(272 days)
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
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.
This document is a 510(k) premarket notification for the TIGR® Matrix Surgical Mesh. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are primarily focused on demonstrating this equivalence through comparative performance data rather than independent clinical efficacy trials with pre-defined success metrics.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating substantial equivalence to the predicate device (TIGR® Matrix Surgical Mesh, K092224). The reported device performance is compared directly against that of the predicate.
| Parameter | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Description | ||
| Fast-resorbing fiber | Degrades after 2 weeks (in vitro), absorbed after 4 months (in vivo) | Equivalent, established as equivalent in-vitro; fast-resorbing fiber fully absorbed after 4 months (sheep study) |
| Slow-resorbing fiber | Maintained strength for 6 months (in vitro), absorbed after ~36 months (in vivo) | Equivalent, established as equivalent in-vitro; slow-resorbing fiber absorbed after ~36 months (sheep study) |
| Technical Characteristics | ||
| Classification | Class II: polymeric surgical mesh | Class II: polymeric surgical mesh |
| Indication for use | Reinforcement of soft tissue where weakness exists | Reinforcement of soft tissue where weakness exists |
| Contraindications | Same as subject device | Same as predicate device |
| Mesh Thickness (mean; mm) | 0.573 | 0.687 |
| Area weight/density (mean; g/m²) | $125 \le x \le 170$ | $125 \le x \le 170$ |
| Porosity (%) | $20 \le x \le 40$ | $20 \le x \le 40$ |
| Weave characteristics | Multifilament, Warp knitted, Mesh | Multifilament, Warp knitted, Mesh |
| Ranges of sizes (mm) | 120x65 to 200x300 | 100x150 to 200x300 |
| Materials | Copolymers (Glycolide, L-lactide and Trimethylene carbonate) | Copolymers (Glycolide, L-lactide and Trimethylene carbonate) |
| Sterility | Sterile EO, SAL 10^-6 | Sterile EO, SAL 10^-6 |
| Shelf Life | 1 year | 2 years |
| Nonclinical Performance Data | ||
| Ball burst strength/Force (Mean; N) | ≥ 250 | ≥ 250 |
| Suture pull-out strength (Mean; N) | ≥ 20 | ≥ 20 |
| Tear Strength (Mean; N) | ≥ 30 | ≥ 30 |
| Stiffness (Bending Modulus; MPa) | ≥ 10 MPa | ≥ 10 MPa |
| Relative Distention at 16N (%) | ≤ 8 | ≤ 8 |
| Degradation Characteristics | Not explicitly quantified, but established | Established as equivalent in-vitro. |
| Biocompatibility | Established | Established |
| Shelf life | 1 year | 2 years |
Note: For the subject device, most parameters are presented as being equivalent or meeting the same threshold as the predicate. Changes in thickness, size range, and shelf life are noted but justified as not impacting substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This is not a traditional "test set" in the context of an AI/algorithm study. The studies described are in vitro (bench testing) and in vivo (animal studies) non-clinical tests.
- Bench Testing: The document does not specify exact sample sizes for each bench test beyond "mean" values, indicating multiple samples were tested. The data provenance is internal testing performed by Novus Scientific AB or contract laboratories (BIOMATECH and NAMSA). This is prospective testing for the subject device and referenced predicate data for the predicate device.
- Animal Studies:
- Rat Study: 30 rats in total (2 groups of 5 rats for each of 3 time periods - 1, 3, and 6 months).
- Sheep Study: 13 sheep in total. Each observation period (4, 9, 15, 24, 36 months) comprised 3 sheep with 10 test meshes and 2 control meshes.
- Data Provenance: Prospective animal studies. Locations of animal studies are not explicitly stated, but the contract labs (BIOMATECH and NAMSA) are mentioned for biocompatibility, which might overlap.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in the context of this device and study type. Ground truth for non-clinical studies is based on standardized test methods, biological endpoints (e.g., histology), and laboratory analyses conducted by qualified personnel following GLP requirements.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for human expert review in diagnostic studies. Here, evaluation is based on scientific methods and observable biological/material responses.
