(84 days)
Combat Ready Clamp K102025
Combat Ready Clamp K102025
No
The device description and performance studies focus on mechanical function and physical testing, with no mention of AI/ML algorithms or data processing.
Yes
The device is used to control difficult bleeds in the inguinal area, addressing a health condition and providing a therapeutic effect by improving the patient's condition.
No
The device description indicates its use is for controlling difficult bleeds, which is a treatment function, not a diagnostic one. It does not mention analyzing patient data to identify a disease or condition.
No
The device description explicitly states it consists of a "belt assembly, with two trapezoidal pressure pads and Threaded T-Handles," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Junctional Emergency Treatment Tool is a mechanical device designed to apply pressure externally to control bleeding in the inguinal area. It does not perform any tests on bodily samples.
- Intended Use: The intended use is for emergent hemorrhage control, which is a direct treatment/intervention, not a diagnostic process.
The description clearly indicates a device for physical intervention to stop bleeding, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.
Product codes
DXC
Device Description
Device Description: The Junctional Emergency Treatment Tool is designed to be used by first responders for emergent purposes. The device is designed to control bleeding in the inguinal area where standard tourniquets cannot be used. The device can be used instead of manual pressure, allowing the healthcare provider to attend to other casualties. The Junctional Emergency Treatment Tool is used to control a difficult bilateral or unilateral bleeding for up to 4 hours until the casualty can be transferred for treatment. The Junctional Emergency Treatment Tool consists of a belt assembly, with two trapezoidal pressure pads and Threaded T-Handles. The two pressure pads allow the provider to treat a casualty with either unilateral or bilateral injuries.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
first responders
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The Junctional Emergency Treatment Tool was tested with a cadaveric model to demonstrate it was consistently capable of stopping simulated vessel blood flow, both in unilateral and bilateral hemorrhage control. The Junctional Emergency Treatment Tool was tested in Non-Clinical Bench Top Testing to demonstrate it was consistently capable of applying forces equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Combat Ready Clamp K102025
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
3 2013 JAN
510(R) Summary 12
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the Junctional Emergency Treatment Tourniquet is provided below.
| Date Summary Prepared | December 14, 2012 |
|---|---|
| Manufacturer/Distributor/Spons | |
| or | North American Rescue |
| 35 Tedwall Court | |
| Greer, SC 29650-4791 USA | |
| 510(k) Contact | North American Rescue, LLC |
| William Slevin | |
| 35 Tedwall Court | |
| Greer, SC 29650-4791 | |
| 864-275-9300 (phone) | |
| wslevin@narescue.com (email) | |
| Trade Name | Junctional Emergency Treatment Tool |
| Common Name | Vascular Clamp |
| Code -Name -Classification | DXC - Vascular Clamp 21 CFR 870.4450: Class II |
| Predicate Devices | Combat Ready Clamp K102025 |
| Device Description | Device Description: The Junctional Emergency Treatment Tool is designed to be |
| used by first responders for emergent purposes. The device is designed to control | |
| bleeding in the inguinal area where standard tourniquets cannot be used. The | |
| device can be used instead of manual pressure, allowing the healthcare provider to | |
| attend to other casualties. The Junctional Emergency Treatment Tool is used to | |
| control a difficult bilateral or unilateral bleeding for up to 4 hours until the casualty | |
| can be transferred for treatment. The Junctional Emergency Treatment Tool consists | |
| of a belt assembly, with two trapezoidal pressure pads and Threaded T-Handles. | |
| The two pressure pads allow the provider to treat a casualty with either unilateral or | |
| bilateral injuries. | |
| Intended Use | The North American Rescue Junctional Emergency Treatment Tool is indicated for |
| emergent purposes to control difficult bleeds in the inguinal area. | |
| Technological Characteristics | The Junctional Emergency Treatment Tool employs trapezoidal pressure pads with |
| threaded T-handles to occlude the femoral artery. The Junctional Emergency Treatment | |
| Tool is attached with a nylon belt and locking mechanism. Additionally, a comparative | |
| bench top test was performed showing the forces applied by the Junctional Emergency | |
| Treatment Tool and the predicate are equivalent. | |
| Non-Clinical Performance | |
| Testing Conclusion | The Junctional Emergency Treatment Tool was tested with a cadaveric model to |
| demonstrate it was consistently capable of stopping simulated vessel blood flow, both in | |
| unilateral and bilateral hemorrhage control. The Junctional Emergency Treatment Tool | |
| was tested in Non-Clinical Bench Top Testing to demonstrate it was consistently capable | |
| of applying forces equivalent to the predicate device. | |
| Substantial Equivalence | |
| Summary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing the |
| Junctional Emergency Treatment Tool was shown to be substantially equivalent to the | |
| predicate device, the Combat Ready Clamp. |
1
Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
North American Rescue Products, LLC c/o Mr. William Slevin 35 Tedwall Court Greer, SC 29650-4791
JAN 3 2013
Re: K123194
Trade/Device Name: Junctional Emergency Treatment Tool Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: December 18, 2012 Received: December 20, 2012
Dear Mr. Slevin:
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.
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 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.
2
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.
Sincerely yours,
Matthew G. Hillebrenner
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known):
Device Name:
Junctional Emergency Treatment Tool
The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.
Prescription Use X
AND/OR
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 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
Ms. Hill
(Division Sion-Off) Division of Cardlovascular Devices
510(k) Number K123194