JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088

K123194 · North American Rescue Products, Inc. · DXC · Jan 3, 2013 · Cardiovascular

Device Facts

• Record ID: K123194
• Device Name: JUNCTIONAL EMERGENCY TREATMENT TOOL MODEL 30-0088
• Applicant: North American Rescue Products, Inc.
• Product Code: DXC · Cardiovascular
• Decision Date: Jan 3, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The North American Rescue Junctional Emergency Treatment Tool is indicated for emergent purposes to control difficult bleeds in the inguinal area.

Device Story

Junctional Emergency Treatment Tool (JETT) is a vascular clamp designed for first responders to control inguinal hemorrhage where standard tourniquets are ineffective. Device consists of a nylon belt assembly, two trapezoidal pressure pads, and threaded T-handles. Operator applies device to casualty; T-handles are tightened to exert pressure on femoral artery, occluding blood flow. Device allows for unilateral or bilateral treatment; replaces manual pressure, enabling provider to attend to other casualties. Used in emergency settings for up to 4 hours until transfer for definitive care. Benefits include hemorrhage control and provider resource optimization.

Clinical Evidence

No clinical data. Evidence consists of non-clinical bench top testing and cadaveric model testing. Cadaveric study demonstrated consistent capability to stop simulated vessel blood flow in unilateral and bilateral hemorrhage. Bench top testing confirmed the device applies forces equivalent to the predicate device.

Technological Characteristics

Vascular clamp featuring two trapezoidal pressure pads, threaded T-handles, and a nylon belt with a locking mechanism. Operates via mechanical compression to occlude the femoral artery. No energy source or software components.

Indications for Use

Indicated for emergent control of difficult unilateral or bilateral inguinal hemorrhage in patients requiring temporary vascular occlusion.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Combat Ready Clamp (K102025)

Submission Summary (Full Text)

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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/Spons<br>or | North American Rescue<br>35 Tedwall Court<br>Greer, SC 29650-4791 USA |
| 510(k) Contact | North American Rescue, LLC<br>William Slevin<br>35 Tedwall Court<br>Greer, SC 29650-4791<br>864-275-9300 (phone)<br>[e-mail] (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<br>used by first responders for emergent purposes. The device is designed to control<br>bleeding in the inguinal area where standard tourniquets cannot be used. The<br>device can be used instead of manual pressure, allowing the healthcare provider to<br>attend to other casualties. The Junctional Emergency Treatment Tool is used to<br>control a difficult bilateral or unilateral bleeding for up to 4 hours until the casualty<br>can be transferred for treatment. The Junctional Emergency Treatment Tool consists<br>of a belt assembly, with two trapezoidal pressure pads and Threaded T-Handles.<br>The two pressure pads allow the provider to treat a casualty with either unilateral or<br>bilateral injuries. |
| Intended Use | The North American Rescue Junctional Emergency Treatment Tool is indicated for<br>emergent purposes to control difficult bleeds in the inguinal area. |
| Technological Characteristics | The Junctional Emergency Treatment Tool employs trapezoidal pressure pads with<br>threaded T-handles to occlude the femoral artery. The Junctional Emergency Treatment<br>Tool is attached with a nylon belt and locking mechanism. Additionally, a comparative<br>bench top test was performed showing the forces applied by the Junctional Emergency<br>Treatment Tool and the predicate are equivalent. |
| Non-Clinical Performance<br>Testing Conclusion | The Junctional Emergency Treatment Tool was tested with a cadaveric model to<br>demonstrate it was consistently capable of stopping simulated vessel blood flow, both in<br>unilateral and bilateral hemorrhage control. The Junctional Emergency Treatment Tool<br>was tested in Non-Clinical Bench Top Testing to demonstrate it was consistently capable<br>of applying forces equivalent to the predicate device. |
| Substantial Equivalence<br>Summary (Conclusion) | Based on the technological; characteristics and non-clinical performance testing the<br>Junctional Emergency Treatment Tool was shown to be substantially equivalent to the<br>predicate 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 [phone] or [phone] 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):

K123194

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