(184 days)
K/DEN: Not Found
Not Found
No
The summary describes a surgical mesh made of polyester and provides performance data from clinical studies. There is no mention of AI, ML, image processing, or any other technology that would indicate the use of AI/ML.
Yes
The device is intended for the repair of hernias and prolapses, which corrects a medical condition and restores function, thus providing therapy.
No
The device is a surgical mesh intended for the repair of hernias and prolapses, which is a therapeutic function, not a diagnostic one. It is used to mend or support tissue, not to identify or characterize a disease or condition.
No
The device is described as a physical mesh made of knitted multifibre polyester, indicating it is a hardware 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 that the Parietex™ surgical mesh is for the repair of hernias and prolapses via surgical procedures (open abdominal or laparoscopic). This is a direct surgical intervention on the body.
- Device Description: The device is a physical mesh made of polyester, designed to be implanted in the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
- Performance Studies: The performance studies focus on biocompatibility and clinical outcomes related to surgical repair and implantation, not on diagnostic testing of biological samples.
Therefore, the Parietex™ surgical mesh is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Parietex™ surgical mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.
Product codes
FTL
Device Description
Mesh made of Biocompatible, knitted multifibre polyester (PET). Each mesh is supplied sterile and nonpyrogenic in a single-use package.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inguinal, Incisional, genito-urinary, rectal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Biocompatibility Tests Standard biocompatibility testing was performed according to the ISO 10993 - 1 Standards and FDA requirements. The device passed all of the following biocompatibility tests: Cytotoxicity, Systemic toxicity, Intracutaneous toxicity, Sensitization, Mutagenicity tests (Ames's test, Chromosomal aberration, Sister chromatid exchange), Implantation tests (Short term implantation, Long term implantation). All tests were performed according to GLP in an American Laboratory.
Clinical Tests:
"Iaparoscopic and open abdominal wall reconstruction using PARIETEX® meshes" · Clinical results on 2.700 hernias. (Paper accepted by "HERNIA" 1998)
Summary: The authors report a series of 2.445 inguinal hernias and 272 incisional hernias treated between 1993 and 1997 by the insertion of a Parietex® mesh via either a laparoscopic (1,595 procedures) or an open approach (578 procedures). Pain scores and time to return to normal activity were lower in the laparoscopic group than in the open surgery group (p
§ 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
510(k) Summary
:
Submitter Information
| Name: | Sofradim Production |
|---|---|
| Address: | 116, avenue du formans |
| 01600 Trevoux, | |
| France | |
| Phone number | +33 (0)4 74 08 90 00 |
| Fax number: | +33 (0) 4 74 08 90 02 |
| Establishment Registration: | 9615742 |
| Name of contact person: | |
| (US Agent) | James McMahon |
| Senior Manager, Regulatory Affairs | |
| Covidien | |
| 15 Crosby drive | |
| Bedford, MA 01730 USA | |
| Phone: (781) 839 1787 | |
| Date prepared: | June 25, 2012 |
| Name of device | |
| Trade or proprietary name: | Parietex |
| Common or usual name: | Surgical Mesh |
| Classification name: | Mesh, Surgical, Polymeric |
| Classification panel: | General and Plastic Surgery (79) |
| Regulation: | 21 CFR 878.3300 |
| Product Code: | FTL |
| Legally marketed devices to | |
| which equivalence is claimed | Mersilene®, (Ethicon, Johnson & Johnson) |
| Ercylene®, (Davis & Geck) | |
| Prolene®, (Ethicon, J & J) | |
| Surgipro®, (U.S.S.C.) | |
| Marlex®, Visilex@ (Bard - Davol) | |
| Atrium®, (Atrium) | |
| Reason for 510(k) submission: | To obtain market clearance on the Parietex Surgical Mesh. |
| Device description: | Mesh made of Biocompatible, knitted multifibre polyester |
| (PET). Each mesh is supplied sterile and nonpyrogenic in a | |
| single-use package. | |
| Intended use of the device: | The Parietex® meshes has the same intended |
| use as the predicate devices: |
- reinforcement of tissue during surgical repair |
1
Indications for use:
Parietex™ surgical mesh; slings or pre-cut implants are intended for the repair of Inguinal and Incisional hernias, genito-urinary and rectal prolapses by promontofixation via open abdominal or laparoscopic approach. No applications other than the ones indicated are recommended.
Mechanical Properties:
| Comparative Table | Parietex™ | Mersilene® | Prolene® | Marlex® | |
|---|---|---|---|---|---|
| (Polyester) | (Polyester) | (Polypropylene) | (Polypropylene) | ||
| Thread | Chain | 68.5 | 115.2 | 57 | 57.2 |
| Resistance (N) | Weft | 55.4 | 15.5 | 74.6 | 55.8 |
| Tear Resistance | Chain | 3.36 | 0.64 |