(117 days)
No
The device description focuses on the material composition of bone cement and the design of fenestrated screws, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is intended to restore the integrity of the spinal column in patients with advanced stage tumors, which is a direct treatment for a medical condition.
No
The device description clearly states it is a bone cement (KYPHON HV-R® Fenestrated Screw Cement) and fenestrated screws (CD HORIZON® Fenestrated Screws) intended to restore the integrity of the spinal column in patients with advanced stage tumors. These are therapeutic products, not diagnostic ones that identify or characterize a disease.
No
The device description clearly outlines physical components: bone cement (powder and liquid) and fenestrated screws. These are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as being used to restore the integrity of the spinal column in patients with advanced stage tumors. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The device description details a bone cement and fenestrated screws used for surgical implantation and structural support. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is clearly intended for surgical intervention and structural support within the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
KYPHON HV-R® Fenestrated Screw Cement
When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Coment is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
CD HORIZON® Fenestrated Screw Set
When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes
PML, MNI
Device Description
KYPHON HV-R® Fenestrated Screw Cement
KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA based (high viscosity, radiopaque) bone cement. KYPHON HV-R® Fenestrated Screw Cement will be provided sterile in two components: 20 grams of powder and nine grams of liquid. The powder contains methylmethacrylate-styrene co-polymer, barium sulfate as a radiopacifier, and di-benzoyl peroxide as an initiator. This liquid contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a promoter and hydroquinone as a stabilizer. The powder and liquid components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer.
CD HORIZON® Fenestrated Screw Set
The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and lumbar spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Clinical data and Non-Clinical testing were provided in support of substantial equivalence of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.”
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, overlapping each other to create a sense of depth and unity. The faces are simple and abstract, with no distinct features other than the outline of the head and neck.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2016
Medtronic Sofamor Danek USA, Incorporated Mr. Lee Grant Distinguished Regulatory Affairs Advisor 1800 Pyramid Place Memphis, Tennessee 38132
Re: K152604
Trade/Device Name: KYPHON HV-R® Fenestrated Screw Cement, CD HORIZON® Fenestrated Screw Set Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, MNI Dated: December 8, 2015 Received: December 9, 2015
Dear Mr. Grant:
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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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/ResourcesforYou/Industry/default.htm. 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.
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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K152604
Device Name KYPHON HV-R® Fenestrated Screw Cement
Indications for Use (Describe)
When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Coment is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
| 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) |
|---|---|
| --------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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Indications for Use
510(k) Number (if known) K152604
Device Name CD HORIZON® Fenestrated Screw Set
Indications for Use (Describe)
When used in conjunction with KYPHON HV-R® Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary – K152604
Medtronic Sofamor Danek USA, Inc.
December 2015
| Submitter | Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis, Tennessee 38132
Telephone: (901) 396-3133
Fax: (901) 346-9738 |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact(s) | Lee Grant
Distinguished Regulatory Affairs Advisor
Direct Telephone – 901-344-0807
Pamela Edwards
Principal Regulatory Affairs Specialist
Direct Telephone -901-399-2125 |
| Date Prepared | December 30, 2015 |
| Trade Name | 1) KYPHON HV-R® Fenestrated Screw Cement
2) CD HORIZON® Fenestrated Screw Set |
| Regulatory Class | 1) KYPHON HV-R® Fenestrated Screw Cement
Class II |
| Regulation Number | 888.3027 Polymethylmethacrylate (PMMA) Bone Cement
PML |
| Regulation Name and Device
Product Classification Code | 2) CD HORIZON® Fenestrated Screw Set
Class II
