Who is the manufacturer of Merit RadialFlo Arterial Catheter?

Merit Medical Singapore Pte. , Ltd. filed the 510(k) submission for Merit RadialFlo Arterial Catheter (K182538).

What is the FDA product code for Merit RadialFlo Arterial Catheter?

FOZ. It is classified under 21 CFR 880.5200 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for Merit RadialFlo Arterial Catheter?

510(k) clearance (submission type: Abbreviated).

What are the predicate devices for Merit RadialFlo Arterial Catheter?

BD Angiocath™ IV Catheter (K151698).

Who can help prepare an FDA 510(k) submission like Merit RadialFlo Arterial Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Merit RadialFlo Arterial Catheter

K182538 · Merit Medical Singapore Pte. , Ltd. · FOZ · Jan 16, 2019 · General Hospital

Device Facts

Record ID	K182538
Device Name	Merit RadialFlo Arterial Catheter
Applicant	Merit Medical Singapore Pte. , Ltd.
Product Code	FOZ · General Hospital
Decision Date	Jan 16, 2019
Decision	SESE
Submission Type	Abbreviated
Regulation	21 CFR 880.5200
Device Class	Class 2

Indications for Use

The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

Device Story

Merit RadialFlo Arterial Catheter is an over-the-needle intravascular catheter; provides vascular access for blood sampling and blood pressure monitoring. Device features a Floswitch hub for flow control and a notched needle for instant blood return confirmation; radiopaque PTFE tubing allows visualization under X-ray/fluoroscopy. Used by clinicians in clinical settings. Device is inserted into patient vasculature; provides real-time pressure data and blood access. Benefits include controlled flow and improved vessel entry confirmation. No therapeutic effect.

Clinical Evidence

Bench testing only. Compliance with ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 9626, and IEC 62366-1. Biocompatibility testing per ISO 10993 series (cytotoxicity, sensitization, intracutaneous, acute systemic toxicity, pyrogenicity, hemocompatibility). Performance testing included radio-detectability, leakage, flow rate, tensile force, and connector integrity.

Technological Characteristics

Over-the-needle intravascular catheter; PTFE tubing with barium sulfate; polycarbonate bush/guide; polypropylene hub/needle grip; polyphenylene oxide button; stainless steel needle/ball; silicon rubber valve. Dimensions: 20G, 45mm length. Sterilization: Ethylene Oxide. Connectivity: None. Standards: ISO 10555-1, ISO 10555-5, ISO 80369-7, ISO 10993.

Indications for Use

Indicated for any patient population requiring vascular access for short-term (less than 30 days) blood sampling and blood pressure monitoring, contingent upon adequate vascular anatomy and procedural appropriateness.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Predicate Devices

BD Angiocath™ IV Catheter (K151698)

