(124 days)
No
The summary describes a physical medical device (catheter) for blood sampling and pressure monitoring. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML. The performance studies focus on physical and material properties, not algorithmic performance.
No.
The device is used for diagnostic purposes (sampling blood and monitoring blood pressure), not for treating a disease or condition.
No
Explanation: The device is used to sample blood and monitor blood pressure, which are measurements taken to provide information about a patient's condition, but it does not directly perform a diagnosis itself.
No
The device description clearly outlines physical components like a catheter, needle, and Floswitch, and the performance studies focus on physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, the Merit RadialFlo Arterial Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to be inserted into the patient's vascular system to sample blood and monitor blood pressure. While blood sampling is involved, the primary purpose is to access the vascular system for direct measurement (blood pressure monitoring) and collection for potential subsequent testing.
- Device Description: The description focuses on the physical characteristics of the catheter for insertion, access, and flow control within the patient's body. It describes features like the needle, catheter material, radiopacity, and flow switch.
- Lack of In Vitro Testing: The device itself does not perform any testing or analysis of the blood outside of the body. It is a tool for accessing and collecting the sample, not for diagnosing conditions based on the sample's properties.
- Performance Studies: The performance studies focus on the physical and biological compatibility of the device for insertion and use within the body (e.g., leakage, biocompatibility, tensile strength, flowrate). They do not describe any studies related to the diagnostic accuracy of analyzing blood samples.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The Merit RadialFlo Arterial Catheter is a medical device used in vivo (within the living body) to facilitate these processes, but it doesn't perform the diagnostic test itself.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FOZ
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 (
§ 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).
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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. | |
|---|---|---|
| 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 |
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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 ( 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 communicating
device with circulating blood contacting for prolonged duration (> 24h to
30d). |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Substantial
Equivalence | Based on the indications for use, design, safety and performance testing,
the subject Merit RadialFlo Arterial Catheter meets the requirements of all
the applicable standards including the FDA recognized consensus
standards that are considered essential for its intended use and is
substantially equivalent to the predicate device (K151698), the BD
Angiocath™ IV Catheter. The difference in technology, design and
materials used are supported by the reference device (K850460), the
Merit Secalon T Catheter (previously named as Viggo Secalon T) currently
manufactured by Merit Medical Singapore Pte. Ltd. |