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/scalp 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/scalp closed to apply direct pressure to the cut edges of the skin/scalp 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 2) Plastic shell 3) Locking mechanism 4) Lock release mechanism

AI/ML Overview

Here's an analysis of the provided text regarding the iTClamp™50 device, specifically focusing on the acceptance criteria and study details:

The provided document is a 510(k) summary for the iTClamp™50, seeking to expand its indication for use to include the scalp. It is not a study proving the device meets acceptance criteria in the typical sense of a clinical trial or a performance study with defined, measurable endpoints for regulatory acceptance. Instead, it argues for "substantial equivalence" to predicate devices based on design, operation, and a cadaver study for the expanded indication.

Therefore, many of the requested fields (like specific acceptance criteria for performance metrics, sample sizes for test sets in a clinical context, expert ground truth, MRMC studies, or training sets) are not directly applicable or explicitly stated in a quantitative manner as they would be for a new or significantly modified device requiring rigorous performance evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an expanded indication based on substantial equivalence, explicit quantitative acceptance criteria for device performance (e.g., a specific percentage reduction in blood loss, time to hemostasis within a certain threshold) are not defined in the provided text. The "acceptance" argument is qualitative and based on the device's ability to effectively control bleeding on the scalp in a cadaver model, aligning with the predicate device's function.

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Safe for use on the scalp	Cadaver study identified no additional risks.
Effective in controlling severe bleeding on the scalp (hemostasis)	Cadaver study demonstrated effectiveness and safety on the scalp.
Performs as intended	Cadaver study ensured the device performed as intended; results indicate suitability for use on the scalp.
Substantially equivalent to predicate devices for scalp use	Performs similarly to predicate devices by applying pressure to control bleeding on scalp wounds.

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

Sample Size: Not explicitly stated as a number of subjects or cases. The study used "cadaver models" which implies a limited number for this type of testing.
Data Provenance: The study was conducted by Innovative Trauma Care, Inc. using cadaver models. There is no mention of country of origin for the cadaver data. The study is prospective in the sense that the testing was performed specifically to support this 510(k) submission, even if it utilized cadavers.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's likely that medical professionals or researchers involved in the cadaver study would have assessed the outcomes, but their specific roles or qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1 consensus) for the cadaver study results.

5. 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 comparative effectiveness study was done. This is a medical device (vascular clamp), not an AI-assisted diagnostic tool, so this type of study is not relevant or applicable.

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

Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent in its design and how it's used by a human clinician. The cadaver study implicitly describes the standalone device's performance when applied.

7. The Type of Ground Truth Used

For the cadaver study, the "ground truth" would be the observed effectiveness of hemostasis (stopping bleeding) in the cadaver models, assessed directly by the researchers. It's an observational outcome within the cadaveric setting. There is no mention of pathology or broader patient outcomes data for the cadaver study.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an algorithm or AI system that requires a "training set."

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

Not applicable. As there is no training set for a physical device, no ground truth needs to be established for it.

Summary

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5.0 510(k) Summary

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

Device Common Name:	Vascular Clamp
Device Proprietary Name:	iTClamp™50	OCT 2 8 2013
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:	July 31, 2013
ClassificationRegulation:	870.4450
Panel:	Cardiovascular
Product Code:	DXC
Predicate Device	K123551 - iTClamp™K012219 - ScalpFix Clip System

Indication for Use

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

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

Device Description

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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/scalp closed to apply direct pressure to the cut edges of the skin/scalp 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

Biocompatibility Testing

Additional Biocompatibility Testing is not necessary to support the modified indication for use. Physical composition of the product and packaging has not changed in anyway; therefore biocompatibility testing is not necessary 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) (K123551) is applicable and no additional bench testing is necessary.

