(94 days)
Exempt
No
The description focuses on mechanical components and manual activation, with no mention of AI/ML terms or functionalities.
Yes
The device is designed to control bleeding and immobilize pelvic fractures, which are direct interventions to improve a patient's health condition.
No
The device is described as a tourniquet to control bleeding and a belt for pelvic fracture immobilization. Its intended use is direct therapeutic intervention, not diagnosis. While it provides feedback on circumferential force, this is for proper application of the device, not for assessing a medical condition.
No
The device description clearly outlines a physical device with a belt/buckle system and an inflatable point pressure device (PPD), indicating it is a hardware-based medical device.
Based on the provided information, the SAM Junctional Tourniquet is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- SAM Junctional Tourniquet Function: The SAM Junctional Tourniquet is a physical 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 as a mechanical device for external application in trauma situations.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
DXC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inguinal area, pelvic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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:
- 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
No clinical testing was performed.
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.
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.
Exempt
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
§ 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).
0
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
1
Legally Marketed Predicate Device(s)
510(k) Number | Product Code | Trade Name | Applicant |
---|---|---|---|
K102025 | DXC | Combat Ready Clamp | Combat Medical Systems |
LLC | |||
6441-D Yadkin Rd | |||
Fayettville, NC 28303 | |||
Exempt | IPW | SAM Pelvic Sling | SAM Medical Products |
27350 SW 95th Ave. | |||
Suite 3038 | |||
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:
-
- Combat Ready Clamp (CRoC), Combat Medical Systems
2
Attribute | SJT | CRoC | |
---|---|---|---|
1 | Inguinal Trauma Patients | Yes | Yes |
2 | Indicated for use to control difficult | ||
bleeds in the inguinal area | Yes | Yes | |
3 | Indicated for immobilization of | ||
pelvic 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 Controlled | |
Buckle | None | ||
9 | Materials | Metal, Injection | |
Molded Plastic, | |||
Textile | Metal, Injection | ||
Molded Plastic, | |||
Textile | |||
10 | Biocompatibility | Yes, per ISO | |
10993-1 | |||
requirements | Not listed in 510 | ||
summary | |||
11 | Shelf Life | N/A | N/A |
12 | Sterile Product | No | No |
13 | Testing to Predicate | Cadaver, Bench | Cadaver, Bench |
:
:
3
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.
4
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.
5
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
6
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