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
Not applicable. This is a surgical mesh, not a diagnostic AI system or medical imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device (surgical mesh), not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical studies:
- Bench Testing: Ground truth is established by physical measurements and adherence to specified standards (e.g., ASTM D3787, ISO 9073-4, ASTM D1388, ASTM D6775).
- Biocompatibility Testing: Ground truth is established by universally recognized biological responses documented through various ISO 10993 tests (e.g., cytotoxicity, genotoxicity, irritation, systemic toxicity, local effects after implantation). This includes microscopic observations and chemical characterization.
- Animal Studies: Ground truth is based on observed biological responses, tissue remodeling, implant degradation, and histological analysis within the animal models.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three overlapping wing-like shapes.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 27, 2017
Novus Scientific AB c/o Mr. Fedrik Bohman Quality Assurance & Regulatory Affairs Manager (acting) Virdings Allé 2 SE 754 50 Uppsala Sweden
Re: K163005
Trade/Device Name: TIGR® Matrix Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: Class II Product Code: OWT Dated: June 26, 2017 Received: June 26, 2017
Dear Mr. Bohman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
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
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Indications for Use
510(k) Number (if known) K163005
Device Name
TIGR® Matrix Surgical Mesh
Indications for Use (Describe)
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY
Submitter's Information
| Name: | Novus Scientific AB |
|---|---|
| Adress: | Virdings allé 2SE-754 50, UppsalaSweden |
| Phone: | +46 18 700 1150 |
| Contact Person: | Mats Norberg |
| E-mail: | mats.norberg@novusscientific.com |
Date of preparation
26 July 2017
Device Name
| Trade Name: | TIGR® Matrix Surgical Mesh |
|---|---|
| Common Name: | Surgical Mesh |
| Classification: | Mesh, Surgical, Polymeric |
| Classification Product Code: | OWT |
| Regulatory number: | §878.3300 |
Predicate Device Name
TIGR® Matrix Surgical Mesh (K092224)
Device Description
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.
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Intended Use
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists. The indication for use of the subject device is identical compared to the predicate device.
| Feature | Subject Device | Predicate Device (K092224) |
|---|---|---|
| TIGR® Matrix Surgical Mesh | TIGR® Matrix Surgical Mesh | |
| Classification | Class II: polymeric surgical mesh | Class II: polymeric surgical mesh |
| Indication for use | TIGR® Matrix Surgical Mesh is indicatedfor use in reinforcement of soft tissuewhere weakness exists. | TIGR® Matrix Surgical Mesh is indicatedfor use in reinforcement of soft tissuewhere weakness exists. |
| Contraindications | Not suitable for reconstruction ofcardiovascular defects.TIGR® Matrix Surgical Mesh mustalways be separated from the abdominalcavity by peritoneum.Not for use following planned intra-operative or accidental opening of thegastrointestinal tract. | Not suitable for reconstruction ofcardiovascular defects.TIGR® Matrix Surgical Mesh must alwaysbe separated from the abdominal cavity byperitoneum.Not for use following planned intra-operative or accidental opening of thegastrointestinal tract. |
Technical Characteristics
The predicate device and the subject device have substantially equivalent technology characteristics, e.g. Design, Material, Sterility etc. The shelf-life is increased to two (2) years compared to the predicate device. The size range has been narrowed for the subject device compared to the predicate device. The measured thickness is also slightly higher for the subject device.
| Feature | Subject DeviceTIGR® Matrix Surgical Mesh | Predicate Device (K092224)TIGR® Matrix Surgical Mesh |
|---|---|---|
| Mesh Thickness (mean; mm) | 0.687 | 0.573 |
| Area weight/density (mean; g/m²) | $125 \le x \le 170$ | $125 \le x \le 170$ |
| Porosity (%) | $20 \le x \le 40$ | $20 \le x \le 40$ |
| Weave characteristics | MultifilamentWarp knitted, Mesh | MultifilamentWarp knitted, Mesh |
| Ranges of sizes (mm) | 100x150 to 200x300 | 120x65 to 200x300 |
| Materials | Copolymers(Glycolide, L-lactideand Trimethylenecarbonate) | Copolymers(Glycolide, L-lactideand Trimethylenecarbonate) |
| Sterility | Sterile EO, SAL 10^-6 | Sterile EO, SAL 10^-6 |
| Shelf Life | 2 years | 1 year |
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Nonclinical performance data
Performance testing was initially evaluated for predicate device in (K092224). Additional/new testing has been performed for the subject device as part of process qualification and validation activities during the manufacturing site change. The predicate device and the subject device have substantially equivalent performance characteristics.
