SUREFIRE GUIDING CATHETER

K140034 · Surefire Medical, Inc. · DQY · Feb 26, 2014 · Cardiovascular

Device Facts

• Record ID: K140034
• Device Name: SUREFIRE GUIDING CATHETER
• Applicant: Surefire Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

Device Story

Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter designed for peripheral vascular access. It features a soft, rounded distal tip for atraumatic tracking and a proximal Luer-Lock hub with strain relief. The device is constructed from Pebax extruded polymer with a radiopacifier for fluoroscopic visualization, a stainless steel braid, and a polymer inner layer. Available in 65 cm and 80 cm lengths with various pre-shaped tip designs (e.g., Axis, Simmons I, Cobra) to accommodate diverse vascular anatomies. Used by physicians in clinical settings to facilitate the advancement of therapeutic devices (e.g., guide wires, infusion syringes) into the peripheral vasculature. Provided sterile for single-patient use.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (ISO 10993 biocompatibility, mechanical performance verification) and a GLP animal study comparing acute performance to the predicate device. Animal study results indicated acceptable and comparable performance to the predicate.

Technological Characteristics

Single-lumen, braided catheter; 5F diameter; 65/80 cm lengths. Materials: Pebax polymer, stainless steel braid, radiopacifier. Sensing/Actuation: None (mechanical). Connectivity: None. Sterilization: Ethylene Oxide (EtO). Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for use in the peripheral vascular system to provide a pathway for the introduction of therapeutic devices.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Medtronic Launcher Guiding Catheter (K030779)

Reference Devices

• Surefire Infusion System (K110459)
• Surefire High-Flow Microcatheter (K121677)
• Surefire Angiographic Catheter (K122506)

Submission Summary (Full Text)

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K140034 p. I of 3

FEB 2 6 2014

## 510(K) SUMMARY

(Date Prepared: February 21, 2014)

Device Name

Surefire Guiding Catheter

# Manufacturer Name and Address

Surefire Medical, Inc. 12415 SW 136 Ave., Unit 3 Miami FL 33186 Establishment Registration Number: 3009428975

#### Submitter Contact Information

Surefire Medical, Inc. 8601 Turnpike Drive, Suite 206 Westminster, CO 8003 1 Contact: Lynne Aronson, Director Regulatory Affairs Phone: [phone] Fax: [phone]

### Common, Classification & Proprietary Names

| Common Name: | Guiding Catheter |
|----------------------------|---------------------------|
| Classification Name: | Percutaneous Catheter |
| Proprietary Name: | Surefire Guiding Catheter |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1250 |
| Product Code: | DQY |

## Predicate Device

Medtronic Launcher Guiding Catheter

K030779

#### Device Description

The Surefire Guiding Catheter provides a pathway to introduce and facilitate the advancement of devices into the peripheral vascular system.

The Surefire Guiding Catheter is a single-lumen, braided, fixed-length 5F catheter with a soft distal tip and a proximal Luer-Lock hub and strain relief. The Pebax extruded polymer is filled with a radiopacifier to provide visibility of the Surefire Guiding Catheter under fluoroscopy.

The Surefire Guiding Catheters are 65 and 80 cm in length with a variety of pre-shaped tip designs (including but not limited to Axis, Simmons I and Cobra) to accommodate access and positioning in a range of peripheral vascular anatomies. The distal tip is rounded for atraumatic tracking.

The Surefire Guiding Catheter is compatible with standard 0.038" OD guide wires, Luer-Lock infusion syringes, rotating hemostatic valves (RHV), and 5F catheter sheath introducers.

The Surefire Guiding Catheter is provided sterile (EtO) for single patient use

#### Indications for Use

The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

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## Biocompatability Testing

Biocompatibility testing of the patient-contact materials used in the construction of the catheter was performed in accordance with ISO 10993-1 for an external communicating device in contact with circulating blood with a limited duration of less than 24 hours.

