Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Device Facts
| Record ID | K173796 |
|---|---|
| Device Name | Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) |
| Applicant | Sofradim Production |
| Product Code | FTL · General, Plastic Surgery |
| Decision Date | Mar 9, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the reinforcement of tissue during surgical repair. Parietex™ Composite Mesh is intended for the reinforcement of tissue during surgical repair. Parietex™ Optimized Composite Mesh is intended for the reinforcement of tissue during surgical repair.
Device Story
Surgical mesh devices used for reinforcement of soft tissues during hernia repair and abdominal wall reconstruction. Devices consist of non-absorbable 3D multifilament polyester (polyethylene terephthalate) textile for long-term support. Composite versions include an absorbable hydrophilic film (porcine collagen, glycerol, and/or polyethylene glycol) on one side to minimize visceral tissue attachment. Some variants include 2D textile flaps for fixation or pre-placed monofilament sutures. Used by surgeons in clinical settings (laparoscopic or open procedures). The mesh provides mechanical reinforcement to the abdominal wall; the absorbable film degrades over time (e.g., <1 month for Optimized Composite). Benefits include tension-free repair and reduced risk of adhesions in cases of direct visceral contact.
Clinical Evidence
No clinical data provided. Substantial equivalence demonstrated via bench testing in accordance with FDA guidance for surgical mesh, including mechanical performance testing and biocompatibility assessment.
Technological Characteristics
Materials: Polyethylene terephthalate (polyester) multifilament yarns; porcine collagen, glycerol, polyethylene glycol (absorbable film). Construction: 2D/3D multifilament textile, rectangular/hexagonal pores. Biocompatibility: ISO 10993-1:2009. Mechanical properties: Bursting strength, suture pull-out strength, seam strength. Sterilization: Not specified.
Indications for Use
Indicated for the repair of inguinal and incisional hernias, abdominal wall repair, and parietal reinforcement of tissues.
Regulatory Classification
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.
Predicate Devices
- Parietex Surgical Mesh (K982532)
- Parietex Composite Mesh (K040998, K050187)
- Parietex Optimized Composite Mesh (K110663, K110815, K110816)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 9, 2018
Sofradim Production % Ms. Angela Arsdale Regulatory Affairs Manager Coviden 60 Middletown Avenue North Haven, Connecticut 06473
Re: K173796
Trade/Device Name: Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: FTL Dated: January 8, 2018 Received: January 9, 2018
Dear Ms. Arsdale:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
{1}------------------------------------------------
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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
# 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) K173796
Device Name
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh
Indications for Use (Describe)
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias
Type of Use (Select one or both, as applicable)
X 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 Druq 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) K173796
#### Device Name
ParietexTM Composite Mesh (PCO and PCO-OS references)
Indications for Use (Describe)
Parietex™ 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 nonabsorbable 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.
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> 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 Druq 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) K173796
Device Name
Parietex™ Optimized Composite Mesh (PCO-X, PCO-FX, and PCO-OSX references)
Indications for Use (Describe)
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 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.
| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |
### 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 Druq 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
In accordance with 21 CFR 807.92, Covidien is hereby submitting the 510(k) Summary of Safety and Effectiveness for 510(k) number K173796 as of December 06, 2017.
| Date Prepared: | February 26, 2018 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Sofradim Production (subsidiary of Covidien llc)<br>116, avenue du Formans<br>01600 Trevoux, France<br>Telephone: +33 (0)4 74 08 90 00<br>Fax: +33 (0) 4 74 08 90 02 |
| Contact: | Angela Van Arsdale<br>Regulatory Affairs Manager<br>60 Middletown Avenue<br>North Haven, CT 06473<br>Phone: (203) 492-5787<br>Fax: (203) 492-5029<br>Email: angela.vanarsdale@medtronic.com |
| Name of device:<br>Trade/Proprietary name: | Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh<br>Parietex™ Composite Mesh<br>Parietex™ Optimized Composite Mesh |
| Common name:<br>Classification name: | Surgical Mesh<br>Mesh, Surgical, Polymeric<br>Product code: FTL<br>Regulation number: 21 CFR 878.3300 |
| Predicate Devices:<br>Trade/Proprietary name<br>(510(k) Number) | Parietex ® Surgical Mesh (new names Parietex™ Hydrophilic 2D,<br>3D, Anatomical Mesh) (K982532)<br>Parietex™ Composite Mesh (K040998, K050187)<br>Parietex™ Optimized Composite Mesh (K110663, K110815,<br>K110816)<br>No reference devices were used in this submission. |
| Common name:<br>Classification name: | Surgical Mesh<br>Mesh, Surgical, Polymeric<br>Product code: FTL<br>Regulation number: 21 CFR 878.3300 |
| Manufacturer: | Sofradim Production<br>116, avenue du Formans<br>01600 Trevoux, France |
# Device Description:
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh
{6}------------------------------------------------
The two-dimensional mesh, with rectangular pores, is available in two different textures: a standard version (TEC references) and a rigid version (TECR references). The textures and transparencies of this mesh make them particularly suitable for the treatment of parietal affections, in particular inguinal hernias, through laparoscopic approach.
