(272 days)
Not Found
No
The device description and performance studies focus on the material properties and degradation of a surgical mesh, with no mention of AI or ML technologies.
Yes.
The device is intended for "reinforcement of soft tissue where weakness exists," which directly addresses and improves a medical condition.
No
Explanation: The device, TIGR® Matrix Surgical Mesh, is intended for reinforcement of soft tissue, indicating a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly states that the device is a surgical mesh knitted from synthetic resorbable fibers, which is a physical, implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "in reinforcement of soft tissue where weakness exists." This describes a surgical implant used in vivo (within the body) to provide structural support.
- Device Description: The description details a surgical mesh made of synthetic resorbable fibers, designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo surgical use.
N/A
Here's the extracted information from the provided FDA summary:
Intended Use / Indications for Use
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
Product codes (comma separated list FDA assigned to the subject device)
OWT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal wall (in animal studies)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Biocompatibility testing:
- Test for genotoxicity, carcinogenicity and reproductive toxicity (Ames Test (mutagenicity)): The bacterial Reverse Mutation Test (Ames Test) was performed. The test article extracts were not toxic and not mutagenic.
- Test for genotoxicity, carcinogenicity and reproductive toxicity (Chromosomal aberration induction in human cells (genotoxicity)): Human lymphocyte cultures were exposed to the test article extract. The extract of the test article did not induce a significant number of chromosomal aberrations in human lymphocytes in culture in the presence or absence of metabolic activations. The extract of the test article met the requirement of the test.
- Tests for Cytotoxicity: The test extract was placed onto triplicate confluent monolayers of L-929 mouse fibroblast cells. The extract of the test articles showed no evidence of causing cell lysis or toxicity greater than a grade 2 (mild reactivity), grade 0 for these test articles. The extract of the text articles met the requirements of the USP and part 5 of ISO 10993 standard. *L-929 mouse fibroblast cells were incubated with test article extracts and evaluated with phase contrast microscopy. The full strength test article extract showed no cytotoxic potential to L-929 mouse fibroblast cells.
- Test for local effects after implantation (Collagen and tissue formation, Local tolerance degradation kinetics): The objective of this study was to evaluate collagen tissue formation and remodeling (1, 3 and 6 months within the test implant. Two groups of 5 rats were implanted with the test and control article (total of 30 rats, n=5 sites per product and per time-period). Test mesh (2x3) cm was sutured onto (1cm x 1cm) full thickness defect created within the abdominal musculature of each animal. Colonization and the local tolerance of the test implant were good and similar or greater as compared to the control implant in terms of degradation at 6 months. The degradation of the large fibers of the test article seemed to be complete at 6 months. The multifilament fiber of the test article showed signs of initial degradation.
- Ethylene oxide sterilization residuals: Each sterilized batch is tested for Ethylene oxide and Ethylene chlorohydrin residuals, via gas chromatography according to ISO 10993-7, Annex A.4. Each batch is evaluated against the limits of exposure defined in ISO 10993-7 section 4.3.2. Product release is conditioned to conformance to the requirements of the standard.
- Tests for irritation and delayed-type hypersensitivity (Part 7.4 Maximization Test for delayed hyper sensitivity): Maximization test for delayed hypersensitivity was performed. * A guinea pig maximization test was performed to evaluate the potential for delayed dermal contact sensitization. No delayed sensitization was induced with either extracts. The score became grade 0. *The topical application of the 0.9% NaCl extract and sesame oil extract evaluated at concentration of 100%, according to the ISO 13993-10 standard, did not induce delayed senstitization in the guinea pig (grade 0). The irritation indexes for the 0.9% NaCl extract became 0 and for the sesame oil extract 0.08, i.e. the difference between the test and control sites was lower than 1.
- Tests for irritation and delayed-type hypersensitivity (Annex B.B. 2 Intracutaneous (Intradermal) Reactivity Test): Two (2) adult albino rabbits were clipped on both flanks. The rabbits received five intracutaneous injections of 0.2 mL of the 0.9% NaCl extract on one side and five injections of 0.2 mL of the corresponding vehicle as negative control. Similarly, the rabbits received five injections of 0.2 mL of the sesame oil extract, and five injections of the corresponding vehicle. The sites were examined at 24, 48 and 72 hours after injection for gross evidence of tissue reactions, such as erythema, edema or necrosis. *An intracutaneous test was performed to evaluate the potential of the material to produce irritation following intradermal injection. Three (3) rabbits received intracutaneous injections. The sites were examined immediately, 24, 48 and 72 hours after injection for gross evidence of tissue reactions, such as erythema, edema or necrosis. *The extracts of the test article met the requirements of the intracutaneous injection test in the rabbit according to the procedure described in the ISO 10993-10 standard.
