(241 days)
Not Found
No
The device description and performance studies focus on the material properties and handling characteristics of bone cement, with no mention of AI or ML.
Yes
The device is a bone cement used to treat pathological fractures of the vertebral body, which is a therapeutic intervention.
No
The device description and intended use indicate it is a bone cement used for treating pathological fractures, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly states it is a two-component bone cement 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 clearly states that the device is a bone cement used for treating pathological fractures of the vertebral body during a balloon kyphoplasty procedure. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details the chemical composition of the bone cement, which is a material implanted into the body.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information. IVDs are designed for in vitro (outside the body) examination of specimens.
Therefore, the KyphX HV-R® Bone Cement is a medical device used for treatment, not for in vitro diagnosis.
N/A
Intended Use / Indications for Use
KyphX HV-R® Bone Cement is indicated for the treatment of pathological fractures of the verteral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty 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
KyphX HV-R® 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
verteral 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)
Testing was conducted to verify the KyphX HV-R® Bone Cement performance for in vivo applications in support of the labeling changes. Handling properties (dough times) were assessed on multiple lots of bone cement, including lots that were manufactured at the extremes of the Setting Time specification range. The dough time and hardening time were also measured at various ambient temperatures using bone filler devices, the intended mode of clinical application. The results of this testing support the determination of substantial equivalence. Therefore, it is concluded that the modified KyphX HV-R Bone Cement is substantially equivalent to the predicate KyphX HV-R Bone Cement.
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.”
0
・;
AUG 1 2 2010
PREMARKET 510(k) SUMMARY
| Summary Date: | August 2010 |
|---|---|
| Trade Name: | KyphX HV-R® 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: 408-548-6501 | |
| 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: | K041584 KyphX HV-R® Bone Cement |
| K033801 KyphX HV-R® Bone Cement | |
| Intended Use: | KyphX HV-R® Bone Cement is indicated for the |
| treatment of pathological fractures of the verteral body | |
| due to osteoporosis, cancer, or benign lesions using a | |
| balloon kyphoplasty 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. |
:
1
| Device Description: | KyphX HV-R® 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: | KyphX HV-R® Bone Cement is provided sterile. KyphX
HV-R® Bone Cement is intended for single-use only. |
| Substantial Equivalence: | Testing was conducted to verify the KyphX HV-R® Bone
Cement performance for in vivo applications in support
of the labeling changes. Handling properties (dough
times) were assessed on multiple lots of bone cement,
including lots that were manufactured at the extremes of
the Setting Time specification range. The dough time and
hardening time were also measured at various ambient
temperatures using bone filler devices, the intended
mode of clinical application. |
| | The results of this testing support the determination of
substantial equivalence. Therefore, it is concluded that
the modified KyphX HV-R Bone Cement is substantially
equivalent to the predicate KyphX HV-R Bone Cement. |
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 1 2 2010
Medtronic Spine LLC % Ms. Mary Rose Sr. Principal Regulatory Affairs Specialist 1221 Crossman Avenue Sunnyvale, California 94089
Re: K093828
Trade/Device Name: KyphX HV-R® Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: July 28, 2010 Received: July 30, 2010
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 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.
3
Page 2 - Ms. Mary Rose
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 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, go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Mark A. Milkeron
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
AUG - 1 - 2 - 2010
INDICATIONS FOR USE
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: KyphX HV-R® Bone Cement
Indications for Use:
KyphX HV-R® Bone Cement is indicated for the treatment of pathological fractures of the verteral body due to osteoporosis, cancer, or benign lesions using a balloon kyphoplasty 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 (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jamee W. Linge
(Divisi Division of Surgical, Orthopedic. and Restorative Devices
510(k) Number K093828
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