The following biocompatibility testing was conducted on the Surefire Infusion System (K110459), Surefire High-Flow Microcatheter (K121677), and Surefire Angiographic Catheter (K122506) which are constructed of the same materials as the Surefire Guiding Catheter. The biocompaibility test requirements for the Surefire Guiding Catheter were met by leveraging previously completed biocompatibility testing.

| Category | Standard | Test Method |
|-----------------------------------------------|--------------|-------------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5 | Cytotoxicity Study Using the ISO Elution Method - 1x Minimal<br>Essential Media Extract |
| Sensitization | ISO 10993-10 | ISO Maximization Sensitization Study - Extract - 0.9% Sodium<br>Chloride Solution Extract |
| | | ISO Maximization Sensitization Study - Extract - Sesame Oil, NF<br>Extract |
| Irritation or<br>Intracutaneous<br>Reactivity | ISO 10993-10 | ISO Intracutaneous Study - Extract - 0.9% Sodium Chloride Solution<br>Extract |
| | | ISO Intracutaneous Study - Extract - Sesame Oil, NF Extract |
| Systemic Toxicity | ISO 10993-11 | ISO Systemic Toxicity Study - Extract - 0.9% Sodium Chloride<br>Solution Extract |
| | | ISO Systemic Toxicity Study - Extract - Sesame Oil, NF Extract |
| | | Pyrogen - Material Mediated - 0.9% Sodium Chloride Solution<br>Extract |
| Hemocompatability | ISO 10993-4 | ASTM Hemolysis - CMF-PBS Extract |
| | | C3a Complement Assay - Normal Human Serum Extract |
| | | SC5b-9 Complement Assay - Normal Human Serum Extract |
| | | Coagulation - ASTM Partial Thromboplastin Time |

All testing was performed in accordance with GLP by NAMSA (Northwood, OH).

Additionally, testing for thrombogenicity was performed on the Surefire Guiding Catheter as a part of the GLP Animal Study.

The results of all of the biocompatibility testing did not indicate any significant biological reaction that would affect the patient due to contact with the materials used in the device construction.

#### Performance Testing

Design verification testing was performed which demonstrated that the Surefire Guiding Catheter meets its specified performance requirements, and is equivalent to the performance of the predicate device. Testing included visual and dimensional inspection, and tests for particulates, kink, tensile strength, torque, trackability/device compatibility, high pressure injection and flow/pressure generation.

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### Animal Testing

A GLP animal study was performed to assess the comparative acute performance of the Surefire Guiding Catheter to the predicate device, as defined by a physician in a clinical environment. The Surefire Guiding Catheter was found to have acceptable performance. Additionally, the Surefire Guiding Catheter was found to have comparable performance to the predicate device.

#### Substantial Equivalence

The Surefire Guiding Catheter is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.

Comparative Summary: Design / Technological Characteristics

The Surefire Guiding Catheter and predicate device are single lumen catheters with Luer-Lock hubs and a variety of shaped tip styles. They have similar constructions consisting of a polymer outer extrusion with radiopacifier, stainless steel braid and polymer inner.

The Surefire Guiding Catheter and predicate device have similar dimensions, with inner and outer diameters that are consistent with a 5F sized catheters are available in a range of lengths. The predicate device is available in a longer length to accommodate use in the coronary application.

Comparative Summary: Indications for Use

The indication statement of the Surefire Guiding Catheter is the same as that of the predicate device with the exception that the predicate device is indicated for use in both the coronary and peripheral vascular system and the Surefire Guiding Catheter indication is limited to use in only the peripheral vascular system. As both devices are indicated for use in the peripheral vascular system, this difference in indications for use does not impact the safety and effectiveness of the Surefire Guiding Catheter when used as indicated.

Comparative Summary: Performance

Animal and bench performance test data demonstrate that the Surefire Guiding Catheter performance is comparable to the predicate device.

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

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

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

February 26, 2014

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

Re: K140034

Trade/Device Name: Surefire Guiding Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 4, 2014 Received: February 5, 2014

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.

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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·· 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,

Kenneth J. Cavanaugh -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K140034

Device Name Surefire Guiding Catheter

Indications for Use (Describe)

The Surefire Guiding Catheter is intended to provide a pathway through which therapeutic devices are introduced. The Surefire Guiding Catheter is intended to be used in the peripheral vascular system.

Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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