(39 days)
Parietex™ lightweight mesh is indicated for inguinal and ventral hernia repair.
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The non-absorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias). The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries. 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™ Lightweight Mesh: Non-absorbable synthetic surgical mesh made of two-dimensional monofilament polyester knitting.
Parietex™ Composite Parastomal Mesh: PARIETEX™ Parastomal Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape. The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol. The second design is made from a three dimensional monofilament polyester fabric with a twodimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film. On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
Parietex™ Composite Ventral Patch: The Parietex™ composite ventral patch is a dual facing mesh composed of a non-absorbable three dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four (4) flaps made out of monofilament polyester textile and two (2) removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with absorbable poly(divcolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh. The fascial side of the mesh ensures abdominal wall reinforcement allowing complete tissue ingrowth. The visceral side of the mesh is composed of porcine origin collagen film, polyethylene glycol and glycerol. This film is absorbable, continuous and hydrophilic and juts out over the edge of the textile. This side physically separates the polyester textile from tissues and organs to minimize tissue attachment to the mesh in case of direct contact with viscera. The four (4) flaps of the Parietex™ composite ventral patch which provide a dedicated fixation surface area are composed of a dyed (D&C Green no. 6) bidimensional monofilament polyester textile. These flaps also facilitate visualization during the semi-peripheral suture fixation. Two (2) dyed (D&C Violet no. 2) PGLA expanders provide shape memory to the mesh and offer stability to facilitate insertion and proper deployment of the mesh through defect. The PGLA component is completely absorbed prior to one (1) year. The device also presents two (2) removable handles (composed of colored tubes and yarns) that are attached to the extremity of the flaps to provide a means for proper positioning of the mesh. They are kept extra corporally during the procedure and discarded after the surgery. The PGLA component and the hydrophilic film are fully absorbable which provide less long term foreign material in the body.
Symbotex™ Composite Mesh: Symbotex™ composite mesh is made out of a three-dimensional monofilament polyester textile, which is 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. The collagen film is essentially degraded in less than 1 month. For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "Flat Sheet with sutures" (SYM-F reorder codes): Non-absorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh. For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fix the mesh.
The provided document is a 510(k) summary for several surgical mesh products, indicating very limited information regarding acceptance criteria and detailed study results typical of clinical performance studies of AI/ML devices. The document focuses on demonstrating substantial equivalence to predicate devices primarily through bench testing, stability studies, and biocompatibility studies, rather than clinical performance or AI algorithm validation.
Here's a breakdown of the requested information based on the document, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present acceptance criteria in a quantitative table with reported device performance for clinical endpoints. Instead, it refers to general performance characteristics and equivalence to predicate devices based on:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Bench Testing (in accordance with FDA's Guidance for the Preparation of a Premarket Notification for Surgical Mesh issued March 2, 1999) | "Bench testing has been conducted... to evaluate the performance characteristics of proposed devices." (The specific performance characteristics tested and their results/acceptance thresholds are not detailed in this summary.) The conclusion states that bench testing results "demonstrate that proposed devices are substantially equivalent to the predicates." This implies the new material met the performance standards of the predicate devices. |
| Stability | "Stability Studies have been conducted and the proposed devices shelf life has been demonstrated." (Specific duration and measures of stability are not provided.) |
| Biocompatibility (in accordance with ISO 10993-1 for a permanent implant, a recognized standard by FDA (#2-156)) | "Biocompatibility studies have been conducted on the proposed polyester based devices..." The conclusion states that preclinical test results "demonstrate that proposed devices are substantially equivalent to the predicates." This implies the new material met the biocompatibility standards required for a permanent implant as per ISO 10993-1. |
| Equivalence in Technological Characteristics | The proposed devices are stated to be equivalent to predicate devices in terms of: Indigenous, Raw materials, Performance characteristics, Biocompatibility, Stability, and Design. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: This information is not provided in the document. The studies referenced are bench testing, stability studies, and biocompatibility studies, which typically involve material samples or animal models, not human test sets in the context of clinical performance for AI/ML.
- Data Provenance: This information is not provided. The studies are technical in nature (bench, stability, biocompatibility).
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/not provided. The assessment for these surgical meshes relies on physical and biological testing, not on expert adjudication of diagnostic images or clinical assessments to establish ground truth for an AI/ML algorithm.
4. Adjudication method for the test set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies, particularly for diagnostic AI/ML. This document describes material science and biological compatibility testing.
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
This information is not applicable/not provided. MRMC studies are relevant for evaluating diagnostic or assistive AI systems. The subject of this 510(k) is a surgical mesh with a change in raw material, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used
For the studies mentioned:
- Bench Testing: Ground truth is established by standardized measurements and tests of physical properties of the mesh following established FDA guidance for surgical mesh.
- Stability Studies: Ground truth relates to maintaining specified physical and chemical properties over time, measured through established analytical methods.
