The iTClamp50 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 iTClamp50 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 iTClamp50 consists of the following components:

1. Suture needles
1. Tray w/Tyvek lid
1. Locking mechanism
1. Lock release mechanism

AI/ML Overview

Here's an analysis of the provided text regarding the iTClamp®50 device, focusing on acceptance criteria and the study proving its performance:

Device: iTClamp®50 (modified version seeking K150813 clearance)
Predicate Device: iTClamp®50 (K140805)

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several "Design verification and validation testing" activities and states that "Design verification and validation testing has demonstrated that the device meets predefined acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results/performance metrics for each test. It rather states what each test was intended to verify.

Acceptance Criteria (Intended Verification)	Reported Device Performance (Summary)
Leakage Test: To verify that the device can create a liquid tight seal.	Demonstrated that the device meets predefined acceptance criteria for creating a liquid tight seal. (No specific quantifiable performance metric provided, e.g., "no leakage for X duration at Y pressure").
Minimum Holding Torque: To verify that the force applied to the device during function does not deform the needles or damage the pressure bars.	Demonstrated that the device meets predefined acceptance criteria for resisting deformation of needles or damage to pressure bars under applied force. (No specific quantifiable performance metric provided).
Needle Pullout Force Test: To verify that the needle pullout force of the device is within specification.	Demonstrated that the device meets predefined acceptance criteria for needle pullout force (i.e., within specification). (No specific quantifiable performance metric provided).
Maximum Arming Force Test: To verify that the force required to arm the device is within specification.	Demonstrated that the device meets predefined acceptance criteria for arming force (i.e., within specification). (No specific quantifiable performance metric provided).
Maximum Closing Force Test: To verify that the force required to close the device is within specification.	Demonstrated that the device meets predefined acceptance criteria for closing force (i.e., within specification). (No specific quantifiable performance metric provided).
Button Disengaging Force Test: To verify that the force required to release the device is within specification.	Demonstrated that the device meets predefined acceptance criteria for button disengaging force (i.e., within specification). (No specific quantifiable performance metric provided).
Operational Environmental Tests: To verify the function of the device within specified environments.	Demonstrated that the device meets predefined acceptance criteria for functioning within specified environments. (No specific quantifiable performance metric or environmental conditions provided).
Usability Tests: To verify the technological modifications did not affect end-user usability of the device.	Demonstrated that the technological modifications did not negatively affect end-user usability. (No specific usability metrics or user feedback provided).
Package Testing: To verify that the updated packaging met specifications for sterility.	Demonstrated that the updated packaging met specifications for sterility. (No specific quantifiable performance metric or sterility assurance level provided).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for any of the design verification and validation tests. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature). These types of tests are typically conducted in a laboratory setting by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information (experts for ground truth) is typically relevant for studies involving subjective interpretation, like imaging analysis. The described tests are primarily engineering design verification and validation tests for a mechanical device. Therefore, the concept of "ground truth established by experts" in the clinical diagnostic sense does not directly apply to these tests. The "ground truth" for these tests would be the established engineering specifications and performance targets set by the manufacturer.

4. Adjudication Method (for the test set)

Given that these are primarily engineering verification tests, an "adjudication method" in the sense of resolving discrepancies between expert interpretations is not applicable. The results of these tests (e.g., force measurements, leakage detection) are objective measurements against predefined specifications.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, the document does not indicate that a Multi Reader Multi Case (MRMC) comparative effectiveness study was done. The studies described are focused on verifying the design and functionality of the device itself, not on comparing reader performance with and without AI assistance, as the iTClamp®50 is a physical medical device, not an AI-powered diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No, the concept of "standalone algorithm performance" is not applicable here as the iTClamp®50 is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for these design verification and validation tests is the predefined engineering specifications and performance requirements for the device. For example, for the "Needle Pullout Force Test," the ground truth would be the specified acceptable range of force. For "Leakage Test," the ground truth is "liquid tight seal" according to a defined methodology.

8. The Sample Size for the Training Set

The concept of a "training set" is relevant for machine learning or AI models. Since the iTClamp®50 is a physical medical device and not an AI algorithm, there is no training set in this context.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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Public Health Service

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

April 30, 2015

Innovative Trauma Care, Inc. Ian Atkinson Chief Technology Officer 3463 Magic Dr., Suite 120 San Antonio, TX 78229

Re: K150813

Trade/Device Name: iTClamp50 Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: March 25, 2015 Received: March 31, 2015

Dear Ian Atkinson:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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" (21 CFR 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

Enclosure

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Indications for Use

510(k) Number (if known) K150813

Device Name iTClamp®50

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50

510(k) Summary 6.0

In accordance with 21 CFR 807.92 the 510(k) Summary for the iTClamp50 is provided below.

