TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Device Facts
| Record ID | K191749 |
|---|---|
| Device Name | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh |
| Applicant | Novus Scientific AB |
| Product Code | OWT · General, Plastic Surgery |
| Decision Date | Mar 26, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.3300 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K191749 · Mar 26, 2020 | TIGR Matrix Surgical Mesh, TIGR Surgical Mesh | Novus Scientific AB | Routine clinical practice medical records; Surgical hernia program clinical quality improvement (CQI) database | Retrospective analysis of 91 patients undergoing abdominal wall reconstruction (AWR) to support the safety and performance of the device for an expanded indication for use. | Abdominal wall reconstruction; Hernia repair; Retrospective cohort; Clinical Quality Improvement; Long-term follow-up |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Surgical Hernia Program CQI Analysis; Retrospective cohort analysis; Follow-up/Duration: Mean follow-up 42.4 months (range 1-102 months); Study Period: August 2011 to September 2015 | Patients undergoing abdominal wall reconstruction (AWR) with TIGR Matrix Surgical Mesh; Sample Size: 91 | Not applicable for this study | Recurrence rate, wound complication rate, mesh-related complications, mesh removal |
Indications for Use
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
Device Story
TIGR Matrix Surgical Mesh is an absorbable, synthetic, knitted mesh for soft tissue and hernia repair. Composed of two resorbable fibers: fast-resorbing (glycolide, lactide, trimethylene carbonate) and slow-resorbing (lactide, trimethylene carbonate). Fast-resorbing fibers provide initial strength; slow-resorbing fibers maintain strength for 6 months, with full absorption by 36 months. Implanted by surgeons in operating rooms. Device provides mechanical reinforcement to abdominal wall or fascial defects; strength gradually decreases as tissue heals and fibers degrade. Benefits include temporary reinforcement during healing without permanent foreign body presence. Device is identical to reference predicate (K163005) with shelf-life extended to 48 months.
Clinical Evidence
Retrospective clinical study of 91 patients (64% female, mean age 57.2) undergoing abdominal wall reconstruction (AWR) between 2011-2015. Mean follow-up 42.4 months. Primary endpoints: recurrence rate and wound complications. Results: 12% overall recurrence rate (4.5% after adopting TAR approach); 27% wound complication rate. No mesh-related complications or removals reported. Data supports durability of repair.
Technological Characteristics
Knitted, multifilament, absorbable surgical mesh. Materials: copolymers of glycolide, L-lactide, and trimethylene carbonate. Warp-knitted diamond pattern. Thickness: 0.687 mm; Area weight: 125-170 g/m²; Porosity: 20-40%. Sterilization: Ethylene Oxide (SAL 10^-6). Biocompatibility per ISO 10993-1.
Indications for Use
Indicated for soft tissue reinforcement in patients undergoing plastic and reconstructive surgery or soft tissue repair, including hernia or fascial defect repair. Contraindicated where permanent wound or organ support is required.
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
- Phasix Mesh (K161424)
Reference Devices
- TIGR Matrix Surgical Mesh (K163005)
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 26, 2020
Novus Scientific AB % Loredana Guseila Director of Regulatory and Clinical Affairs Cygnus Regulatory, LLC 5555 E Palo Verde Drive Paradise Valley, Arizona 85253
Re: K191749
Trade/Device Name: TIGR Matrix Surgical Mesh, TIGR Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWT, OOD, FTL Dated: February 17, 2020 Received: February 25, 2020
Dear Loredana Guseila:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
{1}------------------------------------------------
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Cindy Chowdhury, Ph.D., M.B.A. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K191749
Device Name TIGR Matrix Surgical Mesh
#### Indications for Use (Describe)
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> <span style="color: black;"> <span style="font-weight: bold;"> <span style="font-style: italic;"> <span style="text-decoration: underline;"></span> </span> </span> </span> </span> </span> 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}------------------------------------------------
# 510(k) SUMMARY
#### -SUBMITTER
Novus Scientific, AB Address Virdinas Allé 2 SE-754 50 Uppsala, Sweden
Contact Person: Thomas Engström Telephone Number: + 46 (0)18 751 35 05 Facsimile: +46 (0)18 700 11 51
#### .. DEVICE
510(k) Number: K191749 Trade Name of the Device: TIGR® Matrix Surqical Mesh Common or Usual Name: Mesh, Surgical, Absorbable, Abdominal Hernia Classification Name: General & Plastic Surgery Product Codes: OWT, OOD, FTL Regulation: 21 CFR, 878.3300
#### III. PREDICATE DEVICE
Primary Predicate: CR. Bard. Inc. Phasix Mesh (K161424) Refence Predicate: Novus Scientific, AB TIGR® Matrix Surgical Mesh (K163005)
#### IV. DEVICE DESCRIPTION Technological Characteristics:
The technological characteristics of the device are the same as submitted in the reference predicate (K163005) and very similar to the primary predicate (K161424).
