(176 days)
The ITClamp™ is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla and inguinal areas.
The ITClamp™ is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The ITClamp is a self-locking surgical clamp with suture needles that penetrate the skin to evert the skin edges between pressure bars of the device and anchor it to the skin to reduce slippage and leakage. Pressure is evenly distributed across the bars, which seal the skin over a wound. An adjustable locking mechanism increases or decreases pressure across the wound to achieve a fluid tight seal.
The ITClamp™ controls bleeding by sealing the skin closed to apply direct pressure and create a temporary pool of blood (hematoma) under pressure. This permits formation of a stable clot until the patient can receive medical care and/or surgical repair.
The device is provided sterile and is for single use.
The ITClamp™ consists of the following components:
- Suture needles
- Plastic Shell
- Locking mechanism
- Lock release mechanism
This document is a 510(k) summary for the iTClamp™ device. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics typically seen for AI/ML-based devices. As such, many of the requested fields are not applicable or cannot be extracted from this type of document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 standards (cytotoxicity, acute system toxicity, muscle implantation, pyrogenicity). | Results confirmed that the materials used in the iTClamp™ are safe for its intended use. |
| Bench Performance: Verify suitability of design characteristics for Extreme Temperature Evaluation, Tensile and Compression Test, Torque, and Needle (Bend and Pull). | Results of the testing confirmed the iTClamp™ met design requirements. |
| Animal Performance (Efficacy): Statistically significant improvements in survival, survival time, and blood loss in a lethal junctional bleed model compared to controls or standard gauze packing. | The iTClamp™ resulted in statistically significant improvements in survival, survival time, and blood loss when compared with controls or packing with standard gauze. |
| Tissue Damage (Safety): No tissue damage observed by histological examination after 3 hours of application in an animal model. | Tissue damage was not observed by histological examination after 3 hours of application. |
| Distribution/Aging/Packaging Integrity: Maintain product integrity for intended use through Distribution Challenge Testing, Accelerated Aging Studies, and microbial aerosol testing. | All testing performed resulted in no nonconformance(s). |
2. Sample Size Used for the Test Set and Data Provenance
The document describes an animal study (porcine model) for performance testing.
- Sample Size: Not explicitly stated for the animal study.
- Data Provenance: Porcine (animal model). The study was prospective in nature, as it involved conducting experiments to assess the device's performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This document describes a medical device (a clamp) and its physical and biological performance, not an AI/ML diagnostic or predictive device where expert-established ground truth for a test set would typically be required in the context of image or data interpretation. The ground truth for the animal study's outcomes (survival, blood loss, tissue damage) would be established through direct observation, measurement, and histological analysis by veterinary and scientific personnel, not human "experts" in the context of interpreting data for an algorithm.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is not an AI/ML-based device where adjudication of interpretations would be relevant. The outcomes of the animal study are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This is not an AI/ML-based device, so an MRMC study comparing human readers with and without AI assistance is not applicable.
6. Standalone (Algorithm Only) Performance Study
- No. This is a physical medical device, not an algorithm, so a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used
- For the animal study, the ground truth was outcomes data (survival, survival time, blood loss) and histology (for tissue damage assessment).
- For biocompatibility, the ground truth was established by adherence to ISO 10993 standards and the results of specific assays (cytotoxicity, etc.).
- For bench performance and packaging, the ground truth was established by design requirements and engineering specifications.
8. Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/ML model, so the concept of a "training set" is not relevant.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As above, the concept of a "training set" for an AI/ML model does not apply here.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).