- Tests for systemic toxicity (Acute Systemic Toxicity): A single dose of each extract was injected into five (5) mice per extract, by either intravenous route or intraperitoneal route. Animals were observed immediately and at 4, 24, 48 and 72 hours after systemic injection. Under the conditions of the test, there was no evidence of significant systemic toxicity or mortality after test article extracts injection and therefore meets the requirements of the test.
- Chemical characterization of materials: The chemical characterization test performed are: Exhaustive Extraction (Water, IPA, Hexane) Inductively coupled plasma spectroscopy (ICP) IR Spectrum analysis GC/MS LC/MS. The initial testing performed in preparation of (K092224) identified that extraction of the WK-6 Surgical Mesh with isopropyl alcohol and hexane resulted in a non-volatile residue of 42.2 and 30.8 mg. From the FT-IR analysis it was clear that part of this residue was polydimethylsiloxane which more frequently is referred to as silicone oil. Silicone oil was used as a spin finisher during the fiber spinning process. After knitting and annealing the mesh is cleaned in isopropyl alcohol to remove the spin finisher. The batches used for the first biocompatibility testing were cleaned for 2 minutes in an ultrasonic bath containing Isopropyl alcohol. Cleaning validation of the mesh was later been performed and the operational qualification showed that cleaning need to be continued for 6 minutes using an ultrasonic Isopropyl alcohol bath to fully get rid of the silicone oil as determined by the characteristic FTIR peaks for silicone oil at 2962 cm-1, 1260 cm-1 and shoulder at 1011 cm-1. This was later verified in a performance qualification of the cleaning process. In addition this was further clarified in the Q&A following the FDA review of (K092224). *The chemical characterization test performed are: Exhaustive Extraction (Water, IPA, Hexane) Inductively coupled plasma spectroscopy (ICP) IR Spectrum analysis GC/MS UPLC/MS. *Equivalent testing was performed as part of process validation during the manufacturing site change. Silicone oil usage in the manufacturing of the predicate device has been replaced with castor oil in the manufacturing of the subject device. Castor oil is generally recognized as safe and is permitted as a direct food additive to hinder stickiness of hard candy and vitamin and/or mineral tablets 21CFR part 172.876. Both castor oil and its sulphated counterpart is listed as safe in Indirect additives used in food contact 21CFR part 175-178. Castor oil is also listed as a safe chemical for use in laxative sold as OTC drug and the ethoxylated castor oil is used as an excipient in several drug formulations.
- 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.
- 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 study: 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 study: 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.
- Clinical performance data: No clinical study has been conducted for the subject device for determination of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
TIGR® Matrix Surgical Mesh (K092224)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
510(K) SUMMARY
Submitter's Information
| Name: | Novus Scientific AB |
|---|---|
| Adress: | Virdings allé 2 |
| SE-754 50, Uppsala | |
| Sweden | |
| 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.
