(188 days)
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.
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.
The provided 510(k) summary for Kyphon® Xpede™ Bone Cement does not contain information about acceptance criteria or a study proving its performance against such criteria for a clinical application using AI. This document is a premarket notification for a medical device (bone cement), and the testing described is primarily focused on bench testing and biocompatibility to demonstrate substantial equivalence to previously approved predicate devices, not clinical performance metrics measured in a study with a test set of data.
Therefore, many of the requested categories related to AI performance, ground truth, and human reader studies cannot be populated from this document.
However, I can extract the relevant information regarding the testing that was conducted to demonstrate substantial equivalence.
Here's the breakdown of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not define specific acceptance criteria values in a table format for the mechanical, physical, chemical, or handling tests. Instead, it states that "The results of this testing support the determination of substantial equivalence." This implies that the performance of the Kyphon® Xpede™ Bone Cement fell within acceptable ranges or was comparable to the predicate devices for these various tests.
What is reported is the type of testing conducted to support substantial equivalence:
| Test Category | Description of Test | Reported Performance |
|---|---|---|
| Mechanical | Compressive, tensile, flexural, fatigue | Results supported determination of substantial equivalence to predicate devices. |
| Handling | Dough time, working time | Results supported determination of substantial equivalence to predicate devices. |
| Physical | Viscosity, exotherm, water absorption | Results supported determination of substantial equivalence to predicate devices. |
| Chemical | Monomer elution, molecular weight, glass transition temperature | Results supported determination of substantial equivalence to predicate devices. |
| Biocompatibility | Cytotoxicity, acute systemic toxicity, intracutaneous reactivity | Results supported determination of substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes for each of the bench tests (mechanical, handling, physical, chemical, biocompatibility). These are typically laboratory tests performed on a certain number of material samples.
- Data Provenance: The tests are described as "Testing was conducted to verify the performance of Kyphon® Xpede™ Bone Cement for in vivo applications." This indicates laboratory-based testing, not clinical data from patients. The country of origin for the data is not explicitly stated but can be inferred to be from the manufacturer (Medtronic Spine LLC) or a contracted lab. This is a retrospective analysis of the material properties, not a prospective clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study involving human interpretation of data where expert ground truth is established. The "ground truth" for material properties is derived from standardized laboratory measurements.
4. Adjudication method for the test set
Not applicable. This is not a study involving human interpretation of data for adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a submission for a bone cement, not an AI-powered diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a bone cement, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's evaluation is based on objective, standardized laboratory measurements of material properties (e.g., strength, viscosity, chemical composition, biocompatibility testing against established safety profiles). There is no "expert consensus," "pathology," or "outcomes data" in the traditional sense for these types of tests for substantial equivalence.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
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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 LLC1221 Crossman AvenueSunnyvale, CA 94089Establishment Registration No. 2953769 |
| Contact Person: | Mary RoseSr. Principal Regulatory Affairs Specialist1221 Crossman AvenueSunnyvale, CA 94089Telephone: 408-548-5203Fax: 408-543-6190 |
| Performance Standards: | The requirements of the Food Drug and Cosmetic Act,under section 514 for performance standards, are notapplicable to the KyphX HV-R® Bone Cement. |
| Predicate Devices: | K093829 KyphX HV- R® Bone CementK041584 KyphX HV- R® Bone CementK033801 KyphX HV- R® Bone CementK060300 Confidence High Viscosity Bone Cement |
| Intended Use: | KYPHON® Xpede™ Bone Cement is indicated for thetreatment of pathological fractures of the vertebral bodydue to osteoporosis, cancer, or benign lesions using akyphoplasty or vertebroplasty procedure. Cancerincludes multiple myeloma and metastatic lesions,including those arising from breast or lung cancer, orlymphoma. Benign lesions include hemangioma andgiant cell tumor. |
| Device Description: | KYPHON® Xpede™ Bone Cement is provided as a two-component system. The powder component consists of aPMMA copolymer (polymethyl methacrylate/methyl-methacrylate-styrene-copolymer) with barium sulfate asa radiopacifier and benzoyl peroxide as an initiator. Theliquid component consists of methylmethacrylatemonomer, with the addition of hydroquinone as astabilizer and N,N-dimethyl-p-toluidine as a promoter.The powder and liquid components are mixed prior touse. |
| 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 ofKyphon® 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, glasstransition temperature)- Biocompatibility (cytotoxicity, acute systemictoxicity, intracutaneous reactivity) | |
| The results of this testing support the determination ofsubstantial equivalence. | |
| Therefore, the modified Kyphon® Xpede™ Bone Cement |
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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.
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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
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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
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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
§ 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.”