(113 days)
The PARIETEX™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Parietex™ Composite Ventral Patch is available as a round shape. It is a dual facing mesh composed of a non-absorbable three-dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four flaps made out of a bidimensional monofilament polyester textile and two removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with two poly(glycolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh.
Here's a breakdown of the acceptance criteria and study information for the Parietex™ Composite Ventral Patch, based on the provided 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Parietex™ Composite Ventral Patch were primarily based on demonstrating substantial equivalence to its predicate devices: Parietex™ Composite Mesh (K040998) and Bard Ventralex® Patch (K021736 and K024008). The reported device performance confirmed this equivalence.
| Characteristic Measured | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance |
|---|---|---|
| Textile Mechanical Performance | Equivalent to Parietex™ Composite Mesh (K040998) | Demonstrated equivalency during characterization testing. |
| Assembly Tensile Strength | Equivalent to Bard Ventralex® Patch (K021736 and K024008) | Demonstrated equivalency via traction testing. |
| Collagen Film Performance (Minimizing Tissue Attachment) | Equivalent to Parietex™ Composite Mesh (K040998) | Demonstrated equivalency in in-vivo animal model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The specific numerical sample sizes for the bench testing (textile characterization, traction testing) and the in-vivo animal model are not explicitly stated in the provided summary.
- Data Provenance: The studies were conducted by Sofradim Production (a subsidiary of Covidien llc), which is located in France. The data appears to be retrospective as it was collected as part of a premarket notification application (510(k)) to demonstrate equivalence. The animal model study is preclinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the given 510(k) summary. The studies described are bench and preclinical (animal model) tests, which typically rely on objective measurements rather than human expert interpretation of images or clinical outcomes for their primary endpoints.
4. Adjudication Method for the Test Set
- This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving human interpretation (e.g., radiology reads) to resolve discrepancies among experts. The studies here are bench and animal model tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The studies focused on physical and biological equivalence to predicate devices using bench tests and an animal model, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a surgical mesh, not an algorithm or AI-powered system, so the concept of standalone algorithmic performance does not apply.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations was established through:
- Objective Measurements: For textile mechanical performance and assembly tensile strength, the ground truth was derived from standardized bench testing measurements (e.g., tensile strength, material characterization).
- Preclinical In-vivo Observations: For collagen film performance (minimizing tissue attachment), the ground truth was based on observations and measurements from a representative animal model, comparing the device to the predicate.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical surgical mesh and not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As stated above, this device does not involve a training set for an algorithm.
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K120506 page 1/2
510(k) Summary
JUN 1 3 2012
| Submitter Information | |
|---|---|
| Name: | Sofradim Production (subsidiary of Covidien llc) |
| Address: | 116 avenue du Formans01600 TrevouxFrance |
| 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 McMahonSenior Manager, Regulatory AffairsCovidien15 Crosby DriveBedford, MA 01730 USAPhone: (781) 839 1787 |
| Date prepared: | June 11, 2012 |
| Name of device | |
| Trade or proprietary name: | Parietex™ Composite Ventral Patch |
| 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 towhich equivalence is claimed: | Parietex™ Composite Mesh (K040998) |
| Bard Ventralex® Patch (K021736 and K024008) | |
| Reason for 510(k) submission: | To introduce the Parietex™ Composite Ventral Patch which is adual facing mesh, covered with an absorbable collagen film. |
| Device description: | Parietex™ Composite Ventral Patch is available as a round shape.It is a dual facing mesh composed of a non-absorbable three-dimensional monofilament polyester textile for abdominal wallreinforcement covered by a bioabsorbable hydrophilic collagen filmto minimize visceral attachment. A fixation system composed offour flaps made out of a bidimensional monofilament polyestertextile and two removable handles completes the device. Thisfixation system and the three-dimensional reinforcement textile areassembled with two poly(glycolide-co-L-lactide) (PGLA) expanders.This system facilitates placement and fixation of the mesh. |
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Parietex™ Composite Ventral Patch
Intended use of the device: The Parietex™ Composite Ventral Patch is used for the reinforcement of soft tissues during surgical repair. Indications for use: The Parietex™ Composite Ventral Patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera. Summary comparing the technological characteristics The Parietex™ of the subiect and predicate: Composite Ventral Patch is substantially equivalent to the predicate devices, Parietex™ Composite Mesh (K040998) and Bard Ventralex® Patch (K021736 and K024008), in terms of its technological characteristics and material. The Parietex™ Composite Ventral Patch is equivalent to the polyester textile and hydrophilic collagen film performance as the predicate Parietex™ Composite Mesh (K040998). In addition, the mechanical performance of the fixation polyester flap is also equivalent to the polyester textile of the predicate Parietex™ Composite Mesh (K040998). The proposed Parietex™ Composite Ventral Patch is substantially equivalent to the predicate Bard Ventralex® Patch (K021736 and K024008) in assembly strength. Performance data: Bench testing was conducted in accordance with FDA's guidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed Parietex™ Composite Ventral Patch. Bench testing included : characterizations which demonstrate that . Textile the mechanical performance of the textiles are equivalent to the predicate Parietex™ Composite Mesh (K040998), Traction testing to demonstrate the equivalency of ম the assembly tensile strength of the mesh compared to the predicate Bard Ventralex® Patch (K021736 and K024008). In vivo performance testing on a representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes attachment to the mesh. The results demonstrates that the collagen film performance of Parietex™ Composite Ventral Patch is equivalent to the predicate Parietex™ Composite Mesh (K040998). The results of the bench and preclinical tests demonstrate that the device is substantially equivalent to its predicate devices, Parietex™ Composite Mesh (K040998) and the Bard Ventralex® Patch (K021736 and K024008).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 · Silver Spring, MD 20993-0002
JUN 1 3 2012
Sofradim Production % Surgical Devices, A Global Bus of Covidien Mr. James McMahon Senior Manager, Regulatory Affairs 15 Crosby Drive Bedford, Massachusetts 01730
Re: K120506
Trade/Device Name: PARIETEX ™ Composite Ventral Patch Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL, OXJ Dated: May 11, 2012 Received: May 14, 2012
Dear Mr. McMahon:
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 interstate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Mr. James McMahon
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
is h Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
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Indications For Use
120506 510(k) Number (if known):
Device Name:
PARIETEX™ Composite Ventral Patch
Indications For Use:
The PARIETEX™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and The three-dimensional non-absorbable monofilament polyester incisional hernias). mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danil Keane for MMM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120506
§ 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.