(307 days)
CardioCel is indicated for use as a patch in pericardial closure and the repair of cardiac and vascular defects including intracardiac defects; septal defects, valve and annulus repair; great vessel reconstruction, peripheral vascular reconstruction and suture line buttressing.
The CardioCel device is a cardiovascular patch prepared from glutaraldehyde-crosslinked bovine pericardium using the ADAPT® TEP technology. It is a sterile, light yellow to beige colored, moist, pre-cut, flat sheet of acellular collagen. CardioCel has a shelf life of 24 months when stored between 2°C - 25°C. CardioCel is supplied in three sizes: 4 x 4 cm, 5 x 8 cm and 14 x 7 cm.
The acceptance criteria for the CardioCel device, a cardiovascular patch, are implicitly established by demonstrating substantial equivalence to predicate devices (Edwards Bovine Pericardial Patch K082139 and CV Peri-Guard Cardiovascular Patch K971726) through various studies. The device aims to meet performance characteristics related to mechanical strength, biocompatibility, and clinical safety and efficacy in cardiac repair.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since specific numerical acceptance criteria (e.g., minimum burst strength in MPa) are not explicitly stated, the criteria are inferred from the need to be "substantially equivalent" to predicate devices. The reported performance suggests the device meets these inferred criteria.
| Acceptance Criterion (Inferred from Substantial Equivalence to Predicate Devices) | Reported Device Performance |
|---|---|
| Bench Testing | |
| Burst strength comparable to predicates | CardioCel functional testing, including burst strength, has demonstrated it is a "consistent, stable patch material suitable for cardiovascular repair in high pressure environments." Side-by-side studies demonstrated substantial equivalence to predicate devices. |
| Suture retention strength comparable to predicates | Demonstrated (mentioned as part of functional testing). |
| Tensile strength comparable to predicates | Demonstrated (mentioned as part of functional testing). |
| Crosslink stability comparable to predicates | Demonstrated. Side-by-side studies showed substantial equivalence. |
| Pronase digestion comparable to predicates | Demonstrated. Side-by-side studies showed substantial equivalence. |
| Biocompatibility | |
| Favorable biocompatibility meeting ISO 10993 requirements | Biocompatibility testing according to ISO 10993 confirmed that CardioCel exhibited favorable biocompatibility characteristics, "in common with the predicate devices." Implied equivalent to predicate devices. |
| Non-Clinical Studies (Animal Models) | |
| Effective and durable repair of defects in relevant models | Pivotal studies in sheep models demonstrated that CardioCel provided "effective and durable repair of jugular vein defects and both mitral and pulmonary heart valve defects." |
| Tissue remodeling and preservation of valve function without calcification | The biocompatible properties allowed "tissue remodeling in and around the implant and preservation of valve function. without calcification." |
| Safety and performance in high-pressure hemodynamic environment comparable to predicates | "The safety and performance characteristics of CardioCel in a high pressure hemodynamic environment compare favorably with published animal studies using predicate devices." |
| Clinical Studies | |
| Safety and efficacy in human patients | A clinical study demonstrated "durability, efficacy and favorable hemodynamic properties." |
| No graft-related morbidity or mortality | "There was no graft related morbidity or mortality." |
| No evidence of calcification up to 36 months post-surgery | "No evidence of calcification up to 36 months after surgery." |
| Clinical performance comparable to predicate devices | "The clinical performance of CardioCel compares favorably with clinical studies using predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Clinical Study: 30 pediatric patients.
- Non-Clinical Studies (Animal): Information on the exact number of animals in the sheep model for pivotal studies is not provided, but it states "small and large animal models."
- Data Provenance:
- Clinical Study: Not explicitly stated, but the sponsor is Australian (Admedus Regen Pty Ltd). This suggests the study might have been conducted in Australia or internationally, but the country of origin of the data is not specified.
- Clinical Study Type: Prospective (implied by "A clinical study... was undertaken to assess the safety and efficacy").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- The document describes a clinical study of 30 pediatric patients but does not specify the number of experts used to establish ground truth (e.g., for assessing outcomes, efficacy, or adverse events).
- Qualifications of Experts: Not specified. Decisions in such clinical studies would typically be made by medical professionals (e.g., cardiac surgeons, cardiologists) involved in the care of the patients and evaluation of the device.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method (e.g., 2+1, 3+1) for the test set in either the clinical or non-clinical studies. Outcomes would have been assessed by the clinical investigators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was done or mentioned. This type of study is more common for diagnostic imaging devices rather than implantable patches. The comparison is made against existing predicate devices and literature.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. This device is a physical implant (cardiovascular patch), not an algorithm or software. Therefore, no standalone algorithm-only performance study was conducted. Performance is assessed through bench tests, animal studies, and human clinical trials.
7. Type of Ground Truth Used
- Clinical Study: The "ground truth" for the clinical study would be based on clinical outcomes data (e.g., successful repair, absence of complications, sustained hemodynamic properties, absence of calcification), assessed by medical professionals during follow-up (up to 36 months).
- Non-Clinical (Animal) Studies: Pathology (e.g., tissue remodeling, calcification assessment) and physiological outcomes data (e.g., durability, preservation of valve function in the specific defect models) would serve as ground truth, observed and evaluated by veterinary researchers and pathologists.
- Bench Testing: Direct measurement against engineering specifications and comparative data from predicate devices.
8. Sample Size for the Training Set
- The concept of a "training set" is typically associated with machine learning algorithms. Since this is a medical device (implantable patch), there isn't a traditional "training set" in the computational sense.
- The development and optimization of the CardioCel device and its ADAPT® TEP technology (which likely involved iterative testing and refinement) would represent an analogous "training" phase, but specific sample sizes for this development process are not provided in the summary. For instance, the number of bovine pericardial samples processed or animals used in early-stage development is not detailed.
9. How the Ground Truth for the Training Set Was Established
- Again, since this is not an AI/ML device, the concept of "ground truth for a training set" as it applies to algorithms is not directly relevant.
- However, the development and refinement of the ADAPT® TEP technology itself would have been guided by extensive R&D, where the "ground truth" would have been established through:
- Biochemical and mechanical characterization: Lab experiments to optimize crosslinking, removal of cellular components, and achieve desired physical properties.
- Early animal studies: To assess initial biocompatibility, degradation, and performance, leading to iterative improvements in the manufacturing process.
- These iterations would inform the "training" (i.e., optimization) of the manufacturing process to produce the final device.
§ 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).