However, Innovative Trauma Care has performed cadaver testing to demonstrate substantial equivalence of the iTClamp50 for the new proposed indication for use. The protocol and results for the cadaver study are provided in Appendix C. Cadaver models were tested to ensure the safety and effectiveness of the iTClamp50 device. Predicate testing was also performed to ensure that the device performed as intended. Both the testing of the comparison between the predicate device and the iTClamp™ and the safety and efficacy of the iTClamp™ on the scalp identified no additional risks. The results of the Cadaver Study identifies that the device is suitable for use on the scalp

Performance Testing - Animal

Animal Performance Testing is not necessary to demonstrate substantial equivalence of this device for the new indication for use. An animal study of scalp bleeding is ineffective in that animal scalp bleeds do not hemorrhage at a comparable rate of human scalp hemorrhaging and therefore are ineffective models. In place of animal testing, Innovative Trauma Care, Inc. used a cadaver study to show the effectiveness and safety of the device on the scalp as

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well as compared the device to the predicate, ScalpFix Clip System. Please see Appendix C for the Cadaver Study.

Performance Testing - Clinical Study

Not applicable. Clinical data is not necessary to establish the substantial equivalence of the device.

Substantial Equivalence

A comparison of the iTClamp50 to the predicate devices is provided below. Like the predicate devices, the iTClamp50 is intended to control bleeding through the application of pressure. Also like the predicate ScalpFix Clip System, the iTClamp50 is intended to provide temporary control of severely bleeding scalp wounds until medical and/or surgical repair can be obtained. The iTClamp50 has similar technology to the predicate device. The iTClamp50 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, blood pooling under pressure and eventual clotting. The predicate device, the ScalpFix Clip System, also applies temporary pressure to the wound edge(s) by use of a handheld mechanical applicator to affix the ScalpFix Clip. The iTClamp is applied by using the clinician's hand to actuate the device in order to stop blood flow at the scalp wound. Although the predicate technology utilizes an applicator there are no significant differences in technology in that pressure is utilized to stop blood flow at the point of injury (scalp) in both products. Neither the predicate nor the iTClamp™ raise any new or different types of safety or effectiveness questions.

The available performance data demonstrate that the iTClamp50 is safe and performs effectively in achieving hemostasis for bleeding scalp wounds. The iTClamp50, therefore, is substantially equivalent to the iTClamp50 classified under 870.4450 (procode DXC) as well as the ScalpFix Clip System classified under 21 CFR 882.4150.

	Subject Device	Predicate Device	Predicate Device
510(k) Number	TBD	K012219	K123551
Classification / Procode	870.4450 / DXC	882.4150 / HBO	870.4450 / DXC
Device Name	iTClamp™50	ScalpFix Clip System	iTClamp™50
Manufacturer	Innovative Trauma Care,Inc.	Aesculap, Inc.	Innovative Trauma Care,Inc.
Indication for Use	The iTClamp50 is a traumaclamp device for thetemporary control of severebleeding in the extremities,axilla, inguinal areas andscalp.	Aesculap's ScalpFix ClipSystem is indicated for usein temporary hemostasis ofthe scalp edge.	The iTClamp50 is a traumaclamp device for thetemporary control of severebleeding in the extremities,axilla and inguinal areas.

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ﻪ ﺗ 263

	Subject Device	Predicate Device	Predicate Device
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.	The scalp clips are used fortemporary hemostasis of theopen scalp. It has provenuseful to use plastic clips toligate the scalp duringtrepanation or largeexposures of relatively longdurations, thereby avoidingbleeding at the woundmargin. Aesculap ScalpClips are intended for singleuse only. They may not bere-sterilized. The scalp clipsare packaged as 10 scalpclips per magazine in the boxof 20 magazines.	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 scalp clamp towound edge	Application of pressure byapplying clamp totemporarily seal wound site
Picture	Image: iTClamp50	Image: Aesculap Scalp Clips	Image: iTClamp50

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wavy lines extending from its body, representing the department's mission to protect the health of all Americans.

Public Health Service

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

October 28, 2013

Innovative Trauma Care Inc. Richard Waite 3463 Magic Dr. Suite 120 San Antonio, TX 78229 US

Re: K132651

Trade/Device Name: iTClamp 50 Regulation Number: 21 CFR 870.4450 Regulation Name: . Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: October 3, 2013 Received: October 16, 2013

Dear Richard 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. Ilisting 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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Page 2 - Richard Waite

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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. Zuckerman -S

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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4.0 Indications for Use Statement

510(k) Number (if known): K132651

Device Name: iTClamp™

Indications For Use:

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

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 2013.

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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).