The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.

Device Description

The AAJT-S device is a wedge-shaped bladder that when inflated pushes in on the body Over the target area of application. One of the target areas is the lower abdomen, over the umbilicus, compressing all the structures within, including the descending aorta, to achieve the physiological effects of aortic compression. The other two areas are over the inguinal region or the axilla. In these two areas the region is compressed with the wedge- shaped bladder including the major vasculature that runs through that area.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S):

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study to Prove
Pressure Maintenance: The AAJT-S must stay inflated and maintain the same pressure over the target area for at least a 4-hour period.	Confirmed successful inflation and pressure maintenance for at least a 4-hour period.	Pressure Testing
Component Bond Strength: The bonds of components to the hard cover must withstand normal tensile forces during clinical use.	Demonstrated ability to withstand normal tensile forces.	Force Testing
Biocompatibility (Cytotoxicity): No cytotoxic effects.	Passed ISO 10993-5 (in vitro cytotoxicity).	Biocompatibility Testing
Biocompatibility (Irritation & Skin Sensitization): No irritation or skin sensitization.	Passed ISO 10993-10 (irritation and skin sensitization).	Biocompatibility Testing
Wear Time (Stated Intended Use): Abdominal use: up to 1 hour; Junctional use: up to 4 hours.	Not explicitly stated as a test result, but the pressure test confirms the device maintains pressure for the maximum stated junctional use duration (4 hours). The increased wear time of 1 hour is also noted as a difference from the predicate device.	Pressure Testing implicitly supports junctional wear time.
Pelvic Fracture Stabilization: Indication for use.	Not explicitly stated what testing was conducted to prove this particular indication. The document refers to it as an "additional pelvic stability indication" compared to the predicate.	Not explicitly detailed in the provided text.

Important Note: The provided text does not include specific numeric acceptance values (e.g., "maintain pressure within X mmHg of initial pressure"). It states the qualitative criteria and that the tests were performed to confirm or evaluate these criteria.

Missing Information:

There are no explicit quantitative acceptance criteria or specific performance values reported for the pressure testing (e.g., pressure drop over time).
Similarly, for force testing, no specific force values or deformation limits are given.
The document doesn't detail how the "pelvic fracture stabilization" indication was specifically proven or what criteria were used for that.

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

The provided text does not specify sample sizes for the performance tests (Pressure Testing, Force Testing, Biocompatibility Testing). It mentions these tests were "performed" but not the number of units or replicates used.

Data Provenance: Not applicable in the context of these non-clinical performance tests. These are laboratory tests conducted on the device itself, not patient data.

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

Not applicable. These are non-clinical performance tests conducted on the device, not clinical studies involving expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. This concept applies to clinical studies where experts might disagree on ground truth, requiring an adjudication process. The tests described are objective, non-clinical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The provided text describes non-clinical performance tests of the device itself (pressure, force, biocompatibility), not a clinical study involving human readers or comparative effectiveness with or without AI assistance. The device is a physical medical device (tourniquet), not an AI-powered diagnostic tool.

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

Yes, in the sense that the described tests are standalone device tests. The device's performance was evaluated independently without human-in-the-loop interaction as part of the test (beyond operating the test equipment). However, it's important to clarify that this refers to mechanical device performance, not AI algorithm performance.

7. The Type of Ground Truth Used

The "ground truth" for these non-clinical tests is based on objective physical measurements and established international standards:

Pressure Testing: The ground truth is the measured pressure (e.g., using a pressure sensor) and its change over time.
Force Testing: The ground truth is the applied force and the device's structural integrity under that force, measured by mechanical testing equipment.
Biocompatibility Testing: The ground truth is determined by the results of standardized assays (e.g., cytotoxicity assays, irritation/sensitization tests) as per ISO 10993 standards.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model that requires a training set.

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

Not applicable. As above, this is a physical device, not an AI model.

