Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical infusion catheter with a valve and infusion holes. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The performance studies focus on physical and functional characteristics, not algorithmic performance.

Therapeutic

Yes
The device is described as administering "infusions of various therapeutic solutions," directly implying its role in delivering treatments, which is a characteristic of a therapeutic device.

Diagnostic

No

This device is designed for administering therapeutic solutions into the peripheral vasculature, which is a treatment function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with infusion holes, marker bands, and a valve, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "administer infusions of various therapeutic solutions into the peripheral vasculature of a patient." This describes a device used in vivo (within the body) for delivering treatment.
Device Description: The description details a catheter designed for insertion into blood vessels to deliver fluids. This is consistent with an in vivo therapeutic delivery device.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.

IVD devices are used to perform tests outside the body on samples taken from the body. This device is used inside the body to deliver substances.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

Product codes

KRA

Device Description

The Fountain ValveTip Infusion Catheter is intended to administer infusions of various therapeutic solutions into peripheral vasculature of a patient. The Fountain ValveTip Infusion Catheter has infusion holes at the distal end. These infusion holes allow for passage of thrombolytic fluid. The infusion segment of the catheter is indicated by two radiopaque marker bands. These marker bands can provide the user the means for positioning the infusion length at a desired location with the blood vessel.

The Fountain ValveTip Infusion Catheter uses a valve at the distal tip to seal the catheter to facilitate flow through the catheter and spray distribution through the infusion holes. The valve allows the catheter to track over a 0.035" guide wire to facilitate placement of the catheter. The Fountain ValveTip Catheter is available in 4 and 5 French including usable lengths from 45 cm to 135 cm and infusion segments length from 5cm to 50 cm. The usable length and Infusion lengths are the same as the predicate device configuration and will have same functional infusing characteristics.

This device is provided with the following Merit device which is already marketed in the US (Class II Exempt):
• AccessPLUS™ Hemostasis Valve

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral 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 Fountain ValveTip Infusion Catheter was conducted based on the risk analysis and based on the requirements of the following international standard:

ISO 11135-1:2014, 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. Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
ISO 10993-3:2014, Biological Evaluation of Medical Devices -● Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicitv
ISO 10993-4:2017. 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 10993-7:2008, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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 10993-12, 2012 Biological Evaluation of Medical Devices -Part 12: Sample preparation and reference materials
BS EN ISO 11607-1:2006 Packaging for Terminally Sterilized . Medical Devices. Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
ASTM F 2096-11 Standard Test Method for Detecting Gross Leaks ● in Medical Packaging by Internal Pressurization (Bubble Test)
. ASTM F756:2017 Standard practice for Assessment of Hemolytic Properties of Materials
. ANSI AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
USP 41,NF 36 (USP), GP , Pyrogen Test (2018)
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks ● in porous Medical Packaging by Dye Penetration
. ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F640-12 Standard Test Methods for determining ● Radiopacity for medical use
. ISO 10555-1:2013(E) - Intravascular Catheters - Sterile And Single-Use Catheters - Part 1: General requirements
ISO 10555-3:2013 Intravascular catheters Sterile and single-● use catheters - Part 3: Central venous catheters
ISO 594-1:1996(E) Conical Fittings with 6% (Luer) Taper for . Syringes, Needles and Certain Other Medical Equipment - Part 1:General Requirements
ISO 594-2:1998(E) Conical Fittings with 6% (Luer) Taper for ● Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings

Biocompatibility Testing:
The biocompatibility evaluation for the Fountain ValveTip Infusion Catheter was conducted in accordance with the ISO 10993-1 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" (CDRH's biocompatibility as recognized by FDA). The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Genotoxicity ●
Hemolysis ●
Thrombogenicity
Complement Activation ●
Subacute/Subchronic Toxicity ●
. Implantation

Bench Testing (Safety & Performance Tests):

French size
Usable length ●
Surface ●
Compatible Guide Wire ●
Valve- shall not damage quide wire ●
The guidewire shall not damage the valve ●
Valve penetration and drag force ●
Valve leak test ●
Kink test
ISO-594-2, Gauge test ● ISO-594-2, Liquid leakage test ● ISO-594-2, Air leakage test ● ISO-594-2, Separation force ● ISO-594-2, Unscrewing Torque ● ISO-594-2, Ease of assembly ● ● ISO-594-2, Resisting to overriding ISO-594-2, Stress Cracking ● Design Validation Simulated use testing ● Penetration force ● Drag force . ● Trackability Tip stiffness . Leakage out of tip .
Radio-detectability
Tensile force, tip attachment test

Key results: The results of the testing demonstrated that the subject Fountain ValveTip Infusion Catheter met the predetermined acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K974067

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 7, 2020

Merit Medical Systems, Inc Spriha Pandey Regulatory Affairs Specialist I 1600 West Merit Parkway South Jordan, Utah 84095

Re: K193082

Trade/Device Name: Fountain ValveTip Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: July 9, 2020 Received: July 10, 2020

Dear Spriha Pandey:

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/cdrh/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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K193082

Device Name Fountain ValveTip Infusion Catheter

Indications for Use (Describe)

The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) Summary - K193082

| General
Provisions | Submitter Name:
Address:
Telephone Number:
Fax Number:
Contact Person:
Date Prepared:
Registration Number: | Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan, UT 84095
(801) 316-3845
(801) 826-4174
Mr. Jesse Nelson
August 7, 2020
1721504 |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Trade Name:
Common/Usual Name:
Classification Name:
Regulatory Class:
Product Code:
21 CFR §:
Review Panel: | Fountain ValveTip Infusion Catheter
Infusion Catheter
Catheter, Continuous Flush
II
KRA
870.1210
Cardiovascular |
| Predicate
Device | Trade Name:
Classification Name:
Premarket Notification:
Manufacturer: | Fountain Infusion Catheter and Occluding
Guide Wire
Catheter, Continuous Flush
K974067
Merit Medical Systems, Inc. |
| Device Description | The Fountain ValveTip Infusion Catheter is intended to administer infusions of various therapeutic solutions into peripheral vasculature of a patient. The Fountain ValveTip Infusion Catheter has infusion holes at the distal end. These infusion holes allow for passage of thrombolytic fluid. The infusion segment of the catheter is indicated by two radiopaque marker bands. These marker bands can provide the user the means for positioning the infusion length at a desired location with the blood vessel.

