(61 days)
The Abdominal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
The Abdominal Aortic Tourniquet is a wedge shaped bladder that when inflated pushes in on the lower abdomen compressing all the structures within to include the descending aorta. The Abdominal Aortic Tourniquet (AAT) is designed to be used by military medical personnel in the battlefield to control bleeding in the inguinal area 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. The Abdominal Aortic Tourniquet is used to control a difficult bleed for up to 60 minutes until the injured soldier can be transferred to evacuation personnel for further treatment.
The Abdominal Aortic Tourniquet (AAT) is a medical device designed to control difficult bleeds in the inguinal area, primarily for military medical personnel in battlefield settings. The provided text describes the safety and performance studies conducted to demonstrate its substantial equivalence to predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AAT are implied through the comparison with predicate devices and the outcome of the performance testing. While specific numerical acceptance criteria (e.g., "must achieve X% reduction in blood flow") are not explicitly stated, the studies aimed to show that the AAT could significantly decrease or halt blood flow without causing significant damage or discomfort beyond what is manageable.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical Efficacy in Reducing/Halting Blood Flow | Animal Study (Swine): Flow was essentially undetectable in the femoral catheter during tourniquet application for 60 minutes.Human Study: Average pressure required to cease flow in the common femoral artery (CFA) was 191mmHg (min 150mmHg, max 230mmHg). |
| Safety - Prevent Significant Tissue Damage | Animal Study (Swine): Serum potassium and lactate did not reach clinically significant numbers. Gross and histological examination revealed no signs of significant ischemia or necrosis of the small and large intestine after 60 minutes of application. |
| Safety - Manageable Discomfort | Human Study: Average discomfort at cessation of flow was 6.6 on a 1-10 pain scale (min 4, max 10). All discomfort ceased when the device was released. |
| Duration of Efficacy | Animal Study (Swine): Evaluated for 60 minutes of application. The device is designed for use up to 60 minutes. |
| Substantial Equivalence to Predicate Devices | The Abdominal Aortic Tourniquet was determined to be substantially equivalent to the predicate devices (Combat Ready Clamp, A.T.S. Automatic Pneumatic Tourniquet System) in decreasing or eliminating blood flow, and in its safety and performance profile (non-inferior to predicate devices in these aspects). |
2. Sample Size Used for the Test Set and the Data Provenance
- Animal Study: Eight (8) swine animals. The provenance is not explicitly stated but is implicitly a laboratory or research animal facility. The study design appears prospective.
- Human Study: Nine (9) subjects. The provenance is not explicitly stated regarding country, but it is a prospective study as it involved active measurements during device application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The text does not mention the use of external experts for establishing ground truth for the test sets in the typical sense of expert consensus for diagnostic accuracy.
- In the animal study, "ground truth" for blood flow cessation was established through objective measurements (femoral catheter flow, mean arterial pressure, central venous pressure, intra-abdominal pressure, potassium levels, lactate levels) and gross/histological examination performed by potentially veterinary pathologists or researchers. The number and qualifications of these individuals are not specified.
- In the human study, "ground truth" for blood flow cessation was established using Pulsed-wave Doppler to measure flow in the common femoral artery. Discomfort was self-reported by subjects using the verbal 1-10 pain scale. The personnel conducting the Doppler measurements and recording discomfort would be trained researchers or clinicians, but their specific qualifications and number are not detailed.
4. Adjudication Method for the Test Set
There was no indication of an adjudication method (like 2+1 or 3+1) used for interpreting results in either the animal or human study. The measurements (Doppler flow, pressure, pain scale, lab results, histology) are objective or self-reported outcomes that generally do not require adjudication.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The device is an Abdominal Aortic Tourniquet, a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human readers with AI assistance is not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a way, the studies performed represent the "standalone" performance of the device (tourniquet-only performance). The animal and human studies assessed the device's ability to mechanically stop blood flow and its associated effects, independent of human interpretive input. Human interaction was limited to application and monitoring.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Animal Study: The ground truth for efficacy (blood flow reduction/cessation) was based on direct physiological measurements (femoral catheter flow) and safety (tissue damage) was based on objective laboratory markers (potassium, lactate) and pathology (gross and histological examination of tissues).
- Human Study: The ground truth for efficacy (blood flow reduction/cessation) was based on objective imaging data (Pulsed-wave Doppler measurements of CFA flow). The ground truth for discomfort was self-reported outcomes data (verbal 1-10 pain scale).
8. The Sample Size for the Training Set
No training set is mentioned as this is a physical medical device and not an AI/algorithm-based device requiring machine learning training. The studies described are performance and safety validation studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/algorithm.
