(134 days)
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.
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.
I'm sorry, but without further context, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.
The provided text is an FDA 510(k) clearance letter and a 510(k) summary for the Merit Pursue Microcatheter. This document details the regulatory clearance process and the summary of testing performed to demonstrate substantial equivalence to a predicate device, rather than a specific clinical study with acceptance criteria for an AI/CADe device.
The document lists performance data and testing based on international standards (ISO, ASTM, USP) for the physical and biological properties of the microcatheter (e.g., biocompatibility, resistance to leakage, lubricity, torque strength). It does not describe:
- Acceptance criteria in terms of medical outcomes or diagnostic performance.
- A study proving the device meets these criteria for an AI/CADe system.
- Sample sizes, data provenance, expert qualifications, or ground truth establishment for a diagnostic performance study.
- MRMC studies or standalone performance for an AI algorithm.
Therefore, I cannot fulfill your request for information related to AI/CADe device acceptance criteria and studies from this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo features a stylized depiction of a human figure embraced by a wing-like form. The FDA part of the logo has the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
K173548- 510(k) Summary
| GeneralProvisions | Submitter Name:Address:Telephone Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 208-4583Niloufar Samimi11/15/20171721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Merit Pursue MicrocatheterMicrocatheterPercutaneous catheter2DQY870.1250Cardiovascular |
| PredicateDevice | 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-relatedrecall. | Excelsior™ 1018™ and SL-10 Pre-ShapedMicrocatheterPercutaneous catheterK042568StrykerMaestro MicrocatheterCatheter, Continuous FlushK172081Merit Medical System, Inc. |
| DeviceDescription | The Merit Pursue Microcatheter is available in two Frenchconfigurations, 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 swanneck configurations. The proximal end of the microcatheter consists ofa molded winged hub with a tapered strain relief. The outer surface ofthe distal 80cm of the microcatheter shaft is coated with a hydrophiliccoating designed to facilitate the introduction of the microcatheter intothe vasculature. The microcatheter incorporates a radiopaque markerat the distal tip to facilitate fluoroscopic visualization.The Merit Pursue Microcatheter is offered with two 3mL syringes. | ||
| Indications forUse | The Microcatheter is intended for general intravascular use, includingperipheral and coronary vasculature. Once the subselective region hasbeen accessed, the Microcatheter can be used for the controlled andselective infusion of diagnostic, embolic, or therapeutic materials intovessels. The catheter should not be used in the cerebral vessels. | |
| Comparison toPredicateDevices | The design and technological characteristics of the subject MeritPursue Microcatheter are substantially equivalent to those of thePredicate Device #1, Excelsior™ 1018™ and SL10- Pre-shapedMicrocatheter and Reference Predicate Device #2 MaestroMicrocatheter. The subject device has a similar basic design as thepredicates.The comparison between the subject and the predicate devices isbased on the following:• Similar Intended use• Similar Indications for use• Similar material types that meet ISO 10993 biocompatibilityrequirements• Similar design• Same sterilization methods• Same fundamental technology/principle of operation | |
| PerformanceData | No performance standards have been established under Section 514 ofthe Food, Drug and Cosmetic Act for these devices. Performancetesting of the subject Merit Pursue Microcatheter was conducted basedon the risk analysis and based on the requirements of the followinginternational standards:• ISO 10555-1:2013, Intravascular Catheters – Sterile and single-use catheters – Part 1: General requirements• ISO 11135:2014, Sterilization of health care products - Ethyleneoxide - Requirements for the development, validation and routinecontrol of a sterilization process for medical devices• ISO 10993-1: 2009/Technical Corrigendum 1 2010 BiologicalEvaluation 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 <151> 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 (< 24 hours) duration.
{6}------------------------------------------------
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 ●
Summary of Substantial Equivalence
Based on the indications for use, design, safety and performance testing, the subject Merit Pursue Microcatheter meets the requirements that are considered essential for its intended use and is substantially equivalent to the Predicate Device #1 Stryker, the Excelsior 1018 and SL-10 [K042568].
§ 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).