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.

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Control difficult bleeds in the inguinal area	The SAM Junctional Tourniquet (SJT) is indicated for and shown to control difficult bleeds in the inguinal area through substantial equivalence to K123694 and performance testing (Cadaver, Bench).
Control difficult bleeds in the axilla area	The SJT is indicated for and shown to control difficult bleeds in the axilla area, supported by substantial equivalence to K123694 (for other indications) and performance testing (Cadaver, Bench). This was the new indication for this submission.
Immobilize a pelvic fracture	The SJT is indicated for and shown to immobilize a pelvic fracture through substantial equivalence to K123694 and performance testing (Cadaver, Bench).

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not explicitly state a specific "test set" or its sample size in the context of device performance. The testing mentioned is "Cadaver" and "Bench" testing, which implies laboratory or simulated environments rather than a traditional clinical test set with human patients. The data provenance is not further specified beyond these testing types.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

This information is not provided in the document. The nature of "Cadaver" and "Bench" testing typically involves controlled measurements and evaluations by engineers or medical professionals involved in the product development, rather than a panel of external experts establishing ground truth in the way described for clinical studies.

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of "Cadaver" and "Bench" testing, a formal adjudication method for a test set as seen in clinical trials is unlikely to have been implemented in the traditional sense.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

Not applicable. This device is a physical medical device (tourniquet), not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is irrelevant.

7. Type of Ground Truth Used:

For the performance testing, the "ground truth" would be established through direct physical measurements and observations during the "Cadaver" and "Bench" tests, comparing the device's ability to achieve its stated functions (e.g., occlude arteries, immobilize a pelvic fracture) against predetermined technical specifications or physiological outcomes in the simulated environments. This is a form of technical or functional validation rather than expert consensus, pathology, or outcomes data from human subjects.

8. Sample Size for the Training Set:

Not applicable. As this is a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device's design and functionality are developed through engineering processes, material science, and iterative testing.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for a physical device. The "ground truth" for the device's design and development comes from engineering principles, relevant medical knowledge (e.g., anatomy, physiology of bleeding control and fracture immobilization), and results from iterative bench and cadaver testing during the product development cycle.

Summary

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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)

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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.

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: TraumaPatients	Yes	Yes
2	Indicated for use to control difficultbleeds in the inguinal area	Yes	Yes
3	Indicated for use to control difficultbleeds in the axilla area	Yes	No
4	Indicated for immobilization ofpelvic 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 mechanismIdentical, SpringControlled Buckle	Spring Controlled Buckle

SAM® Junctional Tourniquet 510(k)

Page 5-2

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	SJT Attribute:	New Submission:	Cleared (K123694)
10	Materials	Identical, Metal,Injection MoldedPlastic, Textile	Metal, Injection MoldedPlastic, Textile
11	Biocompatibility	Yes, per ISO 10993-1requirements	Yes, per ISO 10993-1requirements
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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Image /page/3/Picture/1 description: The image contains the text 'Public Health Service'. The text is in a simple, sans-serif font and is horizontally aligned. The text appears to be part of a document or sign.

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

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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

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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

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).