(26 days)
The PARIETEX™ Optimized Composite Mesh (PCO) 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.
The PARIETEX™ Optimized Composite Mesh (PCO) is available in rectangular and round shape. This device is made out of a three-dimensional 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 juts out 5 mm over the edge of the reinforcement.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the PARIETEX™ Optimized Composite Mesh, structured to answer your specific questions.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K110812) is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and performance against those criteria as would be found in a full study report.
However, based on the text, we can infer the key performance areas and the general findings:
| Acceptance Criteria (Inferred from document) | Reported Device Performance (PARIETEX™ Optimized Composite Mesh) |
|---|---|
| Mechanical Resistance / Improved Mechanical Properties (implied from "higher mechanical resistance of the mesh" and "improved mechanical properties") | "demonstrate improved mechanical properties" compared to predicate devices. The knitting textile was modified to achieve this. |
| Handling Resistance of Film (implied from "film more resistant to handling") | The collagen film formulation was changed to achieve a film that is "more resistant to handling." Specific quantitative improvement is not detailed, but the change was made to address this. |
| Equivalent In-Vivo Minimizing Tissue Attachment Property (implied target for new collagen film formulation) | "equivalent in-vivo minimizing tissue attachment property" compared to predicate devices. This property is attributed to the absorbable hydrophilic film minimizing tissue attachment in direct contact with viscera. |
| Overall Performance Characteristics Equivalence (primary goal for 510(k) submission) | "equivalent in performance characteristics to the predicates PARIETEX™ Composite Mesh." This is the overarching conclusion drawn from all performance testing. |
| Safety and Effectiveness (fundamental requirement for device clearance) | Implied to be equivalent in safety and effectiveness for the stated indications for use (reinforcement of tissues during surgical repair, incisional hernias, abdominal wall repair, parietal reinforcement) based on the substantial equivalence determination by FDA. No adverse events are reported in this summary. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes used for the "bench testing" and "pre-clinical study." It only states that these tests were performed:
- Sample Size: Not specified.
- Data Provenance: Not specified regarding country of origin or whether it was retrospective or prospective. "Pre-clinical study" typically implies animal studies or in-vitro tests, which are prospective. "Bench testing" is in-vitro.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and is not provided in a 510(k) summary for a surgical mesh. The testing performed involves objective measurements (mechanical properties, tissue attachment) rather than subjective assessments requiring expert consensus for ground truth.
4. Adjudication Method for the Test Set
This information is not applicable. The listed studies (bench testing, pre-clinical study) are objective tests, not subjective assessments requiring expert adjudication.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation by human readers, and the PARIETEX™ Optimized Composite Mesh is a surgical implant. There is no AI component mentioned or human-in-the-loop performance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done
A standalone algorithm performance study was not done. This is not an AI/software device. The performance studies are for the physical properties and biological interaction of the surgical mesh.
7. The Type of Ground Truth Used
For the studies mentioned:
- Bench Testing: The ground truth would be based on objective physical measurements (e.g., tensile strength, burst strength, tear resistance) performed according to established test methods and standards (likely related to "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh").
- Pre-clinical Study: The ground truth for "minimizing tissue attachment property" would likely be derived from histological examination or macroscopic assessment of tissue ingrowth/adhesion in animal models, comparing the new device to the predicate. The "ground truth" here is the scientific observation and measurement of biological response to the implanted material.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that requires a training set. The "design modifications" (new collagen film formulation, changes to knitting) were likely the result of R&D and engineering design cycles, potentially using iterative testing, but not in the sense of a machine learning training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI model.
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K110812
Pg. 1 of 2
APR 1 9 2011
510(k) Summary of Safety and Effectiveness
| Submitter Information | |
|---|---|
| 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: | April 15, 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 towhich equivalence is claimed: | PARIETEX™ Composite Mesh (K002699 and K040998) |
| Reason for 510(k) submission: | The proposed PARIETEX™ Optimized Composite Mesh hasbeen modified compared to the predicate devices as the knittingtextile has been modified to obtain a higher mechanicalresistance of the mesh and the collagen film formulation hasbeen changed to get a film more resistant to handling. |
| Device description: | The PARIETEX™ Optimized Composite Mesh (PCO) isavailable in rectangular and round shape. This device is madeout of a three-dimensional multifilament polyester knit for wallreinforcement, covered with an absorbable, continuous andhydrophilic film on one of its sides. This film is made up ofcollagen from porcine origin and glycerol, and juts out 5 mmover the edge of the reinforcement. |
| Intended use of the device: | The PARIETEX™ Optimized Composite Mesh (PCO) is usedfor the reinforcement of tissues during surgical repair. |
| Indications for use: | It is indicated for the treatment of incisional hernias, abdominalwall repair and parietal (i.e. pertaining to the walls) |
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reinforcement of tissues. The non-absorbable threedimensional 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:
The subject PARIETEX™ Optimized Composite Mesh (PCO) is equivalent to the predicate devices PARIETEX™ Composite Mesh (K002699 and K040998) in terms of its technological characteristics. No major technological changes are proposed to the predicate devices in this submission. Design modifications included a new collagen film formulation and changes to the knitting. Performance testing was performed on both predicate and proposed mesh. The results of a pre-clinical study and bench testing, performed in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh, demonstrate improved mechanical properties, and equivalent in-vivo minimizing tissue attachment property.
Performance data: Bench testing and pre-clinical testing has been conducted to evaluate the performance characteristics. Testing has shown that the PARIETEX™ Optimized Composite Mesh is equivalent in performance characteristics to the predicates PARIETEX™ Composite Mesh.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white, emphasizing its official and governmental nature.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
APR 1 9 2011
Sofradim Production % Covidien Mr. James McMahon 15 Crosby Drive Bedford, Massachusetts 01730
Re: K110815
Trade/Device Name: PARIETEX™ Optimized Composite Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 22, 2011 Received: March 25, 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 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.
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.lda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/ReportalProblem/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,
A.S. B. Rih
for
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):
Device Name: PARIETEX™ Optimized Composite Mesh
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 × (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)
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Division of Surgical, Orthopedic, and Restorative Devices
| CovidienPremarket Notification | Page 18TM Trademark |
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510(k) Number 
§ 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.