21 CFR 888.3070 Pedicle Screw System
MNI |
| Predicate Devices | 1) KYPHON® HV-R® Bone Cement (Primary Predicate)
K150460 KYPHON® HV-R® Bone Cement (SE 04/28/15)
- CD HORIZON® Spinal System
K042025 CD HORIZON® Spinal System (SE 08/25/04) and
K113174 CD HORIZON® Spinal System (SE 11/21/11) |
| | The predicate devices have not been subject to a design related recall |
| Description of Device | 1) KYPHON HV-R® Fenestrated Screw Cement is self-curing PMMA
based (high viscosity, radiopaque) bone cement. KYPHON HV-R®
Fenestrated Screw Cement will be provided sterile in two components:
20 grams of powder and nine grams of liquid. The powder contains
methylmethacrylate-styrene co-polymer, barium sulfate as a
radiopacifier, and di-benzoyl peroxide as an initiator. This liquid
contains methylmethacrylate monomer, N, N dimethyl-p-toluidine as a
promoter and hydroquinone as a stabilizer. The powder and liquid |
| | components are mixed, in the provided liquid-to-powder proportions, into a homogenous paste, to initiate the polymerization reaction of monomer into polymer. |
| | 2) The CD HORIZON® Fenestrated Screw Set consists of a variety of cannulated multi-axial screws (MAS) with fenestrations offered in diameters ranging from 4.5mm to 10.5mm, with lengths ranging from 30-100mm based on CD HORIZON® LEGACY™ and CD HORIZON® SOLERA™ implants contained in the CD HORIZON® Spinal System. The CD HORIZON® Fenestrated Screws are specifically designed to connect to 4.75mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the CD HORIZON® Spinal System. The screws contain six fenestrations near the distal tip of the screw which provides a controlled means to deliver a small amount of polymethylmethacrylate (PMMA) bone cement into a targeted vertebral body. These screws are provided non-sterile. |
| Indications for Use: | 1) KYPHON HV-R® Fenestrated Screw Cement: When used in conjunction with the CD HORIZON® Fenestrated Screws, KYPHON HV-R® Fenestrated Screw Cement is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. KYPHON HV-R® Fenestrated Screw Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised. |
| | 2) CD HORIZON® Fenestrated Screw Set: When used in conjunction with KYPHON® HV-R Fenestrated Screw Cement, the CD HORIZON® Fenestrated Screws are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion. CD HORIZON® Fenestrated Screws augmented with KYPHON HV-R® Fenestrated Screw Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised. |
| Comparison of Technological
Characteristics with the
Predicate Devices | 1) The KYPHON® HV-R® Fenestrated Screw Cement is identical in composition, method of manufacture and sterilization to the primary predicate Kyphon® H-VR® Bone Cement cleared by the FDA in K150460 (SE 04/28/15). The predicate cement is intended to be used in patients diagnosed with pathological fractures in the vertebral body caused by conditions such as osteoporosis and cancer. The subject cement is also intended to be used in patients with metastatic cancer. Pathological fractures reflect one means in which spinal instability occurs and therefore in both instances the predicate and subject cement are intended to treat spinal instability. The only differences between the subject and predicate cement are the method in which the cement is delivered and that the subject cement is limited to patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of |
| | fusion. |
| | 2) The screws which comprise the CD HORIZON® Fenestrated Screw Set
have the same or similar indications, intended use, fundamental
scientific technology, and are manufactured from similar materials as the
pedicle screws found in the following FDA cleared CD HORIZON®
Spinal System applications: K042025 (SE 08/25/2004) and K113174
(SE 11/21/2011). The predicate screws in this application are cleared for
pedicle fixation in patients with spinal instability caused by tumors. The
subject pedicle screws are also intended to provide pedicle fixation in
patients diagnosed with spinal instability caused by tumors. Both the
predicate and subject screws are cannulated, are manufactured from the
same material, are similar in design, sizes and are intended to be used
with the same spinal rods and connecting components. The primary
difference is the subject screws contain fenestrations which allow
PMMA cement to flow in a controlled manner through the screw and
into the targeted pedicle. |
| Performance Data | Clinical data and Non-Clinical testing were provided in support of substantial
equivalence of the subject device. |
| Conclusion | Based on the provided performance data, the subject KYPHON® HV-R
Fenestrated Screw Cement is substantially equivalent to the KYPHON® HV-R®
Bone Cement (K150460, SE 04/28/15) and the CD HORIZON® Fenestrated
Screw Set is substantially equivalent to the CD HORIZON® Spinal System
(K042025 (SE 08/25/2004) and K113174 (SE 11/21/2011)). |
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