4
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 indicated | |
| for use in reinforcement of soft tissue | ||
| where weakness exists. | TIGR® Matrix Surgical Mesh is indicated | |
| for use in reinforcement of soft tissue | ||
| where weakness exists. | ||
| Contraindications | Not suitable for reconstruction of | |
| cardiovascular defects. | ||
| TIGR® Matrix Surgical Mesh must | ||
| always be separated from the abdominal | ||
| cavity by peritoneum. | ||
| Not for use following planned intra- | ||
| operative or accidental opening of the | ||
| gastrointestinal tract. | Not suitable for reconstruction of | |
| cardiovascular defects. | ||
| TIGR® Matrix Surgical Mesh must always | ||
| be separated from the abdominal cavity by | ||
| peritoneum. | ||
| Not for use following planned intra- | ||
| operative or accidental opening of the | ||
| gastrointestinal 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 Device
TIGR® 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 | Multifilament
Warp knitted, Mesh | Multifilament
Warp knitted, Mesh |
| Ranges of sizes (mm) | 100x150 to 200x300 | 120x65 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 | 2 years | 1 year |
5
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 test
method referenced | Subject Device
TIGR® Matrix
Surgical Mesh | Predicate Device
(K092224)
TIGR® Matrix
Surgical Mesh |
|------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------|----------------------------------------------------------------|
| Ball burst
strength/Force (Mean; N) | ASTM D3787 (2015) | ≥ 250 | ≥ 250 |
| Suture pull-out
strength
(Mean; N) | Novus internal test
method 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 at
16N (%) | ASTM D6775 (2013) | ≤ 8 | ≤ 8 |
| Degradation
Characteristics | ISO 15814:1999 | Established as equivalent in-vitro. | |
| Biocompatibility | ISO 10993, Biological
evaluation of Medical
Devices, 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 test
methods | 2 years | 1 year |
6
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 10993-3 | ||
| Test for genotoxicity, | ||
| carcinogenicity and reproductive | ||
| toxicity | ||
| Ames Test (mutagenicity) | The bacterial Reverse Mutation Test | |
| (Ames Test) was performed. | The test article extracts were not toxic and not | |
| mutagenic. | ||
| ISO 10993-3 | ||
| Test for genotoxicity, | ||
| carcinogenicity and reproductive | ||
| toxicity | ||
| Chromosomal aberration | ||
| induction in human cells | ||
| (genotoxicity) | Human lymphocyte cultures were | |
| exposed to the test article extract. | The extract of the test article did not induce a | |
| significant number of chromosomal | ||
| aberrations in human lymphocytes in culture | ||
| in the presence or absence of metabolic | ||
| activations. The extract of the test article met | ||
| the requirement of the test. | ||
| ISO 10993-5 | ||
| Tests for Cytotoxicity | The test extract was placed onto | |
| triplicate confluent monolayers of L-929 mouse fibroblast cells. | The extract of the test articles showed no | |
| evidence of causing cell lysis or toxicity | ||
| greater than a grade 2 (mild reactivity), grade | ||
| 0 for these test articles. The extract of the text | ||
| articles met the requirements of the USP and | ||
| part 5 of ISO 10993 standard. | ||
| *L-929 mouse fibroblast cells were | ||
| incubated with test article extracts and | ||
| evaluated with phase contrast | ||
| microscopy. | *The full strength test article extract showed | |
| no cytotoxic potential to L-929 mouse | ||
| fibroblast cells. | ||
| ISO 10993-6 | ||
| Test for local | ||
| effects after implantation |
- Collagen and tissue
formation - Local tolerance
degradation kinetics | The objective of this study was to
evaluate collagen tissue formation and
remodeling (1, 3 and 6 months within
the test implant. Two groups of 5 rats
were implanted with the test and
control article (total of 30 rats, n=5
sites per product and per time-period).
Test mesh (2x3) cm was sutured onto
(1cm x 1cm) full thickness defect
created within the abdominal
musculature of each animal. | Colonization and the local tolerance of the
test implant were good and similar or greater
as compared to the control implant in terms of
degradation at 6 months.
The degradation of the large fibers of the test
article seemed to be complete at 6 months.
The multifilament fiber of the test article
showed signs of initial degradation. |
| ISO 10993-7
Ethylene oxide sterilization
residuals | Each sterilized batch is tested for
Ethylene oxide and Ethylene
chlorohydrin residuals, via gas
chromatography according to ISO
10993-7, Annex A.4. | Each batch is evaluated against the limits of
exposure defined in ISO 10993-7 section
4.3.2. Product release is conditioned to
conformance to the requirements of the
standard. |
| ISO 10993-10
Tests for
irritation and delayed-type
hypersensitivity
Part 7.4 Maximization Test for
delayed hyper sensitivity | Maximization test for delayed
hypersensitivity was performed.
- A guinea pig maximization test was
performed to evaluate the potential for
delayed dermal contact sensitization. | No delayed sensitization was induced with
either extracts. The score became grade 0.
*The topical application of the 0.9% NaCl
extract and sesame oil extract evaluated at
concentration of 100%, according to the ISO
13993-10 standard, did not induce delayed
senstitization in the guinea pig (grade 0).
