(101 days)
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No
The provided text describes a surgical mesh made from decellularized bovine pericardium. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device description focuses solely on the material and physical properties of the mesh.
Yes
The intended use statements clearly indicate that the device is used to reinforce soft tissues and for repair surgeries, which are therapeutic interventions aimed at treating or alleviating a condition.
No
The device description indicates ProPatch is a surgical mesh primarily used for reinforcing soft tissues, not for diagnosing conditions. Its function is to provide structural support during repair procedures.
No
The device description clearly states that ProPatch is a surgical mesh manufactured from decellularized bovine pericardium, which is a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- ProPatch Function: ProPatch is a surgical mesh intended for implantation into the body to reinforce soft tissues. It is a physical device used within the body (in vivo) during surgical procedures.
- Intended Use: The intended use clearly describes surgical procedures and reinforcement of tissues within the body, not diagnostic testing of samples.
- Device Description: The description details a surgical mesh made from decellularized bovine pericardium, which is consistent with an implantable device, not a diagnostic test kit or instrument.
Therefore, based on the provided information, ProPatch is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ProPatch® is indicated for implantation to reinforce soft tissues where weakness exists including, but not not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.
ProPatch is indicated for the reinforcement of soft tissues repaired by sutures or by suture anchors during tendon repair surgery including, but not limited to: reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
Product codes
FTM, OXK, OXB, OXH, OXE, OWY
Device Description
ProPatch Soft Tissue Repair Matrix (ProPatch) is a surgical mesh manufactured from decellularized bovine pericardium. Decellularized tissues undergo chemical microbial and viral inactivation processes, are inspected for freedom from defects, packaged, and terminally sterilized via gamma radiation.
ProPatch is comprised of a single layer, nominally 0.6 mm thick, and is provided as a sterile and non-pyrogenic product that is fully hydrated and ready for use without the need for rinsing or rehydration prior to implantation.
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
Soft tissues where weakness exists including, but not limited to: defects of the abdominal and thoracic wall, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, hernias, suture-line reinforcement, and reconstructive procedures.
Also, reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps, or other tendons.
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.)
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Predicate Device(s)
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
y: . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . and Restorative Devices
510(k) Number_K101587
5