SUREFIRE INFUSION CATHETER SYSTEM

K110459 · Surefire Medical, Inc. · DQO · Jun 24, 2011 · Cardiovascular

Device Facts

• Record ID: K110459
• Device Name: SUREFIRE INFUSION CATHETER SYSTEM
• Applicant: Surefire Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jun 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Surefire™ Infusion Catheter System 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™ Infusion Catheter System is a two-part intravascular device consisting of an infusion microcatheter and a guide sheath. Used in angiographic procedures to deliver radiopaque media and therapeutic agents to peripheral vascular sites. Operated manually by clinicians in a clinical setting. Device facilitates targeted delivery of diagnostic and therapeutic substances. Performance verified through bench testing including kink, tensile, high-pressure injection, and infusion efficiency testing. Biocompatibility confirmed per ISO 10993 standards.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and verification, including kink, tensile, high-pressure injection, hub aspiration, embolic agent infusion compatibility, package integrity, corrosion, diagnostic agent compatibility, trackability, dimensional inspection, coating integrity, antegrade flow, infusion efficiency, and acute system toxicity. Biocompatibility testing performed per ISO 10993 (pyrogenicity, irritation, hemolysis, sensitization, cytotoxicity, complement system).

Technological Characteristics

Two-part system: infusion microcatheter and guide sheath. Manually operated. Materials tested for biocompatibility per ISO 10993-1, -4, -5, -10, -11 and ASTM F756. Standards met: ISO 10555-1 (general requirements), ISO 10555-2 (angiographic catheters), ISO 11135-1 (EO sterilization).

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

• Terumo Radifocus GLIDECATH (K090040)
• EmboCath Plus Infusion Microcatheter (K062126)

Submission Summary (Full Text)

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110459 Section 5-1 16 June 2011

Surefire Medical requests that the attached "Summary" for the Surefire™ Infusion Catheter System be distributed upon request under the Freedom of Information Act. This report is a summary of the information presented in this 510(k) submission.

| Owner/Manufacturer: | Surefire Medical, Inc.<br>8601 Turnpike Dr. Manufacturing<br>Suite 206<br>Westminster, CO 80031 | Surefire Medical, Inc.<br>12415 SW136Avenue<br>Unit 3<br>Miami, FL 33186 |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Contact Person: | Cheryl Hastings<br>VP Clinical and Regulatory Affairs<br>303.883.5554 | |
| Date of Summary<br>Preparation: | 16 June 2011 | JUN 2 4 2011 |
| Trade Name: | Surefire™ Infusion Catheter System | |
| 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™ Infusion Catheter System is intended for use in<br>angiographic procedures. It delivers radiopaque media and therapeutic<br>agents to selected sites in the peripheral vascular system. | |
| Device Description: | The Surefire™ Infusion Catheter System is a two-part system comprised<br>of an Infusion Microcatheter and a Guide Sheath. | |
| Principals of Operation/<br>Technology: | The Surefire™ Infusion Catheter System is operated manually. | |

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## Performance Testing & Verification Testing

- Kink Testing .
- . Tensile Testing
- High Pressure Injection Testing ●
- . Hub Aspiration Testing
- Embolic Agent Infusion Compatibility Testing ●
- Package Integrity Testing
- Corrosion Testing .
- . Diagnostic Agent Compatibility Testing
- . Trackability Testing
- . Dimensional Inspection
- . Coating Integrity
- . Antegrade Flow Testing
- Infusion Efficiency �
- Acute System Toxicity .

## Biocompatibility Testing

- Pyrogenic- Test is conducted based on USP, General Chapter, <151> Pyrogen Test. The . procedure is recommended in ISO 10993-11
- intra-cutaneous irritation based on ISO 10993-10: Toxicity of the Paladin Catheter testing was . based on International Organization for Standardization 10993-11
- Hemolysis was tested according to procedures based on ASTM F756, Standard Practices for . Assessment of Hemolytic Properties of Materials and ISO 10993-4
- Sensitization was tested based on the requirements of ISO 10993-10 .
- Particulate USP Standards .
- Cytotoxic effects were tested following the guidelines of ISO 10993-5: .
- Complement System 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 characteristic for this indication for use were determined. It was then justified that the performance of the Surefire™ Infusion Catheter System is substantially equivalent to the performance and safety of the Terumo Radifocus Glidecath. A batterv of tests were performed according to protocols based on the requirements of the following standards and was shown to meet the acceptance criteria that were determined to be applicable to the safety and efficacy of the device:

- · ISO 10555-1 Sterile, single use intravascular catheters Part 1 General requirements.
- · Surefire™ Infusion Catheter System Section 5-1 Premarket Notification Traditional 510(k) Submission 15 February 2011
- · ISO 10555-2 Sterile, single use intravascular catheters Part 2 Angiographic catheters.
- · ISO 10993-1 Biological Evaluation of medical Devices Part 1: Evaluation and Testing, and the FDA Modified ISO 10993 Test Profile
- · ISO 11135-1 Medical Devices -Validation and Routine Control of Ethylene Oxide Sterilization.

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| Additional Safety<br>Information: | Manufacturing controls include visual, functional, dimensional and sterility tests.<br>Blood contacting materials were tested in accordance with the tests re<br>commended in the FDA General program Memorandum. Use of International<br>Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1<br>Evaluation and testing". | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Discussion of<br>Animal Data: | The animal study data is submitted in this 510(k) and is on file at Surefire<br>Medical. | |
| Substantial<br>Equivalence: | The Surefire™ Infusion Catheter System is substantially equivalent in intended<br>use, design, technology/principles of operation to the predicates. The Guide<br>sheath is substantially equivalent to the Terumo Radifocus GLIDECATH,<br>cleared under K090040. The Microcatheter is substantially equivalent to the<br>EmboCath Plus Infusion Microcatheter by BioSphere Medical cleared under<br>K062126. Differences between the devices do not raise any significant issues of<br>safety or effectiveness. | |
| Submitter<br>Information: | Prepared by:<br><br>Prepared for:<br><br>Date: | Cheryl Hastings<br>VP Clinical and Regulatory Affairs<br><br>Surefire Medical, Inc.<br>8601 Turnpike Drive<br>Suite 206<br>Westminster, CO 80031<br><br>June 16, 2011 |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

#### 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 Ms. Cheryl Hastings VP Clinical and Regulatory Affairs 8601 Turnpike Dr., Suite 206 Westminster, CO 80031

JUN 2 4 2011

Re: K110459

Trade/Device Name: Surefire™ Infusion Catheter System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 17, 2011 Received: June 20, 2011

Dear Ms. Hastings:

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

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Page 2 - Ms. Cheryl Hastings

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 vours.

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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Surefire™ Infusion Catheter System Premarket Notification 510(k) Submission

## Indication for Use

510(k) Number (if known):

K110459

Surefire™ Infusion Catheter System Device Name:

Indication for Use:

The SUREFIRE™ INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Over-The-counter Use AND/OR Prescription Use x (21 CFR 801 Subpart C) (part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH,

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number 1/110459

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## Indication for Use

| 510(k) Number (if known): | K110459 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Surefire ^TM Infusion Catheter System |
| Indication for Use: | The SUREFIRE ^TM INFUSION CATHETER SYSTEM is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system. |

AND/OR Prescription Use × (part 21 CFR 801 Subpart D)

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,

i

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number