(84 days)
The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.
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.
The Junctional Emergency Treatment Tool (JETT) is designed to control bleeding in the inguinal area. The device was tested in a cadaveric model and non-clinical bench top testing.
Here's a breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Consistently capable of stopping simulated vessel blood flow in unilateral hemorrhage control. | 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. |
| Consistently capable of stopping simulated vessel blood flow in bilateral hemorrhage control. | 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. |
| Consistently capable of applying forces equivalent to the predicate device (Combat Ready Clamp). | 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. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of cadavers used in the cadaveric model testing. It also doesn't specify the number of tests performed in the non-clinical bench top testing.
- Data Provenance: The cadaveric model testing and non-clinical bench top testing were likely conducted in a controlled laboratory setting, implying a prospective study design for these specific tests. There is no information provided regarding the country of origin of the data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the given document. The document describes the testing conducted on the device itself, not on a dataset requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the given document. The testing described (stopping blood flow, force application) does not involve a process that would typically require an adjudication method among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done. The study described focused on the device's technical performance (stopping blood flow, applying force) and comparison to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This question is not applicable as the device is a physical medical tool (Junctional Emergency Treatment Tool), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used:
For the cadaveric model testing, the ground truth was direct observation of whether simulated vessel blood flow was stopped. For the non-clinical bench top testing, the ground truth was measurement of applied forces and comparison to the predicate device's force application.
8. The Sample Size for the Training Set:
This information is not applicable. The JETT is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reason as above (not an AI/ML model).
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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/Sponsor | North American Rescue35 Tedwall CourtGreer, SC 29650-4791 USA |
| 510(k) Contact | North American Rescue, LLCWilliam Slevin35 Tedwall CourtGreer, SC 29650-4791864-275-9300 (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 beused by first responders for emergent purposes. The device is designed to controlbleeding in the inguinal area where standard tourniquets cannot be used. Thedevice can be used instead of manual pressure, allowing the healthcare provider toattend to other casualties. The Junctional Emergency Treatment Tool is used tocontrol a difficult bilateral or unilateral bleeding for up to 4 hours until the casualtycan be transferred for treatment. The Junctional Emergency Treatment Tool consistsof 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 orbilateral injuries. |
| Intended Use | The North American Rescue Junctional Emergency Treatment Tool is indicated foremergent purposes to control difficult bleeds in the inguinal area. |
| Technological Characteristics | The Junctional Emergency Treatment Tool employs trapezoidal pressure pads withthreaded T-handles to occlude the femoral artery. The Junctional Emergency TreatmentTool is attached with a nylon belt and locking mechanism. Additionally, a comparativebench top test was performed showing the forces applied by the Junctional EmergencyTreatment Tool and the predicate are equivalent. |
| Non-Clinical PerformanceTesting Conclusion | The Junctional Emergency Treatment Tool was tested with a cadaveric model todemonstrate it was consistently capable of stopping simulated vessel blood flow, both inunilateral and bilateral hemorrhage control. The Junctional Emergency Treatment Toolwas tested in Non-Clinical Bench Top Testing to demonstrate it was consistently capableof applying forces equivalent to the predicate device. |
| Substantial EquivalenceSummary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing theJunctional Emergency Treatment Tool was shown to be substantially equivalent to thepredicate device, the Combat Ready Clamp. |
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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.
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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
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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
§ 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).