(148 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a surgical mesh, with no mention of AI or ML.
No
The device is a non-absorbable surgical mesh used for hernia repair, acting as a structural support rather than directly treating a disease or condition in a therapeutic manner. It is a prosthetic implant.
No
The device is a non-absorbable monofilament polypropylene mesh used for surgical repair of abdominal wall hernias. It does not perform any diagnostic function.
No
The device description clearly states it is a "non- absorbable monofilament polypropylene mesh constructed from knitted monofilaments of extruded polypropylene," indicating it is a physical, implantable 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 clearly states the device is for the "repair of abdominal wall hernia... in open or laparoscopic abdominal procedures." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details a "non-absorbable monofilament polypropylene mesh" designed for surgical 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 screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
Product codes
FTL
Device Description
Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene. They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction.
Hermesh 7 polypropylene 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
abdominal wall
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
The following tests were performed to show the safety, efficacy and performance of Allergic Hermiamesh T-Sling. Mutagenicity, Cytotoxicity, Hemolysis, the 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
K070625 Page 1/2
August 1, 2007
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 540 MUTTONTOWN EASTWOODS ROAD Syosset, NY 11791 Tel 516 987-9364 -- 516 584 6818 e-mail: lorenat63@aol.com
April 16, 2012
Date Prepared:
Classification: Polymeric Surgical Mesh (product code FTL) Class II device per 21 CFR 87.8.330
Acres Ad
Common Name: Polymeric Surgical Mesh
Proprietary Name: Hermesh 7
Predicate Devices: K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash)
Device Description: Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene.
They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction.
Hermesh 7 polypropylene 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: May be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional in open or laparoscopic abdominal procedures.
Hermesh 7 are prescriptive devices and should only be used by a licensed physician.
Hermesh 7 have the same indications as predicate devices.
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K070625 page 2/2
Image /page/1/Picture/1 description: The image shows a logo with a figure of a person holding a spear. The figure is standing in front of a circle, and the word "HERNIAMESH" is written across the middle of the circle. The logo is black and white and appears to be a vintage design.
The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene and have similar technological characteristics. Please see Material Safety Data Sheet on page 85 and technological characteristics Comparison table on page 8.
Polypropylene has a long history of biocompatibility.
Hermesh 7 polypropylene meshes 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 Allergic Herniamesh T-Sling. Mutagenicity, Cytotoxicity, Hemolysis, the Sensitization, Systemic Toxicity, Ethylene Oxide Residual