(90 days)
Not Found
No
The summary describes a physical surgical mesh device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a surgical mesh intended for "reinforcement of weak bony tissue," which aligns with an orthopedic support function rather than a direct therapeutic one. Its use for "reinforcement" suggests a mechanical or structural role, not an active biological or physiological treatment.
No
The device is described as a surgical mesh for reinforcing weak bony tissue during orthopedic procedures, not for diagnosing conditions.
No
The device description clearly states it is a "rhombic pattern surgical mesh device," which is a physical implant, not software.
Based on the provided information, the NuVasive® Mesh is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "reinforcement of weak bony tissue in orthopedic procedures." This describes a surgical implant used directly on the patient's body during a procedure.
- Device Description: The description confirms it's a "surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures." Again, this points to a surgical implant.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The NuVasive® Mesh does not perform this function. It is a physical implant used on the body.
Therefore, the NuVasive® Mesh falls under the category of a surgical implant or medical device used in orthopedic procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.
Product codes
EZX
Device Description
The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bony tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthopedic procedures
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
Not Applicable
Key Metrics
Not Found
Predicate Device(s)
K983766, K900138, K974017/K973145
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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: March 14, 2002.
B. Device Name
Trade or Proprietary Name: Common or Usual Name: Classification Name:
NuVasive® Mesh Surgical Mesh Surgical Mesh
C. Predicate Devices
The subject device is substantially equivalent to the Synthes® Synmesh™ System (510([k] submission No. K983766), Depuy-Motech™ Titanium Surgical Mesh (510([k] submission No. K900138), and Sofamor Danek's Timesh™/ Pyramesh™ System (510([k] submission No. K974017/K973145).
D. Device Description
The NuVasive® Mesh is a rhombic pattern surgical mesh device intended for the reinforcement of weak bony tissue during orthopedic surgical procedures. The implant is available in preformed round or oval cylinders, in a variety of different sizes.
E. Intended Use
The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.
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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, materials of composition, indications for use, and such other characteristics as may be associated with the manufacture of any medical device, including sterilization, and labeling.
G. Summary of Non-Clinical Tests
(Not Applicable).
H. Summary of Clinical Tests
(Not Applicable).
I. Conclusions of Non-Clinical and 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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized representation of three human figures, possibly representing people of different ages or backgrounds.
JUN 1 3 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laetitia Bernard Manager of Regulatory Affairs and Quality Assurance NuVasive®, Incorporated 10065 Old Grove Road San Diego, CA 92131
Re: K020853
Trade/Device Name: NuVasive® Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: EZX Dated: March 14, 2002 Received: March 15, 2002
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) 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Laetitia Bernard
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
R. Mark N. Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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V. Draft Labeling
A. Indications for Use
510(k) Number (if known): Ko20953
Device Name: NuVasive® Mesh
Indications for Use:
The NuVasive® Mesh is indicated for use in the reinforcement of weak bony tissue in orthopedic procedures.
Mark Millburn
Division of General, Restorative and Neurological Devices
510(k) Number -
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use OR