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 Description

The 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.

AI/ML Overview

The provided text discusses the TIGR Matrix Surgical Mesh and its substantial equivalence to predicate devices, focusing on technical characteristics and clinical performance to support its expanded indications for use and extended shelf life.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance. Instead, it argues for substantial equivalence based on the device being the same as a reference predicate (K163005) and having similar characteristics to a primary predicate (K161424). Performance is discussed qualitatively and through comparative attributes.

Below is a table summarizing the claimed performance and characteristics, primarily in comparison to the predicate devices:

Characteristic	Acceptance Criteria (Implied by Predicate/Discussion)	Reported Device Performance (TIGR® Matrix Surgical Mesh)
Shelf Life	N/A (Previous: 36 months for K163005)	48 months (Extension supported by additional accelerated and real-time aging studies).
Biocompatibility	In accordance with ISO 10993	Biocompatibility testing in accordance with ISO 10993-1 conducted and demonstrates biocompatibility for intended body contact and duration. (Same as K163005, which states biocompatibility for intended use as a permanent, tissue-contacting, implant device).
Bench Testing	Demonstrates safety and performance	Performed as described in K163005, demonstrating safety and performance for intended use and substantial equivalence to primary predicate. Initial burst strength > 350N (compared to 170-750N for existing products). Mechanical strength maintained well above 16N/cm between 0 and 26 weeks.
Animal Testing	Demonstrates safety and performance	Performed as described in K163005, demonstrating safety and performance for intended use and substantial equivalence to primary predicate. In vivo studies in sheep showed fast-resorbing fiber fully absorbed after 4 months and slow-resorbing fiber absorbed after approximately 36 months.
Human Factors	Demonstrates safety and performance	Performed as described in K163005, confirming safety and performance. Labeling indicates size and length; can be manipulated with gloved hand. Has been used in US clinics since 2010.
Clinical Efficacy (Hernia Repair)	Comparable to primary predicate/predicate devices for soft tissue reinforcement. Low recurrence rates and absence of mesh-related complications.	Recurrence rate: 12% initially, decreased to 4.5% (3/66) after improvements (e.g., TAR approach).Wound complication rate: 27% (25/91).Mesh-related complications: 0% (no mesh-related complications, no mesh removal required).Mean follow-up: 42.4 months (1-102 months).
Mesh Thickness (mean)	Comparable to K163005	0.687 mm (Same as reference predicate K163005).
Area Weight/Density (mean)	Comparable to K163005	125 ≤ X ≤ 170 g/m² (Same as reference predicate K163005).
Porosity	Comparable to K163005	20 ≤ X ≤ 40 % (Same as reference predicate K163005).
Sterility Assurance Level (SAL)	10^-6	10^-6 (Same as primary and reference predicates).

2. Sample Size Used for the Test Set and Data Provenance

Clinical Data Test Set (for hernia repair):
- Sample Size: 91 patients.
- Data Provenance: Real-world clinical evidence from a surgical hernia program. Implied to be retrospective as it describes data collected between 8/2011 and 9/2015. The geographic origin is not explicitly stated but "US clinics" is mentioned, suggesting U.S. data.
Bench, Animal, Biocompatibility, Human Factors Testing: These tests are stated to be "described in (K163005)" for the reference predicate. Specific sample sizes for these tests are not provided in this document, but they were part of the previous submission for the K163005 clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

For the clinical data regarding hernia repair:

The ground truth was established by surgeons' clinical practice within a Clinical Quality Improvement (CQI) program.
The document implies that these were multiple surgeons as part of a "surgical hernia program."
Qualifications: Not explicitly stated, but they are referred to as "surgeons" performing "abdominal wall reconstruction (AWR) operations," indicating medical expertise in this surgical field. Years of experience are not mentioned.

4. Adjudication Method for the Test Set

The clinical data was collected as part of a Clinical Quality Improvement (CQI) program and reflects "real-world clinical evidence."
There's no mention of an independent adjudication method (e.g., 2+1, 3+1 consensus by external experts) for the patient outcomes (recurrence, complications). The outcomes were presumably recorded by the treating surgical team as part of their standard clinical practice and CQI process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done.
The clinical data presented is on the performance of the TIGR Matrix Surgical Mesh itself, not on how human readers/surgeons improve with or without AI assistance. This device is a surgical mesh, not an AI-powered diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical surgical mesh, not an algorithm or AI product. Its performance is intrinsic to the material and its interaction with the human body, not a software component.

7. Type of Ground Truth Used

Clinical Outcomes Data: For the hernia repair clinical data, the ground truth was based on documented patient outcomes (recurrence rates, wound complication rates, mesh-related complications) as observed and recorded in real-world clinical practice.

8. Sample Size for the Training Set

Not applicable. This submission pertains to a physical medical device (surgical mesh), not a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.
The clinical data of 91 patients served to support the expanded indication, which could be considered an evaluation of the device in practice.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI/ML algorithm. The clinical outcomes data cited (91 patients) was collected from routine surgical practice as described in point 3 without specific ground truth establishment for a training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K191749

Device Name TIGR Matrix Surgical Mesh

Indications for Use (Describe)

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)

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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%

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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.

