KYPHON® HV-R® 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® HV-R® 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.

AI/ML Overview

This document is a 510(k) premarket notification for the KYPHON® HV-R® Bone Cement. It primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study of its own performance against specific acceptance criteria. Therefore, most of the requested information regarding a device performance study is not present in this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

This document does not establish new acceptance criteria or report specific device performance metrics from a new study. Instead, it claims substantial equivalence to previously cleared devices (KYPHON® HV-R® Bone Cement (K093828) and KYPHON® Xpede™ Bone Cement (K102397)). The "performance" being demonstrated here is that the new device shares fundamental scientific technology, equivalent implant materials, and sterilization methods with the predicates.

Acceptance Criteria	Reported Device Performance
Not explicitly stated as new criteria. The inherent "acceptance criterion" is demonstrably substantially equivalent to predicate devices.	"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® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011)."
Updated indication does not raise new safety/effectiveness issues.	"The updated indication does not raise new issues of safety or effectiveness."
Intended use identical to predicates.	"The intended use for KYPHON® HV-R® Bone Cement has not changed and is identical to the predicates..."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This document does not describe a new clinical or performance study with a test set. The claim is based on equivalence to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. No new test set or ground truth establishment by experts is described for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No new test set or adjudication method is described.

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 device is bone cement, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only, without human-in-the loop performance) was done:

Not applicable. This device is bone cement, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. No new ground truth data is generated or used for this submission. The "ground truth" for the substantial equivalence claim resides in the prior clearance of the predicate devices based on their established performance and safety profiles.

8. The sample size for the training set:

Not applicable. This document pertains to a medical device (bone cement), not a machine learning model, so there is no concept of a training set.

9. How the ground truth for the training set was established:

Not applicable. As above, there is no training set for this device submission.

In summary: The provided document is a 510(k) submission where the primary argument for clearance is substantial equivalence to already legally marketed predicate devices. It does not contain information about a new performance study with acceptance criteria, test sets, expert adjudication, or AI performance metrics. The information focuses on the technical characteristics and intended use being similar to the predicates, thereby concluding that the device does not raise new questions of safety or effectiveness.

Summary

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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 stylized depiction of a human figure, represented by three overlapping profiles, positioned to the right of the department's name. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2015

Medtronic Sofamor Danek USA, Incorporated Ms. Kathy L. Remsen Senior Regulatory Affairs Program Manager 1800 Pyramid Place Memphis, Tennessee 38132

Re: K150460

Trade/Device Name: KYPHON® HV-R® Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: March 10, 2015 Received: March 13, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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 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/Resourcesfor You/Industry/default.htm. 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 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,

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K150460 Page 1 of 1

INDICATIONS FOR USE

510(k) Number (if known): K150460

Device Name: KYPHON® HV-R® Bone Cement

Indications for Use:

K YPHON® HV-R® 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 X	AND/OR	Over-The-Counter Use _ _
(Part 21 CFR 801 Subpart D)		(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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KYPHON® HV-R® Bone Cement 510(k) Summary

February 2015

Company:	Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738
Contact:	Kathy L. RemsenSenior Regulatory Affairs Program Manager
Proprietary Trade Name:	KYPHON® HV-R® Bone Cement
Common Name:	Bone Cement
Classification Name:	Cement, bone, vertebroplasty
Product Code:	NDN
Regulation:	21 CFR 888.3027
Classification:	II

Description: KYPHON® HV-R® 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® HV-R® 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.

Summary of the Technological Characteristics: The subject KYPHON® HV-R® Bone Cement has the same fundamental scientific technology as the predicates KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone

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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® HV-R® Bone Cement is substantially equivalent to the KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and 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® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011). The updated indication does not raise new issues of safety or effectiveness. The intended use for KYPHON® HV-R® Bone Cement has not changed and is identical to the predicates KYPHON® HV-R® Bone Cement (K093828 S.E. 8/12/2010) and KYPHON® Xpede™ Bone Cement (K102397 S.E. 2/28/2011).

Regulation Number and Section

§ 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.”