(82 days)
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No
The document describes a purely mechanical implantable device with no mention of software, algorithms, or any technology that would suggest AI/ML.
No
The device is described as an implantable PEEK device used as a cement restrictor during orthopedic procedures, which is part of a treatment but not a therapeutic device itself that directly treats a condition or restores health.
No
The device description indicates it is an implantable PEEK device used as a cement restrictor, which is a therapeutic rather than a diagnostic function. It does not mention any ability to diagnose or assess medical conditions.
No
The device description clearly states it is an "implantable PEEK device," indicating it is a physical hardware component, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The NuVasive® Cement Restrictor is an implantable device used to restrict bone cement during surgical procedures in the femur, tibia, and/or humerus. It is a physical device placed within the body.
- Intended Use: Its intended use is as a physical barrier for bone cement, not for analyzing biological samples.
Therefore, based on the provided information, the NuVasive® Cement Restrictor clearly falls outside the definition and function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive® Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
Product codes (comma separated list FDA assigned to the subject device)
JDK
Device Description
The NuVasive® Cement Restrictor is an implantable PEEK device indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
The device is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The hollow core is used to hold bone cement.
The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
femur, tibia, and/or humerus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Applicable
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.
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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.
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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).
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§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.
0
OCT = 7 2003 VII. 510(k) Summary
In accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title of the Code of Federal Regulations Part 807 (21 CFR §807), and in particular §807.92, the following summary of safety and effectiveness information is provided:
A. Submitted by
Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive®, Incorporated 10065 Old Grove Road San Diego, CA 92131 Telephone: (858) 527-1918 Date Prepared: July 16, 2003.
B. Device Name
| Trade or Proprietary Name: | NuVasive® Cement Restrictor |
|---|---|
| Common or Usual Name: | Cement Restrictor |
| Classification Name: | Surgical Mesh/ Prosthesis, Hip, Cement Restrictor |
C. Predicate Devices
The subject device is substantially equivalent to similar previously cleared devices.
D. Device Description
The NuVasive® Cement Restrictor is an implantable PEEK device indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
The device is a hollow device with teeth on two opposing flat sides, offered in a tapered style of various sizes. The hollow core is used to hold bone cement.
The device is available in a variety of different sizes to suit the individual pathology and anatomical conditions of the patient.
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E. Intended Use
The NuVasive® Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, and/or humerous.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
F. Comparison to Predicate Devices
As was established in this submission, the subject device is substantially equivalent to other devices cleared by the agency for commercial distribution in the United States.
Engineering drawings and labeling have demonstrated that the subject device is substantially equivalent, if not identical, to its predicate devices in terms of design, indications for use, and such other characteristics as may be associated with the manufacture of any medical device.
G. Summary of Non-Clinical Tests
(Not Applicable).
H. Summary of Clinical Tests
(Not Applicable).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The logo is black and white.
OCT 7 - 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive, Inc. 10065 Old Grove Road, Suite A San Diego, CA 92131
Re: K032180
Trade/Device Name: NuVasive® Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: JDK Dated: July 16, 2003 Received: July 17, 2003
Dear Ms. Bernard:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the device's labeling:
THIS DEVICE IS NOT INTENDED FOR ANY SPINAL INDICATIONS. WARNING:
THE SAFETY AND EFFECTIVENESS OF THIS DEVICE WHEN IMPLANTED IN THE SPINE HAVE NOT BEEN ESTABLISHED.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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Page 2 - Ms. Laetitia Bernard
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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); good manufacturing practice requirements as set 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
David Salsberg, M.D.
Daniel Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K032180
Device Name: NuVasive® Cement Restrictor
FDA's Statement of the Indications For Use for device:
The NuVasive® Cement Restrictor is indicated for use as a cement restrictor in the femur, tibia, and/or humerus.
This device is not intended for spinal indications. The safety and effectiveness of this device when implanted in the spine have not been established.
for Mark N Millican
Division Sion-()HD Division of General. Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________