- Biocompatibility Studies: Ground truth is established by adherence to ISO 10993-1 standards, which involves evaluating biological responses to the material (e.g., cytotoxicity, irritation, sensitization, systemic toxicity), often using in vitro or in vivo (animal) models. They are not based on expert consensus, pathology in the clinical diagnostic sense, or patient outcomes data in this context for "ground truth".
8. The sample size for the training set
This information is not applicable/not provided. The document describes a material change for a physical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable/not provided. As above, there is no AI/ML algorithm with a training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2014
Sofradim Production Ms. Mary Mellows Senior Regulatory Specialist 60 Middletown Avenue North Haven, Connecticut 06437
Re: K142908
Trade/Device Name: Parietex Lightweight Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: October 7, 2014 Received: October 8, 2014
Dear Ms. Mellows:
This letter corrects our substantially equivalent letter of November 14, 2014.
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ); 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809] ), 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/ResourcesforYou/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}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120 | |
|---|---|---|
| Indications for Use | Expiration Date: January 31, 2017See PRA Statement below. | |
| 510(k) Number (if known) | ||
| Device NameParietexTM Lightweight Mesh | ||
| Indications for Use (Describe) | ||
| ParietexTM lightweight mesh is indicated for inguinal and ventral hernia repair. | ||
| (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 thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand 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 OfficerPaperwork 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 ofinformation unless it displays a currently valid OMB number." | ||
| Type of Use (Select one or both, as applicable)FORM FDA 3881 (8/14) | Page 1 of 1 | Priblishing Services (301) 44 |
{3}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | ||
|---|---|---|
| Food and Drug Administration | ||
| Indications for Use | ||
| Form Approved: OMB No. 0910-0120 | ||
| Expiration Date: January 31, 2017 | ||
| See PRA Statement below. | ||
| 510(k) Number (if known) | ||
| Device Name | Parietex™ Composite Parastomal Mesh | |
| Indications for Use (Describe) | The PARIETEXT™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias.The non-absorbable polyester mesh provides long term reinforcement of soft tissues.The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera. | |
| 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}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
ParietexTM Composite Ventral Patch
Indications for Use (Describe)
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias).
The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. 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) | |
|---|---|
| ------------------------------------------------- | -- |
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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
{5}------------------------------------------------
Food and Drug Administration
Indications for Use
| 510(k) Number (if known) | |
|---|---|
| Device Name | |
| Symbotex™ Composite Mesh |
| Expiration Date: January 31, 2017 | See PRA Statement below. |
|---|---|
| ----------------------------------- | -------------------------- |
| Indications for Use (Describe) | Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries. 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. |
|---|---|
| -------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
DEPARTMENT OF HEALTH AND HUMAN SERVICES
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)
Form Approved: OMB No. 0910-0120
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."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishang Services (301) 443-6740 EF
{6}------------------------------------------------
510(k) summary
| Submitter InformationName: | Sofradim Production (subsidiary of Covidien LLC) |
|---|---|
| Address: | 116, avenue du formans01600 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 MellowsSenior Regulatory Specialist60 Middletown AvenueNorth Haven, CT 06473 |
| Phone: | 203-492-5284 |
| Date prepared: | October 3, 2014 |
| Name of device: | |
| Trade or proprietary name: | Parietex™ Lightweight MeshParietex™ Composite Parastomal MeshParietex™ Composite Ventral PatchSymbotex™ 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 |
{7}------------------------------------------------
Legally marketed devices to which equivalence is claimed:
Parietex™ Monofilament Polyester Mesh (K090858) Parietex™ Composite Mono PM Mesh (K081126) Parietex™ Composite Ventral Patch (K120506) Symbotex™ Composite Mesh (K131969)
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:
Parietex™ Lightweight Mesh
Non-absorbable synthetic surgical mesh made of two-dimensional monofilament polyester knittina.
Parietex™ Composite Parastomal Mesh
PARIETEX™ Parastomal Mesh is made from a monofilament polyester fabric, covered with an absorbable hydrophilic film. The meshes are available in two different designs. Both are round in shape.
The first design is made from a three-dimensional monofilament polyester fabric and has a circular opening in the center. It is completely covered on one side with an absorbable hydrophilic film made of collagen from porcine origin, polyethylene glycol and glycerol.
The second design is made from a three dimensional monofilament polyester fabric with a twodimensional monofilament polyester central band. One side of the second design is completely covered with the hydrophilic film. On the opposite side, only the two dimensional central band is coated with the absorbable hydrophilic film.
On both designs the film extends 5 mm over the external edge of the reinforcement, and also extends around the internal edge of the circular opening if any.
Parietex™ Composite Ventral Patch
The Parietex™ composite ventral patch is a dual facing mesh composed of a non-absorbable three dimensional monofilament polyester textile for abdominal wall reinforcement covered by a bioabsorbable hydrophilic collagen film to minimize visceral attachment. A fixation system composed of four (4) flaps made out of monofilament polyester textile and two (2) removable handles completes the device. This fixation system and the three-dimensional reinforcement textile are assembled with absorbable poly(divcolide-co-L-lactide) (PGLA) expanders. This system facilitates placement and fixation of the mesh.
