(10 days)
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.
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.
The PARIETEX® COMPOSITE Mesh is a surgical mesh used for the reinforcement of tissues during surgical repair, specifically for incisional hernias, abdominal wall repair, and parietal reinforcement of tissues. The device is composed of a polyester mesh and a collagen-based hydrogel component. The study described focuses on a modification to the origin of the collagen in the hydrophilic film, changing it from bovine dermis to porcine dermis.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No statistically significant difference in tissue attachment between porcine and bovine collagen products. | A study was conducted that demonstrated no statistically significant difference between the test groups in tissue attachment. Both the porcine and bovine products were successful at minimizing tissue attachments. |
| No difference in cellular inflammatory reaction. | A histological analysis was performed using randomly selected animals. The study found no difference in the cellular inflammatory reaction to the two products (porcine collagen vs. bovine collagen). |
| Physical performance characteristics of the mesh are not affected by the change in collagen origin. | The document explicitly states: "The hydrophilic collagen film does not affect the physical performance characteristics of the mesh." and "The polyester mesh material used is not modified and remains the same as that described in the current PCO file (K002699)." This implies that the acceptance criterion for physical performance was met by maintaining the core mesh material and ensuring the change in collagen source did not alter its function in this regard. Although not explicitly a "reported performance" of the study presented, the unchanged mesh material is a foundational aspect of equivalence. The successful minimization of tissue attachments also indirectly supports adequate physical performance in a functional context. |
2. Sample Size and Data Provenance:
- Sample Size for Test Set: The document mentions "randomly selected animals" for the histological analysis and "test groups" for the tissue attachment study. However, the specific number of animals or samples used in these studies is not provided.
- Data Provenance: The studies were conducted as part of the regulatory submission (K040998) for a device manufactured by Sofradim Production in France. The data appears to be prospective as it was generated specifically to demonstrate the equivalence of the modified device. The country of origin of the data is not explicitly stated beyond the sponsor's location (France).
3. Number of Experts and Qualifications for Ground Truth:
- This application does not involve human interpretation of medical images or diagnostic data where "experts" would establish ground truth in the traditional sense of a clinical read. Instead, the ground truth is established through pre-clinical scientific methods (tissue attachment measurements, histological analysis) conducted by qualified researchers/scientists in a laboratory setting.
- Therefore, no specific number or qualifications of "experts" for establishing ground truth in the context of clinical interpretation are mentioned or applicable here.
4. Adjudication Method:
- Not applicable. This study involves pre-clinical animal studies and scientific measurements, not human interpretation that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This is a pre-clinical study evaluating material properties and biological response, not a study involving human readers or AI in a diagnostic context.
6. Standalone Performance Study:
- Yes, a standalone performance study was conducted. The studies (tissue attachment and histological analysis) were performed on the device itself (both porcine and bovine collagen versions) to evaluate its biological performance characteristics independent of human interaction in a diagnostic or assistive capacity.
7. Type of Ground Truth Used:
- The ground truth used is based on biological and histological outcomes data obtained from animal studies. This includes quantitative measurements of tissue attachment and qualitative/quantitative cellular inflammatory responses observed through microscopy.
8. Sample Size for Training Set:
- Not applicable. This study is not describing a machine learning algorithm, so there is no training set in the context of AI. The "predicate devices" listed (K002699, K033376) serve as established benchmarks for the current device's performance, but they are not "training sets" for an algorithm.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no AI training set, this question is not relevant. The ground truth for evaluating the device's performance was established through the aforementioned pre-clinical animal studies.
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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.
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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.
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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
§ 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.