SUREFIRE GUIDE SHEATH

K113737 · Surefire Medical, Inc. · DQO · Feb 23, 2012 · Cardiovascular

Device Facts

• Record ID: K113737
• Device Name: SUREFIRE GUIDE SHEATH
• Applicant: Surefire Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Feb 23, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The Surefire® Guide Sheath is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Device Story

Surefire® Guide Sheath is a 0.035" guide wire compatible, single lumen, fixed length intravascular catheter with a luer lock hub. Device acts as a conduit for diagnostic agents and facilitates deployment of therapeutic agents to desired treatment locations in the peripheral vascular system. Operated manually by clinicians during angiographic procedures. Device provides a pathway for delivery of media/agents; output is the successful placement of these substances at the target site. Benefits include precise delivery of diagnostic or therapeutic agents to peripheral vascular sites.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included kink, tensile, high-pressure injection, trackability, torque, dimensional inspection, hub aspiration, embolic agent infusion compatibility, package integrity, corrosion, diagnostic agent compatibility, coating integrity, antegrade flow, and infusion efficiency. Biocompatibility testing performed per ISO 10993 standards (hemolysis, cytotoxicity, irritation, sensitization, pyrogenicity) and USP particulate standards.

Technological Characteristics

Single lumen, fixed length intravascular catheter; 0.035" guide wire compatible; luer lock hub. Materials tested for biocompatibility per ISO 10993-1, -4, -5, -10, -11 and ASTM F756. Manual operation. Sterilization via standard methods. No software or electronic components.

Indications for Use

Indicated for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• Surefire Infusion System (K110459)

Submission Summary (Full Text)

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Surefire® Guide Sheath Premarket Notification Special 510(k

Section 6: 510(k) Summary 24 January 2012

| Owner/Manufacturer: | Owner<br>Surefire Medical, Inc.<br>8601 Turnpike Dr.<br>Suite 206<br>Westminster, CO 80031 | Manufacturer<br>Surefire Medical, Inc.<br>12415 SW 136 Avenue<br>Unit 3<br>Miami, FL 33186 | FEB 2 3 2012 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mario Arbesu<br>Director, Quality Assurance and Regulatory Affairs<br>305.378.2651 | | |
| Date of Summary<br>Preparation: | 24 January 2012 | | |
| Trade Name: | Surefire® Guide Sheath | | |
| Common Name: | Intravascular Catheter | | |
| Classification Name: | Intravascular Diagnostic Catheter | | |
| Classification: | Class II | | |
| Classification Regulation: | 21 CRF Part 870.1200 - Diagnostic intravascular catheter. | | |
| Product Code: | DQO | | |
| Intended Use: | The Surefire® Guide Sheath is intended for use in angiographic<br>procedures. It delivers radiopaque media and therapeutic agents to<br>selected sites in the peripheral vascular system. | | |
| Device Description: | The Surefire® Guide Sheath is designed to act as a conduit for<br>diagnostic agents and facilitates deployment at the desired<br>treatment location. The Guide Sheath is a 0.035" guide wire<br>compatible, single lumen, fixed length catheter body with a luer<br>lock hub. | | |
| Principals of Operation/<br>Technology: | The Surefire® Guide Sheath is operated manually. | | |

### Performance Testing & Verification Testing

The following series of tests have been provided in this submission:

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- Kink Testing
- · Tensile Testing
- · High Pressure Injection Testing
- · Trackability Testing
- · Torque Testing
- Dimensional Inspection

Testing listed below was provided in the original submission. The modifications in this device have no impact on these characteristics:

- · Kink Testing
- · Hub Aspiration Testing
- · Embolic Agent Infusion Compatibility Testing
- · Package Integrity Testing
- · Corrosion Testing
- · Diagnostic Agent Compatibility Testing
- · Coating Integrity
- · Antegrade Flow Testing
- · Infusion Efficiency
- Biocompatability
- -Hemolysis - ASTM F756 and ISO 10993-4
- Cytotoxicity ISO 10993-5 -
- Intra-cutaneous Irritation ISO 10993-10 -
- -Sensitization - ISO 10993-10
- -Pyrogenicity - ISO 10993-11
- -Particulate - USP Standards
- Complement System was performed -

| Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971 Medical<br>Devices- Application of Risk management to medical devices. Performance<br>characteristics for this indication for use were determined. It was then justified<br>that the performance of the Surefire® Guide Sheath is substantially equivalent to<br>the performance and safety of the Surefire® Infusion System. A battery of tests<br>was performed according to protocols based on the requirements of the<br>international standards and was shown to meet the acceptance criteria that were<br>determined to be applicable to the safety and efficacy of the device. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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Additional Safety Manufacturing controls include visual, functional, dimensional and sterility tests. Information: Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing". Substantial The Surefire Guide Sheath is substantially equivalent in intended use, design, Equivalence: technology/principles of operation to the predicate. The Guide sheath is substantially equivalent to the Surefire Infusion System, cleared under K110459.

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Differences between the devices do not raise any significant issues of safety or effectiveness. ·

| Submitter<br>Information: | Prepared by: | Mario Arbesu<br>Director, Quality Assurance and Regulatory Affairs |
|---------------------------|---------------|-----------------------------------------------------------------------------|
| | Prepared for: | Surefire Medical, Inc.<br>12415 SW. 136 Avenue<br>Unit 3<br>Miami, FL 33186 |
| | Date: | January 24, 2012 |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

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

Surefire Medical, Inc. c/o Mr. Mario Arbesu Director, Quality Assurance and Regulatory Affairs 8601 Turnpike Drive Suite 206 Westminster. CO 80031

Re: K113737

Trade Name: Surefire® Guide Sheath Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Diagnostic Catheter Regulatory Class: II (two) Product Code: DQO Dated: January 24, 2012 Received: January 26, 2012

Dear Mr. Arbesu:

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 for use stated in the encreated of 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, de floos mat have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelove, manot of the Act include requirements for annual registration, listing of general ocurities proficturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. Thead now now ver, 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.

FEB 2 3 2012

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## Page 2 – Mr. Mario Arbesu

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 or any I cuttar buttates and entrements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical (21 OFF 1 ar 607) : accessed (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 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" (21) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

10gallanon (21 Cr N 1 ar 500), prices/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. A. Hillebert

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

Enclosures

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# Surefire® Guide Sheath

Premarket Notification Special 510(k) Submission

#### Indication for Use

510(k) Number (if known):

Device Name:

Indication for Use:

#### K113737

Surefire® Guide Sheath

The SUREFIRE® GUIDE SHEATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

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)

M.S. Welle Concurrence of CDRH,

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_ KII3737