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The iTClamp™50 is a clamp device that quickly controls critical bleeding by closing the skin to create a temporary, contained hematoma until surgical repair. The iTClamp50 is a selflocking surgical clamp with suture needles that penetrate the skin to evert the skin edges (similar to sutures or staples) 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 to the cut edges of the skin 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:

1. Suture needles
1. Plastic shell
1. Locking mechanism
1. Lock release mechanism

AI/ML Overview

The provided text describes a 510(k) premarket notification for the iTClamp50, a vascular clamp device. The purpose of this 510(k) is to modify the existing indication for use to include the temporary control of severe bleeding in the neck.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to demonstrating substantial equivalence for the expanded indication of use (neck wounds). The previous 510(k) (K132651) established the device's efficacy for extremities, axilla, inguinal areas, and scalp. For this new 510(k), the key performance aspect is the device's ability to control severe bleeding in the neck.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety: Biocompatibility	Met: No additional biocompatibility testing was deemed necessary. The physical composition, sterilization, and packaging have not changed, so the testing from K132651 is applicable.
Performance: Bench testing (mechanical integrity, fluid seal)	Met: No additional bench performance testing was deemed necessary. The physical composition, packaging, and sterilization have not changed. Bench testing from K132651 is applicable.
Performance: Efficacy in controlling bleeding in neck wounds	Met (via cadaver studies and case studies): Innovative Trauma Care performed cadaver testing to demonstrate the suitability of the iTClamp50 for neck wounds. A second cadaver study compared the iTClamp50's performance with standard of care (direct manual pressure and balloon catheter inflation) and concluded that the device is suitable for neck use and substantially equivalent to the previous 510(k). Additionally, unsolicited case studies from OUS (Outside the US) and off-label use provided supportive data on the device's performance for treating neck wounds.
Usability/User Proficiency: Proper application and removal	Met: A user assessment involving 15 trained first responders (firefighters) was previously conducted for K132651 using a bleeding arm simulator model. This assessment found that training based on the DFU provided sufficient information for successful application and removal, with a needle stick occurrence of

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