SwiftNINJA Microcatheter

K161921 · Merit Medical Systems, Inc. · KRA · Nov 4, 2016 · Cardiovascular

Device Facts

• Record ID: K161921
• Device Name: SwiftNINJA Microcatheter
• Applicant: Merit Medical Systems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Nov 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature. The catheter should not be used in the cerebral vessels.

Device Story

SwiftNINJA Microcatheter is a 2.9 Fr (proximal) / 2.4 Fr (distal) steerable microcatheter. Operator uses a proximal steering dial connected via two internal wires to manipulate the distal tip up to 180 degrees in opposing directions; a dial lock maintains tip orientation. Device features a hydrophilic coating on the distal shaft to facilitate vascular introduction. Used by physicians in clinical settings for sub-selective access and targeted delivery of diagnostic or therapeutic agents. Output is the physical placement of the catheter tip and subsequent infusion of materials. Benefits include enhanced maneuverability for accessing complex vascular anatomy.

Clinical Evidence

No clinical or pre-clinical animal testing was conducted. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), mechanical performance (tensile strength, burst pressure, fatigue, torque, kink resistance), and functional validation (tip articulation, coating effectiveness, radiopacity).

Technological Characteristics

Steerable microcatheter with 2.9 Fr proximal/2.4 Fr distal diameter. Features mechanical steering dial, dual-wire articulation mechanism, and hydrophilic coating. Materials meet ISO 10993 biocompatibility standards. Sterilized via ethylene oxide (ISO 11135). Complies with ISO 594-1/2 for Luer fittings and ASTM standards for packaging and radiopacity.

Indications for Use

Indicated for general intravascular use in peripheral and coronary vasculature for controlled infusion of diagnostic, embolic, or therapeutic materials. Contraindicated for use in cerebral vessels.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Merit Microcatheter (K082613)
• Micrus Courier Enzo Microcatheter (K072526, K070456)

Submission Summary (Full Text)

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

November 4, 2016

Merit Medical Systems, Inc. Luke Meidell Senior Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095

Re: K161921

Trade/Device Name: SwiftNINJA Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: September 30, 2016 Received: October 3, 2016

Dear Luke Meidell:

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 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.

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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,

Brian D. Pullin -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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below

# Indications for Use

510(k) Number (if known) K161921

#### Device Name

SwiftNINJA Microcatheter

#### Indications (Describe)

This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature. The catheter should not be used in the cerebral vessels.

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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# 510(k) Summary - K161921

| General<br>Provisions | Submitter Name: Merit Medical Systems, Inc.<br>Address: 1600 West Merit Parkway South Jordan, UT 84095<br>Telephone Number: [phone]<br>Fax Number: [phone]<br>Contact Person: Luke Meidell<br>Date Prepared: 09/30/2016<br>Registration Number: 1721504 |
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| Subject<br>Device | Trade Name: SwiftNINJA® Microcatheter<br>Common/Usual Name: Continuous Flush Catheter<br>Classification Name: Catheter, Continuous Flush<br>Regulatory Class: 2<br>Product Code: KRA<br>21 CFR §: 870.1210<br>Review Panel: Cardiovascular |
| Primary<br>Predicate<br>Device | Trade Name: Merit Microcatheter<br>Classification Name: Continuous Flush Catheter<br>Premarket Notification: K082613<br>Manufacturer: Merit Medical Systems, Inc.<br>This predicate has not been subject to a design-related recall. |
| Secondary<br>Predicate<br>Device | Trade Name: Micrus® Courier Enzo™ Microcatheter<br>Classification Name: Diagnostic intravascular catheter<br>Premarket Notification: K072526, K070456<br>Manufacturer: Micrus Endovascular Corporation |
| Device<br>Description | The SwiftNINJA® Microcatheter is a 2.9 Fr (proximal) / 2.4 Fr<br>(distal) microcatheter with a steerable/articulating distal tip.<br>Articulation is achieved via a steering dial at the proximal handle<br>which allows the operator to manipulate the tip up to 180 degrees<br>in opposing directions. The steering dial and steerable tip are<br>connected via two operating wires. The wires are located on both<br>lateral walls of the catheter shaft with a connection point on the |
| distal catheter. Tension is applied to either one of the wires by<br>turning the steering dial for manipulation of the tip direction.<br>Once the direction of steerable tip is determined, the steering dial<br>lock may be used for maintaining the intended direction.<br><br>The outer surface of the distal segment of the microcatheter shaft<br>is coated with a hydrophilic coating designed to facilitate the<br>introduction of the microcatheter into the vasculature. | |
| Indications for<br>Use | This microcatheter is intended for general intravascular use,<br>including peripheral and coronary vasculature. Once the sub-<br>selective region has been accessed, the microcatheter can be<br>used for the controlled and selective infusion of diagnostic,<br>embolic, or therapeutic materials into the vasculature. The<br>catheter should not be used in the cerebral vessels.<br><br>The Indications for Use statement for the SwiftNINJA<br>Microcatheter is identical to the predicate device. |
| Comparison<br>to Predicate<br>Device | The SwiftNINJA Microcatheter is similar in design and<br>technological characteristics to the Merit Microcatheter (primary<br>predicate) and the Micrus Courier Enzo Microcatheter (secondary<br>predicate).<br><br>The comparison between the subject, primary predicate, and<br>secondary predicate devices is based on the following:<br>Same intended use Same Indications for Use Similar material types that meet ISO 10993 biocompatibility requirements Same sterilization methods Same fundamental technology/principle of operation between the subject and predicate devices. |
| | Performance<br>Data |

