(148 days)
Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene. They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction. Hermesh 7 polypropylene 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.
The provided 510(k) summary for Hermesh 7 does not contain information about acceptance criteria or a study proving that the device meets these criteria in the context of an AI/ML medical device.
This document describes a conventional surgical mesh device, not an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to the information provided.
The "Testing" section mentions various biocompatibility and sterilization tests conducted to show the safety, efficacy, and performance of the device, in compliance with ISO 10993 and FDA guidance for surgical mesh. These tests are standard for physical medical devices and do not involve AI/ML performance evaluation.
Summary of information that can be extracted, albeit not in the AI/ML context requested:
| Characteristic | Description |
|---|---|
| Acceptance Criteria | Not specified in the provided text in terms of quantitative performance metrics for device function. The document states compliance with ISO 10993 and FDA guidance for surgical mesh. |
| Reported Device Performance | For a traditional surgical mesh, "performance" is generally demonstrated through biocompatibility, mechanical strength, and sterility, rather than metrics like sensitivity, specificity, or AUC. The document lists tests performed: Mutagenicity, Cytotoxicity, Hemolysis, Sensitization, Systemic Toxicity, Ethylene Oxide Residual <1ppm, Sterility Assurance level 10-8, and Ethylene Chlorohydrin Level <2ppm. These are tests for safety and manufacturing quality, not AI performance. |
| Sample Size (Test Set) | Not applicable for an AI device. For the physical device tests, no specific sample sizes for each test are provided, but the tests were performed on the Hermesh 7 product. |
| Data Provenance (Test Set) | Not applicable for an AI device. |
| Number of Experts (Ground Truth) | Not applicable for an AI device. |
| Qualifications of Experts (Ground Truth) | Not applicable for an AI device. |
| Adjudication Method (Test Set) | Not applicable for an AI device. |
| MRMC Comparative Effectiveness Study | No. This is a conventional medical device, not an AI/ML device, so no MRMC study was conducted. |
| Standalone Study (Algorithm Only) | No. This is a conventional medical device. |
| Type of Ground Truth Used | Not applicable for an AI device. For the physical device, compliance with established biological and chemical safety standards (e.g., ISO 10993 parameters, specific chemical residue levels) serves as the "ground truth" for safety and efficacy. |
| Sample Size (Training Set) | Not applicable. This is not an AI/ML device. |
| How Ground Truth for Training Set was Established | Not applicable. This is not an AI/ML device. |
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K070625 Page 1/2
August 1, 2007
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
Submitter: Herniamesh SRL Via Fratelli Meliga 1/C Chivasso, Italy Tel +39 011 9196236 Fax +39 011 9196239
Contact: Lorena Trabucco 540 MUTTONTOWN EASTWOODS ROAD Syosset, NY 11791 Tel 516 987-9364 -- 516 584 6818 e-mail: lorenat63@aol.com
April 16, 2012
Date Prepared:
Classification: Polymeric Surgical Mesh (product code FTL) Class II device per 21 CFR 87.8.330
Acres Ad
Common Name: Polymeric Surgical Mesh
Proprietary Name: Hermesh 7
Predicate Devices: K053424 POPMESH (Caldera Medical Inc.) K041632 MINIMESH® (Mpathy Medical Devices LTD.) K973955 Herniamesh surgical meshes (Herniamesh Srl) K043259 BioBlanket (Kensey Nash)
Device Description: Hermesh 7 prosthesis are non- absorbable monofilament polypropylene meshes constructed from knitted monofilaments of extruded polypropylene.
They are warp knitted in such a way that the mesh may be cut into preshaped designs without unraveling. They maintain excellent isotropic properties because of its knitted construction.
Hermesh 7 polypropylene 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.
Intended Use: May be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional in open or laparoscopic abdominal procedures.
Hermesh 7 are prescriptive devices and should only be used by a licensed physician.
Hermesh 7 have the same indications as predicate devices.
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K070625 page 2/2
Image /page/1/Picture/1 description: The image shows a logo with a figure of a person holding a spear. The figure is standing in front of a circle, and the word "HERNIAMESH" is written across the middle of the circle. The logo is black and white and appears to be a vintage design.
The patient contact materials used in these devices are the same as predicate Testing: devices. All are made of 100% Polypropylene and have similar technological characteristics. Please see Material Safety Data Sheet on page 85 and technological characteristics Comparison table on page 8.
Polypropylene has a long history of biocompatibility.
Hermesh 7 polypropylene meshes 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 Allergic Herniamesh T-Sling. Mutagenicity, Cytotoxicity, Hemolysis, the Sensitization, Systemic Toxicity, Ethylene Oxide Residual <1ppm, Sterility Assurance level 10-8, and Ethylene Chlorohydrin Level <2ppm. Please refer to pages 11 and 14-80 for details of tests.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a blue stylized caduceus, which is a symbol often associated with healthcare and medicine.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Marketing Solutions, Incorporated/Herniamesh SRL % Ms. Lorena Trabucco 540 Muttontown Eastwoods Road Syosset, New York 11791
JUL 12 2012
Re: K070625
Trade/Device Name: Hermesh 7 Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: FTL Dated: July 25, 2007 Received: July 27, 2007
Dear Ms. Trabucco:
This letter corrects our substantially equivalent letter of August 1, 2007.
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 (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 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
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2 - Ms. Lorena Trabucco
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 device-related 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely,
Mark Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image is a black and white logo featuring a figure of a person holding a long object over their shoulders. The figure is inside of a circle, and there is a banner across the middle of the circle. The text "HERNIAMESH" is written in all caps on the banner.
Indications for Use Form
510(k) Number (if known) K070625
Device Name: Hermesh 7
Indications For Use:
Hermesh 7 monofilament polypropylene mesh may be used for repair of abdominal wall hernia, including inguinal, femoral, and incisional, in open or laparoscopic abdominal procedures.
Prescription Use__x
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Daniel Krome by MM
(Division Sign Off)
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K070625
HERNIAMESH SRL Sede legale Via Fratelli Meliga 1/C - 10034 Chivasso (TO) Cap. Soc. € 98.800 I.v. - P.I. 02791540616 - C. F. 02245180613 - N. Iscrizione Rea Torino TO-860622 Tel. +39-0119196236 - fax +39-0119196239 Mall: info@hemlamesh.it - Mail certificata: amministrazione@gec.hemlamesh.it - Sito internet www.hemiamesh.com
§ 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.