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510(k) Data Aggregation
(257 days)
Bondiloxs Topical Hemostatic Granules
Bondiloxs Topical Haemostatic Granules is indicated for use as a temporary topical dressing for external bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures and for temporary external treatment for controlling moderate bleeding.
The product is a chitosan-based haemostatic agent presented in a granular form in a sealed pouch. It is applied directly to the source of bleeding in a topical wound and pressure applied for up to 3 minutes until hemostasis is achieved. Bondiloxs Topical Hemostatic Granules achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound, Bondiloxs Topical Hemostatic Granules quickly forms a strong seal that completely covers the wound.
The provided document is a 510(k) summary for the Bondiloxs Topical Hemostatic Granules. It details the device's comparison to a predicate device and includes information about performance testing.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical thresholds. Instead, it describes performance characteristics and states that the device's performance was "adequate to support a determination of substantial equivalence to the predicate." The acceptance criterion effectively is that the Bondiloxs Topical Hemostatic Granules performs equivalently to the predicate device, CELOX Pro, in relevant tests.
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Hemostasis (Gel plug formation) | Equivalent to predicate device (CELOX Pro) | Bondiloxs Topical Hemostatic Granules and Celox Pro work equivalently well in stopping bleeding. |
| Adhesion strength of plug | Equivalent to predicate device (CELOX Pro) | Not explicitly stated beyond general equivalence for hemostasis. Implied to be equivalent as part of overall haemostatic function. |
| Bleeding control in moderate bleeding situations (porcine model) | Equivalent to predicate device (CELOX Pro) | The results demonstrate that the Bondiloxs Topical Hemostatic Granules and Celox Pro work equivalently well in stopping bleeding in this wound model. |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11. | Demonstrated to be in compliance with the requirements of ISO 10993-1 (Biological Evaluation of Medical Devices), including cytotoxicity, irritation/sensitization, and systemic toxicity testing. Performance was "adequate". |
| Sterilization validation | Compliance with ISO 11137-1 | Performed in compliance with ISO 11137-1. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the animal (porcine) bleeding model tests. It refers to "representative wound models."
- Data Provenance: The studies appear to be prospective in nature, as they involve actively testing the device and predicate in bench and animal models. The country of origin for the data is not explicitly stated, but the manufacturer is Medtrade Products Ltd based in the United Kingdom.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is generally not applicable to the evaluation of a topical hemostatic granule device where performance is assessed through objective measurements (e.g., stopping bleeding, plug formation, adhesion strength, biocompatibility assays) rather than expert interpretation of images or clinical outcomes requiring consensus. The ground truth would be established by the experimental setup and objective measurements.
4. Adjudication Method for the Test Set
Not applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies involving human interpretation where disagreements need to be resolved. Performance was assessed through objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is a topical hemostatic medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, no MRMC study or AI assistance evaluation would have been conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable, as this is not an algorithm or AI-based device. The device itself is a standalone product.
7. The Type of Ground Truth Used
The ground truth for the performance studies was established through:
- Objective Measurements: Such as the observation of hemostasis (stopping of bleeding), gel plug formation, and adhesion strength in bench and animal models.
- Standardized Biological and Sterilization Testing: Compliance with ISO 10993 and ISO 11137 standards for biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity) and sterilization validation.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. Performance was evaluated against a predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
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