| Parameter | Standard testmethod referenced | Subject DeviceTIGR® MatrixSurgical Mesh | Predicate Device(K092224)TIGR® MatrixSurgical Mesh |
|---|---|---|---|
| Ball burststrength/Force (Mean; N) | ASTM D3787 (2015) | ≥ 250 | ≥ 250 |
| Suture pull-outstrength(Mean; N) | Novus internal testmethod TI-0208 | ≥ 20 | ≥ 20 |
| Tear Strength(Mean; N) | ISO 9073-4 (1997) | ≥ 30 | ≥ 30 |
| Stiffness(Bending Modulus;MPa) | ASTM D1388 (2014) | ≥ 10 MPa | ≥ 10 MPa |
| Relative Distention at16N (%) | ASTM D6775 (2013) | ≤ 8 | ≤ 8 |
| DegradationCharacteristics | ISO 15814:1999 | Established as equivalent in-vitro. | |
| Biocompatibility | ISO 10993, Biologicalevaluation of MedicalDevices, Part 1:Evaluating and Testing | Established | Established |
| Electrical Safety | NA | NA | NA |
| Chemical Safety | NA | NA | NA |
| Thermal Safety | NA | NA | NA |
| Radiation Safety | NA | NA | NA |
| Shelf life | Novus internal testmethods | 2 years | 1 year |
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Biocompatibility testing
Biocompatibility testing and classification has been selected and performed in accordance with ISO 10993, Biological evaluation of Medical Devices, Part 1: Evaluating and Testing. TIGR Matrix Surgical Mesh is classified as an implant with permanent contact. Testing has been performed on sterilized devices. The biocompatibility was initially assessed in premarket notification (K092224), since; additional tests, as a result of changes in manufacturing facility and altered standard requirements, have been performed. These additional tests are denoted with a * in the table below. Studies have been conducted at contract laboratories BIOMATECH and NAMSA, in accordance with applicable GLP requirements. Tests are summarized in the table below.
| Test to be considered | Action | Evaluation |
|---|---|---|
| ISO 10993-3Test for genotoxicity,carcinogenicity and reproductivetoxicityAmes Test (mutagenicity) | The bacterial Reverse Mutation Test(Ames Test) was performed. | The test article extracts were not toxic and notmutagenic. |
| ISO 10993-3Test for genotoxicity,carcinogenicity and reproductivetoxicityChromosomal aberrationinduction in human cells(genotoxicity) | Human lymphocyte cultures wereexposed to the test article extract. | The extract of the test article did not induce asignificant number of chromosomalaberrations in human lymphocytes in culturein the presence or absence of metabolicactivations. The extract of the test article metthe requirement of the test. |
| ISO 10993-5Tests for Cytotoxicity | The test extract was placed ontotriplicate confluent monolayers of L-929 mouse fibroblast cells. | The extract of the test articles showed noevidence of causing cell lysis or toxicitygreater than a grade 2 (mild reactivity), grade0 for these test articles. The extract of the textarticles met the requirements of the USP andpart 5 of ISO 10993 standard. |
| *L-929 mouse fibroblast cells wereincubated with test article extracts andevaluated with phase contrastmicroscopy. | *The full strength test article extract showedno cytotoxic potential to L-929 mousefibroblast cells. | |
| ISO 10993-6Test for localeffects after implantation1. Collagen and tissueformation2. Local tolerancedegradation kinetics | The objective of this study was toevaluate collagen tissue formation andremodeling (1, 3 and 6 months withinthe test implant. Two groups of 5 ratswere implanted with the test andcontrol article (total of 30 rats, n=5sites per product and per time-period).Test mesh (2x3) cm was sutured onto(1cm x 1cm) full thickness defectcreated within the abdominalmusculature of each animal. | Colonization and the local tolerance of thetest implant were good and similar or greateras compared to the control implant in terms ofdegradation at 6 months.The degradation of the large fibers of the testarticle seemed to be complete at 6 months.The multifilament fiber of the test articleshowed signs of initial degradation. |
| ISO 10993-7Ethylene oxide sterilizationresiduals | Each sterilized batch is tested forEthylene oxide and Ethylenechlorohydrin residuals, via gaschromatography according to ISO10993-7, Annex A.4. | Each batch is evaluated against the limits ofexposure defined in ISO 10993-7 section4.3.2. Product release is conditioned toconformance to the requirements of thestandard. |
