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 Description

The SwiftNINJA® Microcatheter is a 2.9 Fr (proximal) / 2.4 Fr (distal) microcatheter with a steerable/articulating distal tip. Articulation is achieved via a steering dial at the proximal handle which allows the operator to manipulate the tip up to 180 degrees in opposing directions. The steering dial and steerable tip are connected via two operating wires. The wires are located on both lateral walls of the catheter shaft with a connection point on the distal catheter. Tension is applied to either one of the wires by turning the steering dial for manipulation of the tip direction. Once the direction of steerable tip is determined, the steering dial lock may be used for maintaining the intended direction. The outer surface of the distal segment of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the microcatheter into the vasculature.

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the SwiftNINJA Microcatheter. This document details the device's characteristics and its substantial equivalence to previously cleared devices, but it does not describe a study meant to prove the device meets specific acceptance criteria in the context of AI/ML performance.

Instead, the document focuses on bench testing and biocompatibility testing to demonstrate the device's physical and biological safety and performance, comparing it to predicate devices. There is no mention of an AI/ML component in the SwiftNINJA Microcatheter.

Therefore, I cannot extract information related to:

A table of acceptance criteria and reported device performance in an AI/ML context. The document lists various performance tests for mechanical properties and biocompatibility, but these are not set as acceptance criteria for AI performance metrics (e.g., accuracy, sensitivity, specificity).
Sample size used for the test set and data provenance for AI/ML.
Number of experts used to establish ground truth for an AI/ML test set.
Adjudication method for an AI/ML test set.
Multi-reader multi-case (MRMC) comparative effectiveness study and its effect size for human readers with/without AI assistance.
Standalone (algorithm-only) performance for an AI/ML device.
Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
Sample size for the training set for AI/ML.
How ground truth for the training set was established for AI/ML.

The document explicitly states: "No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of this device." This further confirms that no studies for performance in the sense of clinical effectiveness or AI model evaluation were performed. The "performance data" mentioned refers to the results of the bench and biocompatibility tests.

In summary, the provided document is for a medical device (microcatheter) and details its physical and biological testing for regulatory clearance, not the performance evaluation of an AI/ML component.

Summary

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Image /page/0/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 an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, representing health and human services.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary - K161921

GeneralProvisions	Submitter Name: Merit Medical Systems, Inc.Address: 1600 West Merit Parkway South Jordan, UT 84095Telephone Number: (801) 208-4623Fax Number: (801) 826-4174Contact Person: Luke MeidellDate Prepared: 09/30/2016Registration Number: 1721504
SubjectDevice	Trade Name: SwiftNINJA® MicrocatheterCommon/Usual Name: Continuous Flush CatheterClassification Name: Catheter, Continuous FlushRegulatory Class: 2Product Code: KRA21 CFR §: 870.1210Review Panel: Cardiovascular
PrimaryPredicateDevice	Trade Name: Merit MicrocatheterClassification Name: Continuous Flush CatheterPremarket Notification: K082613Manufacturer: Merit Medical Systems, Inc.This predicate has not been subject to a design-related recall.
SecondaryPredicateDevice	Trade Name: Micrus® Courier Enzo™ MicrocatheterClassification Name: Diagnostic intravascular catheterPremarket Notification: K072526, K070456Manufacturer: Micrus Endovascular Corporation
DeviceDescription	The SwiftNINJA® Microcatheter is a 2.9 Fr (proximal) / 2.4 Fr(distal) microcatheter with a steerable/articulating distal tip.Articulation is achieved via a steering dial at the proximal handlewhich allows the operator to manipulate the tip up to 180 degreesin opposing directions. The steering dial and steerable tip areconnected via two operating wires. The wires are located on bothlateral walls of the catheter shaft with a connection point on the
distal catheter. Tension is applied to either one of the wires byturning the steering dial for manipulation of the tip direction.Once the direction of steerable tip is determined, the steering diallock may be used for maintaining the intended direction.The outer surface of the distal segment of the microcatheter shaftis coated with a hydrophilic coating designed to facilitate theintroduction of the microcatheter into the vasculature.
Indications forUse	This microcatheter is intended for general intravascular use,including peripheral and coronary vasculature. Once the sub-selective region has been accessed, the microcatheter can beused for the controlled and selective infusion of diagnostic,embolic, or therapeutic materials into the vasculature. Thecatheter should not be used in the cerebral vessels.The Indications for Use statement for the SwiftNINJAMicrocatheter is identical to the predicate device.
Comparisonto PredicateDevice	The SwiftNINJA Microcatheter is similar in design andtechnological characteristics to the Merit Microcatheter (primarypredicate) and the Micrus Courier Enzo Microcatheter (secondarypredicate).The comparison between the subject, primary predicate, andsecondary predicate devices is based on the following: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.
	PerformanceData

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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.

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
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.(b)
Classification. Class II (performance standards).