(124 days)
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.
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.
The provided text describes the Merit RadialFlo Arterial Catheter, which is an intravascular catheter for short-term use (less than 30 days) to sample blood and monitor blood pressure. The document focuses on regulatory approval (510(k) submission) and demonstration of substantial equivalence to predicate devices, rather than a study proving the device meets explicit clinical outcome acceptance criteria in an AI context.
Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size) are not applicable or cannot be extracted from this documentation, as it pertains to a medical device's physical and biological performance rather than an AI/ML diagnostic or prognostic system.
However, I can provide information on the device's acceptance criteria based on the regulatory standards it meets and its reported performance against those technical standards.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Specific Criterion (Standard Reference) | Reported Device Performance |
|---|---|---|
| Performance Bench Testing (ISO 10555-1 & 10555-5) | ||
| Radio-detectability | Requirements for catheter visibility under X-ray and fluoroscopy (implicit in ISO 10555-1: 2013). | The radiopaque catheter provides visibility under X-ray and fluoroscopy. (Statement of compliance, specific quantitative results not provided) |
| Freedom from Leakage | Requirements for preventing fluid leakage from the catheter system. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Biocompatibility | General requirements for biological safety. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Hubs | Requirements for connections including luer connections (reference to ISO 80369-7:2016). | Device met acceptance criteria. (Specific quantitative results not provided) |
| Surface | Requirements related to the catheter surface. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Flowrate | Requirements for the flow capacity of the catheter. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Corrosion Resistance | Requirements for resistance to corrosion as per ISO 10555-1: 2013. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Distal Tip | Requirements for the design and integrity of the distal tip. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Peak Tensile Force | Requirements for the tensile strength of the catheter. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Designation of nominal size | Requirements for consistent and accurate sizing. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Colour Code | Requirements for catheter color coding as per ISO 10555-5: 2013. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Catheter Unit | Overall performance and integrity of the catheter unit. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Needle | Requirements for the needle component in over-the-needle catheters as per ISO 10555-5: 2013 and ISO 9626: 2016. The needle includes a unique notch to provide instant blood return. | Device met acceptance criteria; needle performed as designed providing instant blood return. (Specific quantitative results not provided) |
| Vent Fitting | Requirements for the vent fitting. | Device met acceptance criteria. (Specific quantitative results not provided) |
| Biocompatibility Testing (ISO 10993 Series) | ||
| Cytotoxicity | Absence of adverse cellular reactions (ISO 10993-5). | Device found to be biocompatible. (Specific quantitative results not provided) |
| Sensitization | Absence of allergic or hypersensitivity reactions (ISO 10993-10). | Device found to be biocompatible. (Specific quantitative results not provided) |
| Intracutaneous | Absence of local irritation (ISO 10993-10). | Device found to be biocompatible. (Specific quantitative results not provided) |
| Acute Systemic Toxicity | Absence of adverse systemic effects from extracts (ISO 10993-11). | Device found to be biocompatible. (Specific quantitative results not provided) |
| Pyrogenicity | Absence of fever-inducing substances (USP 41, NF 36, <151>). | Device found to be biocompatible (non-pyrogenic). (Specific quantitative results not provided) |
| Hemocompatibility | Absence of adverse reactions with blood (ISO 10993-4). | Device found to be biocompatible. (Specific quantitative results not provided) |
| Sterilization & Packaging Standards | ||
| Sterilization | Compliance with ISO 11135:2014 (Ethylene Oxide Sterilization) and ISO 10993-7:2008/Cor 1:2009 (EO Residuals). | Device demonstrated compliance with relevant sterilization and EO residuals standards. (Specific quantitative results not provided) |
| Packaging | Compliance with ISO 2233:2000, ISO 11607-1:2006, ISO 11607-2:2006, ASTM D4169-16:2016, ASTM F1980-16:2016 for integrity, shelf-life, and transport. | Device demonstrated compliance with packaging and aging standards for sterility maintenance and physical integrity. (Specific quantitative results not provided) |
Study Details:
The document describes a series of bench tests and biocompatibility tests to demonstrate that the Merit RadialFlo Arterial Catheter meets established safety and performance standards for its intended use. This is a traditional medical device approval process, not an AI/ML software validation.
2. Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a single "test set" in the context of an AI/ML study. The studies refer to "a battery of tests" and "results of the testing" which typically involve specific numbers of devices or test samples for each individual test (e.g., a certain number of catheters for tensile strength, a certain number of samples for cytotoxicity testing). These numbers are not provided in the summary.
- Data provenance: The tests are conducted according to internationally recognized consensus standards (ISO, ASTM, IEC, USP). This implies controlled laboratory settings and standardized methodology, rather than patient data from a specific country or retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the defined acceptance criteria of the technical and biological standards, not expert medical opinion on a specific condition.
