(22 days)
No
The device description focuses on the physical materials and mechanical properties of surgical mesh and fixation elements, with no mention of software, algorithms, or data processing related to AI/ML.
No
The device is a surgical mesh primarily used for the repair and reinforcement of soft tissues in hernia defects. While it aids in the physical repair, it does not actively treat a disease or condition in a therapeutic sense, but rather provides structural support.
No
The devices described are surgical meshes and a patch system intended for the repair of hernias, which are therapeutic procedures, not diagnostic ones. They are used to reinforce soft tissues, not to identify or characterize a disease.
No
The device description clearly details physical components made of polyester, polylactic acid, and collagen, indicating it is a physical medical device, not software-only.
Based on the provided information, these devices are not In Vitro Diagnostics (IVDs).
Here's why:
- Intended Use: The intended use clearly states that these devices are for the repair and reinforcement of soft tissues during hernia repair. This is a surgical procedure performed in vivo (within the body).
- Device Description: The descriptions detail the materials and mechanisms of the mesh and its components (pins, grips, film) which are designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of these devices being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVDs are used to perform tests on samples taken from the body, not to be implanted into the body for structural support or repair.
N/A
Intended Use / Indications for Use
Parietex In Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach.
ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.
Product codes
FTL
Device Description
ProGrip™ Self-Gripping Polyester Mesh
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, 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.
The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO and H2O.
Parietex™ Plug and Patch System
The Parietex™ Plug and Patch System is a kit composed of:
- . a pre-cut patch made from monofilament polyester
- . a semi-resorbable disk which is a bi-component made of polyester monofilament and polylactic acid.
ProGrip™ Laparoscopic Self-Fixating Mesh
The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band (polyester dyed with D&C green no. 6) to facilitate their orientation.
The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
groin hernia, inguinal hernia, incisional hernia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of proposed devices.
Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.
Biocompatibility studies have been conducted on the proposed polyester based devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).
Conclusion: Bench testing and preclinical tests results demonstrate that proposed devices are substantially equivalent to the predicates Parietex™ Progrip™ Mesh (K103682), Parietex™ Plug and Patch (K101519) and Progrip™ Laparoscopic Self-Fixating Mesh (K123479).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to create a sense of depth and community.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 28, 2014
Sofradim Production % Ms. Mary Mellows Surgical Devices, a global business unit of Covidien 60 Middletown Avenue North Haven, Conneticut 06473
Re: K142900
Trade/Device Name: ProGrip™ Self-Gripping Polyester Mesh Parietex™ Plug and Patch System ProGrip™ Laparoscopic Self-Fixating Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: October 3, 2014 Received: October 6, 2014
Dear Ms. Mellows:
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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K142900
Device Name Parietex TM Plug and Patch System
Indications for Use (Describe)
Parietex In Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K142900
Device Name
ProGrip™ Laparoscopic Self-Fixating Mesh
Indications for Use (Describe)
ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K142900
Device Name
ProGrip™ Self-Gripping Polyester Mesh
Indications for Use (Describe)
ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary
| Submitter Information
| Name: | Sofradim Production (subsidiary of Covidien LLC) |
|---|---|
| Address: | 116, avenue du formans |
| 01600 Trevoux, France | |
| 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: | Mary Mellows |
| Senior Regulatory Specialist | |
| 60 Middletown Avenue | |
| North Haven, CT 06473 | |
| Phone: | 203-492-5284 |
| Date prepared: | October 3, 2014 |
| Name of device: | |
| Trade or proprietary name: | ProGrip™ Self-Gripping Polyester Mesh |
| Parietex™ Plug and Patch System | |
| ProGrip™ Laparoscopic Self-Fixating 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: | FTI |
6
Legally marketed devices to which equivalence is claimed:
ParietexTM Progrip™ Mesh (K103682) ParietexTM Pluq and Patch (K101519) Progrip™ Laparoscopic Self-Fixating Mesh (K123479)
Reason for 510(k) Submission:
The purpose of this 510(k) is to notify the Agency of the addition of another formulation of raw material, polyester, from the yarn supplier who manufactures the monofilament yarns used in the proposed devices. Eventually the current polvester will no longer be available by the supplier.
