(204 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical performance of a surgical mesh, with no mention of AI or ML technology.
Yes
The device is described as "Surgical Mesh" used for "reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects", which are therapeutic interventions.
No
Explanation: The Reperen® Surgical Mesh is a surgical implant intended for the reconstruction of hernias and soft tissue deficiencies. It is a treatment device, not a diagnostic one. Its purpose is to repair or replace tissue, not to identify or characterize a disease or condition.
No
The device description clearly details a physical surgical mesh made from acrylic polymer, including its dimensions, weight, and material properties. The performance studies also focus on physical characteristics and biocompatibility of the mesh. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Reperen® Surgical Mesh is for the reconstruction of hernias, soft tissue deficiencies, and temporary bridging of fascial defects. These are all surgical procedures performed in vivo (within the living body).
- Device Description: The description details a physical implant made from a biocompatible polymer, designed to be surgically placed within the body.
- Performance Studies: The performance studies focus on mechanical properties (thickness, density, strength, stiffness) and biocompatibility, which are relevant for an implantable device, not a diagnostic test performed on samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Reperen® Surgical Mesh is a surgical implant used for structural support and repair within the body.
N/A
Intended Use / Indications for Use
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects.
Product codes (comma separated list FDA assigned to the subject device)
FTL
Device Description
The Reperen® Surgical Mesh is made from a biocompatible, hydrophobic acrylic polymer. The implant has two distinct layers: 1st layer is a smooth transparent film of spatially cross-linked acrylic polymer with polyamide mesh embedded inside. The 2nd layer is a mesh of spatially cross-linked acrylic polymer, interconnected forming the rough surface. The thickness of the reinforcing layer (in the total thickness of the Reperen® Surgical Mesh) is 0.1 + 0.05 mm. The roughness of the parietal layer for Reperen® Surgical Mesh (all sizes) is about 100 um.
The Reperen® Surgical Mesh is available in six different sizes as described in the table below.
| Designation | Shape | Size in mm | Thickness in mm, | Weight in gm | |
|---|---|---|---|---|---|
| ± 3 mm | ± 0.15 mm | ± 20% | |||
| 1. | Reperen®-15-150-100 | 150 x 100 | 0.4 | 5.4 | |
| 2. | Reperen®-15-200-150 | oval | 200 x 150 | 0.4 | 10.8 |
| 3. | Reperen®-15-250-150 | 250 x 150 | 0.4 | 13.5 | |
| 4. | Reperen®-15-250-200 | 250 x 200 | 0.4 | 18.0 | |
| 5. | Reperen®-15-300-200 | 300 x 200 | 0.4 | 21.6 | |
| 6. | Reperen®-15-370-280 | 370 x 280 | 0.4 | 37.2 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found (Contraindication given for "growth (childhood, pregnancy)")
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)
Performance Data Summary:
The Reperen® Surgical Mesh was subjected to applicable performance/product characterization testing and biocompatibility testing requirements described in the FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (Document issued on March 2, 1999) to determine substantial equivalence to its predicate devices. The Reperent Surgical Mesh met all specified design and performance requirements.
Performance Testing included the following tests.
- Mesh Thickness
- Mesh Density
- Suture Retention Strength
- Tear Resistance
- Uniaxial Tensile Stress
- Ball Burst Testing
- Mesh Stiffness
Biocompatibility Testing was performed per 10993-1 and included the following tests.
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity
- Systemic toxicity (acute)
- Subchronic Toxicity
- Genotoxicity
- Implantation (with histology of the surrounding tissue)
- Hemolysis
- Pyrogenicity
- Chemical Characterization Studies
Animal Studies: In vivo porcine studies were performed to characterize the mechanical strength, tissue response and clinical efficacy in comparison to the predicate device. The results demonstrate that the Reperen® Surgical Mesh performance is substantially equivalent to the predicate.
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.
GORE® DUALMESH® BIOMATERIAL (K992189)
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.
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 9, 2017
IconLab Inc. % Mr. Anil Bhalani RA Consultant Extomed. LLC 24261 Lysanda Drive Mission Viejo, California 92691
Re: K170134
Trade/Device Name: Reperen® Surgical Mesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: Class II Product Code: FTL Dated: July 11, 2017 Received: July 11, 2017
Dear Mr. Bhalani:
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
1
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 the quality systems (QS) 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) K170134
Device Name
Reperen® Surgical Mesh
Indications for Use (Describe)
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects.
| 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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3
510(k) SUMMARY (K170134)
Reperen® Surgical Mesh
| Applicant: | IconLab Inc.
