SAM JUNCTIONAL TOURNIQUET

K131561 · Sam Medical Products · DXC · Jul 24, 2013 · Cardiovascular

Device Facts

• Record ID: K131561
• Device Name: SAM JUNCTIONAL TOURNIQUET
• Applicant: Sam Medical Products
• Product Code: DXC · Cardiovascular
• Decision Date: Jul 24, 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 control difficult bleeds in the axilla area. . . To immobilize a pelvic fracture.

Device Story

Device is a vascular clamp for inguinal and axillary hemorrhage control and pelvic fracture immobilization. Consists of a belt and buckle system; provides user feedback via spring-controlled buckle once minimum circumferential force is reached. Includes a manually activated inflatable Target Compression Device (TCD) to occlude arteries or provide compression over hemostatic agents. Used in trauma and battlefield settings by medical personnel. Provides mechanical compression to stop bleeding for up to 4 hours. Benefits include stabilization of difficult-to-reach junctional bleeds and pelvic fractures.

Clinical Evidence

No clinical data. Evidence consists of bench testing and cadaver studies.

Technological Characteristics

Materials: metal, injection-molded plastic, and textile. Biocompatibility per ISO 10993-1. Mechanism: manual, pneumatic point pressure via inflatable TCD and spring-controlled buckle for force feedback. Non-sterile.

Indications for Use

Indicated for trauma and battlefield patients requiring hemorrhage control in the inguinal or axilla regions, or pelvic fracture immobilization.

Regulatory Classification

Identification

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

Predicate Devices

• SAM Junctional Tourniquet (K123694)

Submission Summary (Full Text)

{0}------------------------------------------------

# 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: [phone]

Fax: [phone]

- Contact: Jack N. McCutcheon QARA Manager
Email: [e-mail]

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)

{1}------------------------------------------------

## 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.

### 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<br>Patients | Yes | Yes |
| 2 | Indicated for use to control difficult<br>bleeds in the inguinal area | Yes | Yes |
| 3 | Indicated for use to control difficult<br>bleeds in the axilla area | Yes | No |
| 4 | Indicated for immobilization of<br>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<br>Identical, Spring<br>Controlled Buckle | Spring Controlled Buckle | |

SAM® Junctional Tourniquet 510(k)

Page 5-2

{2}------------------------------------------------

| | SJT Attribute: | New Submission: | Cleared (K123694) |
|----|---------------------|-----------------------------------------------------------|---------------------------------------------|
| 10 | Materials | Identical, Metal,<br>Injection Molded<br>Plastic, Textile | Metal, Injection Molded<br>Plastic, Textile |
| 11 | Biocompatibility | Yes, per ISO 10993-1<br>requirements | Yes, per ISO 10993-1<br>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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{5}------------------------------------------------

## 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