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 <1%. Since the DFU content and technique for application/removal haven't changed, no additional user testing was conducted for neck wounds.

Study Details that Prove Device Meets Acceptance Criteria:

Sample Size used for the test set and the data provenance:
- Cadaver Studies: The text mentions "cadaver testing" and "a second cadaver study." It does not specify the exact number of cadavers used.
- User Assessment (previously conducted): 15 trained first responders (firefighters) were used. The provenance is not explicitly stated as country of origin, but it describes a simulated environment and users. This was a prospective simulation study.
- Clinical Study (for neck indication): "Unsolicited case studies of OUS and off-label use" were collected. The sample size (number of cases) is not specified. "OUS" indicates external/international data. This data would be retrospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For Cadaver Studies: The text does not explicitly state the number or qualifications of experts establishing ground truth within the cadaver studies themselves. However, the studies were conducted by Innovative Trauma Care, Inc., implying internal expertise in evaluating device performance.
- For User Assessment: The "primary assessment was external leakage of water from the wound," which is an objective measure. User needle sticks were also evaluated. This was likely evaluated by the study organizers (McKee, J., McKee, I., Gao, H., Frost, G., Kirkpatrick, A.W.). Their specific qualifications are not detailed beyond being authors of the mentioned paper.
- For Clinical Study/Case Studies: For the unsolicited case studies, the "ground truth" (i.e., whether the device controlled bleeding) would have been established by the reporting clinicians or healthcare providers treating the patients. Their specific qualifications are not provided in this document.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document does not specify any formal adjudication methods (like 2+1 or 3+1) for the cadaver studies, user assessment, or the unsolicited case studies. Assessments appear to be direct observations or reports.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC or AI-assisted study was conducted. This device is a physical medical device (vascular clamp), not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cadaver Studies: The ground truth for performance in stopping bleeding would be direct observation and measurement of bleeding control within the cadaver model.
- User Assessment: Ground truth included objective measures of "external leakage of water from the wound" and "user needle sticks."
- Clinical Study (Case Studies): The ground truth would be the reported clinical outcome from the patient treatment (e.g., "controlled severe bleeding") based on healthcare provider observations and patient outcomes data.
The sample size for the training set:
- This document describes a 510(k) submission, not the development of a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML. All the described studies are for demonstrating performance or substantial equivalence.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 9, 2014

Innovative Trauma Care, Inc. Richard Waite Sr. Director of Quality Assurance/ Regulatory Affairs 3463 Magic Dr., Suite 120 San Antonio, Texas 78229

Re: K140805

Trade/Device Name: iTClamp50 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: August 15, 2014 Received: August 29, 2014

Dear Mr. Waite:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K140805

Device Name iTClamp50

Indications for Use (Describe)

The iTClamp50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50

510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the iTClamp™50 is provided below.

Device Common Name:	Vascular Clamp
Device Proprietary Name:	iTClamp™50
Submitter:	Innovative Trauma Care, Inc.3463 Magic Dr., Suite 120San Antonio, TX 78229
Contact:	Richard WaiteSr. Director of Quality Assurance/ Regulatory Affairs,3463 Magic Dr., Suite 120San Antonio, TX 78229Office: 210-582-5850 ext. 1932FAX: 210-582-5851Cell: 214-662-9277rwaite@innovativetraumacare.com
Date Prepared:	February 17, 2014
ClassificationRegulation:	870.4450
Panel:	Cardiovascular
Product Code:	DXC
Predicate Device	K132651 - iTClamp™50

Indication for Use

The iTClamp™50 is a trauma clamp device for the temporary control of severe bleeding in the extremities, axilla, inguinal areas, scalp, and neck.

The purpose of this 510(k) is to modify the already cleared indication for use to include use of the device on severe bleeding areas of the neck.

Device Description

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510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50

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 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

Biocompatibility Testing

Additional Biocompatibility Testing is not necessary to support the modified indication for use. Physical composition of the product, sterilization and packaging has not changed in anyway; therefore, biocompatibility testing provided in the previous 510(k) (K132651) is applicable to support this 510(k).

Performance Testing - Bench

Additional bench performance testing is not necessary. The physical composition of the product, packaging and sterilization has not changed in any way. Therefore, the bench testing provided in the previous 510(k) (K132651) is applicable to this 510(k).

