(34 days)
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No
The device description focuses on the biological material and chemical processing, with no mention of AI or ML terms or functionalities.
No
The device is described as a "prosthesis for the surgical repair of soft tissue deficiencies," which acts as a replacement or reinforcement for tissue rather than actively treating a disease or condition to restore health.
No
The device is described as a "prosthesis for the surgical repair of soft tissue deficiencies," indicating its use in treatment rather than diagnosis. The device description also focuses on its material and sterilization process, not on any diagnostic capabilities.
No
The device description clearly states it is a physical product made from bovine pericardium, which is a biological tissue, and undergoes chemical processing and sterilization. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for the surgical repair of soft tissue deficiencies. This is a surgical implant, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility testing.
- Device Description: The description details a biological material (bovine pericardium) used as a prosthesis. This aligns with a surgical implant, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), reagents, or any process related to in vitro testing.
Therefore, this device is a surgical implant, not an IVD.
N/A
Intended Use / Indications for Use
For use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
Product codes
FTM, OWV
Device Description
Supple Peri-Guard® is prepared from bovine pericardium which is crosslinked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.
Supple Peri-Guard is packaged in a container filled with sterile, nonpyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
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 and thoracic wall, diaphragm, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical (hernias)
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)
Supple Peri-Guard K921895 and K923657
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