{8}------------------------------------------------
The fascial side of the mesh ensures abdominal wall reinforcement allowing complete tissue ingrowth. The visceral side of the mesh is composed of porcine origin collagen film, polyethylene glycol and glycerol. This film is absorbable, continuous and hydrophilic and juts out over the edge of the textile. This side physically separates the polyester textile from tissues and organs to minimize tissue attachment to the mesh in case of direct contact with viscera.
The four (4) flaps of the Parietex™ composite ventral patch which provide a dedicated fixation surface area are composed of a dyed (D&C Green no. 6) bidimensional monofilament polyester textile. These flaps also facilitate visualization during the semi-peripheral suture fixation.
Two (2) dyed (D&C Violet no. 2) PGLA expanders provide shape memory to the mesh and offer stability to facilitate insertion and proper deployment of the mesh through defect. The PGLA component is completely absorbed prior to one (1) year.
The device also presents two (2) removable handles (composed of colored tubes and varns) that are attached to the extremity of the flaps to provide a means for proper positioning of the mesh. They are kept extra corporally during the procedure and discarded after the surgery.
The PGLA component and the hydrophilic film are fully absorbable which provide less long term foreign material in the body.
Symbotex™ Composite Mesh
Symbotex™ composite mesh is made out of a three-dimensional monofilament polyester textile, which is covered with an absorbable, continuous and hydrophilic film on one of its sides. This film is made up of collagen from porcine origin and divcerol. The collagen film is essentially degraded in less than 1 month.
For "Flat sheet" (SYM reorder codes): A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh.
For "Flat Sheet with sutures" (SYM-F reorder codes): Non-absorbable pre-placed sutures are tied to the three-dimensional mesh. A dyed monofilament polyester (D&C Green No. 6) marking is positioned on the center of the textile, on the opposite side of the film, and helps center and orient the mesh.
For "With flap" (SYM-OS reorder codes): A dyed (D&C Green No. 6) bi-dimensional monofilament polyester textile flap is attached to the three-dimensional reinforcement and helps place and fix the mesh.
Intended use of the device:
Parietex™ Lightweight Mesh
Parietex™ Lightweight Mesh is intended for the reinforcement of tissue during surgical repair.
No changes to the intended use have been made in this submission.
{9}------------------------------------------------
Parietex™ Composite Parastomal Mesh
Parietex™ Composite Parastomal Mesh is intended for the reinforcement of soft tissue during surqical repair.
No changes to the intended use have been made in this submission.
Parietex™ Composite Ventral Patch
Parietex™ Composite Ventral Patch is intended for the reinforcement of soft tissue during surqical repair.
No changes to the intended use have been made in this submission.
Symbotex™ Composite Mesh
Symbotex™ Composite Mesh is intended for reinforcement of soft tissue where a weakness exists.
No changes to the intended use have been made in this submission.
Indications for use:
Parietex™ Lightweight Mesh
Parietex™ lightweight mesh is indicated for inquinal and ventral hernia repair. No changes to the indications for use have been made in this submission
Parietex™ Composite Parastomal Mesh
The PARIETEX™ Parastomal Mesh is indicated for the reinforcement of soft tissues during surgical repair, and specifically for the repair of parastomal hernias. The nonabsorbable polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh when in direct contact with the viscera.
No changes to the indications for use have been made in this submission
Parietex™ Composite Ventral Patch
The Parietex™ composite ventral patch is used for the reinforcement of soft tissues during surgical repair. It is indicated for the treatment of ventral defects (primary and incisional hernias).
The three-dimensional non-absorbable monofilament polyester mesh provides long term reinforcement of soft tissues. The absorbable hydrophilic film minimizes tissue attachment to the mesh in case of direct contact with the viscera.
No changes to the indications for use have been made in this submission
Symbotex™ Composite Mesh
Symbotex™ composite mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists in procedures involving primary abdominal wall and incisional hernia surgeries.
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.
No substantive changes to the indications for use have been made in this submission
{10}------------------------------------------------
Summary comparing the technoloqical characteristics of the subject and predicate devices:
The proposed Parietex™ Lightweight Mesh. Parietex™ Composite Parastomal Mesh, Parietex™ Composite Ventral Patch, Symbotex™ Composite Mesh manufactured with another formulation of raw material, polyester, from the same yarn supplier as the current polyester are equivalent to predicate Parietex™ Monofilament Polyester Mesh (K090858), Parietex™ Composite Mono PM Mesh (K081126), Parietex™ Composite Ventral Patch (K120506), Symbotex™ Composite Mesh (K131969) 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.
Bench testing has been conducted in accordance with FDA's Guidance for the Preparation of a Premarket Notification 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™ Monofilament Polyester Mesh (K090858), Parietex™ Composite Mono PM Mesh (K081126), Parietex™ Composite Ventral Patch (K120506), Symbotex™ Composite Mesh (K131969).
§ 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.