The Abdominal Aortic and Junctional Tourniquet is indicated for use in the battlefield to control difficult bleeding in the pelvis, inguinal area and axilla.

Device Description

The Abdominal Aortic and Junctional Tourniquet (AAJT) is designed to be used by military medical personnel in the battlefield to control bleeding in the pelvis, inguinal area and axilla where standard tourniquets cannot be used. The device may be used instead of "mechanical pressure", allowing the medic to attend to other injuries or soldiers.

AI/ML Overview

Here's an analysis of the provided text regarding the Abdominal Aortic and Junctional Tourniquet (AAJT) and its performance data:

The provided text describes a 510(k) submission for the Abdominal Aortic and Junctional Tourniquet (AAJT). The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices. The performance testing for this device focuses on its ability to stop blood flow.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the predicate devices' presumed ability to stop blood flow. The AAJT's performance is demonstrated by its effectiveness in stopping blood flow in a human study.

Acceptance Criteria (Implicit from Predicate Devices)	Reported Device Performance (AAJT)
Effective in controlling difficult bleeding	Blood Flow Cessation: In 13/13 subjects, blood flow in both the Popliteal Femoral Artery (PFA) and Abdominal Aorta (AA) was stopped (no spectral Doppler flow).
	Bladder Pressure at Flow Cessation:
	- PFA: 148.5 mm Hg (SD 44.8, max 230, min 80)
	- AA: 168 mm Hg (SD 52.5, max 250, min 80)
Acceptable Pain Levels During Use	Pain at Flow Cessation (Average Maximum):
	- PFA: 3.6
	- AA: 4.1
	Pain After Device Removal: Returned to 0

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 13 human subjects.
- Data Provenance: The study was a "human data study," implying it was a prospective study conducted specifically for this device. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, suggesting it was likely conducted in the US or under US regulatory standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The ground truth (cessation of blood flow) was established by direct measurement using "no spectral Doppler flow in the distal artery." This type of measurement does not typically require a panel of experts for interpretation but rather trained medical professionals or technicians to perform the Doppler ultrasound and interpret the real-time results. No specific number or qualifications of experts are mentioned for establishing this ground truth.
Adjudication method for the test set:
- No adjudication method (e.g., 2+1, 3+1) is mentioned as the "ground truth" was established through objective measurement (Doppler flow).
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 conducted. This device is a physical medical device (tourniquet), not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was conducted. This is a physical device, not an algorithm.
The type of ground truth used:
- The ground truth for effectiveness was direct physiological measurement (cessation of blood flow via spectral Doppler) and subjective patient reporting (pain levels).
The sample size for the training set:
- There is no mention of a "training set" as this is a physical device and not an AI/machine learning algorithm. The study described is a performance study for the device itself.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.

Summary

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510(k) SUMMARY

John Croushorn, M.D. Submitter's Name and Address: Compression Works LLC 1634-A Montgomery Hwy #115 Hoover, AL 35216 DEC 0 6 2013 Telephone: 205-202-1126 e-mail: jcroushorn@gmail.com Date of Preparation: November 12, 2013 Contact Person Michael S. Forstadt Consultant to Compression Works LLC Telephone: 401-521-3294 e-mail: rcforstadt@hotmail.com Name of Medical Device Classification Name: Vascular clamp Common/Usual Name: Vascular clamp Proprietary Name: Abdominal Aortic and Junctional Tourniquet The Abdominal Aortic and Junctional Tourniquet is substantially Substantial Equivalence equivalent to: Compression Works Abdominal Aortic Tourniquet (AAT) device (K112384), the Combat Medical Systems, LLC's Combat Ready Clamp (CRoC) (K130482) and the SAM Junctional Tourniquet (K131561). Device Classification This device, a vascular clamp carries an FDA product code DXC, regulated under 21 CFR 870.4450. Device Description The Abdominal Aortic and Junctional Tourniquet (AAJT) is designed to be used by military medical personnel in the battlefield to control bleeding in the pelvis, inguinal area and axilla where standard tourniquets cannot be used. The device may be used instead of

Abdominal Aortic and Junctional Tourniquet - K133029

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"mechanical pressure", allowing the medic to attend to other injuries or soldiers.

Indications for Use

The Abdominal Aortic and Junctional Tourniquet (AAJT) is indicated for use in the battlefield to control difficult bleeding in the pelvis, inguinal area and axilla.

Technological Comparison to Predicate Devices

	Proposed	Predicate
	AAJT Device	AAT Device
Configuration	Inflatable pneumatic tourniquet	Inflatable pneumatictourniquet
Method ofAction	Manual	Manual
Components	Waistband (belt andcummerband), inflatable airbladder (pneumatic inflator),manual pump	Waistband (belt andcummerband), inflatable airbladder (pneumatic inflator),manual pump

Performance Testing

Results of performance testing have demonstrated that the device is substantially equivalent to the predicate devices.

A human data study in thirteen (13) subjects showed that in all subjects (13/13) the blood flow in both the PFA and the AA were stopped as measured by no spectral Doppler flow in the distal artery. Bladder pressure at zero Doppler flow at the PFA was 148.5 mm Hg (SD 44.8, maximum 230, minimum 80) and at the AA was 168 mm Hg (SD 52.5, maximum 250, minimum 80). Pain averaged a maximum of 3.6 and 4.1 at flow cessation for the PFA and AA respectively and returned to 0 after device removal.

The Abdominal Aortic and Junctional Tourniquet (AAJT) with the additional indications (to control difficult bleeds in the pelvis and axilla area) is substantially equivalent to the predicate AAT device cleared under K 112384. It has equivalent design and materials, addresses the same patient population, has the same mechanism of action and uses no new technology. The new indication does not introduce new safety or performance concerns, and is similar to that of the predicate Combat Ready Clamp and SAM Junctional Tourniquet. Therefore, based on the indications for use, technological characteristics, and comparison to

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predicate devices, the Abdominal Aortic and Junctional Tourniquet has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

December 6, 2013

Compression Works, LLC c/o Michael Forstadt Consultant to Compression Works, LLC 15 Sargent Ave Providence, RI 02906 US.

Re: K133029

Trade/Device Name: Abdominal Aortic and Junctional Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Clamp, Vascular Regulatory Class: Class II Product Code: DXC Dated: September 23, 2013 Received: October 15, 2013

Dear Mr. Forstadt:

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.

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Page 2 - Michael Forstadt

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 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 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/Resourcesfor You/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/ResourcesforYou/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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Indications for Use

510(k) Number (if known): K133029

Device Name: Abdominal Aortic and Junctional Tourniquet

Indications for Use:

The Abdominal Aortic and Junctional Tourniquet is indicated for use in the battlefield to control difficult bleeds in the pelvis, inguinal area and axilla.

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

Over-The-Counter Use (21 CFR 807 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 2013.12.06 15:04:14 -05'00'

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).