Surefire Precision Infusion System

K171355 · Surefire Medical, Inc. · DQO · May 17, 2017 · Cardiovascular

Device Facts

• Record ID: K171355
• Device Name: Surefire Precision Infusion System
• Applicant: Surefire Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: May 17, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Surefire Precision Infusion 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

Coaxial microcatheter system with expandable distal tip; used in angiographic procedures to deliver radiopaque media, flush solutions, and embolic agents (beads/microspheres) to peripheral vascular sites. Physician operates device by advancing/retracting inner microcatheter relative to outer sheath to expand/collapse tip; expansion improves infusion efficiency while maintaining antegrade flow. Teflon inner liner provides lubricity; hydrophilic coating facilitates navigation. Radiopaque markers assist in positioning. Used in clinical settings by interventionalists. Benefits include precise delivery of therapeutic agents to target vessels.

Clinical Evidence

Bench testing and animal study performed. Bench testing verified tensile strength, kink radius, torque resistance, infusion efficiency, antegrade flow, burst pressure, and coating durability. Animal study assessed acute performance in a simulated clinical environment; results confirmed the device met user needs and performed comparably to the predicate.

Technological Characteristics

Coaxial microcatheter; Teflon inner liner; hydrophilic coating; distal expandable tip; radiopaque markers. Sizes: 0.021-0.025 inch ID; 120-150 cm length; 1.5-6 mm vessel compatibility. Sterilization: Ethylene Oxide (EtO). Materials biocompatible per ISO 10993-1. 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 in patients requiring peripheral vascular intervention.

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 021 (K143588)
• Surefire Infusion System (marketed as Surefire Precision Infusion System) (K160662)

Submission Summary (Full Text)

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Public Health Service

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May 17, 2017

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

Surefire Medical, Inc. % Mark Job Official Correspondent Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K171355

Trade/Device Name: Surefire Precision Infusion System Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: March 6, 2017 Received: May 9, 2017

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Fernando
Aguel
Fernando
Aguel-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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# Indications for Use

510(k) Number (if known)

K171355

Device Name Surefire Precision Infusion System

Indications for Use (Describe)

The Surefire Precision Infusion System is intended for use in angiographic procedures.

It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|---------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <span style="font-family: Symbol;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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# 510(K) SUMMARY

### Device Name

Surefire Precision Infusion System

## Manufacturer Name and Address

Surefire Medical, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Owner Operator Number: 10038066

## Submitter Contact Information

Surefire Medical, Inc. 6272 W. 91st Avenue Westminster, CO 80031 Lynne Aronson, VP Regulatory Affairs and Quality Assurance Contact: Phone: [phone] Fax: [phone]

## Common, Classification & Proprietary Names

| Common Name: | diagnostic intravascular catheter |
|----------------------------|------------------------------------|
| Classification Name: | diagnostic intravascular catheter |
| Proprietary Name: | Surefire Precision Infusion System |
| Classification: | Class II |
| Classification Panel: | Cardiovascular Devices |
| Classification Regulation: | 21 CFR 870.1200 |
| Product Code: | DQO |

## Predicate Device

| | ■ Surefire Infusion System 021 | K143588 |
|--|--------------------------------------------------------------------------------|---------|
| | ■ Surefire Infusion System<br>(marketed as Surefire Precision Infusion System) | K160662 |

# Device Description

The Surefire Precision Infusion Systems are coaxial microcatheters with a female luer lock hub at the proximal end, and the Surefire Expandable Tip at the distal end that is sized for use in various sized vessels. The Surefire Precision Infusion Systems are currently available in the following sizes:

| Catalog Number | Inner Diameter | Length | Tip / Vessel Size |
|----------------|----------------|--------|-------------------|
| SPS-21120-35 | 0.021 inch | 120 cm | 1.5 - 3.5 mm |
| SPS-21150-35 | 0.021 inch | 150 cm | 1.5 - 3.5 mm |
| SPS-25120-40 | 0.025 inch | 120 cm | 2 - 4 mm |
| SPS-25150-40 | 0.025 inch | 150 cm | 2 - 4 mm |
| SPS-25120-60 | 0.025 inch | 120 cm | 4 - 6 mm |
| SPS-25150-60 | 0.025 inch | 150 cm | 4 - 6 mm |

The Surefire Precision Infusion System, serves as the conduit for physician-specified agents such as contrast agents, flush solutions, and embolic beads. It is compatible with standard guide wires up to 0.018", and embolic hydrogel particles ≤500μm, and glass microspheres ≤110μm (0.021" lumen) or <150um (0.025" lumen). The Surefire Precision Infusion System has a Teflon inner liner to provide a lubricious surface for passage of physician-specified agents and other accessory devices. The device is hydrophilically coated.