The Fountain ValveTip Infusion Catheter uses a valve at the distal tip to seal the catheter to facilitate flow through the catheter and spray distribution through the infusion holes. The valve allows the catheter to track over a 0.035" guide wire to facilitate placement of the catheter. The Fountain ValveTip Catheter is available in 4 and 5 French including usable lengths from 45 cm to 135 cm and infusion segments length from 5cm to 50 cm. The usable length and Infusion lengths are the same as the predicate device configuration and will have same functional infusing characteristics.

This device is provided with the following Merit device which is already marketed in the US (Class II Exempt):
• AccessPLUS™ Hemostasis Valve | |
| Indications for Use | The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.

Note: There is no change in the Indications for Use Statement from the predicate to the subject device. | |
| Comparison to Predicate Device | The subject device is substantially equivalent to the predicate device based on identical indications for use statement, and same basic performance and safety profile, principle of operation, fundamental design principles, materials and manufacturing technology. The primary reason for submitting this 510(k) is the addition of a valve on the distal tip of the catheter predicate device under 510(k), K974067 and eliminate the use of the occluding wire. | |

4

5

No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for these devices. Performance testing of the subject Fountain ValveTip Infusion Catheter was conducted based on the risk analysis and based on the requirements of the following international standard:

ISO 11135-1:2014, 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. Biological Evaluation of Medical Devices Part ● 1: Evaluation and Testing within a risk management process, and FDA quidance Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices, May 1, 1995
ISO 10993-3:2014, Biological Evaluation of Medical Devices -● Part 3: Tests for Genotoxicity, Carcinogenicity and Reproductive Toxicitv
ISO 10993-4:2017. 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 10993-7:2008, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals

Performance Data

.

ta

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 10993-12, 2012 Biological Evaluation of Medical Devices -Part 12: Sample preparation and reference materials
BS EN ISO 11607-1:2006 Packaging for Terminally Sterilized . Medical Devices. Part 1: Requirements for materials, sterile barrier systems, and packaging systems.
ASTM F 2096-11 Standard Test Method for Detecting Gross Leaks ● in Medical Packaging by Internal Pressurization (Bubble Test)
. ASTM F756:2017 Standard practice for Assessment of Hemolytic Properties of Materials
. ANSI AAMI ST72:2011, Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing
USP 41,NF 36 (USP), GP , Pyrogen Test (2018)
ASTM F 1929-15 Standard Test Method for Detecting Seal Leaks ● in porous Medical Packaging by Dye Penetration
. ASTM D 4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F640-12 Standard Test Methods for determining ● Radiopacity for medical use

Product Specific Standards:

. ISO 10555-1:2013(E) - Intravascular Catheters - Sterile And Single-Use Catheters - Part 1: General requirements

6

ISO 10555-3:2013 Intravascular catheters Sterile and single-● use catheters - Part 3: Central venous catheters
ISO 594-1:1996(E) Conical Fittings with 6% (Luer) Taper for . Syringes, Needles and Certain Other Medical Equipment - Part 1:General Requirements
ISO 594-2:1998(E) Conical Fittings with 6% (Luer) Taper for ● Syringes, Needles and Certain Other Medical Equipment - Part 2: Lock Fittings

Biocompatibility Testing

The biocompatibility evaluation for the Fountain ValveTip Infusion Catheter was conducted in accordance with the ISO 10993-1 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" (CDRH's biocompatibility as recognized by FDA). The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Genotoxicity ●
Hemolysis ●
Thrombogenicity

Safety & Performance Tests cont.

Complement Activation ●
Subacute/Subchronic Toxicity ●
. Implantation

The Fountain ValveTip Infusion Catheter is considered as an externally communicating device with circulating blood contact for a prolonged 24 hours - 30 days.

Performance Testing-Bench

Bench Testing (Safety & Performance Tests)

French size
Usable length ●
Surface ●
Compatible Guide Wire ●
Valve- shall not damage quide wire ●
The guidewire shall not damage the valve ●
Valve penetration and drag force ●
Valve leak test ●
- Kink test

●

7

● .

ISO-594-2, Gauge test ● ISO-594-2, Liquid leakage test ● ISO-594-2, Air leakage test ● ISO-594-2, Separation force ● ISO-594-2, Unscrewing Torque ● ISO-594-2, Ease of assembly ● ● ISO-594-2, Resisting to overriding ISO-594-2, Stress Cracking ● Design Validation Simulated use testing ● Penetration force ● Drag force . ● Trackability Tip stiffness . Leakage out of tip . The results of the testing demonstrated that the subject Fountain ValveTip Infusion Catheter met the predetermined acceptance criteria. Based on the indications for use, design, and performance testing, the Summary of Fountain ValveTip Infusion Catheter meets the requirements that are Substantial considered essential for its intended use and is substantially equivalent Equivalence to the predicate device, the Fountain Infusion Catheter and Occluding Guide Wire, K974067. manufactured by Merit Medical Systems, Inc.
Radio-detectability

Tensile force, tip attachment test