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.

AI/ML Overview

The SAM Junctional Tourniquet (SJT) is a medical device designed to control difficult bleeds in the inguinal area and immobilize pelvic fractures, particularly in battlefield and trauma situations. The FDA cleared its 510(k) submission (K123694) in 2013, determining it substantially equivalent to the Combat Ready Clamp (CRoC).

Here's an analysis of the acceptance criteria and the studies conducted to demonstrate this:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance for the SAM Junctional Tourniquet (SJT) is based on substantial equivalence to a predicate device, the Combat Ready Clamp (CRoC). This means the focus of the acceptance criteria isn't on a predefined set of performance metrics that the SJT must achieve independently, but rather on demonstrating that the SJT is as safe and effective as the predicate device and that any differences do not introduce new safety or performance concerns.

Given the information provided, the acceptance criteria are implicitly linked to the attributes where the SJT is compared to the CRoC, particularly in terms of functionality and safety. The reported device performance is demonstrated through non-clinical testing.

Acceptance Criteria (Implied from Predicate Comparison & Testing)	Reported Device Performance (SJT)
Control difficult bleeds in the inguinal area	Demonstrated through Cadaver and Human Simulation Testing. The device provides point pressure via a pneumatic mechanism, designed for arterial occlusion. While specific bleed control metrics aren't detailed, the testing supports its intended function in this area.
Immobilize pelvic fractures	Demonstrated through Cadaver and Human Simulation Testing. The device can be used as a circumferential pelvic belt for immobilization. CRoC does not have this indication, so SJT's performance in this area establishes its additional utility without introducing new safety concerns, as supported by the testing.
Functional equivalence to CRoC in inguinal bleeding control	The SJT's design, involving a circumferential belt and point pressure, is conceptually similar to CRoC. Differences in the point pressure mechanism (pneumatic vs. screw) and force control (spring-controlled buckle vs. none) were assessed and did not introduce new safety or performance concerns, as stated in the conclusion.
Biocompatibility	Meets ISO 10993-1 requirements. This ensures the materials used in the device are safe for contact with the human body.
Structural Integrity of PPD	PPD Burst Pressure Test and PPD Four Hour Stability Test were performed to ensure the inflatable point pressure device (PPD) can withstand operational pressures and maintain integrity over the intended use duration (up to 4 hours for bleeding control). Specific numerical results are not provided, but the successful completion of these tests indicates performance adequacy.
Material Safety	Raw materials meet USP Plastic Class VI and ISO 10993-1 requirements.
Sterility	Non-sterile product. This is consistent with the predicate device and does not introduce new safety concerns.

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

Sample Size for Test Set: The document explicitly mentions "Cadaver" and "Human Simulation Testing." However, it does not provide specific numerical sample sizes for either of these tests.
Data Provenance: The document does not specify the country of origin for the cadaver or human simulation testing data. It is implied that these are prospective tests conducted specifically for the purpose of demonstrating the device's performance.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth in the cadaver or human simulation testing. Given the premarket notification context, such testing would likely involve trained medical professionals, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1) for the test set. Given the non-clinical nature of the testing described (cadaver and human simulation), it is more likely that performance was assessed based on observation and measurement rather than human reader adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The provided information pertains to a physical medical device (a tourniquet), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not conducted.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. As stated above, this is a physical medical device, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

The ground truth for the non-clinical testing appears to be based on:

Direct observation and measurement during cadaveric studies: To assess the device's ability to achieve arterial occlusion and pelvic immobilization.
Performance metrics in human simulation: Likely involving simulated scenarios to evaluate ease of use, application technique, and effectiveness under specified conditions.
Material specifications and standard testing: For biocompatibility (ISO 10993-1, USP Plastic Class VI) and PPD integrity (burst pressure, stability).

8. The Sample Size for the Training Set

Not applicable. The SAM Junctional Tourniquet 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

Not applicable. No training set was used.

Summary

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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: 503-639-5425

Contact: Jack N. McCutcheon QARA Manager

Email: jack.mccutcheon@sammedical.com

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 SystemsLLC6441-D Yadkin RdFayettville, NC 28303
Exempt	IPW	SAM Pelvic Sling	SAM Medical Products27350 SW 95th Ave.Suite 3038Wilsonville, OR 97007

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 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 difficultbleeds in the inguinal area	Yes	Yes
3	Indicated for immobilization ofpelvic fractures	Yes	No
4	Product code	DXC	DXC
5	Circumferential belt	Yes	Yes
6	Point pressure	Yes	Yes
7	Point pressure mechanism	Manual,Pneumatic	Manual, Screw
8	Force control mechanism	Spring ControlledBuckle	None
9	Materials	Metal, InjectionMolded Plastic,Textile	Metal, InjectionMolded Plastic,Textile
10	Biocompatibility	Yes, per ISO10993-1requirements	Not listed in 510summary
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 (800) 638-2041 or (301) 796-7100 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

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).