(276 days)
The Fountain ValveTip Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
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
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fountain ValveTip Infusion Catheter, structured according to your request.
Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a clinical trial or AI model validation. As such, some of the information you requested (especially regarding AI model performance, human reader studies, and detailed ground truth adjudication for an AI device) is not present in this type of document because the device described is a physical medical catheter, not an AI/software as a medical device (SaMD).
Therefore, many sections of your request will be answered with "Not Applicable (N/A)" or "Not specified in the provided document" because the context is a physical device, not an AI system.
Device: Fountain ValveTip Infusion Catheter
1. A table of acceptance criteria and the reported device performance
For a physical medical device like a catheter, "acceptance criteria" and "performance" are typically related to engineering specifications and conformity to standards rather than AI model metrics. The document references various ISO and ASTM standards and internal bench testing.
| Criterion Type / Test | Acceptance Criteria (Implicitly Met by Standards Compliance) | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Conforms to ISO 10993 series and FDA guidance | Battery of tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Genotoxicity, Hemolysis, Thrombogenicity, Complement Activation, Subacute/Subchronic Toxicity, Implantation) met the requirements. |
| Material Properties | Conformity to relevant standards (e.g., sterilization residuals, radiopacity) | Not explicitly detailed for each, but overall compliance with standards (e.g., ISO 11135-1, ISO 10993-7, ASTM F640-12) indicated. |
| Physical/Mechanical (Bench Tests) | Implicitly met by standards (e.g., ISO 10555-1, ISO 10555-3, ISO 594 series) and internal design specifications. "The subject Fountain ValveTip Infusion Catheter met the predetermined acceptance criteria." | French size, Usable length, Surface, Compatible Guide Wire, Valve not damaging guide wire, Guide wire not damaging valve, Valve penetration and drag force, Valve leak test, Kink test, Radio-detectability, Tensile force (tip attachment), ISO-594-2 tests (Gauge, Liquid leakage, Air leakage, Separation force, Unscrewing Torque, Ease of assembly, Resisting overriding, Stress Cracking), Simulated use testing (Penetration force, Drag force, Trackability, Tip stiffness, Leakage out of tip).All specified tests demonstrated that the device met the predetermined acceptance criteria. |
2. Sample sized used for the test set and the data provenance
For a physical device, "test set" refers to the physical samples tested.
- Sample Size: Not specified quantitatively for each test in the provided summary. It states "Performance testing... was conducted." Typically, engineering tests involve a sufficient number of units to demonstrate statistical confidence or meet regulatory batch release requirements, but exact numbers are not detailed here.
- Data Provenance: N/A for data provenance in the context of a dataset for an AI model. For a physical device, the "data" comes from bench tests and biocompatibility studies performed on manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical medical device (catheter), not an AI/SaMD. "Ground truth" for a physical device is established through validated laboratory tests, engineering measurements, and standardized biological assessments, not expert consensus on images or diagnostic outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
N/A. Not applicable to physical device testing.
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
N/A. This device is not an AI/SaMD. No MRMC study was performed or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This device is a catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For a physical medical device, "ground truth" for performance is defined by:
- Established ASTM/ISO standards: Compliance with predefined physical, mechanical, chemical, and biological properties.
- Engineering specifications: The device's design parameters (e.g., French size, usable length, valve performance) must meet internal specifications.
- Biocompatibility testing against a predicate device or historical data: Bio-reactions are assessed against known safe limits or compared to predicate device performance.
8. The sample size for the training set
N/A. There is no "training set" in the context of a physical medical device that isn't incorporating machine learning.
9. How the ground truth for the training set was established
N/A. Not applicable as there is no training set for this device.
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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
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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
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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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510(k) Summary - K193082
| GeneralProvisions | Submitter Name:Address:Telephone Number:Fax Number:Contact Person:Date Prepared:Registration Number: | Merit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 316-3845(801) 826-4174Mr. Jesse NelsonAugust 7, 20201721504 |
|---|---|---|
| Subject Device | Trade Name:Common/Usual Name:Classification Name:Regulatory Class:Product Code:21 CFR §:Review Panel: | Fountain ValveTip Infusion CatheterInfusion CatheterCatheter, Continuous FlushIIKRA870.1210Cardiovascular |
| PredicateDevice | Trade Name:Classification Name:Premarket Notification:Manufacturer: | Fountain Infusion Catheter and OccludingGuide WireCatheter, Continuous FlushK974067Merit 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. |
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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
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- 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 <151>, 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
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- 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
●
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● .
- 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
§ 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).