(76 days)
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No
The device description and performance studies focus on the material properties and biological effects of a bioresorbable patch, with no mention of AI or ML technology.
Yes
The device is described as providing a temporary matrix during natural tissue repair and offering hemostatic tamponade for splenic injury and lung air leaks, which are therapeutic functions.
No
Explanation: The device is intended to provide a temporary matrix for tissue repair and hemostatic tamponade, not to diagnose a condition.
No
The device description clearly states it is a bioresorbable film containing gelatin, which is a physical material, not software. The performance studies also describe the physical application and effects of the patch.
Based on the provided information, the RapiSeal Patch is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide a temporary matrix for tissue repair and hemostatic tamponade in vivo (within the body), specifically on the spleen and lung. IVD devices are used in vitro (outside the body) to examine specimens like blood, urine, or tissue samples to diagnose diseases or conditions.
- Device Description: The device is a bioresorbable film containing gelatin, applied directly to tissue. This is consistent with a surgical or implantable device, not an IVD.
- Performance Studies: The performance studies involve animal surgery and clinical use in patients, demonstrating its effect on bleeding and air leaks in vivo. IVD performance studies typically involve testing the device's ability to accurately detect or measure substances in biological samples.
Therefore, the RapiSeal Patch is a medical device used in vivo for surgical applications, not an IVD.
N/A
Intended Use / Indications for Use
The RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.
Product codes
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Device Description
Each Patch is supplied The Patch is a bioresorbable film containing gelatin. sterile and non-pyrogenic in a single-use package.
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
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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
Nonclinical Tests:
Biocompatibility: Standard biocompatibility testing was performed according to the FDA-modified matrix recommended in FDA memorandum #G95-1 entitled: "Use of International Standard ISO-10993, Biological Evaluation of Medical Device Part-1: Evaluation and Testing". The product passed all of the following biocompatibility tests: Hemocompatibility Cytotoxicity-ISO agarose overlay Cytotoxicity-ISO elution method Acute Systemic Toxicity Irritation-Intracutaneous Reactivity Genotoxicity-Ames mutagenesis Genotoxicity-Sister chromatid exchange Genotoxicity-Chromosomal aberration Sensitization-Magnusson and Kligman Implantation/Subchronic Toxicity.
Effectiveness: Twelve pigs (6 untreated control animals and 6 Patch treated animals) underwent surgery to mimic splenic injury and bleeding. The Patch was effective in providing a means to approximate and close surgically created wounds in the spleen. In addition, the tamponade provided by the Patch resulted in complete cessation of bleeding at the wound site. Moreover, the reduction in bleeding after Patch application was significantly better than that for the untreated controls. Gross and histological examination at 7 and 28 days post-implant showed no abnormal responses to the Patch in the splenic tissue or in the abdomen, showing the Patch material to be biocompatible. No adhesions associated with Patch use were observed.
Clinical Tests: The RapiSeal Patch was used to treat air leaks in the lung in a total of 48 patients during the pre-commercial phase of the product. No Patch-related complications were reported during this clinical evaluation. In addition, the study demonstrated that the Patch was capable of successfully reducing or sealing air leaks intraoperatively.
Conclusions: The conclusions drawn from the nonclinical and clinical testing were that the product is biocompatible and functional for the intended use.
Key Metrics
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Predicate Device(s)
Dexon "S" Polyglycolic Acid Mesh Davis & Geck
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
FEB 1 8 1997 Appendix E--Revised January 31, 1997
510(k) Summary Fusion Medical Technologies, Inc. The Patch
- Fusion Medical Technologies, Inc. l. Sponsor: 1615 Plymouth Street Mountain View, CA 94043
- Debera Brown Contact Person: Vice President, Regulatory and Clinical Affairs
Date of Summary Preparation: January 31, 1997
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- Device Name:
| Trade Name: | RapiSeal™ Patch |
|---|---|
| Common/Usual Name: | Surgical Patch, Surgical Membrane, Surgical Mesh |
| Classification Name: | Surgical Mesh |
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Identification of the Predicate or Legally Marketed Devices to Which Equivalence 3. is being Claimed:
Dexon "S" Polyglycolic Acid Mesh Davis & Geck -
- Device Description:
Each Patch is supplied The Patch is a bioresorbable film containing gelatin. sterile and non-pyrogenic in a single-use package.
- Device Description:
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న. Intended Use:
The RapiSeal Patch is intended to provide a temporary matrix during the natural tissue repair process, resulting in the additional benefit of hemostatic tamponade.
1
- A Statement of How the Technological Characteristics of the Device Compare to 6. Those of the Predicate or Legally Marketed Device(s) Cited.
| FUSION PATCH | Dexon Mesh | |
|---|---|---|
| Intended Use: | Provide a temporary | |
| matrix during the | ||
| natural tissue repair | ||
| process | Provide temporary | |
| support during the | ||
| natural tissue repair | ||
| process | ||
| Indications for Use: | Hemostatic tamponade | Hemostatic tamponade |
| Product Form: | Thin film | Mesh |
| Materials: | Gelatin | Polyglycolic Acid |
| Absorbable: | Yes | |
| ( |