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510(k) Data Aggregation
(58 days)
RejuvaKnee is intended for use in surgical procedures for the reinforcement and repair of the medial meniscus. In repairing and reinforcing medial meniscal defects, the patient must have an intact meniscal rim and anterior and posterior horns for attachment of the mesh. In addition, the surgically prepared site for the RejuvaKnee must extend at least into the red/white zone of the meniscus to provide sufficient vascularization.
RejuvaKnee reinforces soft tissue and provides a reasonable scaffold that is replaced by the patient's own soft tissue. The RejuvaKnee is not a prosthetic device and is not intended to replace normal body structure.
The RejuvaKnee™ Collagen Meniscus Implant is comprised primarily of bovine Type I collagen (nominally 99%) derived from meniscus. The device is provided in a semi-lunar shape with a triangular cross section to be used to reinforce weakened soft tissue and provide a resorbable scaffold that is replaced by the patient's own tissue.
RejuvaKnee is supplied sterile and is intended for single use.
This is a 510(k) summary for the RejuvaKnee™ Collagen Meniscus Implant.
The device is a resorbable scaffold made of bovine Type I collagen intended for the reinforcement and repair of medial meniscal defects. It is compared to the Ivy Sports Medicine Collagen Meniscus Implant (K170364) as a predicate device.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides a comparison of features between the RejuvaKnee™ Collagen Meniscus Implant and its predicate. Acceptance criteria are implied by the reported values and the claim of substantial equivalence to the predicate.
| Feature | Acceptance Criteria (Implied by Predicate & Device Performance) | RejuvaKnee™ Collagen Meniscus Implant Performance |
|---|---|---|
| Indications for Use | Substantially equivalent to predicate | Same as predicate |
| Material Composition | Type I bovine collagen | Primarily Type I bovine collagen |
| Material Origin | Bovine | Bovine |
| Tissue Source | Not explicitly defined as an acceptance criterion; comparison shown | Meniscus |
| Physical Form | Semi-lunar shape with triangular cross-section | Semi-lunar shape with a triangular cross-section |
| Product Sizes (cm) | Comparable to predicate | Small Medial - 7.5 mm; Large Medial - 9 mm |
| Porosity - SEM | Sufficient to allow for cellular integration from host tissue (>5 micron for RejuvaKnee) | Provides sufficient porosity to allow for cellular integration from host tissue (>5 micron) |
| pH | Comparable to predicate (predicate: 7.12) | 6 - 9.5 |
| Tensile Strength (kg/cm²) | Comparable to predicate (predicate: 62.5 kg/cm²) | ≥ 150 |
| Suturability (kg) | Comparable to predicate (predicate: 0.86 ±0.08 kg) | ≥ 0.5 |
| Thermal Stability (°C) | Comparable to predicate (predicate: 61±1 °C) | 60 ± 3 |
| Biocompatibility | Meets ISO 10993 series of testing | Meets ISO 10993 biocompatibility series of testing |
| Sterility | Sterile, SAL 10-6 using Gamma irradiation | Sterile, SAL 10-6 using Gamma irradiation |
| Pyrogenicity | Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device | Non-pyrogenic - <0.5EU/ml and ≤20.0EU/device |
| Single Use/Reuse | Single use only | Single use only |
2. Sample Size Used for the Test Set and Data Provenance:
- Biocompatibility Testing: Conducted in accordance with ISO 10993-1. Specific sample sizes for each test within the series are not provided but would be standard for such evaluations. Data provenance is not specified but is typically from laboratory testing in a controlled environment.
- Bench Testing: Testing included dimensions, porosity, pH, tensile strength, suturability, pyrogenicity, and thermal stability. "Each lot of finished devices is tested for bacterial endotoxin for lot release." Specific sample sizes per test are not provided but are routine for product characterization. Data provenance is from laboratory testing.
- Animal Testing: The performance was evaluated in goat and canine models. The exact number of animals is not specified. Data provenance is from animal studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable as the studies presented are non-clinical (bench and animal testing). There is no "ground truth" to be established by human experts in the context of diagnostic performance or clinical outcomes for this type of device.
4. Adjudication Method for the Test Set:
This information is not applicable as the studies presented are non-clinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned or performed. The studies are non-clinical and focus on demonstrating substantial equivalence of the material and physical properties of the device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This information is not applicable as the device is a physical medical implant, not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used:
- Bench Testing: The "ground truth" is established by direct measurement against quantitative specifications and comparison to the predicate device's reported characteristics.
- Biocompatibility Testing: The "ground truth" is adherence to the requirements of the ISO 10993-1 standard.
- Animal Testing: The "ground truth" is the observed biological response in the animal models, including safety, biocompatibility, tissue repair/remodeling, and biomechanical function, compared against expected outcomes and published performance of the predicate device.
8. The Sample Size for the Training Set:
This information is not applicable as the studies involve physical device testing, not machine learning or algorithm training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above.
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