(193 days)
No
The 510(k) summary describes a bone cement material and its intended use in a surgical procedure. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is a bone cement used for treating pathological vertebral body fractures, which fall under the scope of therapeutic interventions.
No
Explanation: The device description clearly states that Kyphon® Xpede™ Bone Cement is a two-component system (powder and liquid) used for treating pathological fractures of the vertebral body. It is a material implanted into the body during a procedure, not a tool used to diagnose conditions. Its intended use is therapeutic (treatment), not diagnostic.
No
The device description explicitly states it is a two-component system consisting of powder and liquid components, which are physical substances, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a procedure (cementoplasty) to treat pathological fractures of the vertebral body. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a bone cement, a material used to fill and stabilize bone fractures. This is a medical device used in a surgical or interventional procedure.
- Lack of IVD Characteristics: An IVD is a device used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, Kyphon® Xpede™ Bone Cement is a therapeutic medical device, not an In Vitro Diagnostic.
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 using a cementoplasty or vertebroplasty 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.
Product codes
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
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a circular seal for the Department of Health & Human Services - USA. The seal features the department's logo, which consists of a stylized human figure with three faces in profile, representing the department's focus on health and human well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Medtronic Sofamor Danek USA, Incorporated Ms. Kathy L. Remsen Senior Regulatory Affairs Program Manager 1800 Pyramid Place Memphis, Tennessee 38132
November 16, 2015
Re: K151227
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: September 28, 2015 Received: October 1, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
forth in the quality systems (OS) 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/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 yours,
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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151227
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 using a cementoplasty or vertebroplasty 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.
| 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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KYPHON® Xpede™ Bone Cement September 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® Xpede™ Bone Cement |
| Common Name: | Bone Cement |
| Classification Name: | Cement, bone, vertebroplasty |
| Product Code: | NDN |
| Regulation: | 21 CFR 888.3027 |
| Classification: | II |
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.
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
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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.
Summary of the Technological Characteristics:
The subject Kyphon® Xpede™ Bone Cement has the same fundamental scientific technology as the predicate KYPHON® Xpede™ Bone 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® Xpede™ Bone Cement is substantially equivalent to the predicate 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® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The revision and modification of the wording in the indications for use do not raise new issues of safety or effectiveness. The indications for use statement for KYPHON® Xpede™ Bone Cement has the same Intended Use as the predicate Kyphon® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).