TIGR™ Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers. possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers. In vitro testing showed that the fast-resorbing fiber (glycolide, lactide and trimethylene carbonate) loses its mechanical strength after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the fast-resorbing fiber is fully absorbed after 4 months. The same in vitro testing showed that the slow-resorbing fiber (lactide and trimethylene carbonate) maintains its mechanical strength for 6 months and in vivo studies in the abdominal wall of sheep indicated that the slow-resorbing fiber is absorbed after approximately 36 months.
#### Resorbable fibers
MG17 is composed of polyglycolide and trimethylene carbonate, in a 10-fiber yarn construction. SMC7 is a 43-fiber yarn construction of polylactide and trimethylene carbonate. The MG17 content of the mesh is 40%
{4}------------------------------------------------
### Knitting pattern
The implant is knitted using warp-knitting with interlocking knits that prevent unraveling, to produce a diamond pattern where the MG17 fibers are traversing the open apertures and restricting the mobility of the implant during an initial time period.
### Mechanical characteristics
The initial burst strength of the mesh implant is above 350N. This strength can be compared with existing commercially available products that range between 170-750N. The mechanical strength of the implant will decrease over time as a result of resorption of the fibers. Between 0 and 26 weeks the mechanical strength is kept well above 16N/cm which is above the highest force acting on the abdominal wall. Following 26 weeks the mechanical strength of the mesh implant is gradually lost due to degradation and the newly formed tissue is strong enough to carry the load applied to it. This is the same as for the reference predicate and similar to the primary predicate.
### Principles of Operation
The TIGR® Matrix Surgical Mesh is an absorbable, polymeric, surgical mesh for soft tissue repair, including hernia repair. The principles of operation are the reference and primary predicate devices. There is no change to the device from the reference predicate (K163005), including principle of operation, except for changes in the indication and labeling, and expansion of the shelf life dating from 36 months to 48 months based on successful completion of accelerated and real-time aging studies.
### Substantial Equivalence
The TIGR Matrix Mesh is substantially equivalent to the primary predicate the C.R. Bard Phasix Mesh (K161424), including the proposed indication for use, contraindications, and applicable warnings. The subject device is the exact same device as the reference predicate, the TIGR Surgical Matrix Mesh (K163005), except for proposed labeling changes to match the primary predicate's labeling.
The subject device and the primary and reference predicates have the same general intended use and equivalent indications, contraindications, technological characteristics, and principles of operation. A substantial equivalence matrix comparing the similarities and differences between the subject device and its predicate devices is provided below.
#### V.INDICATIONS FOR USE
The TIGR® Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repair of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
The TIGR® Matrix Surgical Mesh is an Rx prescription device per 21 CFR Part 801, Subpart D.