Summary

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March 03, 2023

Compression Works Inc c/o Trey Thorsen, President O'Connell & Myers, LLC 2020 Bobcat Trail Celina, Texas 75009

Re: K221661

Trade/Device Name: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: January 30, 2023 Received: January 30, 2023

Dear Trey Thorsen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rohini Retarekar -S

for

Katherine Trivedi Acting Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221661

Device Name

Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Indications for Use (Describe)

The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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K221661

Section 5 -510(k) Summary for Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Date:	February 17, 2023
510(k) Owner/Sponsor:	Compression Works
Address:	1634-A Montgomery Hwy #115Hoover, AL 35216
Establishment Number:	3009164961
Telephone Number:	205-202-1136
Contact Person:	Trey Thorsen
Telephone Number:	850-450-3932
Email Address:	trey@oconnellmyers.com

Proposed Device: Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)

Device Common Name:	Vascular Clamp
Product Code:	DXC
FDA Regulation Number:	21 CFR 870.4450
Device Classification:	Class II

Predicate Device: Abdominal Aortic and Junctional Tourniquet (K133029)

Device Common Name:	Wound Dressing
Product Code:	DXC
FDA Regulation Number:	21 CFR 870.4450
Device Classification:	Class II

Reference Device: SAM Junctional Tourniquet (K131561)

Device Common Name:	Wound Dressing
Product Code:	DXC
FDA Regulation Number:	21 CFR 870.4450
Device Classification:	Class II

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5.1 Device Description

5.2 Intended Use

The AAJT-S is intended to control bleeding for up to 1 hour for abdominal use and up to 4 hours for junctional use until the patient can be transported to a health care facility for further treatment.

5.3 Indications for Use

The Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) is indicated for use to control bleeding in the pelvis, inguinal area, axilla and for pelvic fracture stabilization.

5.4 Technological Comparison

The AAJT-S is similar in design and intended use to the 510(k) predicate device, AAJT (K133029). The differences between the subject device and the predicate device are listed below:

. Exchanging the windlass for a ladder strap and ratcheting buckle. This allows the user the ability to tighten the AAJT-S with one hand.
Tightening apparatus of the belt was moved to the front of the device for application convenience.
Addition of the "D" handle allowing for easier acquisition of the belt by gloved hands. ●
Wider belt was added for stability and comfort. ●
Exchanging the three separate cover pieces for one continuous piece of HDPE plastic.
Increased wear time of 1 hour. ●
Additional pelvic stability indication. ●

The AAJT-S is similar in design and indication for use to the 510(k) cleared reference device, SAM Junctional Tourniquet (K131561). The differences between the subject device and the reference device are listed below:

Inflatable bladder:
The SAM Junctional Tourniquet uses a Target Compression Device (TCD) to apply pneumatic pressure. The TCD is an inflatable cone shaped chamber that applies pressure to the target area to stop bleeding. The AAJT-S uses a wedge-shaped bladder to apply pneumatic pressure to the target area to stop bleeding.
. Slack removal:
Once in position the SAM junctional Tourniquet uses Tourniquet uses a Windlass that is turned until the device is secured. Then the windlass is retained in place by a Velcro strap. The AAJT-S uses a ladder strap and ratcheting buckle that secures the device and does not require a Velcro retaining strap.

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5.5 Non-Clinical Performance Testing:

Compression Works performed the following nonclinical performance tests:

Pressure Testing: to confirm the AAJT-S can stay inflated and maintain the same pressure over the target area for at least a 4-hour period.

. Force Testing: to evaluate the bond strength of the components bonded to the hard cover to demonstrate these components can withstand normal tensile forces during clinical use.

5.6 Biocompatibility

The AAJT-S is considered a surface device that may potentially contact intact skin for a duration of <24hrs (per the IFU the maximum duration of device use is no more than 4 hrs). The following biocompatibility testing was performed:

ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation ● and skin sensitization.
ISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation ● and skin sensitization

5.7 Conclusion

The differences between the AAJT-S and the 510(k)-cleared predicates do not introduce new questions of safety or effectiveness. The performance of the AAJT-S is substantially equivalent to the performance of the predicate.

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).