Reference Devices

Merit Secalon T™ Catheter (K850460)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 16, 2019 Merit Medical Singapore Pte. Ltd. Xing Seow Regulatory Affairs Specialist 198 Yishun Avenue 7 Singapore, 768926 Sg Re: K182538 Trade/Device Name: Merit RadialFlo Arterial Catheter Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: Class II Product Code: FOZ Dated: December 12, 2018 Received: December 17, 2018 Dear Xing Seow: 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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about mediation-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). Sincerely, # Stephen C. Browning -S5 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) K182538 Device Name Merit RadialFlo Arterial Catheter #### Indications for Use (Describe) The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. | 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}------------------------------------------------ ## 5.0 510(k) Summary | | Submitter Name: | Merit Medical Singapore Pte. Ltd. | |-----------------------|-------------------------|--------------------------------------------------------------------------------------------| | General Provisions | Address: | 198 Yishun Avenue 7, Singapore 768926 | | | Telephone Number: | (65) 6750-9188 | | | Fax Number: | (65) 6754-3961 | | | Contact Person: | Ms. Xing Ting Seow | | | Date Prepared: | September 10, 2018 | | | | Establishment Registration Number: | | | Trade Name: | Merit RadialFlo™ Arterial Catheter | | Subject Device | Common/Usual Name: | Arterial Catheter | | | Classification Name: | Catheter, Intravascular, Therapeutic, short- term less than 30 days | | | Trade Name: | BD Angiocath™ IV Catheter | | Predicate Device | Common/Usual Name: | Peripheral Intravascular or IV Catheter | | | Classification Name: | Catheter, Intravascular, Therapeutic, short- term less than 30 days | | | Premarket Notification: | K151698 | | | Manufacturer: | Becton Dickinson Infusion Therapy System Inc. | | | Trade Name: | Merit Secalon T™ Catheter (previously named as Viggo Secalon T Catheter) | | | Common/Usual Name: | Intravascular Catheter | | Reference Device | Classification Name: | Catheter, intravascular, therapeutic, short- term less than 30 days | | | Premarket Notification: | K850460 | | | Manufacturer: | Merit Medical Singapore Pte. Ltd. (previously manufactured by Viggo Products Ohmeda) | | | Regulatory Class: | II | | | Product Code: | FOZ | | Classification | 21 CFR §: | 880.5200 | | | Review Panel: | General Hospital | {4}------------------------------------------------ | The Merit RadialFlo Arterial Catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. | | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | Intended Use | The Indications for Use statement for the Merit RadialFlo Arterial Catheter device is same as the predicate device (K151698) except that the predicate device has additional use to administer fluids intravenously. Subject device has one less product claim and product does not have therapeutic effect. The difference does not affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices follow 21 CFR 880.5200 to sample blood and monitor blood pressure. | | | | | Device Description | The Merit RadialFlo Arterial Catheter is an intravascular catheter designed to access the vasculature to sample blood and monitor blood pressure. The device is equipped with a Floswitch to limit blood spill or control flow as needed. The needle includes a unique notch to provide instant blood return upon vessel entry. The radiopaque catheter provides visibility under X-ray and fluoroscopy. The arterial catheter is intended to be in contact with the circulating blood for a prolonged (24 hours to 30 days) duration. The steel needle is in contact with circulating blood for a limited (<24 hours) duration and the flow control plug has indirect blood path contact. All the materials used in Merit RadialFlo Arterial Catheter are biocompatible. | | | | | Comparison to Predicate Device | The proposed Merit RadialFlo Arterial Catheter incorporates similar intended use, design and principle of operation as the predicate devices. Any differences in materials used or specification are supported by the subject device's compliance with FDA recognized standards ISO 10555-1 and ISO 10555-5. The subject device is substantially equivalent to the predicate device (K151698). The technology and design of the Flowswitch is the same as reference device. The material used on the subject device is same as the reference device (K850460) except the Flowswitch button is made using polyphenylene oxide but this has no body contact. There is also an additional component which is the flow control plug that is made of polypropylene with filter membrane to limit blood spill. The flow control plug has indirect blood contact. | | | | | | Attribute | Subject Device – Merit RadialFlo Arterial Catheter | Predicate Device – BD Angiocath™ M IV Catheter (K151698) | Reference Device – Merit Secalon T Catheter (K850460) | | Design | | | | | | | A conventional over-the-needle intravascular catheter with radiopaque Polytetrafluoroet hylene (PTFE) tubing. The needle introducer punctures the skin and allow penetration of the intravascular catheter to the blood vessel. The radiopaque catheter provides visibility under X-ray and fluoroscopy. The catheter is designed with a Floswitch hub with luer connection to control flow of fluid or blood. The needle cannula includes a unique notch to provide instant blood return for recognition of correct blood entry. | A convention al over-the- needle intravascul ar catheter with radiopaque fluorinated ethylene propylene (FEP) tubing. The needle introducer punctures the skin and allow penetration of the intravascul ar catheter to the blood vessel. The catheter provides visibility under X- ray and fluoroscop y. The catheter is designed with a convention al luer hub. A flash chamber for blood flash back for recognition of correct blood entry. | A conventional over-the- needle intravascular catheter with radiopaque Polytetrafluoro ethylene (PTFE) tubing. The needle introducer punctures the skin and allow penetration of the intravascular catheter to the blood vessel. The catheter provides visibility under X-ray and fluoroscopy. The hub is designed with a Floswitch hub with luer connection to control flow of fluid or blood. | | | Material | | | | | | Arterial Catheter | Catheter Tube | Polytetrafluoroet hylene (PTFE) | Fluorinated Ethylene Propylene | Polytetrafluoro ethylene (PTFE) | | | with Barium Sulphate | (FEP) with radiopaque filler | Barium Sulphate | | | Catheter Bush | Polycarbonate | | Polycarbonate | | | Floswitch Housing / Catheter Hub | Polypropylene, (colorant: pink) | Polypropylene (colorant: pink) | Polypropylene | | | Floswitch Button | Polyphenylene Oxide | | Acrylonitrile Butadiene Styrene | | | Steel Ball | Stainless steel | | Stainless steel | | | Silicon Valve | Silicon rubber | | Silicon rubber | | | Guide Bush | Polycarbonate | | Polycarbonate | | | Needle Introducer | Stainless steel | Stainless steel | Stainless steel | | | Needle Grip / hub | Polypropylene | Propionate | Polypropylene | | | Flow Control Plug / Vent Plug | Polypropylene, Acrylic copolymer membrane on nonwoven nylon | Polyethyle ne | NA | | | Protection Tube | Low Density Polyethylene | Polypropyl ene | Low Density Polyethylene | | | Lubricant | Polydimethylsilo xane | Polydimeth ylsiloxane | Polydimethylsil oxane | | | Principle of Operation | Over-Needle Technique | Over-Needle Technique | Over-Needle Technique | | | Catheter Diameter | 20G | 14G, 16G, 18G, 20G, 22G, 24G | 14G, 16G, 18G | | | Catheter Length | 45mm | 19mm, 25mm, 30mm, 48mm, 83mm, 133mm | 90mm, 130mm, 160mm | | | Indications for Use | The Merit RadialFlo Arterial Catheter is a device that | An intravascul ar catheter is a device | The Secalon-T Central Venous Catheter is | | | | is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood and monitor blood pressure. The Merit RadialFlo Arterial Catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure. | that is inserted into the patient's vascular system for short term use (less than 30days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with considerati on given to adequacy of vascular anatomy and appropriateness of procedure. | intended to access to the human circulatory system. This access allows large volume infusion of liquids, blood sampling and infusion of drugs. The Floswitch control the flow of liquids. | | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ FDA guidance and recognized consensus standards have been established for Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days under FDA Product Code FOZ and 21 CFR 880.5200. A battery of tests was performed based on the requirements of the below recognized consensus standards and guidance, as well as biocompatibility, sterilization, and labeling standards and guidance. Conformity to these standards demonstrates that the subject Merit RadialFlo Arterial Catheter met the standards' established acceptance criteria applicable to the safety and effectiveness of the device. #### Safety & Performance Data - . ISO 10555-1: 2013, Intravascular Catheters -- Sterile and Single-Use Intravascular Catheters -- Part 1: General Requirements - . ISO 10555-5: 2013, Intravascular Catheters -- Sterile and Single-Use Catheters -- Part 5: Over-Needle Peripheral Catheters {8}------------------------------------------------ - . ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications -- Part 7: Connectors for intravascular or hypodermic applications - . ISO 9626: 2016, Stainless steel needle tubing for the manufacture of medical devices - Requirement and test methods - . IEC 62366-1:2015, Medical devices - Part 1: Application of usability engineering to medical devices [Including CORRIGENDUM 1 (2016)] - . ISO 2233:2000, Packaging - Complete, filled transport packages and unit loads – Conditioning for testing - ISO 11607-1:2006, Packaging for Terminally Sterilized Medical . Devices - Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems [Including: Amendment 1 (2014)] - . ISO 11607-2: 2006, Packaging for Terminally Sterilized Medical Devices - Part 2: Validation Requirements for Forming, Sealing and Assembly Processes [Including: Amendment 1 (2014)] - . ASTM D4169-16: 2016, Standard Practice for Performance Testing of Shipping Containers and Systems - . ASTM F1980-16: 2016, Standard Guide for Accelerated Aging of Sterile Barrier System for Medical Device - ISO 10993-1:2009 / Cor 1:2010, Biological Evaluation Of Medical ● Devices - Part 1: Evaluation And Testing Within A Risk Management Process [Including: Technical Corrigendum 1 (2010)] - . ISO 10993-4: 2017, Biological evaluation of medical devices – Part 4: Selection of test for interactions 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 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity - . 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 10993-7:2008/Cor 1: 2009, Biological Evaluation Of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals [Including: Technical Corrigendum 1 (2009)] - . AAMI TIR 28:2009, Product Adoption and Process Equivalency for Ethylene Oxide Sterilization - AAMI/ANSI ST72:2011/(R)2016, Bacterial Endotoxins Test . methods, routine monitoring, and alternatives to batch testing {9}------------------------------------------------ - . United States Pharmacopeia 41, National Formulary 36, <151> Pyrogen Test (2018) - . FDA Guidance, Use of International Standard ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process, June 2016 - FDA Guidance, Guidance on Premarket Notification [510(k)] . Submission for Short-Term and Long-Term Intravascular Catheters, March 1995. #### Performance Bench Testing The Merit RadialFlo Arterial Catheter complies with the FDA recognized consensus standards ISO 10555-1 and ISO 10555-5, as outlined within this submission. Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use. Testing included the following from these standards: | ISO 10555-1 | | |----------------------|---------------------------------| | Radio-detectability | Freedom from Leakage | | Biocompatibility | Hubs (reference to ISO 80369-7) | | Surface | Flowrate | | Corrosion Resistance | Distal Tip | | Peak Tensile Force | Designation of nominal size | | ISO 10555-5 | | | Colour Code | Needle | | Catheter Unit | Vent Fitting | #### Biocompatibility testing The biocompatibility evaluation for the Merit RadialFlo Arterial Catheter was conducted in accordance with the FDA Guidance Document "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process,"" June 16, 2016, 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. Testing included the following: - Cytotoxicity ● - Sensitization ● - . Intracutaneous - Acute Systemic Toxicity ● - Pyrogenicity ● - Hemocompatibility ● {10}------------------------------------------------ | | The Merit RadialFlo Arterial Catheter is an externally communicating device with circulating blood contacting for prolonged duration (> 24h to 30d). | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------…

Merit RadialFlo Arterial Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Identification

Predicate Devices

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Submission Summary (Full Text)

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Merit RadialFlo Arterial Catheter

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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