{5}------------------------------------------------
K191749, Page 3 of 7
#### VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Characteristic | Subject Device<br>TIGR® Matrix Surgical<br>Mesh<br>(K191749) | Primary Predicate<br>Phasix™ Mesh<br>(K161424) | Reference Predicate<br>Device<br>TIGR® Matrix Surgical<br>Mesh<br>(K163005) | Equivalency<br>Discussion |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Trade Name | TIGR® Matrix Surgical<br>Mesh | Phasix™ Mesh | TIGR® Matrix Surgical<br>Mesh | N/A |
| Classification | Surgical Mesh | Surgical Mesh | Surgical Mesh | Same |
| Product Code | OWT, OOD, FTL | OOD | OWT, FTL | Equivalent |
| Intended<br>Use/Indication for<br>Use | The TIGR® Matrix Surgical<br>Mesh is indicated for use in<br>the reinforcement of soft<br>tissue, where weakness exists<br>in patients undergoing plastic<br>and reconstructive surgery, or<br>for use in procedures involving<br>soft tissue repair, such as for<br>the repair of hernias or other<br>fascial defects that require the<br>addition of a reinforcing<br>material to obtain the desired<br>surgical result. | The Phasix™ Mesh is<br>indicated to reinforce soft<br>tissue where weakness exists<br>in patients undergoing plastic<br>and reconstructive surgery,<br>or for use in procedures<br>involving soft tissue repair,<br>such as the repair of hernia<br>or other fascial defects that<br>require the addition of a<br>reinforcing or bridging<br>material to obtain the desired<br>surgical result. | N/A | Equivalent to<br>Primary<br>Predicate. |
| Contraindications | TIGR® Matrix Surgical Mesh is<br>fully resorbable, it should not<br>be used in repairs where<br>permanent wound or organ<br>support from the mesh is<br>required. | Because PHASIX™ Mesh is<br>fully resorbable, it should not<br>be used in repairs where<br>permanent wound or organ<br>support from the mesh is<br>required. | N/A | Same as the<br>Primary<br>Predicate. |
| Warnings | The safety and effectiveness<br>of TIGR® Matrix Surgical Mesh<br>in bridging repairs has<br>not been evaluated or<br>established. | The safety and effectiveness<br>of PHASIX™ Mesh in<br>bridging repairs has not been<br>evaluated or established. | N/A | Equivalent to<br>Primary<br>Predicate |
| Regulation | 21 CFR 878.3300 | 21 CFR 878.3300 | 21 CFR 878.3300 | Same |
| Regulatory Class | Class II | Class II | Class II | Same |
| Use | Single Use | Single Use | Single Use | Same |
| Target Population | Adult Population | Adult Population | Adult Population | Same |
| Where Used | Operating Room or<br>MR Suite | Operating Room or<br>MR Suite | Operating Room or<br>MR Suite | Same |
| | MRI/Diagnostic / Surgical<br>Room | MRI/Diagnostic / Surgical<br>Room | MRI/Diagnostic /<br>Surgical Room | Same |
| Energy Used | None | None | None | Same |
| Characteristic | Subject Device<br>TIGR® Matrix Surgical<br>Mesh<br>(K191749) | Primary Predicate<br>Phasix™ Mesh<br>(K161424) | Reference Device<br>TIGR® Matrix Surgical<br>Mesh<br>(K163005) | Equivalency<br>Discussion |
| Human<br>Factors | Labeling indicates size and<br>length | Labeling indicates size and<br>length | Labeling indicates size<br>and length | Same |
| | Can be manipulated with<br>gloved hand | Can be manipulated with<br>gloved hand | Can be manipulated<br>with gloved hand | Same |
| Design | Designed to be placed in the<br>abdominal area | Designed to be placed in the<br>abdominal area | Designed to be placed<br>in the abdominal area | Same |
| | Absorbable | Absorbable | Absorbable | Same |
| | Use in reinforcement of soft<br>tissue where weakness<br>exists | Use in reinforcement of soft<br>tissue where weakness<br>exists | Use in reinforcement of<br>soft tissue where<br>weakness exists | Same |
