(38 days)
No
The device description focuses on the material composition and physical properties of a surgical mesh. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies listed are standard biocompatibility and sterilization tests for medical devices, not performance metrics typically associated with AI/ML algorithms.
No
The device is a prosthesis used for reconstructing soft tissue deficiencies, not a device that provides therapy for a condition.
No
The Relimesh prosthesis is a surgical mesh designed for the reconstruction of soft tissue deficiencies, not for diagnosing medical conditions. Its function is to repair, not to detect or identify a disease.
No
The device description clearly states it is a physical mesh made of polypropylene and ePTFE, supplied as sterile, single-use surgical meshes. This indicates a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects." This describes a surgical implant used in vivo (within the body) for structural support and repair.
- Device Description: The description details a surgical mesh made of polypropylene and ePTFE, designed for implantation.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or treatment.
IVDs are devices used in vitro (outside the body) to analyze biological samples. This device is clearly an implantable surgical device.
N/A
Intended Use / Indications for Use
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects.
Relimesh is a prescriptive device and should only be used by a licensed physician.
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies such as but not limited to hernia repairs and chest wall defects.
Product codes
FTL
Device Description
Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects
Indicated patient Age Range
Not Found
Intended User / Care Setting
licensed physician
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)
The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene with and without ePTFE. They have similar technological characteristics. Polypropylene and ePTFE have a long history of biocompatibility. Relimesh prostheses comply with the requirements of ISO 10993 Biological Evaluation of Medical Devices, In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh" The following tests were performed to show the safety, efficacy and performance of the product. Mutagenicity, Cytotoxicity, Hemolysis, Allergic Sensitization, Systemic Toxicity, Ethylene Oxide Residual
§ 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
K08/327
Page 1 of 4
JUN 1 9 2008
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Submitter: | Herniamesh SRL
Via Fratelli Meliga 1/C
Chivasso, Italy
Tel +39 011 9196236 Fax +39 011 9196239 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Lorena Trabucco
8 Orange Dr.
Jericho, NY 11753
Tel 516 987-9364 Fax 516 938-2751 |
| Device Name: | Relimesh |
| Predicate Devices: | K971745 Composite Mesh (C.R. Bard Inc.)
K070625 Hermesh 7 (Herniamesh Srl) |
| Device Description: | Relimesh prostheses are dual component meshes made of non-absorbable
monofilament polypropylene mesh on one side and a layer of ePTFE on
the other side. |
| | Relimesh is warp knitted in such a way that the mesh may be cut into
preshaped designs without unraveling and will maintain excellent
isotropic properties because of its knitted construction. The ePTFE layer
is heat sealed to the polypropylene layer |
| | These meshes have the necessary strength, flexibility, and durability for
the various stresses which may be encountered in the body. |
| | The devices are supplied as sterile, single-use surgical meshes. |
| Intended Use: | Relimesh prostheses are intended for use in the reconstruction of soft
tissue deficiencies, such as but not limited to the repair of hernias and
chest wall defects |
| | Relimesh is a prescriptive device and should only be used by a licensed
physician. |
1
K08/327
page 2 of 4
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.
The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene with and without ePTFE. They have similar technological characteristics. Polypropylene and ePTFE have a long history of biocompatibility. Relimesh prostheses comply with the requirements of ISO 10993 Biological Evaluation of Medical Devices, In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh" The following tests were performed to show the safety, efficacy and performance of the product. Mutagenicity, Cytotoxicity, Hemolysis, Allergic Sensitization, Systemic Toxicity, Ethylene Oxide Residual