SUREFIRE HI-FLOW MICROCATHETER

K121677 · Surefire Medical, Inc. · DQO · Jun 14, 2012 · Cardiovascular

Device Facts

• Record ID: K121677
• Device Name: SUREFIRE HI-FLOW MICROCATHETER
• Applicant: Surefire Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 14, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Surefire® Hi-Flow Microcatheter 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 Hi-Flow Microcatheter is a 0.027" lumen intravascular catheter featuring a distal Surefire Expandable Tip; designed for use in peripheral vascular angiographic procedures. Physician operates device manually to deliver contrast agents, flush solutions, and embolic beads (≤ 700µm) to target sites. Expandable tip facilitates infusion efficiency while maintaining antegrade flow. Device includes outer sheath for tip deployment/retraction, Teflon inner liner for lubricity, and female luer lock hub. Compatible with standard 0.018" guide wires and rotating hemostatic valves. Used by physicians in clinical settings to deliver therapeutic agents; expandable tip design aims to improve infusion targeting and efficacy compared to standard catheters.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included kink radius, trackability, pull strength, high-pressure injection, infusion agent compatibility, package integrity, corrosion, antegrade flow, infusion efficiency, coating integrity, particulate, tensile, torque, and shelf life. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, toxicity, hemolysis, coagulation, complement system) and USP <151>/<788>.

Technological Characteristics

0.027" lumen microcatheter with distal funnel-shaped Surefire Expandable Tip. Materials: Teflon inner liner, hydrophilically coated outer sheath. Dimensions: 120cm usable length; tip sizes for 3.0-4.5 mm and 4.0-6.0 mm vessels. Manual operation. Biocompatibility per ISO 10993; performance per ISO 10555-1 and ISO 10555-2. Sterile, single-use.

Indications for Use

Indicated for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. Compatible with embolic particles ≤ 700µm and vessels 3.0-6.0 mm in diameter.

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 Catheter System (K110459)

Submission Summary (Full Text)

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Section 5: 510(k) Summary 26 April 2012

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JUN 1 4 2012

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| 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 SW136 Avenue<br>Unit 3<br>Miami, FL 33186 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| Contact Person: | Mario Arbesu<br>Director, Quality Assurance and Regulatory Affairs<br>305.378.2651 | |
| Date of Summary<br>Preparation: | 26 April 2012 | |
| Trade Name: | Surefire® Hi-Flow Microcatheter | |
| 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® Hi-Flow Microcatheter is intended for use in<br>angiographic procedures. It delivers radiopaque media and<br>therapeutic agents to selected sites in the peripheral vascular<br>system. | |
| Device Description: | The Surefire® Hi-Flow Microcatheter is an 0.027" lumen<br>microcatheter with the Surefire Expandable Tip at the distal<br>end. It has an outer sheath to facilitate deployment and<br>retraction of the Surefire Expandable Tip. The infusion<br>catheter serves as the conduit for physician-specified agents<br>such as contrast agents, flush solutions, and embolic beads.<br>It is compatible with standard 0.018" guide wires, infusion<br>syringes, rotating hemostatic valves (RHVs), and embolic<br>particles 700µm or less in size. The proximal end of the<br>device features a female luer lock hub. The microcatheter<br>has a Teflon inner liner to provide a lubricious surface for<br>passage of physician-specified agents and other accessory.<br>devices. The outer sheath is hydrophilically coated. The<br>usable length of the device is 120cm. The distal soft,<br>pliable, funnel-shaped Surefire Expandable Tip is available | |

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in two tip sizes, targeted to treat vessels of 3.0 - 4.5 mm and 4.0 - 6.0 mm.

## Principals of Operation/ Technology:

The Surefire® Hi-Flow Microcatheter is operated manually.

### Performance Testing & Verification Testing

- · Kink Radius Testing
- · Trackability Testing
- · Pull Strength Testing ·
- · High Pressure Injection Testing
- · Infusion Agent Compatibility Testing
- · Package Integrity (Pouch Bubble) Testing
- · Device Corrosion Testing
- · Antegrade Flow Testing
- · Infusion Efficiency Testing
- · Visual and Dimensional Inspections
- · Coating Integrity Testing
- · Particulate Testing
- · Tensile Testing
- · Torque Testing
- · Shelf Life Testing

#### Biocompatibility Testing

- · Cytotoxicity Tested in accordance with ISO 10993-5
- · Sensitization Tested in accordance with ISO 10993-10
- · Intra-cutaneous irritation Tested in accordance with ISO 10993-10
- · Toxicity Tested in accordance with ISO 10993-11
- · Pyrogenicity Tested in accordance with USP General Chapter <151> Pyrogen Test recommended in ISO 10993-11
- · Hemolysis Tested in accordance with ASTM F756 and ISO 10993-4
- · Coagulation Tested in accordance with ASTM F2382
- · Particulate Tested in accordance with USP 788
- · Complement System Testing was performed

#### Performance/Safety: A risk/hazard analysis was conducted according to EN ISO 14971

(Medical Devices-Application of Risk management to medical devices). Performance characteristics for this indication for use were identified which included a review of both ISO 10555-1 (Intravascular catheters -Sterile and single-use catheters - Part 1: General requirements) and ISO 10555-2 (Sterile, single-use intravascular catheters - Part 2: Angiographic catheters). It was then determined that the performance of the Surefire® Hi-Flow Microcatheter is substantially equivalent to the performance and safety of the Surefire Infusion Catheter System. A battery of tests was performed according to protocols based on the requirements of recognized standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device.

Additional Safety Information:

Manufacturing controls include visual; functional, dimensional and sterility tests. Blood contacting materials were tested in accordance with the tests recommended in the FDA General program Memorandum. Use

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Substantial

Equivalence:

of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1 Evaluation and testing".

The Surefire® Hi-Flow Microcatheter is substantially equivalent in intended use, design, and technology/principles of operation to the predicate. Both devices share the same Indications for Use. Both devices make use of the Surefire Expandable Tip at the distal end of the microcatheter to increase the infusion efficiency of the device while maintaining sufficient antegrade flow. Both systems are compatible with solutions containing embolic agents, specifically hydrogels ≤ 700 µm and glass beads ≤ 190 um. Both devices include configurations intended for use in vessels of 4.0 - 6.0 mm in diameter. The proposed device contains an additional configuration for use in vessels of 3.0 - 4.5 mm in diameter. The Microcatheter is substantially equivalent to the Surefire® Infusion Catheter System, cleared under K110459. Differences between the devices do not raise any issues of safety or effectiveness.

Test data provided in bench tests demonstrate that the device is as safe, as effective, and performs at least as safely and effectively as the predicate device.

| 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: | April 26, 2012 |

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

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

JUN 1 4 2012

Surefire Medical, Inc. c/o Mark Job Responsible Third Party Official Regulatory Technical Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K121677

Trade/Device Name: Surefire Hi-Flow Microcatheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (Two) Product Code: DQO Dated: June 6, 2012 Received: June 7, 2012

Dear Mr. Job:

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.

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#### Page 2 - Mr. Mark Job

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 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 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

W.g. Hilleben

fa 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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Section 4 Indication for Use 26 April 2012

Indication for Use

510(k) Number (if known):

Device Name:

Indication for Use:

Surefire® Hi-Flow Microcatheter

The SUREFIRE® HI-FLOW MICROCATHETER 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

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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)

M9f Killeben

(Division Sign-Off) Division of Cardiovascular Devices

K121677 510(k) Number