The CRoC™ is designed to be used by emergency medical personnel in the battlefield. The device is designed to control bleeding in anatomical areas where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the medic to attend to other injuries. The Combat Ready Clamp is used to control a difficult bleed for up to 4 hours until the injured can be transferred to evacuation personnel or other medical personnel for further treatment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Combat Ready Clamp (CRoC™) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in terms of specific performance metrics with target values (e.g., "must stop blood flow within X seconds at Y pressure"). Instead, the performance data section describes a qualitative objective: the capability of stopping simulated vessel blood pressure.

Acceptance Criteria (Implied/Qualitative)	Reported Device Performance
Capable of stopping simulated vessel blood pressure in the axilla area. (Implicit: Demonstrating functionality for its stated indication of controlling difficult bleeds where standard tourniquets cannot be used, specifically in the axilla, as a substantial equivalence claim to a predicate that focused on inguinal area).	The CRoC™ was "tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure in the axilla area." This demonstrates the device's ability to achieve its intended function in a relevant anatomical region. The substantial equivalence claim further implies that this performance is comparable to the predicate device's demonstrated efficacy.

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

Sample Size: The text states "cadaver model" (singular), implying a very small sample size, potentially a single cadaver or unquantified number of cadaveric specimens. It does not provide a specific number.
Data Provenance: The study was conducted using a "cadaver model," which is an ex-vivo, simulated environment. The country of origin of the data is not specified, but the applicant is based in the USA. The study design is prospective in the sense that the experiment was performed to evaluate the device.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical assessment or image interpretation. The evaluation was a direct mechanical test on a cadaver model to ascertain if the device could effectively stop simulated blood pressure. Therefore, there's no mention of experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical or image-based test set requiring an adjudication method. The test was a direct physical demonstration of mechanical function.

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

Not applicable. The device is a physical vascular clamp, not an AI/software device involving human readers or interpretation.

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

Not applicable. The device is a physical vascular clamp, not an algorithm or software. The "standalone" performance here refers to the device's physical ability to stop blood flow independently.

7. The Type of Ground Truth Used

The "ground truth" in this context was the direct, observable physical outcome: the cessation of simulated vessel blood pressure. This is a direct measure of the device's mechanical efficacy in controlling bleeding, rather than an interpretation by experts, pathology, or long-term outcomes data.

Specific Type: Direct physical measurement/observation in a cadaver model.

8. The Sample Size for the Training Set

Not applicable. The CRoC™ is a physical medical device, not a machine learning or AI algorithm that requires a training set of data.

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

Not applicable, as there is no training set for a physical device.

Summary

{0}------------------------------------------------

K 130482

APR 2 9 2013

5.0 510(k) Summary

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Combat Ready Clamp (CRoCTM) device is provided below.

Device Common Name:	Vascular Clamp
Device Proprietary Name:	Combat Ready Clamp (CROCTM)
Submitter:	Combat Medical Systems, LLC5845-D Yadkin RoadFayetteville, NC 28303
Contact:	Calley HerzogConsultantBiologics Consulting Group, Inc.Phone: 720-883-3633Email: cherzog@bcg-usa.com
Date Prepared:	April 18, 2013
ClassificationRegulation:	21 CFR 870.4450, Class II, 510(k)
Panel:	Cardiovascular
Product Code:	DXC
Predicate Device:	K102025, Combat Ready Clamp

Indication for Use:

The Combat Ready Clamp (CRoC™) is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas.

Device Description:

Performance Data:

To establish the substantial equivalence the CRoC™ was tested with a cadaver model to show that it was capable of stopping simulated vessel blood pressure in the axilla area.

Substantial Equivalence:

{1}------------------------------------------------

Based on technological characteristics and performance data the CRoC™ has been shown to be substantially equivalent to the predicate device, the Combat Ready Clamp as cleared in K102025.

Device Comparison Table
	New Device	Predicate Device
510(k)Number	K130482	K102025
Device Name	Combat Ready Clamp (CRoCTM)	Combat Ready Clamp (CRoCTM)
Manufacturer	Combat Medical Systems, LLC	Combat Medical Systems, LLC
Picture	Image: Combat Ready Clamp	Image: Combat Ready Clamp
Indication	The Combat Ready Clamp isindicated for use in the battlefieldto control difficult bleeds in theinguinal and axilla areas.	The Combat Ready Clamp isindicated for use in the battlefield tocontrol difficult bleeds in theinguinal area.
Dimensions	8"x12 1/4"x9" (extended)	8"x12 1/4"x9" (extended)

යි. ප

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

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

April 29, 2013

Combat Medical Systems. LLC C/O Biologics Consulting Group, Inc. 13417 Quivas St. Westminster, Colorado 80234 Attention: Calley Herzog

Re: K130482

Trade/Device Name: Combat Ready Clamp (CRoC TM) Regulation Number: 21 CFR 807.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: February 25, 2013 Received: February 26, 2013

Dear Ms. Herzog:

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. Iisting 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.

{3}------------------------------------------------

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Matthew G亮剧illebrenner

for

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

Enclosure

{4}------------------------------------------------

4.0 Indications for Use Statement

510(k) Number (if known): K130482_

Device Name: Combat Ready Clamp (CRoC™)

Indications For Use:

The Combat Ready Clamp is indicated for use in the battlefield to control difficult bleeds in the inguinal and axilla areas.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D) (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)

Page 1 of 1_

Matthew G퀘咖llebrenner

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).