(38 days)
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies, such as but not limited to the repair of hernias and chest wall defects
Relimesh prostheses are dual component meshes made of non-absorbable monofilament polypropylene mesh on one side and a layer of ePTFE on the other side.
Relimesh is warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling and will maintain excellent isotropic properties because of its knitted construction. The ePTFE layer is heat sealed to the polypropylene layer
These meshes have the necessary strength, flexibility, and durability for the various stresses which may be encountered in the body.
The devices are supplied as sterile, single-use surgical meshes.
This document describes the premarket notification (510(k)) for the Herniamesh Relimesh, a surgical mesh intended for the reconstruction of soft tissue deficiencies. The device's acceptance criteria and the study proving it meets these criteria are established through a comparison to legally marketed predicate devices, Composite Mesh (C.R. Bard Inc.) and Hermesh 7 (Herniamesh Srl).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Relimesh device are based on demonstrating substantial equivalence to predicate devices through functional and material characteristic comparisons. The specific acceptance criteria are that the Relimesh device's performance characteristics (suture retention, burst strength, tensile strength) are comparable to or better than the predicate devices, and that its material properties and intended use are similar. The reported device performance is shown in the table below:
| Characteristic | Acceptance Criteria (inferred by predicate) | Relimesh Performance | Predicate 1: Hermesh 7 (K070625) Performance | Predicate 2: Composite Mesh (K971745) Performance |
|---|---|---|---|---|
| Material/Design | Monofilament Polypropylene & ePTFE | Polypropylene & ePTFE | 100% Polypropylene | Polypropylene & ePTFE |
| Mesh Weight (g/sq. m) | Within historical range of predicates | 78 ± 6% | 19 | 214 |
| Filament Diameter (μ) | Within historical range of predicates | 120 | 80 | 160 |
| Thickness Mesh (mm) | Within historical range of predicates | 0.5 ± 10% | 0.27 mm | 1.5 mm |
| % Porosity | Within historical range of predicates | 86.8 | 91.9 | 83 |
| Suture Retention (N) | Comparable to or better than predicates | 24.60 | 8.75 | 26 ± 7.56 |
| Burst Strength (Kpa) | Comparable to or better than predicates | 378 | 359 | 1316 ± 3.8 |
| Tensile Strength (N/cm) | Comparable to or better than predicates | 24 ± 6 | 17.7 | N/A |
| Biocompatibility | Compliant with ISO 10993 | Compliant | - | - |
| Sterility | SAL 10^-6, EtO Residual <1 ppm | Compliant | - | - |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "test set" in the context of clinical studies for acceptance criteria. The evaluation is based on pre-clinical bench testing and material characterization. The provided data originates from Herniamesh SRL (Italy) and C.R. Bard Inc. for their respective predicate devices. The studies are by nature prospective as they are specifically conducted to support the 510(k) submission. No human biological samples are mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. The ground truth for this medical device submission is established through objective engineering and material science standards and biocompatibility testing, rather than expert medical interpretation of images or clinical outcomes from a test set.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a test set requiring adjudication in the context of clinical data or expert interpretation. The evaluation relies on direct measurement and compliance with established standards.
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 submission is for a physical surgical mesh, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or software device. Performance is evaluated based on the physical and material properties of the mesh itself.
7. The Type of Ground Truth Used
The ground truth used for this submission is:
- Bench Testing Data: Objective measurements of physical properties like suture retention, burst strength, and tensile strength.
- Material Characterization: Analysis of material composition (Polypropylene, ePTFE), mesh weight, filament diameter, thickness, and porosity.
- Biocompatibility Standards: Compliance with ISO 10993 for biological evaluation of medical devices.
- Sterilization Standards: Compliance with Ethylene Oxide Residual (<1 ppm), Sterility Assurance Level 10^-6, and Ethylene Chlorohydrin Level (<2ppm).
- Predicate Device Data: Performance characteristics of legally marketed predicate devices serve as the benchmark for substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this type of medical device. The "ground truth" for demonstrating substantial equivalence is established through the comprehensive testing and characterization of the Relimesh device in comparison to established predicate devices and recognized industry standards (e.g., ISO 10993).
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K08/327
Page 1 of 4
JUN 1 9 2008
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS
| Submitter: | Herniamesh SRLVia Fratelli Meliga 1/CChivasso, ItalyTel +39 011 9196236 Fax +39 011 9196239 |
|---|---|
| Contact: | Lorena Trabucco8 Orange Dr.Jericho, NY 11753Tel 516 987-9364 Fax 516 938-2751 |
| Device Name: | Relimesh |
| Predicate Devices: | K971745 Composite Mesh (C.R. Bard Inc.)K070625 Hermesh 7 (Herniamesh Srl) |
| Device Description: | Relimesh prostheses are dual component meshes made of non-absorbablemonofilament polypropylene mesh on one side and a layer of ePTFE onthe other side. |
| Relimesh is warp knitted in such a way that the mesh may be cut intopreshaped designs without unraveling and will maintain excellentisotropic properties because of its knitted construction. The ePTFE layeris heat sealed to the polypropylene layer | |
| These meshes have the necessary strength, flexibility, and durability forthe various stresses which may be encountered in the body. | |
| The devices are supplied as sterile, single-use surgical meshes. | |
| Intended Use: | Relimesh prostheses are intended for use in the reconstruction of softtissue deficiencies, such as but not limited to the repair of hernias andchest wall defects |
| Relimesh is a prescriptive device and should only be used by a licensedphysician. |
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K08/327
page 2 of 4
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.
