(90 days)
No
The device description and performance studies focus on the material properties and mechanical performance of a bone cement, with no mention of AI or ML technology.
Yes
The device is indicated for the treatment of pathological fractures of the vertebral body and sacral vertebral body/ala. "Treatment" suggests a therapeutic purpose.
No
This device is a bone cement used for treating pathological fractures, not for diagnosing them. It is used in surgical procedures like kyphoplasty and vertebroplasty.
No
The device description clearly states that KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin provided as a powder and liquid, which are manually mixed. This is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical procedure (cementoplasty, kyphoplasty, vertebroplasty, sacroplasty) involving the injection of bone cement into the vertebral body or sacrum to treat fractures. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is a bone cement, a material used for structural support and fixation within the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with such specimens for diagnostic purposes.
The device is a medical device used in a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications 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 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.
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
vertebral body, sacral vertebral body or ala
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)
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.
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 ( ISO 10993-11, Absence of pyrogens), Genotoxicity (Ames test) (ISO 10993-3, Non-mutagenic), Genotoxicity (Mouse Lymphoma) (ISO 10993-3 ISO/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.
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.
K151227, K163032, K171938, K191148
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
April 18, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and 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. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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
2
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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3
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 |
4
| 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.
5
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™ Bone
Cement
(Predicate Device,
K102397, K151227,
K163032, K171938 and
K191148) | 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 Significant
Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Mixing/Application | Manual | Manual | Same |
| Powder Sterilization
Method | Gamma-ray irradiation | Gamma-ray irradiation | Same |
| Sterility Assurance Level
(SAL) - Powder | 10-6 | 10-6 | Same |
| Liquid Sterilization
Method | 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
6
| 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) | Same
Different |
| Other Significant
Components | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Benzoyl peroxide
N,N-Dimethyl-p-toluidine
Hydroquinone | Same |
| Mixing/Application | Manual | Manual | Same |
| Powder Sterilization
Method | Gamma-ray irradiation | Irradiation | Same |
| Sterility Assurance
Level (SAL) – Powder | 10-6 | 10-6 | Same |
| Liquid Sterilization
Method | 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 (
ISO 10993-11 | Absence of pyrogens |
| Genotoxicity (Ames test) | ISO 10993-3 | Non-mutagenic |
| Genotoxicity (Mouse
Lymphoma) | ISO 10993-3
ISO/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.