(61 days)
Not Found
No
The device description and performance studies focus on mechanical compression and do not mention any AI/ML components or data processing for decision-making.
Yes
The device is described as controlling difficult bleeds in the inguinal area and is used to halt blood flow in the abdominal aorta for up to 60 minutes, which directly addresses a medical condition (hemorrhage) through physical intervention.
No
The Abdominal Aortic Tourniquet is a therapeutic device designed to control bleeding by mechanically compressing blood vessels. It does not provide any diagnostic information about a patient's condition.
No
The device description clearly states it is a "wedge shaped bladder that when inflated pushes in on the lower abdomen," indicating a physical, hardware-based device. The performance studies also describe testing of this physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro) to analyze these samples.
- Device Function: The Abdominal Aortic Tourniquet is a mechanical device applied externally to the body to physically compress structures and control bleeding. It does not analyze any biological samples.
- Intended Use: The intended use is to control bleeding in the inguinal area, a physical intervention, not a diagnostic test.
The description clearly indicates a physical device used for a therapeutic purpose (controlling bleeding), not a diagnostic purpose involving the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Abdominal Aortic Tourniquet is indicated for use in the battlefield to control difficult bleeds in the inguinal area.
Product codes
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal area, abdominal aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
military medical personnel in the battlefield
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Average pressure required to cease flow: 191mmHg (minimum 150mmHg, maximum 230mmHg).
Average discomfort at cessation of flow: 6.6 (minimum 4, maximum 10).
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 LLC
1634-A Montgomery Hwy #115
Hoover, AL 35216 |
|-------------------------------|-------------------------------------------------------------------------------------------------|
| Telephone: | 205-202-1126 |
| e-mail: | jcroushorn@gmail.com |
| Contact Person | Ruth C. Forstadt, RAC
Regulatory 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.
1
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.
| | Proposed
AAT Device | Predicate
Combat Ready Clamp | Predicate
A.T.S. Automatic
Tourniquet System |
|---------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Configuration | Inflatable pneumatic
tourniquet | Expandable aluminum
clamp | Inflatable pneumatic
tourniquet |
| Method of
Action | Manual | Manual | Automatic |
| Components | Waistband (belt and
cumberband),
inflatable air bladder
(pneumatic inflator),
manual pump | Base plate, vertical and
horizontal arins,
pressure handle,
pressure disc, adjustable
strap | Control unit, pneumatic
tourniquet cuff,
connector tubing from
control 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.
2
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
3
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
4
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)
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