65 Enterprise
Aliso Viejo, CA 92656 |
|----------------------------------|--------------------------------------------------------------------------------------------------------|
| Company Contact: | Anil Bhalani
RA Consultant
ExtoMed, LLC
Phone: 949-596-9001
Email: anilbhalani@outlook.com |
| Date Summary Prepared: | August 7, 2017 |
| Trade Name: | Reperen® Surgical Mesh |
| Common/Classification Name: | Surgical Mesh, Class II |
| Regulation Number/Name: | 21 CFR §878.3300, Surgical Mesh |
| Review Panel: | General and Plastic Surgery |
| Product Code: | FTL |
| Substantially Equivalent Device: | GORE® DUALMESH® BIOMATERIAL (K992189) |
Device Description:
The Reperen® Surgical Mesh is made from a biocompatible, hydrophobic acrylic polymer. The implant has two distinct layers: 1st layer is a smooth transparent film of spatially cross-linked acrylic polymer with polyamide mesh embedded inside. The 2nd layer is a mesh of spatially cross-linked acrylic polymer, interconnected forming the rough surface. The thickness of the reinforcing layer (in the total thickness of the Reperen® Surgical Mesh) is 0.1 + 0.05 mm. The roughness of the parietal layer for Reperen® Surgical Mesh (all sizes) is about 100 um.
The Reperen® Surgical Mesh is available in six different sizes as described in the table below.
| Designation | Shape | Size in mm | Thickness in mm, | Weight in gm | |
|---|---|---|---|---|---|
| $\pm 3$ mm | $\pm 0.15$ mm | $\pm 20%$ | |||
| 1. | Reperen®-15-150-100 | 150 x 100 | 0.4 | 5.4 | |
| 2. | Reperen®-15-200-150 | oval | 200 x 150 | 0.4 | 10.8 |
| 3. | Reperen®-15-250-150 | 250 x 150 | 0.4 | 13.5 | |
| 4. | Reperen®-15-250-200 | 250 x 200 | 0.4 | 18.0 | |
| 5. | Reperen®-15-300-200 | 300 x 200 | 0.4 | 21.6 | |
| 6. | Reperen®-15-370-280 | 370 x 280 | 0.4 | 37.2 |
4
Indications for Use:
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects.
Contraindications:
Not for reconstruction of cardiovascular defects. Use of this product in applications other than those indicated has the potential for serious complications, such as aneurysm formation or undesired healing to surrounding tissues.
- Do not use in patients during growth (childhood, pregnancy) .
- . Do not use in the presence of undeleted foreign bodies in the wound, the presence of signs of purulent infection (contaminated wounds)
- . Do not use with uncontrolled and/or active bleeding
- . Strangulated hernia with evidence of necrotic changes in the internal organs of the abdominal cavity
- . Hypoproteinemia (cancer, cirrhosis)
Intended Use:
The Reperen® Surgical Mesh is indicated for use in the reconstruction of hernias, soft tissue deficiencies and temporary bridging of fascial defects. It is not intended to be used for the reconstruction of cardiovascular defects.
Performance Data Summary:
The Reperen® Surgical Mesh was subjected to applicable performance/product characterization testing and biocompatibility testing requirements described in the FDA Guidance for the Preparation of a Premarket Notification Application for a Surgical Mesh (Document issued on March 2, 1999) to determine substantial equivalence to its predicate devices. The Reperent Surgical Mesh met all specified design and performance requirements.
Performance Testing included the following tests.
- Mesh Thickness
- Mesh Density
- Suture Retention Strength ●
- Tear Resistance
- Uniaxial Tensile Stress ●
- Ball Burst Testing ●
- Mesh Stiffness
Biocompatibility Testing was performed per 10993-1 and included the following tests.
- Cytotoxicity
- Sensitization ●
- Irritation or Intracutaneous reactivity
- Systemic toxicity (acute)
- Subchronic Toxicity
- Genotoxicity
- Implantation (with histology of the surrounding tissue) ●
- Hemolysis
- Pyrogenicity ●
- Chemical Characterization Studies ●
5
Animal Studies
In vivo porcine studies were performed to characterize the mechanical strength, tissue response and clinical efficacy in comparison to the predicate device. The results demonstrate that the Reperen® Surgical Mesh performance is substantially equivalent to the predicate.
Voluntary Safety and International Agency Standards:
The following voluntary and international agency standards and guidelines were reviewed and are followed in the development of the Reperen® Surgical Mesh to ensure its safety and suitability for its intended use:
- ISO 11135 Second Edition 2014, Sterilization of health care products -- Ethylene oxide --. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
- . AAMI / ANSI / ISO 10993-7:2008(R) 2012, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals.
- ISO 10993-1:2009, Biological evaluation of medical devices -- Part 1: Evaluation and ● testing within a risk management process.
Substantial Equivalence: The technological differences between the Reperen® Surgical Mesh and the predicate device, GORE® DUALMESH® BIOMATERIAL (K992189) do not raise new questions of safety or effectiveness.
Conclusion:
Information in the 510(k) submission demonstrates that the Reperen® Surgical Mesh is substantially equivalent to its predicate device.