(54 days)
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No
The device description is solely focused on the material and physical characteristics of a titanium mesh, with no mention of software, algorithms, or any computational processing that would suggest AI/ML. The lack of sections related to image processing, AI/ML terms, training/test sets, and performance metrics further supports this conclusion.
No
The device description and predicate devices indicate it is a surgical mesh primarily used for structural support and augmentation, not for treating a disease or condition.
No
The device description indicates it is a Titanium Mesh, likely for surgical implantation or structural support, and the listed predicate devices are also meshes, plates, and screws used for augmentation or reconstruction. There is no information suggesting it is used to identify or diagnose a condition.
No
The device description explicitly states it is a "laser cut segment of precision expanded, flattened and annealed Titanium Mesh," which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- No mention of in vitro testing: The description focuses on a physical titanium mesh used for surgical purposes. There is no indication that it is used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical characteristics of the mesh (laser cut, expanded, flattened, annealed Titanium Mesh). This is consistent with a surgical implant or material, not an IVD.
- Lack of IVD-related information: The document is missing key information typically found in IVD submissions, such as intended use for diagnostic purposes, sample types, reagents, or performance characteristics related to diagnostic accuracy.
- Predicate Devices: The listed predicate devices are all surgical implants or materials (augmentation mesh, bone plates and screws, reconstructive surgery system). This further supports that the device is intended for surgical use, not in vitro diagnostics.
Therefore, the IMTEC/TitaniumMesh is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.
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)
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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.
Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532, Osteomed. , Osteomed MSS (Ti Ridge Augmentation Material) K963394, Walter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482, TiMesh Inc., Reconstructive Surgery System,K923491
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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§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.
0
510 (k) Summary of Safety and Effectiveness
SUBMITTED BY:
M. K. Patterson, Jr. PhD Sr Vice President Regulatory Affairs IMTEC Corporation 2401 North Commerce Ardmore, Oklahoma 73401 (405) 223-4456
F.D.A Registration Number: 1645158 Owner / Operator Number: 9003407
Date Submitted: March 5,1997
CLASSIFICATION/COMMON OR USUAL NAME/ DEVICE NAME:
Classification Name: Precision expanded Titanium foil (CFR 878.3300) Common/ Usual Name: Titanium Mesh. Proprietary Name: IMTEC/ TitaniumMesh
PREDICATE DEVICE:
Leibinger, Micro-Titanium Augmentation Mesh ( M-TAM™) K 862532 Osteomed. , Osteomed MSS (Ti Ridge Augmentation Material) K963394 Walter Lorenz Surgical, Inc., Ti Mini Bone Plate and Screws, K862482 TiMesh Inc., Reconstructive Surgery System,K923491
DEVICE DESCRIPTION:
The IMTEC/TitaniumMesh consists of a laser cut segment of precision expanded, flattened and annealed Titanium Mesh of a specific size dimension and pore dimension. The device will be marketed sterile.