SAM JUNCTIONAL TOURNIQUET

K123694 · Sam Medical Products · DXC · Mar 7, 2013 · Cardiovascular

Device Facts

• Record ID: K123694
• Device Name: SAM JUNCTIONAL TOURNIQUET
• Applicant: Sam Medical Products
• Product Code: DXC · Cardiovascular
• Decision Date: Mar 7, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SAM Junctional Tourniquet is indicated for battlefield and trauma situations: - To control difficult bleeds in the inguinal area. - To immobilize a pelvic fracture.

Device Story

SAM Junctional Tourniquet (SJT) is a vascular clamp designed for battlefield and trauma settings to control inguinal hemorrhage and immobilize pelvic fractures. The device features a circumferential belt and buckle system; it provides user feedback once a minimum circumferential force is achieved. An inflatable point pressure device (PPD) is then manually activated to occlude the artery or provide compression over a hemostatic agent. The device is intended for use up to 4 hours. It serves as a dual-purpose tool for hemorrhage control and pelvic stabilization. By providing targeted pressure, it benefits patients with non-tourniquetable inguinal bleeds. It is operated by medical personnel in trauma or field environments.

Clinical Evidence

No clinical testing was performed. Evidence is based on bench testing, including PPD burst pressure tests, 4-hour stability tests, human simulation testing, and cadaver studies. Materials meet USP Plastic Class VI and ISO 10993-1 biocompatibility requirements.

Technological Characteristics

Materials: Metal, injection-molded plastic, textile. Sensing/Actuation: Spring-controlled buckle for force feedback; manual pneumatic inflation for PPD. Form factor: Circumferential belt. Biocompatibility: ISO 10993-1 compliant. Non-sterile.

Indications for Use

Indicated for battlefield and trauma patients requiring control of inguinal hemorrhage or immobilization of pelvic fractures.

Regulatory Classification

Identification

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

Predicate Devices

• Combat Ready Clamp (K102025)
• SAM Pelvic Sling (Exempt)

Submission Summary (Full Text)

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# 510(k) Summary SAM Medical Products, Inc. SAM® Junctional Tourniquet ¯

MAR 7 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510{k} number is: _K123694

#### Contact Details

Applicant Name: SAM Medical Products, Inc

SAM Medical Products, Inc

27350 SW 95th Avenue, Suite 3038

Wilsonville, OR 97070

503-639-5474 Phone:

Fax: [phone]

Contact: Jack N. McCutcheon QARA Manager

Email: [e-mail]

Date Prepared: November 15, 2012

Device Name

Trade Name: SAM Junctional Tourniquet

Common Name: Vascular Clamp

Classification Name: Clamp Vascular

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# Legally Marketed Predicate Device(s)

| 510(k) Number | Product Code | Trade Name | Applicant |
|---------------|--------------|--------------------|-----------------------------------------------------------------------------------|
| K102025 | DXC | Combat Ready Clamp | Combat Medical Systems<br>LLC<br>6441-D Yadkin Rd<br>Fayettville, NC 28303 |
| Exempt | IPW | SAM Pelvic Sling | SAM Medical Products<br>27350 SW 95th Ave.<br>Suite 3038<br>Wilsonville, OR 97007 |

#### Device Description

The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage. The device is designed to control bleeding in the inguinal area where standard Tourniquets cannot be used. The SAM Junctional Tourniquet is used to control bleeding for up to 4 hours.

A key feature of the device is a belt/buckle system which provides feedback to the user after a minimum circumferential force around the patient is obtained, after which an inflatable point pressure device (PPD) is manually activated to occlude an artery or to provide compressive force over a Hemostatic agent.

The SAM Junctional Tourniquet can also be used as a Circumferential Pelvic belt for pelvic fracture immobilization.

# Intended Use/Indications for use

The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

- � To control difficult bleeds in the inguinal area.
- . To immobilize a pelvic fracture

#### Substantial Equivalence Comparison

The SAM® Junctional Tourniquet has new technological characteristics. These new characteristics do not introduce new concerns of safety or performance.

The SAM Junctional Tourniquet (SJT) is similar in design and intended use to marketed products manufactured by:

- 1) Combat Ready Clamp (CRoC), Combat Medical Systems

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| | Attribute | SJT | CRoC |
|----|-----------------------------------------------------------------------|------------------------------------------------|------------------------------------------------|
| 1 | Inguinal Trauma Patients | Yes | Yes |
| 2 | Indicated for use to control difficult<br>bleeds in the inguinal area | Yes | Yes |
| 3 | Indicated for immobilization of<br>pelvic fractures | Yes | No |
| 4 | Product code | DXC | DXC |
| 5 | Circumferential belt | Yes | Yes |
| 6 | Point pressure | Yes | Yes |
| 7 | Point pressure mechanism | Manual,<br>Pneumatic | Manual, Screw |
| 8 | Force control mechanism | Spring Controlled<br>Buckle | None |
| 9 | Materials | Metal, Injection<br>Molded Plastic,<br>Textile | Metal, Injection<br>Molded Plastic,<br>Textile |
| 10 | Biocompatibility | Yes, per ISO<br>10993-1<br>requirements | Not listed in 510<br>summary |
| 11 | Shelf Life | N/A | N/A |
| 12 | Sterile Product | No | No |
| 13 | Testing to Predicate | Cadaver, Bench | Cadaver, Bench |

:

:

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# Non-clinical Testing

#### Bench Testing:

- PPD Burst Pressure Test .
- . PPD Four Hour Stability Test
- The raw materials meet USP Plastic Class VI and ISO 10993-1 requirements .
- . Human Simulation Testing
- Cadaver ●

# Clinical Testing

No clinical testing was performed.

#### Conclusion

The SAM Junctional Tourniquet is substantially equivalent to the Combat Ready Clamp. The SAM Junctional Tourniquet introduces new design, materials and technology, but these differences do not introduce new safety or performance concerns. The evidence from the performance bench testing further supports the substantial equivalence.

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Image /page/4/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 features a staff with a snake winding around it, and three horizontal lines below. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 7, 2013

SAM Medical Products C/O Jack N. McCutcheon 27350 SW 95t0 Ave Ste 3038 Bldg 30 Wilsonville, Oregon 97070

Re: K123694

Trade/Device Name: SAM Junctional Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: January 23, 2013 Received: January 24, 2013

Dear Mr. McCutcheon:

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,

# Bram D厚ù@kerman

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

510(k) Number: K123694

Device Name: SAM® Junctional Tourniquet

Indications for Use:

The SAM Junctional Tourniquet is indicated for battlefield and trauma situations:

- To control difficult bleeds in the inguinal area. .
- To immobilize a pelvic fracture. .

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Bram D. 2013.03.0