(242 days)
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No
The summary describes a physical surgical mesh and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The intended use states that the device is implanted to reinforce soft tissue where weakness exists, which is a therapeutic action.
No
Explanation: The device, a surgical mesh system, is described as being implanted to reinforce soft tissue, not to diagnose a condition.
No
The device description clearly states it is a "series of specialized shapes of surgical mesh made from commercially available polyester suture fibers," indicating a physical, implantable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be "implanted to reinforce soft tissue where weakness exists." This describes a device that is surgically placed within the body to provide structural support.
- Device Description: The device is described as "surgical mesh made from commercially available polyester suture fibers." This is a physical implantable material.
- Lack of IVD Characteristics: IVD devices are used in vitro (outside the body) to examine specimens (like blood, urine, or tissue) to provide information about a person's health. The provided description does not mention any interaction with biological specimens or diagnostic testing.
Therefore, the Surgical Mesh System is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Mesh System is intended to be implanted to reinforce soft tissue where weakness exists. The device is intended for one-time use.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The NuVasive Surgical Mesh System consists of a series of specialized shapes of surgical mesh made from commercially available polyester suture fibers. All sizes incorporate regions of reinforced holes to assist secure anchoring of the mesh to tissue. Thoodpoines are available in a variety of different shapes and 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
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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)
Mechanical testing was presented.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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
JUL 1 7 2006
Image /page/0/Picture/1 description: The image shows the text "NuVasive®, Incorporated". The text is in a serif font and is black. The registered trademark symbol is next to the word NuVasive.
510(k) Premarket Notification Surgical Mesh System