(10 days)
Not Found
No
The 510(k) summary describes a surgical mesh made of polyester and collagen, intended for tissue reinforcement. There is no mention of any software, algorithms, or data processing capabilities that would indicate the use of AI or ML. The performance studies focus on material properties and tissue interaction, not algorithmic performance.
Yes
The device is a surgical mesh used for the reinforcement of tissues and repair of hernias, which are therapeutic interventions.
No
This device is a surgical mesh used for the reinforcement of tissues during surgical procedures, not for identifying a disease or condition.
No
The device description clearly states it is a surgical mesh made from physical materials (polyester and collagen-based hydrogel) and is used in surgical procedures. It is a physical implant, 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 "reinforcement of tissues, during surgical repair of incisional hernias, abdominal wall repair, and parietal reinforcement of tissues." This describes a surgical implant used directly on the patient's body to provide structural support.
- Device Description: The description details a "surgical mesh" made from polyester and a collagen-based hydrogel. This is a physical device intended for implantation.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies described focus on tissue attachment and inflammatory reaction, which are relevant to the biocompatibility and effectiveness of a surgical implant, not a diagnostic test.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. This device is a surgical implant used in vivo (within the body) for structural repair.
N/A
Intended Use / Indications for Use
The PARIETEX® Composite Mesh is used for the reinforcement of tissues,during surgical The PARIETEX Composite Mesil is assurement of incisional hernias, abdominal wall repair, and parietal (i.c. pertaining to the walls) reinforcement of tissues. The non-resorbable three-dimensional polyester mesh provides long-term reinforcement of soft tissues. On the dimensional polyester thesh provides form of the every attachment to the mesh in case of direct contact with the viscera.
Product codes
FTL
Device Description
The PARIETEX® COMPOSITE Mesh is a surgical mesh used during open (laparotomy) procedures or during laparoscopic procedures. The PARIETEX® COMPOSITE Mesh is made from polyethylenc terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance charactcristics of the mesh but serves to separate the coated side of the mesh from underlying tissues to minimize tissue attachment and ingrowth. The PARIETEX® COMPOSITE Mesh is offered in several sizes and shapes to accommodate the type and approach of the surgical procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
incisional hernias, abdominal wall, parietal (i.e., pertaining to the walls)
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)
A study was conducted and demonstrated that there was no statistically significant difference between the test groups in tissue attachment. Both the porcine and bovine products were successful at minimizing tissue attachments. A histological analysis was also performed using randomly selected animals. Additionally, there was no difference in the cellular inflammatory reaction to the two products.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sofradim PARIETEX®COMPOSITE Meshes, K002699, Sofradim UGYTEX® Mesh, K033376
Reference Device(s)
Not Found
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)
Not Found
§ 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 for PARIETEX® COMPOSITE Mesh
1. SPONSOR
APR 2 9 2004
Sofradim Production 116 Avenue du Formans 01600 Trevoux France
Christophe COSSON Contact: Telephone: 33 (0)4 74 08 90 00 Facsimile: 33 (0)4 74 08 90 02
2. DEVICE NAME
PARIETEX® COMPOSITE Mesh Proprietary Name: Common/Usual Name: Surgical Mesh Classification Name: Surgical Mesh
PREDICATE DEVICES 3.
Sofradim PARIETEX®COMPOSITE Meshes, K002699 Sofradim UGYTEX® Mesh, K033376
4. DEVICE DESCRIPTION
The PARIETEX® COMPOSITE Mesh is a surgical mesh used during open (laparotomy) procedures or during laparoscopic procedures. The PARIETEX® COMPOSITE Mesh is made from polyethylenc terephtalate (polyester) and a collagen-based hydrogel component. The hydrophilic collagen film does not affect the physical performance charactcristics of the mesh but serves to separate the coated side of the mesh from underlying tissues to minimize tissue attachment and ingrowth. The PARIETEX® COMPOSITE Mesh is offered in several sizes and shapes to accommodate the type and approach of the surgical procedure.
1
న. INTENDED USE
The PARIETEX® COMPOSITE Mesh is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hermas, abdominal wall repair, and parietal (i.e., pertaining to the walls) reinforcement of tissues. The nonresorbable three-dimensional polyester mesh provides long-term reinforcement of soft tissues. On the opposite side, the resorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE
The Sofradim PARIETEX COMPOSITE (PCO) meshes are identical to the current PARIETEX® COMPOSITE (PCO) (K002699) meshes with the exception of a modification in the origin of the collagen of the hydrophilic film. In the current PCO meshes, the oxidized collagen is obtained from bovine dermis. In the proposed PCO meshes, the collagen is obtained from porcine dermis.
7. PERFORMANCE TESTING
The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699). A study was conducted and demonstrated that there was no statistically significant difference between the test groups in tissue attachment. Both the porcine and bovine products were successful at minimizing tissue attachments. A histological analysis was also performed using randomly selected animals. Additionally, there was no difference in the cellular inflammatory reaction to the two products.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 9 2004
Sofradim Production c/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K040998
Trade/Devicc Name: Sofradim PARIETEX® COMPOSITE (PCO) Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: April 16, 2004 Received: April 19, 2004
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstatc commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has madc a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Mary McNamara-Cullinane, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) I market notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please it you desire of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KO40998
Indications for Use
510(k) Number (if known):
Device Name: Sofradim PARIETEX®COMPOSITE (PCO) Mesh
Indications for Use:
The PARIETEX® Composite Mesh is used for the reinforcement of tissues,during surgical The PARIETEX Composite Mesil is assurent of incisional hernias, abdominal wall repair, and parietal (i.c. pertaining to the walls) reinforcement of tissues. The non-resorbable threedimensional polyester mesh provides long-term reinforcement of soft tissues. On the dimensional polyester thesh provides form of the every attachment to the mesh in case of direct contact with the viscera.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K640998