(156 days)
The PARIETEX™ OPTIMIZED COMPOSITE MESH is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
PARIETEX™ Optimized Composite Mesh is available in rectangular and round shape. This device is made out of a threedimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and extends 5 mm over the edge of the reinforcement. One or many non-absorbable color monofilaments are tied to the three-dimensional mesh
The provided text describes the PARIETEX™ Optimized Composite Mesh, a surgical mesh, and its comparison to predicate devices, but it does not contain acceptance criteria or detailed study results for a device that uses AI or machine learning.
In general, information about acceptance criteria and comprehensive study results for AI/ML devices typically includes quantifiable metrics (e.g., sensitivity, specificity, AUC for diagnostic devices; accuracy, precision for other AI applications), thresholds for these metrics, and detailed breakdowns of how these metrics were achieved in various test sets.
The document discusses "performance data" which refers to bench testing and in-vivo animal model testing for the surgical mesh in question, focusing on mechanical properties and reduction of visceral attachment compared to a predicate device. This is a medical device, but not one that employs artificial intelligence or machine learning for diagnostic or predictive purposes, which is what the prompt seems to be geared towards.
Therefore, I cannot fulfill the request as formatted, as the input document does not provide information relevant to AI/ML device performance and acceptance criteria.
If the request is for the acceptance criteria and study general to this surgical mesh (and not specific to AI/ML):
Based on the provided text, here's what can be inferred about the acceptance criteria and studies (non-AI/ML specific):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance | Comments |
|---|---|---|---|
| Mechanical Strength | Higher mechanical resistance compared to predicate device. | "Improved mechanical properties of proposed device versus predicate." | Bench testing conducted. |
| Visceral Attachment | Collagen film minimizes visceral attachment to the mesh, equivalent to predicate. | "The results demonstrated the performance of the collagen film of PARIETEX™ Optimized Composite Mesh was equivalent to the predicate." | In-vivo performance testing on animal model conducted. |
| Suture Compliance | Compliance with Tensile Strength Suture US Monograph for Dermalon® threads. | "Confirmation tests on Dermalon® threads were conducted and demonstrated the compliance with the Tensile Strength Suture US Monograph." | Confirmed ability to fill the suture function. |
| Overall Performance | Performs as well as or better than the legally marketed predicate devices. | "The results of the nonclinical and pre-clinical tests demonstrate that the device performs as well as or better than the legally marketed predicate devices." |
2. Sample size used for the test set and the data provenance:
- Mechanical Testing (Bench): Not specified. Likely involves a sufficient number of devices for statistical analysis of mechanical properties.
- In-vivo performance testing (Animal Model): Not specified.
- Data Provenance: The document does not specify the country of origin for the animal study, but the submitter is based in France. The study is prospective in the sense that it evaluates the performance of the new mesh design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- This type of information (expert review for ground truth) is not applicable to the mechanical and animal model studies described for this surgical mesh. The "ground truth" for mechanical properties is typically established by engineering standards and measurements, while for the animal study, it would be direct observation and pathological assessment of visceral attachment by veterinary pathologists or researchers. No specific number or qualifications of such experts are mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the types of studies described (bench testing, animal model). Adjudication methods are more commonly used in clinical trials or image-based diagnostic studies involving human interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC study was not done. This device is a surgical mesh, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, this is not an AI algorithm. Therefore, standalone performance (in the context of AI) is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Bench Testing: Mechanical measurements against engineering standards.
- In-vivo Performance Testing: Direct histological or gross pathological assessment of visceral attachment in an animal model.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
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KII0663
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510(k) Summary of Safety and Effectiveness
. . .
