(119 days)
Not Found
No
The summary describes a bone cement and its intended use and testing, with no mention of AI or ML capabilities.
Yes
The device is a bone cement used in procedures (kyphoplasty or vertebroplasty) to treat pathological fractures of the vertebral body and sacrum, aiming to restore stability and alleviate pain, which aligns with the definition of a therapeutic device.
No
The device is a bone cement used for treating pathological fractures, not for diagnosing them. It is indicated for treatment procedures like cementoplasty, kyphoplasty, and vertebroplasty.
No
The device description clearly states it is a two-component system consisting of powder and liquid components, which are physical substances, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Kyphon® Xpede™ Bone Cement Function: The provided description clearly states that Kyphon® Xpede™ Bone Cement is a material used within the body during a surgical procedure (cementoplasty, kyphoplasty, vertebroplasty, sacroplasty) to treat pathological fractures. It is a physical implant/filler, not a device that analyzes biological samples.
The description focuses on the composition of the cement, its intended use in surgical procedures, and performance studies related to its behavior within the body (like extravasation). This aligns with the characteristics of a medical device used in vivo, not an IVD used in vitro.
N/A
Intended Use / Indications for Use
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
NDN
Device Description
Kyphon® Xpede™ 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, sacral vertebral body, sacrum
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
A cadaver study in support of the expanded indication was completed. This study was performed to evaluate the extravasation behavior of the Kyphon® Xpede™ Bone Cement during sacroplasty procedures. The study also defined the surgical procedure steps and imaging needed to minimize the risk of extravasation for the sacroplasty procedure. Both the long-axis and short-axis surgical techniques were evaluated for cement extravasation. The procedure and imaging review was performed by trained physicians. The calculated extravasation rate with the Kyphon® Xpede™ Bone Cement was within the extravasation rate range of the published sacroplasty literature.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical literature data and cadaveric testing was provided to support the substantial equivalence of the subject device. A retrospective clinical literature review was performed to examine the potential benefits and associated risks of using PMMA bone cement using a sacral vertebroplasty or sacroplasty procedure. The five articles reviewed provided clinical outcomes of 462 patients utilizing both the long-axis and short-axis surgical technique demonstrating the safety and efficacy of PMMA bone cement when used in the sacrum.
A cadaver study in support of the expanded indication was completed. This study was performed to evaluate the extravasation behavior of the Kyphon® Xpede™ Bone Cement during sacroplasty procedures. The study also defined the surgical procedure steps and imaging needed to minimize the risk of extravasation for the sacroplasty procedure. Both the long-axis and short-axis surgical techniques were evaluated for cement extravasation. The procedure and imaging review was performed by trained physicians. The calculated extravasation rate with the Kyphon® Xpede™ Bone Cement was within the extravasation rate range of the published sacroplasty literature.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized representation of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 27, 2017
Medtronic Inc. Ms. Pamela Edwards Principal Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K163032
Trade/Device Name: Kyphon® Xpede " Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: January 27, 2017 Received: January 30, 2017
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 Part 801); medical device reporting (reporting of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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
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.
Indications for Use
510(k) Number (if known)
K163032
Device Name Kyphon® Xpede™ Bone Cement
Indications for Use (Describe)
Kyphon® Xpede™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions 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. 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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510(k) Summary Medtronic Sofamor Danek USA, Inc.
October 21, 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 | |
| Jeff Sprague | |
| Sr. Regulatory Affairs Program Manager | |
| Direct Telephone: 901-344-1326 | |
| Date Prepared | October 21, 2016 |
| Common Name | Kyphon® Xpede™ 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 | Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| K150582, S.E. 06/12/2015 (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® Xpede™ 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® Xpede™ 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. 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. | |
| Comparison of | |
| Technological | |
| Characteristics | |
| with | |
| the | The subject Kyphon® Xpede™ Bone Cement has the same or similar indications |
| for use, intended use, materials and fundamental scientific technology as the | |
| Predicate Devices | predicates Vertaplex® High Viscosity (HV) Radiopaque Bone Cement |
| (K150582, S.E. 06/12/2015) 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 | |
| predicate Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). | |
| Performance Data | Clinical literature data and cadaveric testing was provided to support the |
| substantial equivalence of the subject device. | |
| A retrospective clinical literature review was performed to examine the potential | |
| benefits and associated risks of using PMMA bone cement using a sacral | |
| vertebroplasty or sacroplasty procedure. The five articles reviewed provided | |
| clinical outcomes of 462 patients utilizing both the long-axis and short-axis | |
| surgical technique demonstrating the safety and efficacy of PMMA bone cement | |
| when used in the sacrum. | |
| A cadaver study in support of the expanded indication was completed. This | |
| study was performed to evaluate the extravasation behavior of the Kyphon® | |
| Xpede™ Bone Cement during sacroplasty procedures. The study also defined | |
| the surgical procedure steps and imaging needed to minimize the risk of | |
| extravasation for the sacroplasty procedure. Both the long-axis and short-axis | |
| surgical techniques were evaluated for cement extravasation. The procedure and | |
| imaging review was performed by trained physicians. The calculated | |
| extravasation rate with the Kyphon® Xpede™ Bone Cement was within the | |
| extravasation rate range of the published sacroplasty literature. | |
| Conclusion | Based on the provided performance data, the subject Kyphon® Xpede™ Bone |
| Cement is substantially equivalent to the primary predicate Vertaplex® High | |
| Viscosity (HV) Radiopaque Bone Cement (K150582, S.E. 06/12/2015) and | |
| Kyphon® Xpede™ Bone Cement (K151227, S.E. 11/16/2015). |
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