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- BS EN 20594-1 1994/ISO 594-1:1986, Conical fittings with a ● 6% (Luer) taper for svringes, needles and certain other medical equipment - Part 1: General requirements.
- ISO 594-2:1998. Conical fittings with 6% (Luer) taper for . syringes, needles and certain other medical equipment - Part 2: Lock fittings.
- . ISO 11135:2014, Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- ISO 10993-1:2009. Biological Evaluation of Medical Devices -. Part 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
- ISO 10993-3:2014, Biological Evaluation of Medical Devices ● – Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicity
- ISO 10993-4:2002 (Amd.1:2006), Biological evaluation of ● medical devices – Part 4: Selection of tests for interaction with blood
- ISO 10993-5:2009, Biological evaluation of medical devices . Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008. Biological evaluation of medical devices -. Part 7: Ethylene oxide sterilization residuals
- ISO 10993-10:2010, Biological evaluation of medical devices – Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
- ASTM F756-13:2013, Standard practice for assessment of ● hemolytic properties of materials
- . United States Pharmacopeia 38, National Formulary 33, 2015 <151> Pyrogen Test
- ISO 11607-1: 2009/Amd.1:2014, Packaging for terminally . sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- ISO 11607-2: 2006/Amd.1:2014, Packaging for terminally ● sterilized medical devices – Part 2: Validation requirements for forming, sealing and assembly processes.
- . ISO 2233:2000, Packaging - Complete, filled transport packages and unit loads - Conditioning for testing.
- ASTM D4169-14:2014, Standard practice for performance ● testing of shipping containers and systems

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- ASTM F2096-11:2011, Standard Test Method for Detecting ● Gross Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
- ASTM F1929-98:1998 (Reapproved 2004), Standard Test . Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.
- ASTM F640-12:2012, Standard test methods for determining radiopacity for medical use.

The following performance data were provided in support of the substantial equivalence determination.

# Biocompatibility testing

The biocompatibility evaluation for the SwiftNINJA Microcatheter was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993. 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

- Cytotoxicity
- Sensitization
- Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Genotoxicitv ●
- Hemolysis ●
- Thrombogenicity ●
- Complement Activation ●

The SwiftNINJA Microcatheter is considered tissue contacting for a duration of less than 24 hours.

# Performance Testing-Bench

- Gauging
- Liquid leakage under high static pressure conditions ●

# Performance

- Air leakage ●
### Data cont.

- Separation force
- Unscrewing torque ●
- Ease of assembly .
- Resistance to overriding ●
- Stress cracking ●
- Visual inspection ●

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- Dimensional inspection ●
- Catheter body tensile strength / elongation ●
- Catheter tip tensile strength / elongation
- Catheter body to hub tensile strength ●
- . Catheter burst to failure
- Power injection
- Dead space (priming volume) ●
- Microcatheter quide wire passage ●
- Tip articulation / dial spring functionality / dial lock knob ●
- Multiple articulation (fatique test) ●
- . Radiodetectability
- Freedom from damage under high dynamic pressure ● conditions
- Catheter body fatigue
- Shaft radius of collapse with guide wire ●
- Shaft radius of collapse without quide wire ●
- Kink resistance ●
- Lubricious coating effectiveness ●
- Lubricious coating coverage ●
- Torque to failure
- Design validation ●
- . Neqative pressure collapse
- Embolic Delivery
- Particulate ●

No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of this device.

#### Summary of Substantial Equivalence

Based on the Indications for Use, design, safety and performance testing, the subject SwiftNINJA Microcathetermeets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Microcatheter, K082613.