(275 days)
Not Found
No
The device description and intended use focus on the mechanical properties of screws and bone cement for spinal stabilization, with no mention of AI or ML technologies.
Yes
The device is intended to restore the integrity of the spinal column in patients with advanced stage tumors, which is a therapeutic purpose.
No
The device is a medical implant (screws and bone cement) used to restore the integrity of the spinal column in patients with advanced stage tumors. It is a treatment device, not a diagnostic one.
No
The device description clearly details physical components: screws and bone cement. There is no mention of software as a component or the primary function of the device.
Based on the provided text, 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 application within the body.
- Device Description: The device is described as screws and bone cement used for spinal fixation and augmentation. These are physical implants and materials used directly in a surgical procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are typically used to test samples like blood, urine, or tissue outside of the body to provide diagnostic information. This device is clearly intended for direct surgical implantation and structural support within the patient's body.
N/A
Intended Use / Indications for Use
NuVasive® Reline® Fenestrated Screws
When used in conjunction with High V+ Bone Cement, the Nu Vasive Reline 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. NuVasive Reline Fenestrated Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
High V+ Bone Cement
When used in conjunction with the Nu Vasive Reline Fenestrated Screws, High V+ Bone 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. High V+ Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
Product codes (comma separated list FDA assigned to the subject device)
PML, NKB, KWP
Device Description
The NuVasive Reline Fenestrated Screws are available in a variety sizes and are designed to connect to 5.0mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the NuVasive Reline System. The screws contain 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 sterile or non-sterile.
The High V+ Bone Cement is a self-curing PMMA based (high viscosity, radiopaque) bone cement. High V+ Bone Cement is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder contains polymethylmethacrylate, barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The 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.
The purpose of this 510(k) is to expand the indications for use for the NuVasive Reline Fenestrated Screws to include its use with High V+ Bone Cement in the treatment of advanced stage tumors of the thoracic and lumbar spine.
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
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)
To compare the mechanical properties of the NuVasive Reline Fenestrated Screws with High V+ Bone Cement and Medtronic CD Horizon Fenestrated Screw with Kyphon HV-R Bone Cement, axial pull-out and removal torque testing was performed according to ASTM F2193. Additionally, a comparison study of the cement flow and bolus formation of the the subject and predicate device was performed.
The subject devices were found to be substantially equivalent to the predicates. No clinical studies were conducted.
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.
K160989, K152604, K161114, K152604
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue box with the letters FDA in white. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 28, 2018
NuVasive, Incorporated Ms. Olga Lewis Senior Manager, Medical Affairs 7475 Lusk Boulevard San Diego, California 92121
Re: K180498
Trade/Device Name: High V+ Bone Cement, NuVasive® Reline® Fenestrated Screws Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: PML, NKB, KWP Dated: October 25, 2018 Received: October 26, 2018
Dear Ms. Lewis:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 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.
Ronald P. Jean -S
for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180498
Device Name
NuVasive® Reline® Fenestrated Screws with High V+ Bone Cement
Indications for Use (Describe) NuVasive® Reline® Fenestrated Screws
When used in conjunction with High V+ Bone Cement, the Nu Vasive Reline 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. NuVasive Reline Fenestrated Screws augmented with High V+ Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
High V+ Bone Cement
When used in conjunction with the Nu Vasive Reline Fenestrated Screws, High V+ Bone 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. High V+ Bone 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------- |
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3
Image /page/3/Picture/0 description: The image shows the Nuvasive logo. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray, and the tagline "Speed of Innovation" in a smaller font below. The logo is clean and modern, with a focus on innovation and technology.
A.