Device description:
ProGrip™ Self-Gripping Polyester Mesh
The mesh and the overlapping flaps of the pre-cut versions are made of knitted monofilament polyester and have polylactic acid monofilament resorbable pins on one of the sides. These pins facilitate placing, 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.
The monofilament polylactic acid pins are bioresorbable and contribute to the fixation of the mesh to surrounding tissue during at least 8 weeks. The polylactic acid pins degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO and H2O.
Parietex™ Plug and Patch System
The Parietex™ Plug and Patch System is a kit composed of:
- . a pre-cut patch made from monofilament polyester
- . a semi-resorbable disk which is a bi-component made of polyester monofilament and polylactic acid.
ProGrip™ Laparoscopic Self-Fixating Mesh
The mesh is made of knitted monofilament polyester with monofilament polylactic acid resorbable grips on one side and a resorbable film made of collagen from porcine origin and glycerol, on the other side. The grips allow positioning and fixation of the mesh to the surrounding tissue, while the collagen film facilitates mesh handling and deployment. The mesh presents a green band (polyester dyed with D&C green no. 6) to facilitate their orientation.
The monofilament polylactic acid grips are bioresorbable and provide the fixation of the mesh to surrounding tissue for at least 8 weeks. The polylactic acid grips degrade and resorb in vivo by hydrolysis and are metabolized by the body into CO2 and H2O.
Intended use of the device:
ProGrip™ Self-Gripping Polyester Mesh
ProGrip™ Self-Gripping Polyester Mesh is intended for the reinforcement of tissue during surqical repair.
No changes to the intended use have been made in this submission.
7
Parietex™ Pluq and Patch System
Parietex™ Pluq and Patch System is intended for the reinforcement of soft tissues during surqical repair.
No changes to the intended use have been made in this submission.
ProGrip™ Laparoscopic Self-Fixating Mesh
ProGrip™ Laparoscopic Self-Fixating Mesh is intended for the reinforcement of tissue during surqical repair.
No changes to the intended use have been made in this submission.
Indications for use:
ProGrip™ Self-Gripping Polvester Mesh
ProGrip™ Self-Gripping Polyester Mesh is indicated for inguinal and incisional hernias repair.
No changes to the indication for use have been made in this submission.
Parietex™ Plug and Patch System
Parietex™ Plug and Patch System is indicated for the reinforcement of soft tissues during repair of groin hernia defects by open approach.
No changes to the indication for use have been made in this submission.
ProGrip™ Laparoscopic Self-Fixating Mesh
ProGrip™ Laparoscopic Self-Fixating Mesh is indicated for the reinforcement of soft tissues during repair of inguinal hernia defects by laparoscopic approach. No changes to the indication for use have been made in this submission.
Summary comparing the technoloqical characteristics of the subject and predicate devices:
The proposed ProGrip™ Self-Gripping Polyester Mesh, Parietex™ Plug and Patch System and ProGrip™ Laparoscopic Self-Fixating Mesh manufactured with another formulation of raw material, polyester, from the same yarn supplier as the current polyester are equivalent to predicate Parietex™ Progrip™ Mesh (K103682), Parietex™ Plug and Patch (K101519) and Progrip™ Laparoscopic Self-Fixating Mesh (K123479) in terms of the following technological characteristics:
- -Indication
- Raw materials -
- -Performance characteristics
- -Biocompatibility
- Stability -
- -Design
Performance data: This change consists of the addition of another formulation of raw material, polyester, for the subject devices.
8
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh issued March 2, 1999 to evaluate the performance characteristics of proposed devices.
Stability Studies have been conducted and the proposed devices shelf life has been demonstrated.
Biocompatibility studies have been conducted on the proposed polyester based devices in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156).