(134 days)
No
The description focuses on the physical characteristics, materials, and performance testing of a microcatheter, with no mention of AI or ML capabilities.
No
The device is described as a microcatheter used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials, but it is not itself a therapeutic device; rather, it is a tool for delivering therapeutic materials.
Yes
The "Intended Use / Indications for Use" section states: "Once the subselective region has been accessed, the Microcatheter can be used for the controlled and selective infusion of diagnostics, embolic, or therapeutic materials into vessels." This indicates that the device is intended to facilitate the infusion of diagnostic materials.
No
The device description clearly details a physical microcatheter with specific dimensions, materials, and features, indicating it is a hardware device, not software-only.
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 being used intravascularly for the infusion of materials into vessels. This is a therapeutic or interventional use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a hydrophilic coating and radiopaque markers for visualization during the procedure. This aligns with an interventional device.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. The "diagnostics" mentioned in the intended use likely refers to diagnostic agents that are infused, not the device itself performing a diagnostic test.
In summary, the Merit Pursue Microcatheter is an interventional device used for delivering substances within the body, not a device used to perform diagnostic tests on samples outside the body.
N/A
Intended Use / Indications for Use
The 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 diagnostics, embolic, or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.
Product codes
DQY
Device Description
The Merit Pursue Microcatheter is available in two French configurations, 2.9F (proximal) / 2.0F (distal) and 2.8F (proximal / 1.7F (distal) and 110cm, 130cm and 150cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the microcatheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the microcatheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Merit Pursue Microcatheter is offered with two 3mL syringes.
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 Merit Pursue Microcatheter was conducted based on the risk analysis and based on the requirements of the following international standards:
• ISO 10555-1:2013, Intravascular Catheters – Sterile and single-use catheters – Part 1: General requirements
• 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/Technical Corrigendum 1 2010 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, and FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2010)
• ISO 10993-4: 2017, Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactions with Blood
• ISO 10993-4:2002/Amendment 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 10993-10:2010. 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
• United States Pharmacopeia 40, National Formulary 35, 2017 Pyrogen Test
• ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials
• ISO 10993-7:2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
• 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
• ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The biocompatibility evaluation for the Merit Pursue Microcatheter was conducted in accordance with FDA guidance use of International standard ISO-10993, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Pyrogenicitv
- Hemolysis
- Thrombogenicity
- Complement Activation
Performance Testing-Bench / ISO 594-2 Performance testing/ Design verification: - Gauging
- Separation Force
- Unscrewing Torque
- Ease of Assembly
- Resistance to Overriding
- Stress Cracking
ISO 10555-1 Performance testing: - Surface
- Freedom from Liquid Leakage
- Freedom from Air Leakage
Performance Data cont.: - Power injection Peak Tensile Force
- Corrosion Resistance
Additional Testing (Design verification and validation): - Lubricity
- Dimensional testing
- Design Validation
- Marker Band Retention
- Tip Shape
- Torque Strength
- Radio-detectability
- Kink Resistance
- Chemical Compatibility
- Particulate Analysis
Key Results: The Merit Pursue Microcatheter is considered to have circulating blood contact for a limited (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
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March 30, 2018
Merit Medical Systems, Inc. Niloufar Samimi Regulatory Affairs Specialist II 1600 West Merit Parkwav South Jordan, Utah 84095
Re: K173548
Trade/Device Name: Merit Pursue Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 5, 2018 Received: November 17, 2017
Dear Niloufar Samimi:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
M.A. Hillemann
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173548
Device Name Merit Pursue Microcatheter
Indications for Use (Describe)
The 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 diagnostics, embolic, or therapeutic materials into vessels. 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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K173548- 510(k) Summary
| 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) 208-4583
Niloufar Samimi
11/15/2017
1721504 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Merit Pursue Microcatheter
Microcatheter
Percutaneous catheter
2
DQY
870.1250
Cardiovascular |
| Predicate
Device | Premarket Notification Predicate #1:
Trade Name:
Classification Name:
Premarket Notification:
Manufacturer:
Premarket Notification Reference Predicate #2:
Trade Name:
Classification Name:
Premarket Notification:
Manufacturer:
These predicate devices have not been subject to a design-related
recall. | Excelsior™ 1018™ and SL-10 Pre-Shaped
Microcatheter
Percutaneous catheter
K042568
Stryker
Maestro Microcatheter
Catheter, Continuous Flush
K172081
Merit Medical System, Inc. |
| Device
Description | | The Merit Pursue Microcatheter is available in two French
configurations, 2.9F (proximal) / 2.0F (distal) and 2.8F (proximal / 1.7F
(distal) and 110cm, 130cm and 150cm lengths. The distal tip of the |
| | microcatheter is offered in straight or pre-shaped 45 degree and swan
neck configurations. The proximal end of the microcatheter consists of
a molded winged hub with a tapered strain relief. The outer surface of
the distal 80cm of the microcatheter shaft is coated with a hydrophilic
coating designed to facilitate the introduction of the microcatheter into
the vasculature. The microcatheter incorporates a radiopaque marker
at the distal tip to facilitate fluoroscopic visualization.
The Merit Pursue Microcatheter is offered with two 3mL syringes. | |
| Indications for
Use | The 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
vessels. The catheter should not be used in the cerebral vessels. | |
| Comparison to
Predicate
Devices | The design and technological characteristics of the subject Merit
Pursue Microcatheter are substantially equivalent to those of the
Predicate Device #1, Excelsior™ 1018™ and SL10- Pre-shaped
Microcatheter and Reference Predicate Device #2 Maestro
Microcatheter. The subject device has a similar basic design as the
predicates.
The comparison between the subject and the predicate devices is
based on the following:
• Similar Intended use
• Similar Indications for use
• Similar material types that meet ISO 10993 biocompatibility
requirements
• Similar design
• Same sterilization methods
• Same fundamental technology/principle of operation | |
| Performance
Data | No performance standards have been established under Section 514 of
the Food, Drug and Cosmetic Act for these devices. Performance
testing of the subject Merit Pursue Microcatheter was conducted based
on the risk analysis and based on the requirements of the following
international standards:
• ISO 10555-1:2013, Intravascular Catheters – Sterile and single-
use catheters – Part 1: General requirements
• 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/Technical Corrigendum 1 2010 Biological
Evaluation of Medical Devices Part 1: Evaluation and Testing | |
4
5
within a risk management process, and FDA quidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" (2010)
- . ISO 10993-4: 2017, Biological Evaluation of Medical Devices -Part 4: Selection of Tests for Interactions with Blood
- ISO 10993-4:2002/Amendment 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 10993-10:2010. 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
- United States Pharmacopeia 40, National Formulary 35, 2017 Pyrogen Test
- ASTM F756-17 Standard Practice for Assessment of Hemolytic . Properties of Materials
- ISO 10993-7:2008, Biological evaluation of medical devices -. Part 7: Ethylene oxide sterilization residuals
- 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
- . ISO 594-2: 1998 Conical fittings with 6% (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Merit Pursue Microcatheter was conducted in accordance with FDA guidance use of International standard ISO-10993, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. The battery of testing included the following tests:
- Cytotoxicity ●
- Sensitization
- Irritation .
- Acute Systemic Toxicity ●
- Pvrogenicitv ●
- Hemolysis ●
- Thrombogenicity ●
- Complement Activation ●
The Merit Pursue Microcatheter is considered to have circulating blood contact for a limited (