(64 days)
Not Found
No
The document describes a bone cement material and its intended use, with no mention of AI or ML technology in the device description, intended use, or any other section.
Yes
The device is used for the treatment of pathological fractures of the vertebral body, indicating a therapeutic purpose.
No
This device is a bone cement used for treating pathological fractures of the vertebral body. It is a therapeutic device, not a diagnostic one.
No
The device description clearly states it is a two-component system consisting of powder and liquid, which are physical components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Description: The provided description clearly states that KYPHON® HV-R® Bone Cement is a two-component system (powder and liquid) that is mixed and used in a surgical procedure (kyphoplasty or vertebroplasty) to treat fractures of the vertebral body.
- Intended Use: The intended use is to treat pathological fractures of the vertebral body by filling the fracture with bone cement. This is a therapeutic procedure performed directly on the patient's body, not a diagnostic test performed on a sample outside the body.
Therefore, based on the provided information, KYPHON® HV-R® Bone Cement is a medical device used in a surgical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. 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.
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
KYPHON® HV-R® Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.
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)
Not Found
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human figure, represented by three overlapping profiles, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2015
Medtronic Sofamor Danek USA, Incorporated Ms. Kathy L. Remsen Senior Regulatory Affairs Program Manager 1800 Pyramid Place Memphis, Tennessee 38132
Re: K150460
Trade/Device Name: KYPHON® HV-R® Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: March 10, 2015 Received: March 13, 2015
Dear Ms. Remsen:
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Lori A. Wiggins -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K150460 Page 1 of 1
INDICATIONS FOR USE
510(k) Number (if known): K150460
Device Name: KYPHON® HV-R® Bone Cement
Indications for Use:
K YPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a kyphoplasty or vertebroplasty procedure. 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.
| Prescription Use X | AND/OR | Over-The-Counter Use _ _ |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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KYPHON® HV-R® Bone Cement 510(k) Summary
February 2015
| Company: | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Kathy L. Remsen
Senior Regulatory Affairs Program Manager |
| Proprietary Trade Name: | KYPHON® HV-R® Bone Cement |
| Common Name: | Bone Cement |
| Classification Name: | Cement, bone, vertebroplasty |
| Product Code: | NDN |
| Regulation: | 21 CFR 888.3027 |
| Classification: | II |
Description: KYPHON® HV-R® Bone Cement is provided as a two component system. The powder component consists of a PMMA copolymer (polymethylmethacrylate/ methyl-methacrylate-styrene copolymer) with barium sulfate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer, with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as a promoter. The powder and liquid components are mixed prior to use.
Indications for Use: KYPHON® HV-R® Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer or benign lesions using a kyphoplasty or vertebroplasty procedure. 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.
Summary of the Technological Characteristics: The subject KYPHON® HV-R® Bone Cement has the same fundamental scientific technology as the predicates KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone
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Cement (K102397 S.E. 2/28/2011). The subject device utilizes equivalent implant materials and sterilization methods.
Identification of Legally Marketed Devices: The subject KYPHON® HV-R® Bone Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).
Conclusion: The design features, device materials, chemical composition, device performance, packaging of the device materials, manufacturing and sterilization methods are substantially equivalent to the previously cleared KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The updated indication does not raise new issues of safety or effectiveness. The intended use for KYPHON® HV-R® Bone Cement has not changed and is identical to the predicates KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).