All meshes made by Hemiamesh are made of monofilament polypropylene. The meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hernias, femoral hernias, inscisional hernias as well as thoracic wall defects.

Device Description

Herniamesh products Hertra 1. 2 & 2A and Hermesh 3, 4 & 5 have the same intended uses as Trelex Mesh and Marlex Mesh. All are used in the repair of primary or recurrent inguinal hernias (particularly when facial structures are weak), primary or recurrent inscisional hernias so large that the fascial edges of the hernial ring cannot be approximated (generally one-fourth of the abdominal wall), femoral hernias, or chest wall defects where it is not possible to use autogenous tissue to prevent or correct lung herniation.

Herniamesh Plugs T1, T2 & T3 have the same intended use as the Marlex Mesh Dart which is used for the repair of hernias with a three dimensional shape i.e. femoral, inguinocrueal or large recurrent inguinal hernias.

AI/ML Overview

This document is a 510(k) premarket notification for Herniamesh surgical meshes, demonstrating substantial equivalence to predicate devices (Trelex Mesh and Marlex Mesh). It doesn't report on an AI/ML device or a study with typical acceptance criteria like sensitivity, specificity, accuracy, etc. Instead, the "acceptance criteria" here are questions related to establishing substantial equivalence for a medical device submitted under a 510(k) pathway.

Therefore, the requested information elements (1-9) which are typically associated with performance studies for AI/ML devices or clinical trials, are not applicable to this document. The document focuses on demonstrating equivalence in terms of indications, intended use, and technological characteristics.

Here’s a breakdown of why each requested point isn't directly applicable in the context of this 510(k) summary:

1. A table of acceptance criteria and the reported device performance: This document doesn't present a study with quantitative performance metrics for the Herniamesh products as it's a submission for substantial equivalence based on material, design, and intended use, not clinical efficacy or diagnostic accuracy. The "acceptance criteria" are the four questions posed by the FDA's decision-making process for substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of a performance study described here. The evaluation is a comparison against existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" to establish through expert consensus in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as points 2 and 3.
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/ML device, and no MRMC study or human reader improvement is discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" is not a concept that applies to this type of substantial equivalence submission.
8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

Summary of the document's approach to "acceptance criteria":

The document defines "acceptance criteria" (though not explicitly called that) as the four questions from the FDA's "substantial Equivalence" Decision-Making Process:

Does New Device Have Same Indication Statement?
- Reported performance/Finding: Yes. All indications are identical to predicate devices (repair of abdominal wall hernias, femoral hernias, chest wall defects).
New Device Has Same Intended Use and May be "Substantially Equivalent"?
- Reported performance/Finding: Yes. Intended uses are the same as predicate devices (e.g., repair of primary/recurrent inguinal hernias, incisional hernias, femoral hernias, chest wall defects).
Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?
- Reported performance/Finding: Yes. Made of the same material (polypropylene monofilament of various thickness). Design and structure (monofilament knitted into a mesh design, flat or three-dimensional) are the same as predicate devices.
Are The Descriptive Characteristics Precise Enough to Ensure Equivalence?
- Reported performance/Finding: Yes. Since materials, design, and structure are the same, the descriptive characteristics applying to predicate devices also apply to Herniamesh products. Process validation will ensure properties are maintained.

Conclusion:

Based on answering "Yes" to all four questions, the Herniamesh surgical meshes are deemed "Substantially Equivalent" to the predicate devices. This is the "study" and "proof" provided within this 510(k) submission for regulatory acceptance.

Summary

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K973955

PREMARKET NOTIFICATION FOR HERNIAMESH PRODUCTS

MAY 11 1998

SUMMARY OF SAFETY AND EFFECTIVENESS

The Herniamesh surgical meshes are substantially equivalent to Trelex mesh currently marketed by Meadox Medicals, and to Marlex Mesh and the Marlex Mesh Dart currently marketed by Bard Vascular Systems Division, C.R. Bard, Inc. Trelex Mesh and Marlex mesh are both available in a variety of shapes and sizes. The "510 (k) "substantial Equivalence" Decision-Making Process (Detailed)" decision tree was utilized to make a determination of substantial equivalence (see Exhibit I). The answers to the following four questions lead to a determination of substantial equivalence.

1. Does New Device Have Same Indication Statement?

Yes, all of the indications for Herniamesh products are identical to those of the predicate devices. All are indicated for the repair of abdominal wall hernias, femoral hernias or chest wall defects.

2. New Device Has Same Intended Use and May be "Substantially Equivalent"?

Yes, the intended use of Herniamesh products are the same as predicate devices.

3. Does New Device Have Same Technological Characteristics, e.g., Design, Materials, etc.?

Yes, Herniamesh products have the same technological characteristics as predicate devices. Herniamesh products, Trelex mesh, Marlex Mesh and the Marlex Mesh Dart are all made of the same material. All are a polypropylene monofilament of various thickness.

The design and structureof Herniamesh products Hertra 1, 2, & 2A, Hermesh 3, 4 & 5 and Plug T1 are the same as Trelex Mesh and Marlex Mesh. All are a monofilament knitted into a mesh design and flat in structure.

The design and srtucture of Herniamesh Plugs T2 and T3 are the Marlex Mesh Datt. All are a monofilament knitted into a mesh design and three-dimensional in structure with the same indications for use. The major differences between all of these products are the thickness of the monofilament and the type of knit used to achieve the mesh design.

4. Are The Descriptive Characteristics Precise Enough to Ensure Equivalence?

Yes, since Herniamesh products are constructed of the same materials, have the same design and the same structure as predicate devices then the descriptive characteristics that apply to Trelex Mesh, Marlex Mesh and the Marlex Mesh Dart also apply to Herniamesh products. The process validation will demonstrate that these properties are maintained.

"Substantially Equivalent" Determination

Based on the above answers the surgical meshes produced by Herniamesh are substantially equivalent to the predicate devices, Trelex Mesh, Marlex Mesh and the Marlex Mesh Dart.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | 1998

Ms. Lorena A. Trabucco •Herniamesh 1802 North 103 Avenue 68114 Omaha, Nebraska

K973955 Re: Herniamesh Surgical Meshes Trade Name: Requlatory Class: II Product Code: FTL Dated: March 9, 1998 March 12, 1998 Received:

Dear Ms. Trabucco:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Trabucco

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K973955

Device Name: HERNIAMESH - SURGICAL MESHES

Indications For Use:

All meshes made by Hemiamesh are made of monofilament polypropylene. The mestes are All mesties made of Trematics are mace of e meshes are designed to be used in the surgical repair of abdominal wall hernias such as primary or recurrent inguinal hernias, femoral hernias, inscisional hernias as well as thoracic wall defects.

filledsformal neimas is well as diesigned with specific characteristics for each of the different types of hernioplasty. (please refer to product pamphiet )

(PLSASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEBDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K973955

Prescription Use(Per 21 CFR 801.109)	X
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Over-The-Counter Use
(Optional Format :-2-96)

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.