(114 days)
Not Found
No
The description focuses on the mechanical and material properties of the microcatheter and its steerable tip mechanism. There is no mention of AI, ML, image processing, or any software-driven decision-making or analysis.
No
Explanation: The device is a microcatheter designed for the delivery of diagnostic, embolic, or therapeutic materials, but it is not itself a therapeutic device. Its function is to facilitate therapy, not to provide it directly.
Yes
The "Intended Use / Indications for Use" states that the microcatheter can be used for the "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature." This indicates its role in procedures that involve diagnosis.
No
The device description clearly describes a physical microcatheter with a steerable tip, handle, wires, and coating, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the microcatheter is for "general intravascular use" and for the "controlled and selective infusion of diagnostic, embolic, or therapeutic materials into the vasculature." This describes a device used within the body for delivering substances or accessing areas, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical catheter with a steerable tip and mechanisms for manipulation. This is consistent with an invasive medical device, not an IVD which typically involves reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, test methods, or diagnostic results derived from testing samples in vitro.
Therefore, the SwiftNINJA® Microcatheter is an invasive medical device used for accessing and delivering materials within the vasculature, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
- Genotoxicity
- Hemolysis
- Thrombogenicity
- Complement Activation
Performance Testing-Bench:
- Gauging
- Liquid leakage under high static pressure conditions
- Air leakage
- Separation force
- Unscrewing torque
- Ease of assembly
- Resistance to overriding
- Stress cracking
- Visual inspection
- 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 guide wire passage
- Tip articulation / dial spring functionality / dial lock knob
- Multiple articulation (fatigue 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 guide wire
- Kink resistance
- Lubricious coating effectiveness
- Lubricious coating coverage
- Torque to failure
- Design validation
- Negative pressure collapse
- Embolic Delivery
- Particulate
No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of this device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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.
1
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
2
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary - K161921
| General
Provisions | Submitter Name: Merit Medical Systems, Inc.
Address: 1600 West Merit Parkway South Jordan, UT 84095
Telephone Number: (801) 208-4623
Fax Number: (801) 826-4174
Contact Person: Luke Meidell
Date Prepared: 09/30/2016
Registration Number: 1721504 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject
Device | Trade Name: SwiftNINJA® Microcatheter
Common/Usual Name: Continuous Flush Catheter
Classification Name: Catheter, Continuous Flush
Regulatory Class: 2
Product Code: KRA
21 CFR §: 870.1210
Review Panel: Cardiovascular |
| Primary
Predicate
Device | Trade Name: Merit Microcatheter
Classification Name: Continuous Flush Catheter
Premarket Notification: K082613
Manufacturer: Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall. |
| Secondary
Predicate
Device | Trade Name: Micrus® Courier Enzo™ Microcatheter
Classification Name: Diagnostic intravascular catheter
Premarket Notification: K072526, K070456
Manufacturer: Micrus Endovascular Corporation |
| 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. | |
| 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.
The Indications for Use statement for the SwiftNINJA
Microcatheter is identical to the predicate device. |
| Comparison
to Predicate
Device | The SwiftNINJA Microcatheter is similar in design and
technological characteristics to the Merit Microcatheter (primary
predicate) and the Micrus Courier Enzo Microcatheter (secondary
predicate).
The comparison between the subject, primary predicate, and
secondary 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. |
| | Performance
Data |
4
5
- 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 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 ●
7
- 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.