(139 days)
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 cementoplasty (i.e. 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. Pathologic fracture may include a symptomatic vertebral body microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height.
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.
The provided document is a 510(k) premarket notification for a medical device: KYPHON® HV-R® Bone Cement. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove acceptance criteria for a new device's performance.
Therefore, the information requested in your prompt (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details) is not present in this document.
This type of submission (510(k)) primarily demonstrates that a new device is as safe and effective as another legally marketed device (the predicate). It usually relies on comparisons of technological characteristics, materials, and intended use, rather than new clinical trials or performance studies against specific acceptance criteria for a novel technology or AI algorithm.
Summary of why the requested information is not in the document:
- Acceptance Criteria & Device Performance: The document doesn't define new acceptance criteria for the KYPHON® HV-R® Bone Cement's performance. Instead, it asserts that its performance characteristics (design features, device materials, chemical composition, device performance, packaging, manufacturing, sterilization) are "substantially equivalent" to predicate devices.
- Sample Sizes (Test/Training) & Data Provenance: Not applicable, as no new performance study data is presented. The document is about comparing to existing predicates.
- Expert Ground Truth & Adjudication: Not applicable, as there's no diagnostic or analytical performance study requiring expert review.
- MRMC Study / Standalone Performance: Not applicable, as this is not a diagnostic device or AI algorithm with human-in-the-loop interaction.
- Ground Truth Type: Not applicable.
- Training Set Details: Not applicable.
The document states: "The subject KYPHON® HV-R® Bone Cement has the same fundamental scientific technology as the predicates KYPHON® HV-R® Bone Cement (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone Cement (K151227 S.E. 11/16/2015). The subject device utilizes equivalent implant materials, sterilization methods and bacterial endotoxin testing applying the same 20 EU/mL pyrogen limit specifications utilizing the gel clot test method as the predicates..." This highlights the comparative nature of the submission.
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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked one behind the other, representing the department's focus on people and health.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis, Tennessee 38132
August 24, 2016
Re: K160983
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: August 1, 2016 Received: August 2, 2016
Dear Ms. Edwards:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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.
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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,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160983
Device Name Kyphon® HV-R® Bone Cement
Indications for Use (Describe)
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 cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. Cancer includes multiple myeloma and metastatic lesions. including those arising from breast or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathologic fracture may include a symptomatic vertebral body 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/14)
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510(k) Summary Medtronic Sofamor Danek
KYPHON® HV-R® Bone Cement
August 2016
| Submitter | Medtronic Sofamor Danek USA, Inc. |
|---|---|
| 1800 Pyramid Place | |
| Memphis, Tennessee 38132 | |
| Telephone: (901) 396-3133 | |
| Fax: (901) 346-9738 | |
| Contact | Pamela Edwards |
| Principal Regulatory Affairs Specialist | |
| Direct Telephone: 901-399-2125 | |
| Date Prepared | March 2016 |
| Common Name | KYPHON® HV-R® Bone Cement |
| Regulatory Class | Class II |
| Regulation Number | 21 CFR 888.3027 |
| Regulation Name and Device | Polymethylmethacrylate (PMMA) bone cement |
| Product Classification Code | NDN |
| Predicate Devices | KYPHON® HV-R® Bone Cement |
| K150460, S.E. 04/28/2015 (Primary Predicate) | |
| KYPHON® Xpede™ Bone Cement | |
| K151227, S.E. 11/16/2015 | |
| The predicate devices have not been subject to a design related recall. | |
| Description of Device | 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 cementoplasty (i.e. 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. Pathologic fracture may include a symptomatic vertebral body | |
| microfracture (as documented by appropriate imaging and/or presence of a lytic | |
| lesion) without obvious loss of vertebral body height. |
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| Comparison of TechnologicalCharacteristics with thePredicate Devices | The subject KYPHON® HV-R® Bone Cement has the same fundamentalscientific technology as the predicates KYPHON® HV-R® Bone Cement(K150460 S.E. 4/28/2015) and KYPHON® Xpede™ Bone Cement (K151227S.E. 11/16/2015). The subject device utilizes equivalent implant materials,sterilization methods and bacterial endotoxin testing applying the same 20EU/mL pyrogen limit specifications utilizing the gel clot test method as thepredicates KYPHON® HV-R® Bone Cement (K150460 S.E. 4/28/2015) andKYPHON® Xpede™ Bone Cement (K151227 S.E. 11/16/2015). |
|---|---|
| Conclusion | The design features, device materials, chemical composition, deviceperformance, packaging of the device materials, manufacturing and sterilizationmethods are substantially equivalent to the previously cleared KYPHON® HV-R® Bone Cement (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ BoneCement (K151227 S.E. 11/16/2015). The updated indication does not raise newissues 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 (K150460 S.E. 4/28/2015) and KYPHON® Xpede™ BoneCement (K151227 S.E. 11/16/2015). |
§ 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.”