(540 days)
Tutopatch bovine pericardium is intended for the reinforcement of tissue during general and plastic surgery repair. The labeling reveals that the applicant and all predicate devices have the same intended use as a general and plastic surgery surgical mesh.
Tutopatch bovine pericardium is intended for use to reinforce soft tissue where weakness exists in general and plastic surgery applications and is indicated for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, repair of rectal prolapse using an abdominal approach (excluding rectocele), reconstruction of the pelvic floor using an abdominal approach (excluding transvaginal repair of pelvic organ prolapse), and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, ventral, scrotal, and umbilical).
Tutopatch bovine pericardium is a Tutoplast® Processed, solvent-dehydrated gamma irradiated preserved bovine pericardium surgical mesh. Tutopatch bovine pericardium consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic formulative structure to support replacement by new endogenous tissue. Tutopatch bovine pericardium is supplied in sterile double-packaged peelable pouches and comes in a variety of sizes.
Here's a summary of the acceptance criteria and the study information for the Tutopatch bovine pericardium device, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The FDA submission for Tutopatch bovine pericardium does not define specific quantitative acceptance criteria in the provided text. Instead, it states that the device was evaluated against general performance standards for safety, biocompatibility, and mechanical strength. The reported performance indicates that the device met these general expectations.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Safety | Tutopatch bovine pericardium has been evaluated for safety. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. The Tutoplast® Process leaves no deleterious residue and minimizes antigenic potential. The device is terminally sterilized by gamma-irradiation. The manufacturer believes the Tutoplast® Process poses no additional questions of safety. |
| Biocompatibility | Tutopatch bovine pericardium has been evaluated for biocompatibility. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. The processing ensures the tissue is reduced to its fiber and mineral components, and the process leaves no deleterious residue. |
| Toxicity | Tutopatch bovine pericardium has been evaluated for toxicity. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. |
| Pyrogenicity | Tutopatch bovine pericardium has been evaluated for pyrogenicity. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. |
| Sterility | Tutopatch bovine pericardium has been evaluated for sterility. The finished products are terminally sterilized by gamma-irradiation. In all instances, it functioned as intended, and all test results and characteristics observed were as expected. |
| Mechanical Strength / Structural Characteristics | Tutopatch bovine pericardium has been evaluated for mechanical strength. The device consists of collagenous connective tissue with three-dimensional intertwined fibers, providing multidirectional mechanical strength. It retains the mechanical strength and elasticity of the native tissue. The gamma-irradiated material exhibits excellent tensile strength, burst strength, and reapproximates well around suture holes, resisting leakage of fluids. It has a wall thickness similar to that of native pericardium and is flexible. In all instances, it functioned as intended. |
| Biomechanical Characteristics | Data collected demonstrate the device has the necessary biomechanical characteristics to function safely and effectively as a surgical mesh. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the data provenance (e.g., country of origin of the data, retrospective or prospective). It simply states that the device was "evaluated by a number of tests."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The provided text does not mention the use of experts to establish ground truth for a test set, nor does it refer to any clinical studies involving expert assessment. The evaluation appears to be based on laboratory and material property testing.
4. Adjudication Method for the Test Set
As there's no indication of a test set requiring expert ground truth or human assessment, an adjudication method is not applicable/not mentioned in the provided documentation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or mentioned in the provided documentation. The submission focuses on the material properties and processing of the surgical mesh rather than comparative clinical performance involving human readers or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a physical surgical mesh, not a software algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the evaluation of the Tutopatch bovine pericardium appears to be based on established material science principles, biocompatibility standards, and mechanical testing protocols as they apply to surgical mesh materials. The tests performed include assessments for safety, biocompatibility, toxicity, pyrogenicity, sterility, and mechanical strength. This is not a clinical "ground truth" derived from patient outcomes or expert consensus on diagnostic imaging.
8. The Sample Size for the Training Set
This is not applicable as the device is a physical surgical mesh and not an AI or machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as the device is a physical surgical mesh and not an AI or machine learning model.
§ 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.