(71 days)
Not Found
No
The summary describes a mechanical device for controlling bleeding and does not mention any AI or ML components or functionalities.
Yes.
The device is used to control difficult bleeding, which is a therapeutic intervention aimed at treating an injury.
No
The device is a medical tourniquet designed to control bleeding, not to diagnose a medical condition.
No
The device description clearly describes a physical tourniquet ("Abdominal Aortic and Junctional Tourniquet (AAJT)") designed to apply mechanical pressure to control bleeding. The performance studies also involve human subjects and measure physical parameters like blood flow and bladder pressure, indicating a hardware component.
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 to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The Abdominal Aortic and Junctional Tourniquet is a physical device applied externally to the body to control bleeding. It does not involve testing samples taken from the body.
- Lack of IVD-related information: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic measurements based on bodily fluids or tissues.
The device is a therapeutic device used for hemostasis (stopping bleeding) through external pressure.
N/A
Intended Use / 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.
Product codes
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pelvis, inguinal area and axilla
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
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.
Key Metrics
Not Found
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
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 pneumatic |
tourniquet | ||
Method of | ||
Action | Manual | Manual |
Components | Waistband (belt and | |
cummerband), inflatable air | ||
bladder (pneumatic inflator), | ||
manual pump | Waistband (belt and | |
cummerband), inflatable air | ||
bladder (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)