Device Common Name:	Vascular Clamp
Device Proprietary Name:	iTClamp50
Submitter:	Innovative Trauma Care, Inc.3463 Magic Dr., Suite 120San Antonio, TX 78229
Contact:	Ian Atkinson, Chief Technology OfficerOffice: 780-638-2485Cell: 403-999-2462Fax: 587-523-3958Email: iatkinson@itraumacare.com
Date Prepared:	March 25, 2015
ClassificationRegulation:	870.4450
Panel:	Cardiovascular
Product Code:	DXC
Predicate Device	K140805 – iTClamp50, 510(k) Clearance October 9, 2014

Indication for Use

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

Device Description

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Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50

The device is provided sterile and is for single use.

The iTClamp50 consists of the following components:

1. Suture needles
1. Tray w/Tyvek lid
1. Locking mechanism
1. Lock release mechanism

Substantial Equivalence

The modified iTClamp50 has the following similarities to the previous version of the iTClamp (predicate), which have previously received 510(k) concurrence (K140805):

Have the same indicated use
. Have the identical shelf life of 4 years
Use the same operating principle and fundamental scientific technology
Incorporate the same basic design
Have the same materials making point of contact with user and patient

Like the predicate device, the iTClamp50 is intended to control bleeding through the application of pressure to compressible areas (where application of direct pressure will control bleeding) in the scalp, extremities, and all junctional areas (inguinal areas, axilla and neck). It is not intended for internal bleeding into the chest or abdomen. The updated iTClamp50 is the same device that was previously cleared in K140805 in that it provides temporary bleeding control to wounds in the scalp, extremities, and all junctional areas (inguinal areas, axilla and neck) until medical and/or surgical repair can be obtained. The iTClamp50 (also the predicate) applies pressure to the severely bleeding wound by sealing off the everted skin surrounding the wound by direct external contact with the plastic pressure bar, which leads to pressure on the cut edges of the skin, allowing blood to pool under pressure and eventually resulting in clot formation.

The modified iTClamp50 has the following technological modifications compared to the predicate:

1. Mechanical change to the one-way locking mechanism
1. Material change to the one-way locking mechanism (non-patient contacting)
1. Mechanical change to the lock release mechanism

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Special 510(k): Device Modification Innovative Trauma Care, Inc. iTClamp®50

1. Modifications to the opposing arms for improved grip
1. Updated packaging from a polypropylene calm shell to a polypropylene tray with a tyvek lid.

The modified iTClamp raises no new or different types of effectiveness or safety questions. There is no change to the fundamental scientific principles of the technology. Design verification and validation testing has demonstrated that the device meets predefined acceptance criteria and is substantially equivalent to the previously cleared device. This testing was conducted to verify suitability of the design characteristics of the device and provide evidence that the final design of the product meets previously established and cleared finished product specifications. The design verification and validation activities consisted of the following:

1. Leakage Test- to verify that the device can create a liquid tight seal.
1. Minimum Holding Torque to verify that the force applied to the device during function does not deform the needles or damage the pressure bars.
1. Needle Pullout Force Test to verify that the needle pullout force of the device is within specification
1. Maximum Arming Force Test to verify that the force required to arm the device is within specification
1. Maximum Closing Force Test to verify that the force required to close the device is within specification
1. Button Disengaging Force Test to verify that the force required to release the device is within specification
1. Operational Environmental Tests to verify the function of the device within specified environments.
1. Usability Tests to verify the technological modifications did not affect enduser usability of the device.
1. Package Testing to verify that the updated packaging met specifications for sterility.

Based on the design verification and validation test results, the iTClamp50, is substantially equivalent to the iTClamp50 classified under 870.4450.

A comparison of the new technologically modified iTClamp50 to the previous version of the iTClamp (predicate) is provided below.

	Subject Device	Predicate Device
510(k) Number	TBD	K140805
Classification / Procode	870.4450 / DXC	870.4450 / DXC
	Subject Device	Predicate Device
Device Name	iTClamp50	iTClamp50
Manufacturer	Innovative Trauma Care,Inc.	Innovative Trauma Care,Inc.
Indication for Use	same	The iTClamp50 is a traumaclamp device for thetemporary control of severebleeding in the extremities,axilla, inguinal areas scalpand neck.
Device Design	same	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/Fundamental ScientificPrinciple	same	Application of pressure byapplying clamp totemporarily seal wound site
One-way lockingmechanism	One-way double-rowratchet	One-way clutch
Packaging	Polypropylene tray withTyvek lid	Polypropylene clam shell
Arm	Inner and outer arm aretextured, introduction ofthumbhole, increasedsurface area to improve grip	Arm contains texturizedgripping bar
	Subject Device	Predicate Device
Picture	Image: A clear plastic medical device with a red circular component in the center.	Image: A clear plastic medical device with two metal cylinders.

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Special 510(k): Device Modification Innovative Trauma Care, Inc.

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Special 510(k): Device Modification Innovative Trauma Care, Inc.

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).