic effects- |
Performance Testing: Performance testing was performed to characterize the bone cement in accordance with special controls guidance document. This testing included the following:
- Mixing and application characteristics (e.g., dough time, setting time)
- Chemical composition (e.g., residuals, molecular weight and polymer structure, glass ● transition temperature)
- Thermal properties (e.g., polymerization temperature) ●
- Mechanical properties (e.g., modulus and flexural properties, static compression and . bending, fatigue testing, fracture toughness and viscoelasticity)
- . Sacroplasty testing (extravasation rate)
Results show comparable performances to the predicate devices and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20.
The performance data demonstrate that the new devices are substantially equivalent to the predicate device and meet the requirements of the Special Controls Guidance document.
§ 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.”