(59 days)
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No
The summary describes a surgical mesh for hernia repair and does not mention any AI or ML components or functionalities.
Yes
The statement "The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair" indicates it is used for treatment, which classifies it as a therapeutic device.
No
The device is a surgical mesh for hernia repair, not a tool for diagnosing medical conditions.
No
The device description clearly states it is a "surgical mesh," which is a physical hardware component, not software. The performance studies also focus on hardware-related testing like biocompatibility and sterility.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a surgical mesh for hernia repair." This is a device used in vivo (within the body) during a surgical procedure.
- Device Description: The description confirms it's a "surgical mesh for reinforcement of a hernia defect." Again, this describes a physical implant used during surgery.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This description contains none of these elements. There's no mention of analyzing samples, diagnostic information, or laboratory testing.
The Kugel Hernia Patch™ is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.
Product codes
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Device Description
The Kugel Hernia Patch™ is a surgical mesh for reinforcement of a hernia defect.
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 and the groin area
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)
The following tests and validation have been or will be performed on the Kugel Hernia Patch™: - Biocompatibility per ANSI/AAMI/ISO 11135-1994 . Sterility validation per ANSIAAMI/ISO 11135-1994 - Sterility testing per industry accepted protocols ● - LAL testing per industry accepted test protocols - Packaging integrity process validation - NTSB shipping durability test ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Atrium Polypropylene Mesh
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
OCT 11 1996
Kugel Hernia Patch™ 510(k) Summary
In accordance with 21 CFR section 807.92 Surgical Sense, Inc. is submitting the following safety and effectiveness summary.
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Submitter Information Surgical Sense, Inc. 2108 Scenic Bay Drive Arlington, TX 76103 817-457-7067 Contact: J. Doug Inman Prepared: August 5, 1996
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Name of Device
Proprietary Name: Kugel Hernia Patch™ Common Name: Surgical Mesh Classification Name: Surgical Mesh
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Substantially equivalent to Atrium Polypropylene Mesh
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The Kugel Hernia Patch™ is a surgical mesh for reinforcement of a hernia defect.
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The intended use of the Kugel Hernia Patch™ is a surgical mesh for hernia repair. It is indicated for use in all forms of hernia repair. A few examples of hernia repair are Inguinal, Fermoral, Incisional and Ventral hernia repairs in the abdominal wall and the groin area.
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The Kugel Hernia Patch™ is equivalent to the Atrium Polypropylene Mesh in that it has the same intended use (hernia repair), the same material (polypropylene mesh) and the same sterilization method (EtO).
The Kugel Hernia Patch™ has been designed using materials from existing medical devices. The following tests and validation have been or will be performed on the Kugel Hernia Patch™:
- Biocompatibility per ANSI/AAMI/ISO 11135-1994
- . Sterility validation per ANSIAAMI/ISO 11135-1994
- Sterility testing per industry accepted protocols ●
- LAL testing per industry accepted test protocols
- Packaging integrity process validation
- NTSB shipping durability test ●