(63 days)
KYPHON™ HV-RTM 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 procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. 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. Pathological 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.
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.
This document describes the premarket notification (510(k)) for the KYPHON™ HV-R™ Bone Cement. It's important to note that this device is a medical implant (bone cement), and therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical and literature-based performance validations, not studies involving AI or imaging software performance.
The provided text does not contain information related to an AI/ML device, nor does it discuss acceptance criteria and studies demonstrating AI performance. Instead, it focuses on the substantial equivalence of a bone cement product based on its material properties, indications for use, and a review of clinical literature and cadaveric testing.
Therefore, I cannot extract the information required for the prompt's specific questions regarding AI/ML device performance and testing (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance, training set details).
The information that can be extracted relevant to the bone cement device is as follows:
Acceptance Criteria and Device Performance (for the Bone Cement):
The document doesn't present an explicit "acceptance criteria table" in the typical sense for mechanical or biological properties with specific numerical targets. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, supported by:
- Technological Characteristics Comparison: The subject device has "the same or similar indications for use, intended use, materials and fundamental scientific technology" as the predicates. This implies that the performance characteristics (e.g., strength, setting time, radiopacity, biocompatibility) are expected to be similar or within acceptable ranges.
- Performance Data:
- Clinical Literature Review: Examination of potential benefits and associated risks of using PMMA bone cement in sacral vertebroplasty/sacroplasty procedure.
- Cadaver Study: Evaluation of extravasation behavior during sacroplasty procedures, aiming to minimize risk. The calculated extravasation rate with the new device was "within the extravasation rate range of the predicate."
Summary of Device Performance (as stated in the document):
| Performance Aspect | Reported Device Performance |
|---|---|
| Clinical Efficacy/Safety (Literature Review) | Five articles reviewed provided clinical outcomes of 462 patients demonstrating safety and efficacy of PMMA bone cement when used in the sacrum. |
| Extravasation Behavior (Cadaver Study) | Extravasation rate with the KYPHON™ HV-R™ Bone Cement was within the extravasation rate range of the predicate. Surgical procedure steps and imaging needed to minimize extravasation risk were defined. |
Regarding the AI/ML specific questions from the prompt:
Since this document is about bone cement, not an AI/ML device, none of the following AI/ML-specific questions can be answered from the provided text:
- Sample sizes used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
May 18, 2018
Medtronic Sofamor Danek USA, Inc. Laveeda Leflore Regulatory Affairs Specialist 1800 Pyramid Place Memphis. Tennessee 38132
Re: K180700
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 15, 2018 Received: March 16, 2018
Dear Ms. Leflore:
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 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);
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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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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Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
Indications for Use
510(k) Number (if known)
K180700
Device Name KYPHON™ HV-R™ Bone Cement
Indications for Use (Describe)
KYPHON™ HV-RTM 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 procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. 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. Pathological 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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510(k) Summary Medtronic Sofamor Danek USA, Inc.
May 15, 2018
| Submitter | Medtronic Sofamor Danek USA, Inc.1800 Pyramid PlaceMemphis, Tennessee 38132Telephone: (901) 396-3133Fax: (901) 346-9738 |
|---|---|
| Contact | Laveeda LefloreRegulatory Affairs SpecialistDirect Telephone: 901-399-2953 |
| Jeff SpragueSr. Regulatory Affairs Program ManagerDirect Telephone: 901-344-1326 | |
| Date Prepared | May 15, 2018 |
| Common Name | Kyphon™ HV-R™ Bone Cement |
| Regulatory Class | Kyphon™ HV-R™ Bone Cement |
| Regulation Number | Class II |
| Regulation Name and Device | 21 CFR 888.3027 |
| Product Classification Code | Polymethylmethacrylate (PMMA) bone cementNDN |
| Predicate Devices | 1) Kyphon™ Xpede™ Bone Cement K163032, S.E. 02/27/2017 (PrimaryPredicate) |
| 2) Kyphon™ HV-R™ Bone Cement K160983, S.E. 08/24/2016 | |
| The predicate devices have not been subject to a design related recall. | |
| Description of Device | 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) withbarium sulfate as a radiopacifier and benzoyl peroxide as an initiator. Theliquid component consists of methylmethacrylate monomer, with theaddition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine asa promoter. The powder and liquid components are mixed prior to use. |
| Indications for Use: | KyphonTM HV-RTM Bone Cement is indicated for the treatment ofpathological fractures of the vertebral body due to osteoporosis, cancer, orbenign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty)procedure. It is also indicated for the fixation of pathological fractures ofthe sacral vertebral body or ala using sacral vertebroplasty or sacroplasty.Cancer includes multiple myeloma and metastatic lesions, including thosearising from breast or lung cancer, or lymphoma. Benign lesions includehemangioma and giant cell tumor. Pathologic fracture may include asymptomatic vertebral body microfracture (as documented by appropriateimaging and/or presence of a lytic lesion) without obvious loss ofvertebral body height. |
| Comparison of TechnologicalCharacteristics with thePredicate Devices | The subject KyphonTM HV-RTM Bone Cement has the same or similarindications for use, intended use, materials and fundamental scientifictechnology fundamental scientific technology as the predicates KyphonTMXpedeTM Bone Cement K163032, (S.E. 02/27/2017) and KyphonTM HV-RTMBone Cement (K160983, S.E. 8/24/2016). The subject device utilizesequivalent implant materials, sterilization methods and bacterial endotoxintesting applying the same 20 EU/ml pyrogen limit specifications utilizingthe gel clot test method as the predicate KyphonTM HV-RTM Bone Cement(K160983, S.E. 8/24/2016). |
| Performance Data | Clinical literature data and non-clinical cadaveric testing is provided tosupport the substantial equivalence of the subject device.A retrospective clinical literature review was performed to examine thepotential benefits and associated risks of using PMMA bone cement usinga sacral vertebroplasty or sacroplasty procedure. The five articlesreviewed provided clinical outcomes of 462 patients utilizing both thelong-axis and short-axis surgical technique demonstrating the safety andefficacy of PMMA bone cement when used in the sacrum.A cadaver study in support of the expanded indication was completed.This study was performed to evaluate the extravasation behavior of theKyphonTM HV-RTM Bone Cement during sacroplasty procedures. The studyalso defined the surgical procedure steps and imaging needed to minimizethe risk of extravasation for the sacroplasty procedure. Both the long-axisand short-axis surgical techniques were evaluated for cementextravasation. The procedure and imaging review was performed bytrained physicians. The calculated extravasation rate with the KyphonTMHV-RTM Bone Cement was within the extravasation rate range of the |
| Conclusion | Based on the provided performance data, the subject Kyphon™ HV-R™Bone Cement is substantially equivalent to the primary predicate Kyphon™Xpede™ Bone Cement (K163032, S.E. 02/27/2017) and Kyphon™ HV-R™Bone Cement (K160983, S.E. 08/24/2016). |
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§ 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.”