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The Surefire Precision Infusion System has an outer sheath to facilitate expanding and collapsing the Surefire Expandable Tip. There are three radiopaque markers located just proximal and distal to the Surefire Expandable Tip. The Tip can be expanded or collapsed for re-positioning during an interventional procedure by simply retracting or advancing the inner microcatheter while holding the outer sheath stationary. When expanded, the Expandable Tip is designed to improve infusion efficiency of compatible embolic agents while maintaining antegrade flow in the vessel.

The Surefire Precision Infusion System is provided sterile (EtO) for single patient use.

## Indications for Use

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

## Biocompatability Testing

Biocompatibility testing (listed below) of the patient-contact materials used in the construction of the modified Surefire Precision Infusion System were 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 testing was conducted in accordance with GLP by NAMSA (Northwood, OH).

Additionally, testing for thrombogenicity was performed on the modified Surefire Precision Infusion System Catheter as a part of an Animal Study.

The results 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.

| Category | Standard | Test Method |
|--------------------------------------------|--------------|----------------------------------------------------------------------------------------|
| Cytotoxicity | ISO 10993-5 | Cytotoxicity Study Using the ISO Elution Method – 1x Minimal Essential Media Extract |
| Sensitization | ISO 10993-10 | ISO Maximization Sensitization Study – Extract – 0.9% Sodium Chloride Solution Extract |
| | | ISO Maximization Sensitization Study – Extract – Sesame Oil, NF Extract |
| Irritation or<br>Intracutaneous Reactivity | ISO 10993-10 | ISO Intracutaneous Study – Extract – 0.9% Sodium Chloride Solution Extract |
| | | ISO Intracutaneous Study – Extract – Sesame Oil, NF Extract |
| Systemic Toxicity | ISO 10993-11 | ISO Systemic Toxicity Study – Extract – 0.9% Sodium Chloride Solution Extract |
| | | ISO Systemic Toxicity Study – Extract – Sesame Oil, NF Extract |
| | | Pyrogen – Material Mediated – 0.9% Sodium Chloride Solution 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 |

# Performance Testing

The following design verification / validation tests were performed as a result of the risk analysis assessment of the material modifications. The test results demonstrate that the modified Surefire Precision Infusion System meets the same performance specifications and acceptance criteria as the predicate device.

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- Tensile (Pull) Strengths (distal tip) ■
- Kink Radius
- 트 Torque Resistance
- . Infusion Efficiency
- . Antegrade Flow
- . Particulates
- 트 Embolic Agent Compatibility
- Burst Pressure
- Coating Durability and Uniformity
- Frictional Force
- Base Catheter Insertion/Retraction Force
- I Visual and Dimensional
- . EtO Residuals

The following testing was leveraged from previous testing of the predicate device:

- I Tensile (Pull) Strengths (proximal hub/handle)
- Corrosion
- I Diagnostic Agent Compatibility
- . Packaging & Labeling Visual Inspection
- . Package Seal Strength
- . Package Integrity

## Animal Testing

An animal study was performed to assess the comparative acute performance of the modified Surefire Precision Infusion System to the predicate device, as defined by physicians in a simulated clinical environment. The modified Surefire Precision Infusion System was found to be acceptable in all evaluated categories, met the defined user needs, and performed comparably to the predicate device.

## Substantial Equivalence

The modified Surefire Precision Infusion System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate.

Comparative Summary: Design / Technological Characteristics

The modified Surefire Precision Infusion System and predicate device are coaxial microcatheters with the Surefire Expandable Tip at the distal end. Both infusion systems have an outer catheter to facilitate expanding and collapsing the Surefire Expandable Tip.

The modified Surefire Precision Infusion System and the predicate device are constructed of similar materials utilizing similar construction and manufacturing processes.

The predicate and modified are available in the same range of sizes: inner diameters 021" to 025". lengths 120 cm to 150 cm, and tip/vessel size 1.5 mm to 6 mm.

The modified Surefire Precision Infusion System and predicate device are provided in identical packaging, sterilized by ethylene oxide, and labeled for single use only.

## Comparative Summary: Indications for Use

The modified Surefire Precision Infusion System has the same indications for use as the predicate device. Both devices are intended for use in angiographic procedures to deliver radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

## Comparative Summary: Performance

Animal and bench performance test data demonstrate that the modified Surefire Precision Infusion System performance is comparable to the predicate device.

In summary, the modified Surefire Precision System is substantially equivalent in intended use, design, and technology/principles of operation to the predicate device. Animal and bench performance test data demonstrate that the modified Surefire Precision Infusion System performance is comparable to the predicate device. Differences between the devices do not raise any issues of safety or effectiveness.