FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Synovis Collagen Matrix is an implantable biologic patch made from non-crosslinked bovine pericardium, intended for the reconstruction and repair of the pericardium. This device received 510(k) clearance (K122306) based on substantial equivalence to predicate devices, primarily Veritas® Collagen Matrix.

The device's safety and performance were evaluated through non-clinical testing, including bench testing and animal studies.

Acceptance Criteria and Device Performance:

Acceptance Criteria Category	Specific Test	Reported Device Performance	Study Type
Mechanical Properties	Suture retention	Bench testing results support performance requirements	Bench Testing
	Thickness	Bench testing results support performance requirements	Bench Testing
	Amine index	Bench testing results support performance requirements	Bench Testing
	Tensile	Bench testing results support performance requirements	Bench Testing
	Burst	Bench testing results support performance requirements	Bench Testing
Sterility & Packaging	Sterilization validation	Bench testing results support performance requirements	Bench Testing
	Packaging and shelf-life	Bench testing results support performance requirements	Bench Testing
Biocompatibility	Biocompatibility	Performed in accordance with ISO 10993-1.	Bench Testing
Systemic Toxicity	Systemic toxicology	No detectable systemic or site-specific toxicity at all time points.	Swine Animal Model
Tissue Integration/Remodeling	Histological examination (Swine)	Device was readily remodeled and integrated into the adjacent host connective tissue.	Swine Animal Model
Healing & Mechanical Integrity	Pneumonectomy stump repair, chest wall defect repair	No systemic or implant site specific toxicity; minimal inflammation, minimal foreign body response or fibrosis; complete healing of bronchial stump with no air leaks; repaired chest wall defects had sufficient mechanical integrity and remained hernia-free for 90 days.	Canine Animal Model
Remodeling (Canine)	Histological analysis (Canine)	Undergoes extensive remodeling through host tissue integration, leading to connective tissue indistinguishable from adjacent host tissue.	Canine Animal Model
Adhesion Formation	Adhesion formation	Demonstrates minimal tissue attachment to the device in case of direct contact with viscera.	Rat Animal Model

Details of the Studies:

Sample size used for the Test Set and Data Provenance:
- Bench Testing: The document does not specify the exact sample sizes for each bench test (suture retention, thickness, amine index, tensile, burst, sterilization validation, packaging, shelf-life, biocompatibility). These tests are typically conducted in a laboratory setting. Data provenance is implied to be from the manufacturer's internal testing.
- Animal Studies:
  - Swine Model: Used for systemic toxicology and histological examination. The exact number of swine is not specified.
  - Canine Model: Used for pneumonectomy stump repair and chest wall defect repair. The exact number of canines is not specified.
  - Rat Model: Used for adhesion formation evaluation. The exact number of rats is not specified.
- All animal studies were conducted prospectively as part of the device evaluation process. The country of origin for the data is not specified but is assumed to be part of the manufacturer's regulatory submission process.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- The studies described are non-clinical (bench and animal studies). Ground truth for these studies is established through objective measurements (e.g., mechanical properties, chemical analysis) and histopathological examination by qualified veterinarians and pathologists, typically employed by contract research organizations or the device manufacturer. The specific number and qualifications of these experts are not provided in the summary.
Adjudication Method for the Test Set:
- Not applicable as these were non-clinical bench and animal studies, not human clinical trials involving expert review and adjudication of patient data for diagnostic accuracy.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This type of study is relevant for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Synovis Collagen Matrix is an implantable surgical patch, not an imaging device.
Standalone Algorithm Performance:
- Not applicable. This device is a biocompatible surgical implant, not a standalone algorithm.
Type of Ground Truth Used:
- For bench testing: Objective measurements of physical and chemical properties.
- For animal studies: Histopathology (histological examination), clinical observation (e.g., absence of air leaks, hernia-free), and systemic toxicology (laboratory analysis).
Sample Size for the Training Set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The term "training set" is used for machine learning models, not for traditional medical devices like surgical implants. The animal studies served as preclinical evaluation, not "training."
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.

Summary

Regulation Number and Section

§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.

(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).