510(k) Summary
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR §807.92, the following summary of information is provided:
Submitted by: Olga Lewis Senior Manager, Medical Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121
Date Prepared: October 25, 2018
B. Device Name
| Trade or Proprietary Name: | NuVasive® Reline® Fenestrated Screws |
|---|---|
| Common or Usual Name: | Intervertebral Body Fusion Device |
| Classification Name: | Pedicle Screw Spinal System, Spinal Interlaminal |
| Fixation Orthosis, Spinal Intervertebral Body Fixation | |
| Device Class: | Class II |
| Classification: | 21 CFR §888.3070 |
| Product Code: | NKB, KWP |
| Trade or Proprietary Name: | High V+® Bone Cement |
| Common or Usual Name: | Bone cement |
| Classification Name: | Polymethylmethacrylate (PMMA) bone cement |
| Device Class: | Class II |
| Classification: | 21 CFR § 888.3027 |
| Product Code: | PMI |
C. Predicate Devices
The subject NuVasive Reline Fenestrated Screws are substantially equivalent to the primary predicate device, the NuVasive Reline System (K160989) and the additional predicate device, Medtronic Sofamor Danek USA, Inc., CD HORIZON Fenestrated Screw Set (K152604).
The subject High V+ Bone Cement is substantially equivalent to the predicate device, the Teknimed High V+ (K161114) and the additional predicate device, Medtronic Sofamor Danek USA, Inc., KYPHON HV-R Fenestrated Screw Cement (K152604).
D. Device Description
The NuVasive Reline Fenestrated Screws are available in a variety sizes and are designed to connect to 5.0mm, 5.5mm, and 6.0mm diameter rods and associated connecting components contained within the NuVasive Reline System. The screws contain 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 sterile or non-sterile.
4
Image /page/4/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a purple and gray abstract shape on the left, followed by the word "NUVASIVE" in gray. Below the word "NUVASIVE" is the phrase "Speed of Innovation" in a smaller font.
The High V+ Bone Cement is a self-curing PMMA based (high viscosity, radiopaque) bone cement. High V+ Bone Cement is provided sterile in two components: 20 grams of powder and 8.6 grams of liquid. The powder contains polymethylmethacrylate, barium sulfate and hydroxyapatite as radiopacifier, and benzoyl peroxide as an initiator. The 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.
The purpose of this 510(k) is to expand the indications for use for the NuVasive Reline Fenestrated Screws to include its use with High V+ Bone Cement in the treatment of advanced stage tumors of the thoracic and lumbar spine.
E. Intended Use
High V+ Bone Cement:
When used in conjunction with the NuVasive Reline Fenestrated Screws, High V+ Bone 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. High V+ Bone Cement is limited to use at spinal levels where the structural integrity of the spine is not severely compromised.
NuVasive Reline Fenestrated Screws:
When used in conjunction with High V+Bone Cement, the NuVasive Reline 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. NuVasive Reline Fenestrated Screws augmented with High V+Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
F. Technological Characteristics
As was established in this submission, the subject High V+ Bone Cement is identical in composition, method of manufacture and sterilization to the primary predicate Teknimed High V+ cleared by FDA in K161114. In addition, the subject High V+ Bone Cement is substantially equivalent to the predicate Medtronic Sofamor Danek USA, Inc., KYPHON HV-R Fenestrated Screw Cement cleared by the FDA in K152604 for use with CD HORIZON Fenestrated Screws in the treatment of advanced stage tumors involving the thoracic and lumbar spine.
As was established in this subject NuVasive Reline Fenestrated Screws are identical in materials and substantially equivalent in design to the primary predicate NuVasive Reline System cleared by FDA in K160989 and are substantially equivalent to other predicate devices cleared by the FDA for commercial distribution in the United States. The subject device was shown to be substantially equivalent and have equivalent technological characteristics to its predicate device through comparison in areas including design, labeling/intended use, material composition, and function.
5
G. Performance Data
To compare the mechanical properties of the NuVasive Reline Fenestrated Screws with High V+ Bone Cement and Medtronic CD Horizon Fenestrated Screw with Kyphon HV-R Bone Cement, axial pull-out and removal torque testing was performed according to ASTM F2193. Additionally, a comparison study of the cement flow and bolus formation of the the subject and predicate device was performed.
The subject devices were found to be substantially equivalent to the predicates. No clinical studies were conducted.
H. Conclusions
Based on the indications for use, technological characteristics, and comparison to predicate devices, the subject NuVasive Reline Fenestrated Screws and High V+ Bone Cement have been shown to be substantially equivalent to legally marketed predicate devices.