Submitter Information
公
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AUG 1 1 2011
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| Name: | Sofradim Production |
|---|---|
| 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: | James McMahonManager, Regulatory AffairsCovidien15 Crosby driveBedford, MA 01730 USAPhone: (781) 839 1787 |
| Date prepared: | March 4, 2011 |
| Name of device | |
| Trade or proprietary name: | PARIETEX™ Optimized Composite Mesh |
| 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: | PARIETEX™ Composite Mesh (K002699 and K040998)Dermalon® suture (K930586)BIOMESH® CA.B.S.'Air® (K072962) |
| Reason for 510(k) submission: | To introduce the PARIETEX™ Optimized Composite mesh which ismade from a three-dimensional multifilament polyester knit coveredwith an absorbable, continuous and hydrophilic film on one side.The multifilament polyester material provides long term wallreinforcement while the hydrophilic film minimizes tissueattachment to the mesh in case of direct contact with the viscera.One or many non-absorbable color monofilament threads are pre-tied to the three-dimensional mesh to facilitate placement andfixation of the mesh. The proposed PARIETEX™ OptimizedComposite Mesh has been improved compared to the predicatedevices as the knitting textile has been modified to obtain a highermechanical resistance of the mesh and the collagen filmformulation has been changed to get a film more resistant to handling. |
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PARIETEX™ Optimized Composite Mesh is available Device description: in rectangular and round shape. This device is made out of a threedimensional multifilament polyester knit for wall reinforcement, covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and glycerol, and extends 5 mm over the edge of the reinforcement. One or many non-absorbable color monofilaments are tied to the three-dimensional mesh
The PARIETEX™ Optimized Composite Mesh is used for the Intended use of the device: reinforcement of tissues during surgical repair.
It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Summary comparing the technological characteristics of the subject and predicate devices:
Indications for use:
ﺔ
The subject PARIETEX™ Optimized Composite Mesh is equivalent to the predicate devices PARIETEX™ Composite Mesh (K002699, K040998) and Dermalon® suture (K981532) in terms of its technological characteristics and material. The three-dimensional multifilament polyester knit and and monofilament sutures are identical to the predicates. No major technological changes are proposed to the currently marketed devices PARIETEX™ Composite Mesh and Dermalon® suture in this submission.
Performance data: Bench testing was conducted in accordance with FDA's quidance for the Preparation of a Premarket Notification Application for Surgical Mesh to evaluate the performance characteristics of the proposed PARIETEX™ Optimized Composite Mesh. Bench testing for Surgical Mesh included physical characterization and extensive mechanical performance testing with comparison to the predicate PARIETEX™ Composite Mesh. These tests demonstrated improvement of mechanical properties of proposed device versus predicate.
Confirmation tests on Dermalon® threads were conducted and demonstrated the compliance with the Tensile Strength Suture US Monograph. This tests confirmed Dermalon ability to fill the suture function.
In-vivo performance testing on representative animal model was conducted in comparison with predicate to demonstrate the collagen film minimizes visceral attachment to the mesh. The results demonstrated the performance of the collagen film of PARIETEX™ Optimized Composite Mesh was equivalent to the predicate.
The results of the nonclinical and pre-clinical tests demonstrate that the device performs as well as or better than the legally marketed predicate devices.
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Image /page/2/Picture/1 description: The image shows a logo or emblem. On the left side, there is text that reads "DEPARTMENT OF HEALTH & HIG.", arranged in a circular fashion. To the right of the text, there is a stylized graphic that resembles a bird in flight, composed of three curved lines. The overall impression is that of an official seal or symbol, possibly related to a health or government organization.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford, Massachusetts 01730
AUG 11 2011
Re: K110663
Trade/Device Name: PARIETEX™ Optimized Composite Mesh (PCO-FX references) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: August 3, 2011 Received: August 5, 2011
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 Mcdical 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.
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
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Page 2 - Mr. James McMahon
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.
fa. Nola Vercia D.N
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
510(k) Number (if known): V110663
PARIETEX™ Optimized Composite Mesh (PCO-FX references) Device Name:
Indications For Use:
The PARIETEX™ OPTIMIZED COMPOSITE MESH is used for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-absorbable three-dimensional polyester mesh provides long term reinforcement of soft tissues. On the opposite side, the absorbable hydrophilic film minimizes tissue 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 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daind Knare ken MXM
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K11663
§ 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.