(7 days)
PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
PARIETENE PROGRIP™ Mesh is available in 2 forms:
• Pre-cut, elliptic slit mesh with self-gripping overlapping flap
(right or left side)
• Rectangular simple mesh
These meshes and the overlapping flaps of the pre-cut versions
are made of knitted monofilament polypropylene with polylactic
acid (PLA) resorbable pins on one of the sides. The PLA pins
facilitate placement, positioning and fixation of the overlapping
flap and the mesh to the surrounding tissue. A colored yarn
marker on the medial edge of the pre-cut mesh helps orientation.
Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the requested categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Performance Characteristics (General): The device should be equivalent in performance characteristics to the predicate device. | Equivalent in Performance Characteristics: Testing has shown that the PARIETENE PROGRIP™ is equivalent in performance characteristics to the predicate PARIETEX PROGRIP™. |
| Material Biocompatibility: The device materials should be biocompatible. | Biocompatible Materials: PARIETENE PROGRIP™ Mesh is comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only states "Bench testing has been conducted to evaluate the performance characteristics of PARIETENE PROGRIP™." It does not specify the sample size for this testing. It also does not specify the provenance of data (e.g., country of origin, retrospective/prospective), as it appears to be lab-based bench testing rather than clinical study data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. Bench testing typically does not involve human expert adjudication in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not provided as the evaluation was based on bench testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a medical device for surgical hernia repair, not an AI diagnostic tool. Therefore, there is no information about human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable as the device is a surgical mesh, not an algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluation appears to be established through bench testing results compared to the predicate device's known performance characteristics. This is a direct comparison of physical properties and performance metrics rather than a clinical ground truth like expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable as the device is a physical surgical mesh and not an AI/machine learning model that would require a 'training set'.
9. How the Ground Truth for the Training Set was Established
This information is not applicable due to the nature of the device.
{0}------------------------------------------------
Special 510(k) - PARIETENE PROGRIP™ MESH
1 1 1 1 1 1 1
· ·
510(k) Summary of Safety and Effectiveness
| SUBMITTER: | Sofradim Production116, avenue du formans01600 Trevoux, FrancePhone: 33 04 74 08 90 00 | K101197 |
|---|---|---|
| CONTACT PERSON: | Sharon AlexanderAssociate Manager, Regulatory AffairsCovidien60 Middletown AvenueNorth Haven, CT 06473 USAPhone: (203) 492-6060 | MAY - 5 2010 |
| DATE PREPARED: | April 26, 2010 | |
| TRADE/PROPRIETARY NAME: | PARIETENE PROGRIP™ Mesh | |
| COMMON/USUAL NAME: | Surgical Mesh | |
| CLASSIFICATION NAME: | Mesh, Surgical, Polymeric | |
| PREDICATE DEVICE(S): | PARIETEX Progrip™ Mesh (K081050)PARIETENE™ Mesh (K991400)PARIETEX™ TET Mesh (K003990) | |
| DEVICE DESCRIPTION: | PARIETENE PROGRIP™ Mesh is available in 2 forms:• Pre-cut, elliptic slit mesh with self-gripping overlapping flap(right or left side)• Rectangular simple meshThese meshes and the overlapping flaps of the pre-cut versionsare made of knitted monofilament polypropylene with polylacticacid (PLA) resorbable pins on one of the sides. The PLA pinsfacilitate placement, positioning and fixation of the overlappingflap and the mesh to the surrounding tissue. A colored yarnmarker on the medial edge of the pre-cut mesh helps orientation. | |
| INDICATION: | PARIETENE PROGRIP™ Mesh is indicated for inguinal andincisional hernia repair. | |
| TECHNOLOGICALCHARACTERISTICS: | PARIETENE PROGRIP™ meshes are made with knittedmonofilament polypropylene and monofilament polylactic acidresorbable pins. The intended use and fundamental technology ofPARIETENE PROGRIP™ Mesh are equivalent to that of thepredicate PARIETEX PROGRIP™. | |
| MATERIALS: | PARIETENE PROGRIP™ Mesh is comprised of biocompatiblematerials that are in compliance with ISO 10993-1 and/or USPstandards. | |
| PERFORMANCE DATA: | Bench testing has been conducted to evaluate the performancecharacteristics of PARIETENE PROGRIP™. Testing has shownthat the PARIETENE PROGRIP™ is equivalent in performancecharacteristics to the predicate PARIETEX PROGRIP™. |
:
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sofradim Production % Covidien - Div. of Tyco Healthcare Group LP Ms. Sharon Alexander Associate Manager, Regulatory Affairs 60 Middletown Avenue North Haven, Connecticut 06473
MAY - 5 2010
Re: K101197
Trade/Device Name: Parietene Progrip Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: April 28, 2010 Received: April 28, 2010
Dear Ms. Alexander:
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
{2}------------------------------------------------
Page 2 - Ms. Sharon Alexander
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 (OS) 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
KIQULS 510(k) Number (if known):
Device Name:
PARIETENE PROGRIP™ Mesh is indicated for inguinal and incisional hernia repair.
Prescription Use × (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)
David Krause for MXM
(Divisi Division of Surgical, Orthope and Restorative Device
Page 1 of _
510(k) Number K101147
§ 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.