SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS

K122506 · Surefire Medical, Inc. · DQX · Sep 17, 2012 · Cardiovascular

Device Facts

• Record ID: K122506
• Device Name: SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
• Applicant: Surefire Medical, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Surefire® High Flow Angiographic Catheter is intended for use where angiographic diagnosis is indicated.

Device Story

Surefire High Flow Angiographic Catheter (SAC) is a single-lumen, fixed-length guide catheter used to facilitate advancement of a microcatheter to a target vessel. Device features a reinforced proximal section for insertion, barium sulfate-filled extrusion for fluoroscopic visibility, and a braided tungsten-filled shaped tip for visual feedback and atraumatic tracking. Compatible with 0.038" guidewires, Luer lock infusion syringes, and rotating hemostatic valves. Supplied sterile with a peel-away introducer for single-patient use. Operated manually by clinicians in a clinical setting under fluoroscopic guidance. Provides visual feedback of catheter location; assists in delivering microcatheters to target sites for diagnostic angiography.

Clinical Evidence

Bench testing only. Testing included kink radius, trackability, pull strength, high-pressure injection, infusion agent compatibility, package integrity, device corrosion, and shape retention. Biocompatibility testing performed per ISO 10993 (cytotoxicity, sensitization, irritation, toxicity, pyrogenicity, hemolysis, coagulation, complement system, and thrombogenicity) and USP 788 (particulate).

Technological Characteristics

Single-lumen, fixed-length intravascular catheter. Materials include barium sulfate-filled extrusion and braided tungsten-filled tip. Compatible with 0.038" guidewires. Sterile, single-use. Complies with ISO 10555-1 and ISO 10555-2. Biocompatibility per ISO 10993. Manual operation.

Indications for Use

Indicated for use in patients requiring angiographic diagnosis. Prescription use only.

Regulatory Classification

Identification

A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.

Special Controls

*Classification.* Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Angiodynamics Soft-Vu Angiographic Catheter (K112452)

Submission Summary (Full Text)

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K122506

Surefire® High Flow Angiographic Catheter Premarket Notification Traditional 510(k) Submission

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Section 5: 510(k) Summary 16 July 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 SW136 Avenue<br>Unit 3<br>Miami, FL 33186 | SEP 2 0 2012 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Mario Arbesu<br>Director, Quality Assurance and Regulatory Affairs<br>305.378.2651 | | |
| Date of Summary<br>Preparation: | 16 July 2012 | | |
| Trade Name: | Surefire® High Flow Angiographic Catheter | | |
| 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® High Flow Angiographic Catheter is intended for<br>use where angiographic diagnosis is indicated. | | |
| Device Description: | The Surefire High Flow Angiographic Catheter (SAC) is<br>used to facilitate advancement of the Surefire High Flow<br>Microcatheter to the target vessel. The SAC is a single<br>lumen, fixed length guide catheter with a Luer Lock Hub. It<br>is compatible with standard 0.038" guide wires, Luer lock<br>infusion syringes, and rotating hemostatic valves (RHVs).<br>The angiographic catheter has an approximate length of 65<br>cm (usable length). A reinforced proximal section allows<br>for ease of insertion and the barium sulfate filled extrusion<br>provides clear fluoroscopic images of the shaft. A braided<br>tungsten filled shaped tip provides visual feedback for the<br>location of the guide catheter under fluoroscopy. The distal<br>tip is rounded for atraumatic tracking. A shaped tip will<br>assist to deliver the Surefire High Flow Angiographic<br>Catheter to the desired target site. A peel-away Introducer<br>is supplied with the SAC to insert the shaped tip into a<br>catheter sheath introducer. The system is provided sterile<br>(FO) for single patient use. The Angiographic Catheter is | | |

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Surefire® High Flow Angiographic Catheter Premarket Notification Traditional 510(k) Submission

Section 5: 510(k) Summary 16 July 2012

packaged in sealed sterile protective pouches and product boxes.

## Principals of Operation/

Technology:

The Surefire® High Flow Angiographic Catheter 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

# Biocompatibility Testing

- · Cytotoxicity Tested in accordance with ISO 10993-5
- · Sensitization Tested in accordance with ISO 10993-10
- · Intra-cutancous 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 in accordance with ISO 10993-4
- · Thrombogenicity Testing 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 High Flow Angiographic Catheter is substantially equivalent to the performance and safety of the Angiodynamics Soft-Vu Angiographic Catheter. 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

- · Visual and Dimensional Inspections
- · Shape Retention Testing
- · Particulate Testing
- · Tensile Testing
- · Torque Testing
- · Shelf Life Testing

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| | Surefire® High Flow Angiographic Catheter<br>Premarket Notification Traditional 510(k) Submission | Section 5: 510(k) Summary<br>16 July 2012 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | the tests recommended in the FDA General program Memorandum.<br>Biocompatibility testing was conducted in accordance with International<br>Standard ISO 10993, "Biological Evaluation of Medical Devices Part -1<br>Evaluation and testing". |
| Substantial<br>Equivalence: | The Surefire® High Flow Angiographic Catheter is substantially<br>equivalent in intended use, design, and technology/principles of operation<br>to the predicate. Both devices share the same Indications for Use. Both<br>devices have a 5F outer diameter. The tip of both the predicate and the<br>proposed device have an equivalent geometry. Both products are designed<br>to be compatible with 0.038" guidewires. The Microcatheter is<br>substantially equivalent to the Angiodynamics Soft-Vu Angiographic<br>Catheter, cleared under K112452. Differences between the devices do not<br>raise any issues of safety or effectiveness. | |
| | | Test data provided in bench tests demonstrate that the device is as safe, as<br>effective, and performs at least as safely and effectively as the predicate<br>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: | July 16, 2012 |

:

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird symbol.

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

April 11, 2013

Surefire Medical, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313

Re: K122506

Trade/Device Name: Surefire® High Flow Angiographic Catheter Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: June 8, 2012 Received: August 16, 2012

Dear Mr. Job:

This letter corrects our substantially equivalent letter of September 20, 2012.

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

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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/Resourcesfor You/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,

Matthew G. Hillebrenner

for

for 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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### Indication for Use

510(k) Number (if known):

Device Name:

Indication for Use:

Surefire® High Flow Angiographic Catheter

The SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER is intended for use where angiographic diagnosis is indicated.

X 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)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

L. Le

(Dhisicri 9:7):1. Off) Division in Cardiovascular Devices 122506 510:-., Number