| ISO 10993-10Tests forirritation and delayed-typehypersensitivityPart 7.4 Maximization Test fordelayed hyper sensitivity | Maximization test for delayedhypersensitivity was performed.* A guinea pig maximization test wasperformed to evaluate the potential fordelayed dermal contact sensitization. | No delayed sensitization was induced witheither extracts. The score became grade 0.*The topical application of the 0.9% NaClextract and sesame oil extract evaluated atconcentration of 100%, according to the ISO13993-10 standard, did not induce delayedsenstitization in the guinea pig (grade 0).The irritation indexes for the 0.9% NaClextract became 0 and for the sesame oilextract 0.08, i.e. the difference betweenthe test and control sites was lower than1. |
| ISO 10993-10Tests forirritation and delayed-typehypersensitivityAnnex B.B. 2Intracutaneous (Intradermal)Reactivity Test | Two (2) adult albino rabbits wereclipped on both flanks. The rabbitsreceived five intracutaneousinjections of 0.2 mL of the 0.9% NaClextract on one side and five injectionsof 0.2 mL of the correspondingvehicle as negative control. Similarly,the rabbits received five injections of0.2 mL of the sesame oil extract, andfive injections of the correspondingvehicle.The sites were examined at 24, 48 and72 hours after injection forgross evidence of tissue reactions,such as erythema, edema or necrosis.*An intracutaneous test wasperformed to evaluate the potential ofthe material to produce irritationfollowing intradermal injection.Three (3) rabbits receivedintracutaneous injections. The siteswere examined immediately, 24, 48and 72 hours after injection for grossevidence of tissue reactions, such aserythema, edema or necrosis. | *The extracts of the test article met therequirements of the intracutaneous injectiontest in the rabbit according to the proceduredescribed in the ISO 10993-10 standard. |
| ISO 10993-11Tests forsystemic toxicityAcute Systemic Toxicity | A single dose of each extract wasinjected into five (5) mice per extract,by either intravenous route orintraperitoneal route. Animals wereobserved immediately and at 4, 24, 48and 72 hours after systemic injection. | Under the conditions of the test, there was noevidence of significant systemic toxicity ormortality after test article extracts injectionand therefore meets the requirements of thetest. |
| ISO 10993-3Test for genotoxicity,carcinogenicity and reproductivetoxicityCarcinogenicity | Not performed | Chronic toxicity and carcinogenicity studiesas suggested in ISO 10993-1 assupplementary tests were not considerednecessary as the chemical structure of the twopolymers as well as their degradationproducts do not suggest a carcinogenicpotential. Neither of the two polymericmaterials used in mesh nor their degradationproducts are in a class that has producedpositive carcinogenic results; furthermoreprior studies, in vitro and in vivo, of themutagenic potential for this type of materialsdo not indicate the need for additional testing. |
| ISO 10993-11Tests for systemic toxicityChronic Toxicity | Not performed | |
| ISO 10993-18 Chemicalcharacterization of materials | The chemical characterization testperformed are:Exhaustive Extraction(Water, IPA, Hexane)Inductively coupled plasmaspectroscopy (ICP)IR Spectrum analysisGC/MSLC/MS | The initial testing performed in preparation of(K092224) identified that extraction of theWK-6 Surgical Mesh with isopropyl alcoholand hexane resulted in a non-volatile residueof 42.2 and 30.8 mg. From the FT-IR analysisit was clear that part of this residue waspolydimethylsiloxane which more frequentlyis referred to as silicone oil.Silicone oil was used as a spin finisher duringthe fiber spinning process. After knitting andannealing the mesh is cleaned in isopropylalcohol to remove the spin finisher.The batches used for the first biocompatibilitytesting were cleaned for 2 minutes in anultrasonic bath containing Isopropyl alcohol.Cleaning validation of the mesh was laterbeen performed and the operationalqualification showed that cleaning need to becontinued for 6 minutes using an ultrasonicIsopropyl alcohol bath to fully get rid of thesilicone oil as determined by thecharacteristic FTIR peaks for silicone oil at2962 cm-1, 1260 cm-1 and shoulder at1011 cm-1. This was later verified in aperformance qualification of the cleaningprocess.In addition this was further clarified in theQ&A following the FDA review of(K092224). |
