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.

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

AI/ML Overview

The provided document is a 510(k) summary for the Reperen® Surgical Mesh, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on a clinical study where "performance" is measured in terms of diagnostic accuracy or similar metrics for AI/software devices.

Therefore, the typical questions regarding AI/software device performance, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.

This document describes a surgical mesh, which is a physical implant, and its performance is evaluated through physical and biological testing, as well as an animal study, to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the available information in the context of device acceptance, though it won't perfectly fit the requested AI/software performance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The device (Reperen® Surgical Mesh) was subjected to performance and biocompatibility testing and an in vivo animal study to determine its substantial equivalence to a predicate device, GORE® DUALMESH® BIOMATERIAL (K992189). The document states that the device "met all specified design and performance requirements."

Since this is a 510(k) summary for a physical mesh, the "acceptance criteria" are related to physical properties and biocompatibility, not diagnostic performance. The document doesn't explicitly list numerical acceptance criteria with corresponding performance values but states compliance.

Acceptance Criteria (Type of Test)	Reported Device Performance
Performance Testing:
Mesh Thickness	Met specified design requirements
Mesh Density	Met specified design requirements
Suture Retention Strength	Met specified design requirements
Tear Resistance	Met specified design requirements
Uniaxial Tensile Stress	Met specified design requirements
Ball Burst Testing	Met specified design requirements
Mesh Stiffness	Met specified design requirements
Biocompatibility Testing (per ISO 10993-1):
Cytotoxicity	Met specified design requirements
Sensitization	Met specified design requirements
Irritation or Intracutaneous reactivity	Met specified design requirements
Systemic toxicity (acute)	Met specified design requirements
Subchronic Toxicity	Met specified design requirements
Genotoxicity	Met specified design requirements
Implantation (with histology)	Met specified design requirements
Hemolysis	Met specified design requirements
Pyrogenicity	Met specified design requirements
Chemical Characterization Studies	Met specified design requirements
Animal Studies	Performance substantially equivalent to predicate device (mechanical strength, tissue response, clinical efficacy)

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

Test Set (for physical/biocompatibility testing): Not specified in terms of numerical sample sizes for each test, but standard test methods would dictate appropriate sample numbers. The tests are laboratory-based, not patient data-based.
Test Set (for animal study): Described as "In vivo porcine studies." The exact number of animals is not specified in this summary.
Data Provenance: The physical and biocompatibility testing were laboratory-based. The animal study involved "porcine" (pig) models. This is prospective experimental data.

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

This concept is not applicable as this is not a diagnostic device or AI software. "Ground truth" for a physical device like a surgical mesh is established by standardized physical measurements, chemical analyses, and histopathological evaluations, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable for this type of device and testing.

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 not an AI or diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the performance testing, the "ground truth" is derived from standardized physical and mechanical measurements against predefined specifications (e.g., thickness, tensile strength limits). For biocompatibility, it's defined by biological responses within acceptable limits according to ISO 10993 standards and histopathological findings in the animal study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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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

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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

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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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510(k) SUMMARY (K170134)

Reperen® Surgical Mesh

Applicant:	IconLab Inc.65 EnterpriseAliso Viejo, CA 92656
Company Contact:	Anil BhalaniRA ConsultantExtoMed, LLCPhone: 949-596-9001Email: 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 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

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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:

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 ●

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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.

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.