| | Repair of hernias and other<br>soft tissues | Repair of hernias and other<br>soft tissues | Repair of soft tissues | Same as<br>primary<br>predicate<br>Equivalent to<br>primary<br>Predicate and<br>the same as<br>reference<br>predicate. |
| Performance | Clinical data for hernia repair | No Clinical Data | No Clinical Data | Equivalent to<br>primary<br>Predicate and<br>the same as<br>reference<br>predicate. |
| Biocompatibility | Biocompatibility testing and<br>classification has been<br>selected and performed in<br>accordance with ISO 10993,<br>Biological evaluation of<br>Medical Devices, Part 1:<br>Evaluating and Testing. | Biocompatibility testing<br>conducted to date per the<br>requirements of ISO 10993-<br>1 indicates the device is<br>biocompatible for its<br>intended use as a<br>permanent, tissue-<br>contacting, implant device. | Biocompatibility testing<br>and classification has<br>been selected and<br>performed in<br>accordance with ISO<br>10993, Biological<br>evaluation of Medical<br>Devices, Part 1:<br>Evaluating and Testing. | Same |
| Sterilization | Sterile EO | Sterile EO | Sterile EO | Same |
| Packaging | Tyvek envelope and foil<br>pouch | Tyvek envelope and foil<br>pouch | Tyvek envelope and foil<br>pouch | Same |
| Shelf Life | 48 months | Unknown | 36 months | Equivalent |
| Characteristic | Subject Device<br>TIGR® Matrix<br>Surgical Mesh<br>(K191749) | Primary Predicate<br>Phasix™ Mesh<br>(K161424) | Reference Device<br>TIGR® Matrix Surgical<br>Mesh<br>(K163005) | Equivalency<br>Discussion |
| Mesh Thickness<br>(mean) | 0.687 mm | Unknown | 0.687 mm | Same as<br>reference<br>predicate. |
| Area<br>Weight/Density<br>(mean) | $125 ≤ X ≤ 170 g/m²$ | Unknown | $125 ≤ X ≤ 170 g/m²$ | Same as<br>reference<br>predicate. |
| Porosity | $20 ≤ X ≤ 40 %$ | Unknown | $20 ≤ X ≤ 40 %$ | Same as<br>reference<br>predicate. |
| Weave<br>Characteristics | Multifilament, warp,<br>knitted, mesh | Knitted P4HB<br>monofilament | Multifilament, warp,<br>knitted, mesh | Equivalent |
| Ranges of sizes | 100 X 150 to 200 X<br>300 mm | 3" Circle<br>4" x 6" Rectangle<br>6" x 8" Rectangle<br>8" x 10" Rectangle<br>10" x 12" Rectangle<br>4.5" Circle<br>2.4" x 6.3" Rectangle<br>3" x 3" Square<br>3" x 6.3" Rectangle<br>3" x 8" Rectangle<br>4" x 4" Square<br>4" x 8" Rectangle<br>4" x 10" Rectangle<br>6" x 10" Rectangle<br>6" x 12" Rectangle<br>8" x 8" Square<br>8" x 12" Rectangle<br>8" x 16" Rectangle<br>10" x 16" Rectangle<br>12" x 12" Square<br>12" x 18" Rectangle<br>14" x 14" Square<br>16" x 16" Square<br>18" x 18" Square<br>19.5" x 19.5" Square | 100 X 150 to 200 X 300<br>mm | Equivalent |
| Materials | Copolymers (Glycolide,<br>L-lactide and<br>Trimethylene<br>carbonate) | Poly-4-Hydroxybutyrate | Copolymers (Glycolide,<br>L-lactide and<br>Trimethylene carbonate) | Equivalent |
| Sterility | SAL 10-6 | SAL 10-6 | SAL 10-6 | Same |
{6}------------------------------------------------
{7}------------------------------------------------
{8}------------------------------------------------
#### VII. PREFORMANCE DATA
The subject device is the same as the reference predicate the TIGR® Matrix Surgical Mesh (K163005). All relevant preclinical test results/reports for the TIGR® Matrix Surgical Mesh were submitted in K163005. Additional performance data provided with this submission is to support an expansion of shelf life dating from 36 to 48 months.
### a. Biocompatibility
The subject device is the same as the reference predicate the TIGR® Matrix Surgical Mesh (K163005). The devices are identical with the same materials of construction, processing, packaging, and sterilization. Applicable ISO 10993-1 Biocompatibility Testing was conducted and demonstrates that the subject device is biocompatible for its intended body contact and duration.