The three-dimensional mesh (TET references) has hexagonal pores. The flexibility, porosity and low density of this mesh make it particularly suitable for the treatment of parietal affections, in particular incisional and inguinal hernias, through open approach.
The Parietex™ hydrophilic 2-dimensional mesh, hydrophilic 3-dimensional mesh and hydrophilic anatomical mesh has been adapted for various techniques of abdominal repair. The rectangular mesh is designed for the repair of inguinal and incisional hernias in a preperitoneal or pre-muscular approach.
The pre-cut and slit mesh is suitable for the repair of inguinal hernias via anterior approach using the tension free technique.
The folding mesh (in two-dimensional textile) is designed for the repair of direct or indirect inguinal hernias through a laparoscopic approach (trans-abdominal or pre-peritoneal or totally extra-peritoneal). Some codes have a slit for the passage of the cord.
The anatomical mesh is mainly designed for the repair of inguinal hernias via laparoscopic or posterior open procedures and is available for the left and/or right side.
Parietex™ Composite Mesh is a composite mesh made out of a three-dimensional (3D) multifilament polyester textile 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, polyethylene glycol and glycerol and juts out 5 mm over the edge of the reinforcement. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the 3D reinforcement and helps place and fixate the mesh (PCO-OS references).
Parietex™ Optimized Composite Mesh is made out of a three-dimensional (3D) multifilament polyester 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. The film is essentially degraded in less than 1 month. For some references, a bi-dimensional (2D) multifilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fixates the mesh (PCO-OSX references). For some references, one or many non-absorbable color monofilaments are tied (pre-placed sutures) to the three-dimensional mesh (PCO-FX references).
This change is a vendor change only, there are no changes to the material composition. Both the original material and the new materials are derived from the same base material.
{7}------------------------------------------------
# Intended Use:
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the reinforcement of tissue during surgical repair1.
Parietex™ Composite Mesh is intended for the reinforcement of tissue during surgical repair.
Parietex™ Optimized Composite Mesh is intended for the reinforcement of tissue during surgical repair.
### Indications for use:
Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh is intended for the repair of inguinal and incisional hernias.
Parietex™ 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 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 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.
{8}------------------------------------------------
Summary comparing the the technological characteristics of the subject and predicate device:
The proposed modified devices Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh, ParietexTM Composite Mesh and ParietexTM Optimized Composite Mesh manufactured with the two new polyester (polyethylene terephthalate) multifilament yarns from the two new suppliers, are substantially equivalent to the predicate devices ParietexTM Hydrophilic 2D, 3D, Anatomical Mesh (K982532), Parietex™ Composite Mesh (K040998, K050187) and Parietex™ Optimized Composite Mesh (K110663, K110815, K110816) in terms of :
- Indications
- Material
- . Performance characteristics
- Biocompatibility ●
- Stability ●
- Design
Materials: The biocompatibility of the proposed modified Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh, Parietex™ Composite Mesh and Parietex™ Optimized Composite Mesh has been evaluated and found compliant with ISO Standard 10993-1:2009 (FDA recognition number #2-220).
Performance data: This change consists of the addition of two new polyester (polyethylene terephthalate) multifilament yarns from two new suppliers for the subject devices. These yarns are used to manufacture the textiles of the devices. The following performance data is provided in support of the substantial equivalence determination:
- In vitro (bench) tests have been performed in accordance . with the FDA Guidance: "Guidance for the Preparation of a Premarket Notification Application of a Surgical Mesh" dated March 2, 1999 to evaluate the performance characteristics of the subject devices. The following mesh characteristics were assessed:
- Pore size -
- Thickness -
- Surface density -
- Bursting strength -
- -Bursting distension
- -Breaking strength
- -Elongation at break
- -Tear strength
- Suture pull-out strength -
Suture pull-out tests were performed on the pre-placed sutures of the proposed modified Parietex™ Optimized Composite Mesh (for PCO-FX references) to assess the
{9}------------------------------------------------
strength of the textile/suture assembly. Seam strength tests were performed on the textiles assemblies of the proposed modified Parietex™ Hydrophilic 2D and Anatomical Mesh (for TECR1410DP2 and TECT references). Parietex™ Composite Mesh and Parietex™ Optimized Composite Mesh (for PCO-OS, PCO-OSX references) to assess the strength of the textiles assembly.
- Stability studies were conducted and the shelf life of the ● proposed modified devices was demonstrated.
- . Biocompatibility evaluation was performed and confirmed that the proposed modified Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh, Parietex™ Composite Mesh and Parietex™ Optimized Composite Mesh are compliant with ISO Standard 10993-1:2009 (FDA recognition number #2-220) for their intended patient contact profile.
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
# Conclusion:
All testing demonstrates that the proposed modified devices are substantially equivalent to the predicate devices Parietex™ Hydrophilic 2D, 3D, Anatomical Mesh (K982532), Parietex™ Composite Mesh (K040998, K050187) and ParietexTM Optimized Composite Mesh (K110663, K110815, K110816).