The irritation indexes for the 0.9% NaCl
extract became 0 and for the sesame oil
extract 0.08, i.e. the difference between
the test and control sites was lower than
-
|
| ISO 10993-10
Tests for
irritation and delayed-type
hypersensitivity
Annex B.B. 2
Intracutaneous (Intradermal)
Reactivity Test | Two (2) adult albino rabbits were
clipped on both flanks. The rabbits
received five intracutaneous
injections of 0.2 mL of the 0.9% NaCl
extract on one side and five injections
of 0.2 mL of the corresponding
vehicle as negative control. Similarly,
the rabbits received five injections of
0.2 mL of the sesame oil extract, and
five injections of the corresponding
vehicle.
The sites were examined at 24, 48 and
72 hours after injection for
gross evidence of tissue reactions,
such as erythema, edema or necrosis.
*An intracutaneous test was
performed to evaluate the potential of
the material to produce irritation
following intradermal injection.
Three (3) rabbits received
intracutaneous injections. The sites
were examined immediately, 24, 48
and 72 hours after injection for gross
evidence of tissue reactions, such as
erythema, edema or necrosis. | *The extracts of the test article met the
requirements of the intracutaneous injection
test in the rabbit according to the procedure
described in the ISO 10993-10 standard. |
| ISO 10993-11
Tests for
systemic toxicity
Acute Systemic Toxicity | A single dose of each extract was
injected into five (5) mice per extract,
by either intravenous route or
intraperitoneal route. Animals were
observed immediately and at 4, 24, 48
and 72 hours after systemic injection. | Under the conditions of the test, there was no
evidence of significant systemic toxicity or
mortality after test article extracts injection
and therefore meets the requirements of the
test. |
| ISO 10993-3
Test for genotoxicity,
carcinogenicity and reproductive
toxicity
Carcinogenicity | Not performed | Chronic toxicity and carcinogenicity studies
as suggested in ISO 10993-1 as
supplementary tests were not considered
necessary as the chemical structure of the two
polymers as well as their degradation
products do not suggest a carcinogenic
potential. Neither of the two polymeric
materials used in mesh nor their degradation
products are in a class that has produced
positive carcinogenic results; furthermore
prior studies, in vitro and in vivo, of the
mutagenic potential for this type of materials
do not indicate the need for additional testing. |
| ISO 10993-11
Tests for systemic toxicity
Chronic Toxicity | Not performed | |
| ISO 10993-18 Chemical
characterization of materials | The chemical characterization test
performed are:
Exhaustive Extraction
(Water, IPA, Hexane)
Inductively coupled plasma
spectroscopy (ICP)
IR Spectrum analysis
GC/MS
LC/MS | The initial testing performed in preparation of
(K092224) identified that extraction of the
WK-6 Surgical Mesh with isopropyl alcohol
and hexane resulted in a non-volatile residue
of 42.2 and 30.8 mg. From the FT-IR analysis
it was clear that part of this residue was
polydimethylsiloxane which more frequently
is referred to as silicone oil.
Silicone oil was used as a spin finisher during
the fiber spinning process. After knitting and
annealing the mesh is cleaned in isopropyl
alcohol to remove the spin finisher.
The batches used for the first biocompatibility
testing were cleaned for 2 minutes in an
ultrasonic bath containing Isopropyl alcohol.
Cleaning validation of the mesh was later
been performed and the operational
qualification showed that cleaning need to be
continued for 6 minutes using an ultrasonic
Isopropyl alcohol bath to fully get rid of the
silicone oil as determined by the
characteristic FTIR peaks for silicone oil at
2962 cm-1, 1260 cm-1 and shoulder at
1011 cm-1. This was later verified in a
performance qualification of the cleaning
process.
In addition this was further clarified in the
Q&A following the FDA review of
(K092224). |
| | *The chemical characterization test
performed are:
Exhaustive Extraction
(Water, IPA, Hexane)
Inductively coupled plasma
spectroscopy (ICP)
IR Spectrum analysis
GC/MS
UPLC/MS | *Equivalent testing was performed as part of
process validation during the manufacturing
site change. Silicone oil usage in the
manufacturing of the predicate device has
been replaced with castor oil in the
manufacturing of the subject device. Castor
oil is generally recognized as safe and is
permitted as a direct food additive to hinder
stickiness of hard candy and vitamin and/or
mineral tablets 21CFR part 172.876. Both
castor oil and its sulphated counterpart is
listed as safe in Indirect additives used in food
contact 21CFR part 175-178. Castor oil is
also listed as a safe chemical for use in
laxative sold as OTC drug and the ethoxylated
castor oil is used as an excipient in several
drug 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.