K Number

Device Name

SAM JUNCTIONAL TOURNIQUET

Manufacturer

SAM MEDICAL PRODUCTS

Date Cleared

2013-07-24

(55 days)

Product Code

DXC

Regulation Number

870.4450

Intended Use

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

Device Description

The SAM Junctional Tourniquet addresses the issue of non-tourniquetable inguinal hemorrhage and axilla hemorrhage. The device is designed to control bleeding in the inguinal area or axilla 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 Target Compression Device (TCD) 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K123694

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and manual activation, with no mention of AI/ML terms or functionalities.

Therapeutic

Yes

The device is designed to control bleeding and immobilize fractures, which are therapeutic interventions.

Diagnostic

The device is described as a tourniquet designed to control bleeding and immobilize pelvic fractures, which are therapeutic actions, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly details a physical belt/buckle system and an inflatable Target Compression Device (TCD), indicating it is a hardware-based medical device, not software-only.

IVD (In Vitro Diagnostic)

No, 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 provide information about a person's health.
SAM Junctional Tourniquet Function: The SAM Junctional Tourniquet is a mechanical device applied externally to the body to control bleeding and immobilize pelvic fractures. It does not involve testing samples from the body.

The description clearly indicates its use in a trauma setting for external application to control hemorrhage and immobilize fractures. This falls under the category of a therapeutic or surgical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Product codes (comma separated list FDA assigned to the subject device)

DXC

Device Description

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 Target Compression Device (TCD) 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

inguinal area, axilla area, pelvic

Indicated Patient Age Range

Not Found

Intended User / Care Setting

battlefield and trauma situations

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)

Bench Testing:

. Cadaver
. TCD Four Hour Stability Test

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123694

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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).

Summary

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

In accordance with 21 CFR 807.87(h) and 21 CFR 807.92 the 510(k) Summary for the SAM Junctional Tourniquet (SJT) device is provided below.

K131561 The assigned 510(k) number is: _

Contact Details

Applicant Name: SAM Medical Products, Inc

SAM Medical Products, Inc

27350 SW 95th Avenue, Suite 3038

Wilsonville, OR 97070

Phone: 503-639-5474

Fax: 503-639-5425

Contact: Jack N. McCutcheon QARA Manager
Email: jack.mccutcheon@sammedical.com

Date Prepared: May 10, 2013

Device Name

Trade Name: SAM Junctional Tourniquet
Common Name: Vascular Clamp
Classification Name: Clamp Vascular
K123694, SAM Junctional Tourniquet Predicate Device:

SAM® Junctional Tourniquet 510(k)

Device Description

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

Substantial Equivalence Comparison

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

SAM Junctional Tourniquet (SJT), SAM Medical Products

	SJT Attribute:	New Submission:	Cleared (K123694)
1	Target Population: Trauma
Patients	Yes	Yes
2	Indicated for use to control difficult
bleeds in the inguinal area	Yes	Yes
3	Indicated for use to control difficult
bleeds in the axilla area	Yes	No
4	Indicated for immobilization of
pelvic fractures	Yes	Yes
5	Product code	DXC	DXC
6	Circumferential belt	Yes	Yes
7	Point pressure	Yes	Yes
8	Point pressure mechanism	Manual, Pneumatic	Manual, Pneumatic
9	Force control mechanism
Identical, Spring
Controlled Buckle	Spring Controlled Buckle

SAM® Junctional Tourniquet 510(k)

Page 5-2

	SJT Attribute:	New Submission:	Cleared (K123694)
10	Materials	Identical, Metal,
Injection Molded
Plastic, Textile	Metal, Injection Molded
Plastic, Textile
11	Biocompatibility	Yes, per ISO 10993-1
requirements	Yes, per ISO 10993-1
requirements
12	Shelf Life	N/A	N/A
13	Sterile Product	No	No
14	Performance Testing	Cadaver, Bench	Cadaver, Bench

Non-clinical Testing

Bench Testing:

. Cadaver
. TCD Four Hour Stability Test

Clinical Testing

No clinical testing was performed.

Conclusion

The SAM Junctional Tourniquet with the additional indication for use (to control difficult bleeds in the axilla area) is substantially equivalent to the SAM Junctional Tourniquet cleared under 510(k) K123694. It is of equivalent design and materials, it addresses the same patient population, it has the same mechanism of action and it uses no new technology. The new indication for use does not introduce new safety or performance concerns.

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

July 24, 2013

SAM Medical Products, Inc. C/O Jack N. McCutcheon Ouality Assurance and Regulatory Affairs Manager 27350 SW 9510 Avenue, Suite 3038 Wilsonville, OR 97070

Re: K131561

Trade/Device Name: SAM® Junctional Tourniquet Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: May 28, 2013 Received: May 30, 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

Page 2 - Mr. Jack N. McCutcheon

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.

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/ResourcesforYou/Industry/default.htm. 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,

M. G. Hillebrand

for

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

Enclosure

Indications for Use

510(k) Number: _K131561

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 control difficult bleeds in the axilla 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)

M.A. Hillemann