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K191749, Page 3 of 7

VI. COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Characteristic	Subject DeviceTIGR® Matrix SurgicalMesh(K191749)	Primary PredicatePhasix™ Mesh(K161424)	Reference PredicateDeviceTIGR® Matrix SurgicalMesh(K163005)	EquivalencyDiscussion
Trade Name	TIGR® Matrix SurgicalMesh	Phasix™ Mesh	TIGR® Matrix SurgicalMesh	N/A
Classification	Surgical Mesh	Surgical Mesh	Surgical Mesh	Same
Product Code	OWT, OOD, FTL	OOD	OWT, FTL	Equivalent
IntendedUse/Indication forUse	The TIGR® Matrix SurgicalMesh is indicated for use inthe reinforcement of softtissue, where weakness existsin patients undergoing plasticand reconstructive surgery, orfor use in procedures involvingsoft tissue repair, such as forthe repair of hernias or otherfascial defects that require theaddition of a reinforcingmaterial to obtain the desiredsurgical result.	The Phasix™ Mesh isindicated to reinforce softtissue where weakness existsin patients undergoing plasticand reconstructive surgery,or for use in proceduresinvolving soft tissue repair,such as the repair of herniaor other fascial defects thatrequire the addition of areinforcing or bridgingmaterial to obtain the desiredsurgical result.	N/A	Equivalent toPrimaryPredicate.
Contraindications	TIGR® Matrix Surgical Mesh isfully resorbable, it should notbe used in repairs wherepermanent wound or organsupport from the mesh isrequired.	Because PHASIX™ Mesh isfully resorbable, it should notbe used in repairs wherepermanent wound or organsupport from the mesh isrequired.	N/A	Same as thePrimaryPredicate.
Warnings	The safety and effectivenessof TIGR® Matrix Surgical Meshin bridging repairs hasnot been evaluated orestablished.	The safety and effectivenessof PHASIX™ Mesh inbridging repairs has not beenevaluated or established.	N/A	Equivalent toPrimaryPredicate
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 orMR Suite	Operating Room orMR Suite	Operating Room orMR Suite	Same
	MRI/Diagnostic / SurgicalRoom	MRI/Diagnostic / SurgicalRoom	MRI/Diagnostic /Surgical Room	Same
Energy Used	None	None	None	Same
Characteristic	Subject DeviceTIGR® Matrix SurgicalMesh(K191749)	Primary PredicatePhasix™ Mesh(K161424)	Reference DeviceTIGR® Matrix SurgicalMesh(K163005)	EquivalencyDiscussion
HumanFactors	Labeling indicates size andlength	Labeling indicates size andlength	Labeling indicates sizeand length	Same
	Can be manipulated withgloved hand	Can be manipulated withgloved hand	Can be manipulatedwith gloved hand	Same
Design	Designed to be placed in theabdominal area	Designed to be placed in theabdominal area	Designed to be placedin the abdominal area	Same
	Absorbable	Absorbable	Absorbable	Same
	Use in reinforcement of softtissue where weaknessexists	Use in reinforcement of softtissue where weaknessexists	Use in reinforcement ofsoft tissue whereweakness exists	Same
	Repair of hernias and othersoft tissues	Repair of hernias and othersoft tissues	Repair of soft tissues	Same asprimarypredicateEquivalent toprimaryPredicate andthe same asreferencepredicate.
Performance	Clinical data for hernia repair	No Clinical Data	No Clinical Data	Equivalent toprimaryPredicate andthe same asreferencepredicate.
Biocompatibility	Biocompatibility testing andclassification has beenselected and performed inaccordance with ISO 10993,Biological evaluation ofMedical Devices, Part 1:Evaluating and Testing.	Biocompatibility testingconducted to date per therequirements of ISO 10993-1 indicates the device isbiocompatible for itsintended use as apermanent, tissue-contacting, implant device.	Biocompatibility testingand classification hasbeen selected andperformed inaccordance with ISO10993, Biologicalevaluation of MedicalDevices, Part 1:Evaluating and Testing.	Same
Sterilization	Sterile EO	Sterile EO	Sterile EO	Same
Packaging	Tyvek envelope and foilpouch	Tyvek envelope and foilpouch	Tyvek envelope and foilpouch	Same
Shelf Life	48 months	Unknown	36 months	Equivalent
Characteristic	Subject DeviceTIGR® MatrixSurgical Mesh(K191749)	Primary PredicatePhasix™ Mesh(K161424)	Reference DeviceTIGR® Matrix SurgicalMesh(K163005)	EquivalencyDiscussion
Mesh Thickness(mean)	0.687 mm	Unknown	0.687 mm	Same asreferencepredicate.
AreaWeight/Density(mean)	$125 ≤ X ≤ 170 g/m²$	Unknown	$125 ≤ X ≤ 170 g/m²$	Same asreferencepredicate.
Porosity	$20 ≤ X ≤ 40 %$	Unknown	$20 ≤ X ≤ 40 %$	Same asreferencepredicate.
WeaveCharacteristics	Multifilament, warp,knitted, mesh	Knitted P4HBmonofilament	Multifilament, warp,knitted, mesh	Equivalent
Ranges of sizes	100 X 150 to 200 X300 mm	3" Circle4" x 6" Rectangle6" x 8" Rectangle8" x 10" Rectangle10" x 12" Rectangle4.5" Circle2.4" x 6.3" Rectangle3" x 3" Square3" x 6.3" Rectangle3" x 8" Rectangle4" x 4" Square4" x 8" Rectangle4" x 10" Rectangle6" x 10" Rectangle6" x 12" Rectangle8" x 8" Square8" x 12" Rectangle8" x 16" Rectangle10" x 16" Rectangle12" x 12" Square12" x 18" Rectangle14" x 14" Square16" x 16" Square18" x 18" Square19.5" x 19.5" Square	100 X 150 to 200 X 300mm	Equivalent
Materials	Copolymers (Glycolide,L-lactide andTrimethylenecarbonate)	Poly-4-Hydroxybutyrate	Copolymers (Glycolide,L-lactide andTrimethylene carbonate)	Equivalent
Sterility	SAL 10-6	SAL 10-6	SAL 10-6	Same

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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.

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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).

Regulation Number and Section

§ 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.