### b. Bench Testing
Bench testing performed is described in (K163005) for the reference predicate, which is the same device as the subject device except for the proposed labeling changes. These tests demonstrate the safety and performance of the subject device for its intended use and substantial equivalence to the primary predicate device.
### c. Animal Testing
Animal testing performed is described in (K163005) for the reference predicate, which is the same device as the subject device except for the proposed labeling changes. These tests demonstrate the safety and performance of the subject device for its intended use and substantial equivalence to the primary predicate device.
### d. Human Factors Testing
Human factors testing performed is described in (K163005) for the reference predicate, which is the same device as the subject device except for the proposed labeling changes, which do not impact human factors performance. The TIGR surgical mesh has been used in US clinics since 2010. These tests demonstrate the safety and performance of the subject device for its intended use and substantial equivalence to the primary predicate device.
#### e. Clinical Data
Introduction: Clinical data were not required to demonstrate substantial equivalence of the TIRG Matrix Surgical Mesh to the predicate device. However, real-world clinical evidence were included with this submission to support the safety and performance of the TIGR Matrix Surgical Mesh for its proposed expanded indication for use to match the primary predicate device's labeling. Long-term follow-up was obtained.
Methods: The use of hernia mesh is a common practice in abdominal wall reconstruction (AWR) operations. A surgical hernia program implemented the principles of Clinical Quality Improvement (CQI), under the CQI requlations and applicable national and local laws, including the rules and regulations of the Privacy Rule 45 CFR Part 160 and Subparts A and E of Part 164 (the HIPAA Privacy Rule) and the US Government Agency for Healthcare Research and Quality (AHRQ). Patients were informed of the CQI process and allowed to choose whether to receive any particular treatment option.
{9}------------------------------------------------
Commercially available TIGR Surgical Matrix Mesh was implanted as part of the surgeons' clinical practice, along with the use of a variety of other hernia meshes (resorbable and permanent) used for abdominal wall reconstruction (AWR). Patients were offered the option of various surgical approaches and meshes (including the option of not receiving a mesh). Surgical options included open and laparoscopic approaches. Patients with active infection were not offered a laparoscopic approach.
Results: A total of 91 patients undergoing AWR were included between 8/2011 and 9/2015 (49 months). There were 58 female (64%) and 33 male (36%) patients. The average age was 57.2 years (28 – 80). The average BMI was 34.0 (17.6 – 53.4). There were 52 patients (57%) with recurrent hernias. Mean hernia defect size was 306.6 cm2 (24 – 720) and mean mesh size was 471.7 cm2 (112 - 600). Outcomes included a mean length of stay of 7.5 davs (0 -49), a recurrence rate of 12% (11/91) and a wound complication rate of 27% (25/91). The recurrence rate decreased to 4.5% (3/66) after several improvements, including adopting a transversus abdominus release (TAR) approach, were implemented. There were no mesh related complications and no mesh removal (partial or total) was required. The mean followup length was 42.4 months (1 - 102).
Conclusion: All 91 patients who underwent AWR with and without active infection and/or contamination, the TIGR Matrix Surgical Mesh was used. In this group patients there were no mesh related complications and no mesh removals required. Long-term follow-up > 3 years demonstrated the durability of the repair with TIGR Matrix in a TAR approach for AWR.
#### CONCLUSION VIII.
The TIGR Matrix Surgical Mesh and its primary predicate (K161424) have the same intended use and similar indications, technological characteristics and principles of operation. Minor differences between the subject device and the primary predicate do not present any new issues of safety or effectiveness. The TIGR Matrix Surgical Mesh is the same device as the reference predicate (K163005) with only minor differences in the indication for use to add hernia repair as part of soft tissue repair and removal of a contraindication to match the primary predicate's labeling, as supported by the preclinical and clinical performance testing. The TIGR Matrix Surgical Mesh is substantially equivalent to the primary predicate (K161424).