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K112384 page lot 2
OCT 1 8 2011
SECTION 2 – 510(k) SUMMARY
Abdominal Aortic Tourniquet
| Submitter's Name and Address: | John Croushorn, M.D.Compression Works LLC1634-A Montgomery Hwy #115Hoover, AL 35216 |
|---|---|
| Telephone: | 205-202-1126 |
| e-mail: | jcroushorn@gmail.com |
| Contact Person | Ruth C. Forstadt, RACRegulatory Affairs Consultant to Compression Works LLC |
| Telephone: | 401-521-3294 |
| e-mail: | rcforstadt@hotmail.com |
Date Prepared: October 6, 2011
| Name of Medical Device | |
|---|---|
| Classification Name: | Vascular Clamp |
| Common/Usual Name: | Vascular Clamp |
| Proprietary Name: | Abdominal Aortic Tourniquet (AAT) |
Substantial Equivalence
The Abdominal Aortic Tourniquet is substantially equivalent to:
Combat Medical System's Combat Ready Clamp (K102025) and the Zimmer A.T. S. Automatic Pneumatic Tourniquet System (K012632).
Device Classification
This device carries an FDA product code DXC, and is classified as a Vascular Clamp under 21 CFR 870.4450.
Device Description
The Abdominal Aortic Tourniquet is a wedge shaped bladder that when inflated pushes in on the lower abdomen compressing all the structures within to include the descending aorta. The Abdominal Aortic Tourniquet (AAT) is designed to be used by military medical personnel in the battlefield to control bleeding in the inguinal area 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. The Abdominal Aortic Tourniquet is used to control a difficult bleed for up to 60 minutes until the injured soldier can be transferred to evacuation personnel for further treatment.
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K112384 page 2 of 2
Indications for Use
Technological Comparison to Predicate Devices The Abdominal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
| ProposedAAT Device | PredicateCombat Ready Clamp | PredicateA.T.S. AutomaticTourniquet System | |
|---|---|---|---|
| Configuration | Inflatable pneumatictourniquet | Expandable aluminumclamp | Inflatable pneumatictourniquet |
| Method ofAction | Manual | Manual | Automatic |
| Components | Waistband (belt andcumberband),inflatable air bladder(pneumatic inflator),manual pump | Base plate, vertical andhorizontal arins,pressure handle,pressure disc, adjustablestrap | Control unit, pneumatictourniquet cuff,connector tubing fromcontrol unit to cuff |
Safety and Performance
Results of performance and safety testing have demonstrated that the device is substantially equivalent to the predicate devices.
Non-clinical testing included burst pressure testing on the bench, as well as animal testing. The animal testing was performed in eight (8) swine animals to evaluate the mechanical efficacy of the Abdominal Aortic Tourniquet device to significantly decrease or halt blood flow in the abdominal aorta for 60 minutes without causing tissue damage. Mean arterial pressure (MAP), central venous pressure (CVP), intra-abdominal pressure, potassium levels, lactate levels were measured and tissue histology was completed. Flow was essentially undetectable in the femoral catheter during the tourniquet application. Serum potassium and lactate did not reach clinically significant numbers. Gross and histological examination revealed no signs of significant ischemia or necrosis of the small and large intestine. The Abdominal Aortic Tourniquet was determined to be substantially equivalent to the predicate devices in decreasing or eliminating blood flow.
A human data study in nine (9) subjects was performed to measure the pressure required in the Abdominal Aortic Tourniquet to reduce or cease blood flow in the common femoral artery (CFA) and the discomfort caused to the subject during the procedure. Pulsed-wave Doppler was used to measure the flow in the CFA every 30mmHG as measured on the Abdominal Aortic Tourniquet manometer. Discomfort was measured using the verbal 1-10 pain scale. The average pressure required to cease flow was 191mmHg with a minimum of 150mmHg and maximum of 230mmHg. The average discomfort at cessation of flow was 6.6 with a minimum of 4 and maximum of 10. All discomfort ceased when the device was released. The Abdominal Aortic Tourniquet device was determined to be substantially equivalent to the predicate devices in decreasing or eliminating blood flow in the CFA.
Based on the indications for use, technological characteristics, and comparison to predicate devices, the Abdominal Aortic Tourniquet has been shown to be substantially equivalent to predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/0 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with stylized feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 1 8 2011
Compression Works LLC. c/o Ruth Forstadt 15 Sargent Ave. Providence, RI 02906
Re: K112384
Trade/Device Name: Abdominal Aortic Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II (two) Product Code: DXC Dated: September 27, 2011 Received: October 4, 2011
Dear Ms. 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, Jrug, 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 mighteding.
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 devine 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 aft the Act or any Federal statutes and regulations administered by other Federal agencies. Your must
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Page 2 - Ms. Ruth Forstadt
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.
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.
lua.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
Bram D/Zuckerman, M.D. Directør Diysion of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 112384 page 1 of
Indications for Use
510(k) Number (if known): K112384
Device Name: Abdominal Aortic Tourniquet
Indications for Use:
The Abdominal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Page 1 of 1
(Division Sign-Off) Povices
§ 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).