| *The chemical characterization testperformed are:Exhaustive Extraction(Water, IPA, Hexane)Inductively coupled plasmaspectroscopy (ICP)IR Spectrum analysisGC/MSUPLC/MS | *Equivalent testing was performed as part ofprocess validation during the manufacturingsite change. Silicone oil usage in themanufacturing of the predicate device hasbeen replaced with castor oil in themanufacturing of the subject device. Castoroil is generally recognized as safe and ispermitted as a direct food additive to hinderstickiness of hard candy and vitamin and/ormineral tablets 21CFR part 172.876. Bothcastor oil and its sulphated counterpart islisted as safe in Indirect additives used in foodcontact 21CFR part 175-178. Castor oil isalso listed as a safe chemical for use inlaxative sold as OTC drug and the ethoxylatedcastor oil is used as an excipient in severaldrug formulations. |
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Shelf life
Accelerated and real time stability studies of the mesh and packaging have been performed for TIGR® Matrix Surgical Mesh as part of process qualification and validation activities during the manufacturing site change. The conclusion of the performed studies is that there are only no or vague declining trends of quality characteristics defined in the product specification.
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Animal studies
Additional testing has not been conducted for the subject device for determination of substantial equivalence. Animal studies conducted for the predicate device (K092224) are summarized below.
Rat
A 6 months implantation study in rats were performed to study local tissue response, tissue remodeling and implant degradation. For each selected time period (1, 3 and 6 months) two groups of five rats were each implanted with test mesh (TIGR® Matrix Surgical Mesh) and control mesh (Prolene®), altogether 30 rats. The surgery was performed by creating a full thickness defect, 10 mm x 10 mm, within the abdominal wall musculature. Degradation of the fast-resorbing fiber of the test mesh seemed to be completed at 6 months whereas the slowresorbing fibers showed no signs of degradation.
Sheep
An implantation study in sheep, evaluated at 4, 9, 15, 24 and 36 months was performed to study local tissue response, tissue remodeling and degradation of the mesh in a larger animal having a larger tension in the abdominal wall. A total of 13 sheep were implanted with four meshes. Each observation comprised 3 sheep with 10 test meshes (TIGR® Matrix Surgical Mesh) and 2 control meshes (Prolene®). A full thickness, 3 cm x 3 cm square, defect was created within the abdominal wall musculature. The abdominal was removed carefully to leave the peritoneum intact. A mesh of 8 cm x 8 cm was used to cover the defect with an overlap. Microscopic observations of the implant sites were performed after termination. Histological analysis was performed to evaluate the local tolerance and material degradation. Degradation of the fast/resorbing fiber of the test mesh seemed to be completed after 4 months while the slow/resorbing fibers showed no signs of degradation and were still present after 9 months. After 36 months, the test mesh was fully resorbed and only microscopic implant residues could be found in the tissue.
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Clinical performance data
The changes to labeling proposed in this submission were initiated by the results of a clinical study, where the long-term performance for repair of inguinal hernia was investigated for the predicate device. No clinical study has been conducted for the subject device for determination of substantial equivalence.
Conclusion
Since nonclinical bench performance testing data and biocompatibility studies are well understood for this type of device, nonclinical performance data are deemed sufficient to support substantial equivalence. As shown in this summary. TIGR® Matrix Surgical Mesh is substantially equivalent to the predicate device in intended use, indication for use, fundamental design and technology, and principles of operation. Novus Scientific AB has made this determination of substantial equivalence based on intended use, indications for use, technological characteristics and nonclinical performance. Based on the 510(k) and the information provided herein, we conclude that the Subject Device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.
§ 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.