The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene with and without ePTFE. They have similar technological characteristics. Polypropylene and ePTFE have a long history of biocompatibility. Relimesh prostheses comply with the requirements of ISO 10993 Biological Evaluation of Medical Devices, In addition appropriate tests have been conducted in accordance with the FDA Guidance Document "Guidance for the Preparation of a Premarket Notification Application for Surgical Mesh" The following tests were performed to show the safety, efficacy and performance of the product. Mutagenicity, Cytotoxicity, Hemolysis, Allergic Sensitization, Systemic Toxicity, Ethylene Oxide Residual <1 ppm, Sterility Assurance level 10-6, and Ethylene Chlorohydrin Level <2ppm. Please refer specific tests for more details. Summary of Similarities Relimesh and the predicate devices have the same intended use, which is for & Differences: the reconstruction of soft tissue deficiencies. The technological characteristics are the same or similar to the predicate devices in that the materials used to manufacture theses products are similar; polypropylene and ePTFE. The differences to predicate devices include mesh thickness, the shape, mesh knit structure, diameter of the filament used to weave the mesh and the thickness of the ePTFE layer. Please refer to charts on following page for specific details.
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K081327
page 3 of 4
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.
| Product | MeshWeightg / sq. m | FilamentDiameter μ | ThicknessMesh mm | Material | % Porosity | SizesCm |
|---|---|---|---|---|---|---|
| RelimeshHerniamesh SRL | 78 ± 6% | 120 | 0.5 ± 10% | Polypropylene& ePTFE | 86.8 | flat sheetsof varioussizes &preshapes |
| Hermesh 7Herniamesh SRL(K070625) | 19 | 80 | 0.27 mm | 100 %Polypropylene | 91.9 | flat sheetsof varioussizes &preshapes |
| Composite MeshC.R. Bard Inc.(K 971745) | 214 | 160 | 1.5 mm | Polypropylene& ePTFE | 83 | flat sheetsof varioussizes &preshapes |
Technological Characteristics Comparison Table
| Product | Suture RetentionN | Burst strengthKpa | Tensile strengthN/cm |
|---|---|---|---|
| RelimeshHerniamesh SRL | 24.60 | 378 | $24 \pm 6$ |
| Hermesh 7Herniamesh SRL(K070625) | 8.75 | 359 | 17.7 |
| Composite MeshC.R. Bard Inc.( K 971745) | $26 \pm 7.56$ | $1316 \pm 3.8$ | N/A |
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K081327
perr +074
New 510 (k) Notification for Herniamesh Relimesh
510(K) SUMMARY OF SAFETY & EFFECTIVENESS Cont.
Table of Similarities and Differences / Substantial Equivalence to Predicate Devices
| Feature | HerniameshRelimesh | BardComposix EX Mesh | HerniameshHermesh 7 |
|---|---|---|---|
| 510(k) No. | To be determined | K971745 | K070625 |
| Classification | Class II: PolymericSurgical Mesh | Class II: PolymericSurgical Mesh | Class II: PolymericSurgical Mesh |
| Indication | mesh used for thereconstruction of softtissue deficiencies | mesh used for thereconstruction of softtissue deficiencies | mesh used for thereconstruction of softtissue deficiencies |
| ProductDesign | monofilamentpolypropylene / ePTFE | monofilamentpolypropylene / ePTFE | Polypropylene |
| Materials | Polypropylene / ePTFE | Polypropylene / ePTFE | Polypropylene |
| Sterilization | EtO | EtO | EtO |
| Packaging | Double tyvek pouch | Double tyvek pouch | Double tyvek pouch |
| Tissue Ingrowth | Complete tissueincorporation ofimplant, ePTFE sidereduces incidence of | Complete tissueincorporation of implant,ePTFE side reducesincidence of | Complete tissueincorporation of implant |
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Image /page/4/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 a stylized image of an eagle or bird-like figure with outstretched wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 9 2008
Herniamesh S.R.L. % Marketing Solutions Inc. Ms. Lorena Trabucco 8 Orange Drive Jericho, New York 11753
Re: K081327
Trade/Device Name: Relimesh Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: June 3, 2008 Received: June 5, 2008
Dear Ms. Trabucco:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in 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.
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Page 2 - Ms. Lorena Trabucco
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark M. Millican
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K081327
.
Device Name: Relimesh
Indications For Use:
Relimesh prostheses are intended for use in the reconstruction of soft tissue deficiencies such as but not limited to hernia repairs and chest wall defects.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Milne QL. Forman
(Divisi Division of General, Restorative, and Neurological Devices
Page 1 of 1
510(k) Number K081327
9
§ 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.