(207 days)
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No
The summary describes surgical meshes and plugs for hernia repair, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is used for the surgical repair of hernias and thoracic wall defects, which are therapeutic interventions.
No
The device is described as a surgical mesh used for the repair of hernias and wall defects, which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly states the product is a mesh made of monofilament polypropylene, which is a physical material used in surgical repair, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the devices are for the "surgical repair of abdominal wall hernias" and "thoracic wall defects." This describes a surgical implant used in vivo (within the body) for structural repair.
- Device Description: The description reinforces this by detailing the materials (monofilament polypropylene) and how they are used in surgical procedures for hernia repair and chest wall defects.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is a surgical implant used in vivo.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FTL
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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
abdominal wall hernias, femoral hernias, chest wall defects, thoracic wall defects
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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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.
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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.
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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).
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§ 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.
0
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.
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.
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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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
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
3
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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 |
|---|---|
| ------------------------------------------ | --- |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format :-2-96) |