(60 days)
No
The description focuses on mechanical steering and standard performance testing, with no mention of AI/ML terms or data processing.
No
The device is a microcatheter designed to deliver therapeutic materials, but it is not a therapeutic device itself. Its function is to facilitate the delivery, not to provide therapy 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 it's used for delivering diagnostic materials, which makes it a component in a diagnostic process.
No
The device description clearly details a physical microcatheter with a steerable tip, operating wires, a steering dial, and a hydrophilic coating. The performance studies also focus on physical and mechanical properties of the catheter, not software performance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a microcatheter for general intravascular use, including the infusion of diagnostic, embolic, or therapeutic materials. This is a device used within the body for procedural purposes, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details the mechanical aspects of the microcatheter, focusing on its steerable tip and how it's manipulated. This aligns with an interventional device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to determining the presence or absence of a disease or condition through in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This microcatheter's function is to access and deliver substances within the vasculature, which is an interventional procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective 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® Steerable Microcatheter is a 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)
Performance testing of the subject SwiftNINJA Steerable Microcatheter was conducted based on the risk analysis and based on the requirements of the following international standards: ISO 10555-1: 2013+A1:2017, Intravascular Catheters – Sterile and single-use catheters - Part 1: General requirements. ISO 10555-3:2013, Intravascular Catheters - Sterile and single-use catheters - Part 3: Central venous catheters. ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for syringes, 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 80369-7, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications 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.
The biocompatibility evaluation for the SwiftNINJA Steerable Microcatheter was conducted in accordance with the FDA guidance document "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,' 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, Hemolysis, Thrombogenicity (from K161921), Complement Activation.
Performance Testing-Bench included: 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 tip to shaft tensile strength, Catheter shaft to hub tensile strength, Microcatheter guide wire passage, Catheter burst to failure, Power injection, Dead space (priming volume), Tip articulation / dial spring functionality / dial lock knob, Multiple articulation (fatique test), Radiodetectability, Freedom from damage under high dynamic pressure conditions, Catheter body fatique, 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, Packaging Testing.
No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device.
Based on the Indications for Use, design, safety and performance testing, the subject SwiftNINJA Steerable Microcatheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the predicate device, the Merit Microcatheter, K161921.
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.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 16, 2021
Merit Medical Systems, Inc. Luke Meidell Principal Regulatory Affairs Specialist 1600 West Merit Parkway South Jordan, Utah 84095
Re: K211525
Trade/Device Name: SwiftNINJA® Steerable Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: May 14, 2021 Received: May 17, 2021
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211525
Device Name SwiftNINJA Steerable Microcatheter
Indications for Use (Describe)
This microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective 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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3
| General
Provisions | Submitter Name:
Address:
Telephone Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 208-4623
Luke Meidell
07/13/2021
1721504 |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | SwiftNINJA® Steerable Microcatheter
Continuous Flush Catheter
Catheter, Continuous Flush
2
KRA
870.1210
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | SwiftNINJA Steerable Microcatheter
Continuous Flush Catheter
K161921
Merit Medical Systems, Inc.
This predicate has not been subject to a design-related recall. |
| Reference
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Courier Microcatheter
Diagnostic Intravascular Catheter
K070456
Codman Neurovascular |
| Device
Description | The SwiftNINJA® Steerable Microcatheter is a 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. | |
4
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 Indications for the vasculature. The catheter should not be used in the cerebral Use vessels. The Indications for Use statement for the SwiftNINJA Microcatheter is identical to the predicate device. The SwiftNINJA Steerable Microcatheter has the same design and technological characteristics as the predicate SwiftNINJA Steerable Microcatheter. The subject device differs from the predicate device in French size, Lengths, exact material composition, number of marker bands, and shaft braiding. The comparison between the subject and reference devices is based Comparison to on the following: Predicate Device ● Same intended use Same Indications for Use ● Same material types that meet ISO 10993 biocompatibility ● requirements . Same sterilization methods Same fundamental technology/principle of operation between . the subject and predicate devices No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject SwiftNINJA Steerable Microcatheter was conducted based on the risk analysis and based on the requirements of the following international standards: ISO 10555-1: 2013+A1:2017, Intravascular Catheters – Sterile and . single-use catheters - Part 1: General requirements. . ISO 10555-3:2013, Intravascular Catheters - Sterile and single-Performance use catheters - Part 3: Central venous catheters. ISO 594-1:1986, Conical fittings with a 6% (Luer) taper for Data ● syringes, 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 80369-7, Small-bore connectors for liquids and gases in . healthcare applications - Part 7: Connectors for intravascular or hypodermic applications 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.
5
- ISO 10993-1:2009. Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA guidance 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 Toxicitv
- 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: 2019, Packaging for terminally sterilized medical ● devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.
- o ISO 11607-2: 2019, 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
- 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 Steerable Microcatheter was conducted in accordance with the FDA guidance document "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing Within a Risk Management Process,' 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:
6
| Cytotoxicity |
|---|
- Sensitization ●
- Irritation ●
- Acute Systemic Toxicity
- Pyrogenicity ●
- Hemolysis ●
- Thrombogenicity (from K161921) ●
- . Complement Activation
The SwiftNINJA Steerable Microcatheter is considered tissue contacting for a duration of less than 24 hours.
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 tip to shaft tensile strength ●
- Catheter shaft to hub tensile strength ●
Microcatheter guide wire passage
- Catheter burst to failure ●
- Power injection ●
●
- Dead space (priming volume)
Performance
- Data cont.
- Tip articulation / dial spring functionality / dial lock knob
- Multiple articulation (fatique test) ●
- Radiodetectability ●
- Freedom from damage under high dynamic pressure conditions ●
- Catheter body fatique ●
- 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 ●
- Packaging Testing ●
No clinical or pre-clinical testing was conducted to evaluate the substantial equivalence of the device.
Based on the Indications for Use, design, safety and performance Summary of testing, the subject SwiftNINJA Steerable Microcatheter meets the Substantial requirements that are considered essential for its intended use and is Equivalence substantially equivalent to the predicate device, the Merit Microcatheter, K161921.