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

AI/ML Overview

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.

Summary

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5.0 510(k) Summary

MAY 1 4 2013

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

Device Common Name:	Vascular Clamp
Device Proprietary Name:	iTClampTM
Submitter:	Innovative Trauma Care, Inc.3463 Magic Dr., Suite 120San Antonio, Texas 78229
Contact:	Richard WaiteSr. Director of Quality Assurance/ Regulatory Affairs,
	3463 Magic Dr., Suite 120
	San Antonio, TX 78229
	Office: 210-582-5850 ext. 1932
	FAX: 210-582-5851
	Cell: 214-662-9277
	rwaite@innovativetraumacare.com
Date Prepared:	November 16, 2012
ClassificationRegulation:	870.4450
Panel:	Cardiovascular
Product Code:	DXC
Predicate Device	K102025 - Combat Ready ClampCombat Medical Systems LLC

Indication for Use

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

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Device Description

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

Biocompatibility testing was performed according to ISO 10993 including, cytotoxicity, acute system toxicity, muscle implantation and pyrogenicity. Results confirmed that the materials used in the ITClamp™ are safe for its intended use.

Performance Testing - Bench

Results from the performance testing were provided. The laboratory performance testing was conducted to verify suitability of the design characteristics of the device. The testing consisted of the following: Extreme Temperature Evaluation, Tensile and Compression Test, Torque, and Needle (Bend and Pull). Results of the testing confirmed the ITClamp™ met design requirements.

Performance Testing - Animal

Animal testing was performed in a porcine model to assess ITClamp™ performance in a lethal junctional bleed model. 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 was not observed by histological examination after 3 hours of application.

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Performance Testing- Distribution/Aging/Packaging Integrity

Distribution Challenge Testing and Accelerated Aging Studies were completed to ensure that product integrity is maintained for the intended use. Due to the complexity and non-standard packaging system, microbial aerosol testing was performed to prove the structural integrity of the packaging unit. All testing preformed resulted in no nonconformance(s),

Substantial Equivalence

A comparison of the ITClamp to the predicate devices is provided below. Like the predicate devices, the ITClamp is intended to control bleeding through the application of direct pressure. Also like the predicate Combat Ready Clamp, the ITClamp is intended to provide emergency control of severely bleeding vascular wounds until medical and/or surgical repair can be obtained. The ITClamp has different technology than the predicate device. The ITClamp applies pressure to the severely bleeding wound by sealing off the skin surrounding the wound, which leads to blood pooling under pressure and eventual clotting. The predicate device, the Combat Ready Clamp, also applies direct pressure but this is achieved by a applying an external mechanical clamp above the inguinal area to stop blood flow into the area. Although the technology of the proposed device differs from the predicate, it does not raise any new or different types of safety or effectiveness questions.

The available performance data demonstrate that the ITClamp is safe and performs effectively in achieving hemostasis for severely bleeding wounds. The ITClamp, therefore, is substantially equivalent to other devices regulated under 21 CFR 870.4450.

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510(k) Premarket Notification

iTClamp™

	New Device	Predicate Device
510(k) Number	K123551	K102025
Classification / Procode	870.4450 / DXC	870.4450 / DXC
Device Name	ITClampTM	Combat Ready Clamp
Manufacturer	Innovative Trauma Care,Inc.	Combat Medical Systems
Indication for Use	The ITClampTM is atrauma clamp device forthe temporary control ofsevere bleeding in theextremities, axilla andinguinal areas.	The Combat Ready Clamp isindicated for use in thebattlefield to control difficultbleeds in the inguinal area.
Device Design	ITClamp is a self-lockingsurgical clamp with sutureneedles that penetrate theskin to evert the skin edgesbetween pressure bars ofthe device and anchor it tothe skin to reduce slippageand leakage. Pressure isevenly distributed acrossthe bars, which seal theskin over a wound. Anadjustable lockingmechanism increases ordecreases pressure acrossthe wound to achieve afluid tight seal or woundclosure as desired.	The CRoC (Combat ReadyClamp) is designed to controldifficult bleeds in the inguinalregion. The CRoC can beused in a tactical environmentwhere traditional methods ofhemorrhage control are notpossible and standardtourniquets cannot be applied.It provides compression tolarge vessels and directpressure to difficult woundsthus controlling hemorrhageand eliminating the need formanual pressure. It is anexpandable aluminum clampthat is durable, collapsible,light weight, and easilyremoved.
Device Operation	Application of pressure byapplying clamp totemporarily seal woundsite	Application of pressure byapplying mechanical clamp
Picture	Image: ITClamp	Image: Combat Ready Clamp

ﺎ ﻳﻌﺘﺒﺮ ﺍﻟ

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.

Public Health Service

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

May 14, 2013

Innovative Trauma Care, Inc. C/O Richard Waite 3463 Magic Dr., Suite 120 San Antonio, Texas 78229

Re: K123551

Trade/Device Name: iTClamp Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: April 5, 2013 Received: April 9, 2013

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zittokerman -S

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 Statement 4.0

510(k) Number (if known):

Device Name: ITClamp™

Indications For Use:

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

Prescription Use _X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman -S
2013.05.14 14:22:39 -04'00'

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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).