4. Adjudication method for the test set:
- Not applicable, as this refers to a medical device's physical and biological performance against predefined technical standards, not interpretation of data by human readers.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a physical intravascular catheter, not an AI/ML diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used:
- Technical Standards and Specifications: The ground truth for performance is established by the acceptance criteria defined within the referenced international standards (
ISO 10555-1,ISO 10555-5,ISO 80369-7,ISO 9626,IEC 62366-1,ISO 2233,ISO 11607-1,ISO 11607-2,ASTM D4169-16,ASTM F1980-16,ISO 11135,AAMI TIR 28,AAMI/ANSI ST72). - Biological Compatibility Principles: The ground truth for biocompatibility is established by the acceptance criteria defined within the referenced international standards (
ISO 10993-1,ISO 10993-4,ISO 10993-5,ISO 10993-10,ISO 10993-11,ISO 10993-7) and theUnited States Pharmacopeia 41.
8. The sample size for the training set:
- Not applicable. This type of device approval does not involve a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established:
- Not applicable.
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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
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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
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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) |
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5.0 510(k) Summary
| Submitter Name: | Merit Medical Singapore Pte. Ltd. | |
|---|---|---|
| GeneralProvisions | 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 SystemInc. | |
| Trade Name: | Merit Secalon T™ Catheter(previously named as Viggo Secalon TCatheter) | |
| 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 ViggoProducts Ohmeda) | |
| Regulatory Class: | II | |
| Product Code: | FOZ | |
| Classification | 21 CFR §: | 880.5200 |
| Review Panel: | General Hospital |
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| 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 toPredicate 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 RadialFloArterial Catheter | PredicateDevice –BDAngiocath™M IVCatheter(K151698) | ReferenceDevice – MeritSecalon TCatheter(K850460) | |
| Design | ||||
| A conventionalover-the-needleintravascularcatheter withradiopaquePolytetrafluoroethylene (PTFE)tubing.The needleintroducerpunctures theskin and allowpenetration ofthe intravascularcatheter to theblood vessel.The radiopaquecatheterprovidesvisibility underX-ray andfluoroscopy.The catheter isdesigned with aFloswitch hubwith luerconnection tocontrol flow offluid or blood.The needlecannula includesa unique notchto provideinstant bloodreturn forrecognition ofcorrect bloodentry. | Aconventional over-the-needleintravascular catheterwithradiopaquefluorinatedethylenepropylene(FEP)tubing.The needleintroducerpuncturesthe skinand allowpenetrationof theintravascular catheterto thebloodvessel.Thecatheterprovidesvisibilityunder X-ray andfluoroscopy.Thecatheter isdesignedwith aconventional luer hub.A flashchamberfor bloodflash backforrecognitionof correctbloodentry. | A conventionalover-the-needleintravascularcatheter withradiopaquePolytetrafluoroethylene(PTFE) tubing.The needleintroducerpunctures theskin and allowpenetration oftheintravascularcatheter to theblood vessel.The catheterprovidesvisibility underX-ray andfluoroscopy.The hub isdesigned witha Floswitchhub with luerconnection tocontrol flow offluid or blood. | ||
| Material | ||||
| ArterialCatheter | CatheterTube | Polytetrafluoroethylene (PTFE) | FluorinatedEthylenePropylene | Polytetrafluoroethylene(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 | AcrylonitrileButadieneStyrene | ||
| 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 copolymermembrane 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 RadialFloArterial Catheteris a device that | An intravascul ar catheteris a device | The Secalon-TCentral VenousCatheter is | |
| is inserted intothe patient'svascular systemfor short termuse (less than30 days) tosample bloodand monitorblood pressure.The MeritRadialFloArterial Cathetermay be used forany patientpopulation withconsiderationgiven toadequacy ofvascularanatomy andappropriatenessof procedure. | that isinsertedinto thepatient'svascularsystem forshort termuse (lessthan30days) tosampleblood,monitorbloodpressure,oradministerfluidsintravenously. Thesecathetersmay beused forany patientpopulationwithconsideration given toadequacyof vascularanatomyandappropriatenessofprocedure. | intended toaccess to thehumancirculatorysystem. Thisaccess allowslarge volumeinfusion ofliquids, bloodsampling andinfusion ofdrugs. TheFloswitchcontrol the flowof liquids. |
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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
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- . 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
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- . 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 ●
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| The Merit RadialFlo Arterial Catheter is an externally communicatingdevice with circulating blood contacting for prolonged duration (> 24h to30d). | |
|---|---|
| Summary ofSubstantialEquivalence | Based on the indications for use, design, safety and performance testing,the subject Merit RadialFlo Arterial Catheter meets the requirements of allthe applicable standards including the FDA recognized consensusstandards that are considered essential for its intended use and issubstantially equivalent to the predicate device (K151698), the BDAngiocath™ IV Catheter. The difference in technology, design andmaterials used are supported by the reference device (K850460), theMerit Secalon T Catheter (previously named as Viggo Secalon T) currentlymanufactured by Merit Medical Singapore Pte. Ltd. |
§ 880.5200 Intravascular catheter.
(a)
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.(b)
Classification. Class II (performance standards).