(267 days)
Colorado Therapeutics Xenograft Implant is intended to be used for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes.
It is supplied sterile.
It is intended for one-time use.
Colorado Therapeutics Xenograft Implant is a sterile implant consisting of porcine pericardium. It is glutaraldehyde cross-linked, sterilized by ethylene oxide (EO) and packaged dry with no rehydration required. The Colorado Therapeutics proprietary process produces a uniquely thin and dry xenograft implant that provides the suitable strength, and biocompatibility for a soft tissue repair implant.
The provided document is a 510(k) premarket notification for a medical device called the "Colorado Therapeutics Xenograft Implant." It details the device's characteristics, intended use, and comparison to predicate devices, focusing on non-clinical testing to establish substantial equivalence.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it describes compliance with guidance and equivalence to predicate devices for various tests. Therefore, the table below will summarize the tested parameters and the finding of equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Non-Clinical Tests: | Equivalence to Predicate Devices (Permacol™ Surgical Implant, K120605, and Surgisis® Biodesign® Hernia Graft, K980431) or compliance with published guidance. |
| Biocompatibility (cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation, hemolysis, subchronic toxicity, chronic toxicity) | Both the Xenograft Implant and predicate devices underwent the same testing, suggesting comparable biocompatibility. |
| Product Characterization: | |
| - Glutaraldehyde residuals | Data reported. |
| - Heavy metals (final and unprocessed porcine pericardium) | Data reported. |
| - Volatile organic compounds | Data reported. |
| - Collagen typing | Device is comprised primarily of Collagen Type II, Type III, and Type IV. |
| - Collagenase degradation | In vitro collagenase evaluation showed equivalent degradation scores for the XI material and K120605 Permacol device. |
| - Pore structure | Data reported. |
| - DNA concentration | Data reported. |
| - Mesh thickness | Comparisons made via measurements of histological images, suggesting comparable thickness. |
| - Mesh weave characteristics | Data reported. |
| - Mesh density | Data reported. |
| - Tensile strength | Bench testing demonstrated mechanical properties (including tensile strength) of the Xenograft Implant and predicates are substantially equivalent through uniaxial testing. |
| - Device stiffness | Bench testing demonstrated mechanical properties (including device stiffness) of the Xenograft Implant and predicates are substantially equivalent through uniaxial testing. |
| - Suture pullout strength | Bench testing demonstrated mechanical properties (including suture pullout strength) of the Xenograft Implant and predicates are substantially equivalent. |
| - Tear resistance | Bench testing demonstrated mechanical properties (including tear resistance) of the Xenograft Implant and predicates are substantially equivalent. |
| In Vivo Resorption Profile and Inflammatory Response | Animal model (rabbits with inlay, bridged hernia repair) showed histopathological matrix degeneration scores equivalent to predicate K120605 Permacol. At 90 days, both had equivalent mild to moderate inflammatory response scores. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Biocompatibility: Not specified. The text indicates "Both predicates underwent the same testing," implying the Xenograft Implant also underwent this testing, but the number of samples or subjects is not provided.
- Product Characterization: Not specified for each individual test.
- In Vivo Resorption Profile and Inflammatory Response: Rabbits were used in an animal model, but the specific number of rabbits is not disclosed.
- Bench Testing (Mechanical Properties): Not specified.
- Data Provenance: The studies were non-clinical (bench testing and animal studies). The document does not specify the country of origin for these studies, but the submitting company is based in the USA (Colorado). The studies are inherently "prospective" in the sense that they were conducted for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the studies are non-clinical (bench testing and animal studies) and do not involve human expert interpretation of data in the way a clinical study or AI algorithm validation would. The "ground truth" here is derived from objective measurements and histological assessments by trained personnel in laboratory settings.
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. There is no mention of adjudication by human experts for the non-clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Tests Submitted: Not Applicable; no clinical tests are submitted for this 510(k)." The entire submission focuses on non-clinical data and substantial equivalence to predicate devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a "Xenograft Implant" (surgical mesh), not an AI algorithm or software device. Therefore, the concept of standalone algorithm performance is irrelevant.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Objective Measurements: For product characterization (e.g., glutaraldehyde residuals, heavy metals, collagen concentration, pore structure, thickness, mechanical properties like tensile strength, stiffness, suture pullout, tear resistance).
- Histopathological Assessments: For in vivo studies on resorption profile and inflammatory response in animal models.
- Established Test Methods: Compliance with standard biocompatibility testing protocols.
- Comparison to Predicate Devices: The primary method of establishing "ground truth" for substantial equivalence is demonstrating that the new device performs equivalently to previously cleared predicate devices for the same tests.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical medical implant, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable as there is no training set for a physical implant device.
§ 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.