(188 days)
Not Found
No
The 510(k) summary describes a bone cement and its physical, chemical, and mechanical properties. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for the treatment of pathological fractures of the vertebral body, which is a medical condition, making it a therapeutic device.
No
The device is a bone cement used for treating pathological fractures, not for diagnosing diseases or conditions.
No
The device description clearly states it is a two-component system consisting of powder and liquid components, which are physical substances, not software. The performance studies also focus on mechanical, handling, physical, and chemical properties, further indicating a hardware/material-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone cement used for treating pathological fractures of the vertebral body through surgical procedures (kyphoplasty or vertebroplasty). This is a therapeutic and structural application within the body.
- Device Description: The description details the chemical composition of a bone cement, which is a material implanted or used within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) as a structural material.
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 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
NDN
Device Description
KYPHON® Xpede™ Bone Cement is provided as a two-component system. The powder component consists of a PMMA copolymer (polymethyl methacrylate/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
Testing was conducted to verify the performance of Kyphon® Xpede™ Bone Cement for in vivo applications. The following testing was conducted:
- Mechanical (compressive, tensile, flexural, fatigue)
- Handling (dough/working time)
- Physical (viscosity, exotherm, water absorption)
- Chemical (monomer elution, molecular weight, glass transition temperature)
- Biocompatibility (cytotoxicity, acute systemic toxicity, intracutaneous reactivity)
The results of this testing support the determination of substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K093829, K041584, K033801, K060300
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.”
0
FEB 28 2011
510(k) Summary for Kyphon® Xpede™ Bone Cement
| Summary Date: | December 2010 |
|---|---|
| Trade Name: | Kyphon® Xpede™ Bone Cement |
| Common Name: | PMMA Bone Cement |
| Classification Name: | Bone Cement (21 CFR part 888.3027) |
| Device Code, Class: | NDN, Class II |
| Manufacturer's Name: | |
| Address: | Medtronic Spine LLC |
| 1221 Crossman Avenue | |
| Sunnyvale, CA 94089 | |
| Establishment Registration No. 2953769 | |
| Contact Person: | Mary Rose |
| Sr. Principal Regulatory Affairs Specialist | |
| 1221 Crossman Avenue | |
| Sunnyvale, CA 94089 | |
| Telephone: 408-548-5203 | |
| Fax: 408-543-6190 | |
| Performance Standards: | The requirements of the Food Drug and Cosmetic Act, |
| under section 514 for performance standards, are not | |
| applicable to the KyphX HV-R® Bone Cement. | |
| Predicate Devices: | K093829 KyphX HV- R® Bone Cement |
| K041584 KyphX HV- R® Bone Cement | |
| K033801 KyphX HV- R® Bone Cement | |
| K060300 Confidence High Viscosity Bone Cement | |
| Intended 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 | |
| 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. | |
| Device Description: | KYPHON® Xpede™ Bone Cement is provided as a two- |
| component system. The powder component consists of a | |
| PMMA copolymer (polymethyl methacrylate/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. | |
| Sterilization: | KYPHON® Xpede™ Bone Cement is provided sterile. |
| KYPHON® Xpede™ Bone Cement is intended for single- | |
| use only. | |
| Substantial Equivalence: | Testing was conducted to verify the performance of |
| Kyphon® Xpede™ Bone Cement for in vivo applications. | |
| The following testing was conducted: |
- Mechanical (compressive, tensile, flexural, fatigue)
- Handling (dough/working time)
- Physical (viscosity, exotherm, water absorption)
- Chemical (monomer elution, molecular weight, glass
transition temperature) - Biocompatibility (cytotoxicity, acute systemic
toxicity, intracutaneous reactivity) |
| | The results of this testing support the determination of
substantial equivalence. |
| | Therefore, the modified Kyphon® Xpede™ Bone Cement |
1
510(k) Summary for Kyphon® Xpede™ Bone Cement
is substantially equivalent to the predicates, Kyphon HV-R Bone Cement, and Confidence High Viscosity Bone Cement.
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized eagle with its wings spread. The eagle is facing to the right and has its head turned to the left.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic Spine LLC % Ms. Mary Rose Sr. Principal Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089
FEB 2 8 251
Re: K102397
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: February 22, 2011 Received: February 23, 2011
Dear Ms. Rose:
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 accordiner with the provisions of the Federal Food, Drug, and Cosmetic Act (Act (Act that do not require approval of the Federal Food, Drug,
You may, therefore, market the dovice, subject to the 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
3
Page 2 - Ms. Mary Rose
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 and listing);
device-related adverse events (21 CFR Part 801); medical device reporting of medi device-related adverse events) (21 CFR 803); good manufacturing (reporting of medical
forth in the quality systems (QS) requestion (11 OFR 803); good manufacturing as set forth in the quality systems (QS) regulation (2) CFR Part 820); and if a pplicable, 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 go to http://www.fda.gov/AboutFDA/CentersOffices/Offices/Offices/Uploms/Splays/Classes
the Center for Devices and Radiological Heolth.in CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health s (CDRH's) Office of Compliance. Also, him for
note the regulation entitled. "Mishranding by references of Compliance. Also, p note the regulation entitled, "Misbranding by reference to premarket notification" (21.00)
807.97). For questions regarding the reporting of remarket notification" (21CFR Pa and of the same of the standing by relection of adverse events undification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR reg CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll the more of the more of its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet and Consum http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
.mcdermott.com/ICES/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Aing B rh
fr
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
KYPHON® Xpede Bone Cement Device Name:
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 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 V (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Divisio (Division Sign-of Surgical, Orthopedic, and Restorative Devices
Page _________________________________________________________________________________________________________________________________________________________________________ of
510(k) Number K102397