Innovative Trauma Care has performed cadaver testing to demonstrate substantial equivalence of the iTClamp50 for the new proposed indication for use on neck wounds. In addition, a second cadaver study was generated which compared the performance of the iTClamp50 and standard of care, i.e. tamponade by direct manual pressure and balloon catheter inflation in a wound. The results of the Cadaver Studies demonstrate that the device is suitable for use on the neck and is substantially equivalent to the previous 510(k) K132651.

A user assessment was performed utilizing 15 trained first responders (fire fighters) to ensure the Directions for Use (DFU) were appropriate to support the clearance of K132651. The assessment utilized a bleeding arm simulator model. The simulator model uses a pulsing pump motor to delivery pulses of simulated blood (water) through a wound in the arm with pressure of 80-90 mmHg. The environmental conditions they were exposed to were: Normal conditions, cold hands, non-dominant hand, and dominant hands, low light, strobe lights, in a shower and underwater using a skin pad, fatigued hand exhausted), with fire gloves

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510(k) Premarket Notification Innovative Trauma Care, Inc. iTClamp™50

on. These were completed using both wet hands (to simulate blood they were wetted with glycerol/water solution) and dry hands wearing vinyl exam gloves (except when wearing firefighting gloves and gear). The primary assessment was external leakage of water from the wound while the pump continued to run. Additionally, user needle sticks were evaluated. The outcome of the user assessment identified that the training based upon the DFU provided sufficient information for all participants to successfully apply and remove the device; the occurrence of needle stick was <1% in 270 device applications (Environmental use of the iTClamp™ 50 in a group of firefighters, Mckee, J., Mckee, I., Gao, H., Frost, G., Kirkpatrick, A. W.) The DFU content for the application and removal of the device has not changed and the technique remains the same within the scope of the expanded Indications for Use, therefore no additional user testing was conducted to support the temporary control of severe bleeding in neck wounds.

Performance Testing - Animal

Not applicable. Animal Performance Testing is not necessary to establish the substantial equivalence of the device.

Performance Testing - Clinical Study

Case studies were captured to support product performance for the cleared indications. For expansion of the indication to include temporary control of severe bleeding in the neck, data from unsolicited case studies of OUS and off-label use provided supportive data on the device performance for treatment of neck wounds.

Substantial Equivalence

The iTClamp50 is the same device that was previously cleared in K132651 to provide temporary bleeding control to wounds in the extremities, axilla, inguinal areas, and scalp until medical and/or surgical repair can be obtained. The iTClamp™ used for the new indication on the neck raises no new or different types of effectiveness questions because direct pressure is the standard of care for bleeding wounds to the neck.

The available performance data support use of the iTClamp50 for neck wounds. The iTClamp50, therefore, is substantially equivalent to the already cleared iTClamp50 classified under 870.4450.

	Subject Device	Predicate Device
510(k) Number	TBD	K132651
Classification / Procode	870.4450 / DXC	870.4450 / DXC
Device Name	iTClampTM50	iTClampTM50
Manufacturer	Innovative Trauma Care, Inc.	Innovative Trauma Care, Inc.
	Subject Device	Predicate Device
Indication for Use	The iTClamp50 is a traumaclamp device for thetemporary control of severebleeding in the extremities,axilla, inguinal areas, scalpand neck.	The iTClamp50 is a traumaclamp device for thetemporary control of severebleeding in the extremities,axilla, inguinal areas andscalp.
Device Design	iTClamp50 is a self-lockingsurgical clamp with sutureneedles that penetrate theskin to evert the skin edgesbetween pressure bars of thedevice and anchor it to theskin to reduce slippage andleakage. Pressure is evenlydistributed across the bars,which seal the skin over awound. An adjustablelocking mechanismincreases or decreasespressure across the woundto achieve a fluid tight sealor wound closure as desired.	iTClamp50 is a self-lockingsurgical clamp with sutureneedles that penetrate theskin to evert the skin edgesbetween pressure bars of thedevice and anchor it to theskin to reduce slippage andleakage. Pressure is evenlydistributed across the bars,which seal the skin over awound. An adjustablelocking mechanismincreases or decreasespressure across the woundto achieve a fluid tight sealor wound closure as desired.
Device Operation	Application of pressure byapplying clamp totemporarily seal wound site	Application of pressure byapplying clamp totemporarily seal wound site
Picture	Image: iTClamp50	Image: iTClamp50

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510(k) Premarket Notification Innovative Trauma Care, Inc.

Innovative Trauma Care, Inc.
iTClamp™ iTClamp™50

Regulation Number and Section

§ 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).