(21 days)
The FOUNTAINTM Infusion Catheter and Occluding Guide Wire is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient
This device is a 4 French infusion catheter and system.
The provided text describes a 510(k) premarket notification for the FOUNTAIN Infusion Catheter and Occluding Guide Wire. This is a notification of substantial equivalence to a predicate device, not a study that establishes acceptance criteria through new performance data. Therefore, many of the requested details about acceptance criteria, full device performance, and study methodology are not present in the provided document.
However, I can extract the information that is available and clarify what is missing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by substantial equivalence to predicate) | Reported Device Performance (Summary of testing performed) |
|---|---|
| Functional Integrity | Functional testing performed to evaluate integrity and performance. |
| Biocompatibility | Biocompatibility testing performed in accordance with ISO 10993-1-1994 and FDA G95-1. Found to be biocompatible, non-toxic, and acceptable for intended use. |
| Material Equivalence | Manufactured from the same materials as the predicate device. |
| Technological Equivalence (Construction & Physical Specifications) | Technologically comparable to the predicate devices (Merit 5F Fountain) in construction and physical specifications. |
| Design, Manufacturing, and Sterilization | Representative of current industry practices. |
| Intended Use | Administers infusions of various therapeutic solutions into the peripheral vasculature. |
Missing Information: Specific quantitative acceptance criteria (e.g., burst pressure, flow rates, etc.) are not provided in this document. The document primarily states that testing was performed and the device was found acceptable or comparable to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for functional or biocompatibility testing.
- Data Provenance: Not specified. The context is a 510(k) submission to the FDA (USA).
- Retrospective/Prospective: Not specified. The functional and biocompatibility tests would typically be laboratory (in-vitro) studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable: This type of information is generally relevant for AI/software device studies or clinical studies involving expert interpretation, which is not the nature of this 510(k) premarket notification. The tests described are functional and biocompatibility tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are typically used in clinical studies or studies where expert consensus is needed to establish ground truth from ambiguous data. The testing described (functional, biocompatibility) does not involve this kind of adjudication.
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
- No: An MRMC comparative effectiveness study was not done. This is a conventional medical device, not an AI/software device. The document explicitly states: "Clinical testing was not performed on the subject catheter due to the similarities to the predicate device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is a physical medical device (catheter and guide wire), not an algorithm or AI. Standalone performance for an algorithm is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Functional Testing: The "ground truth" for functional testing would be the pre-defined engineering specifications and performance benchmarks (e.g., material strength, flow rates).
- Biocompatibility Testing: The "ground truth" for biocompatibility is established by the methods and endpoints defined in international standards (ISO 10993-1) and FDA guidance (G95-1) for evaluating biological responses to medical device materials.
- No Clinical Ground Truth: As clinical testing was not performed, there is no clinical outcomes data, pathology, or expert consensus on clinical findings.
8. The sample size for the training set
- Not Applicable: This is a physical medical device, not an AI/machine learning model. There is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable: (See point 8).
Summary of Device and Study presented in the 510(k) document:
The 510(k) document describes the FOUNTAIN Infusion Catheter and Occluding Guide Wire. The submission aimed to demonstrate substantial equivalence to a predicate device (5 French FOUNTAINTM Infusion Catheter Occluding Guide Wire, K974067, and K991619 Fountain Infusion System).
The primary "study" cited to support this equivalence is:
- Functional testing (In-vitro): Performed to evaluate the device's integrity and performance. The document states that based on these results, the device was deemed "safe and effective and is acceptable in design and construction for its intended use." Specific details on the nature or results of this testing are not provided beyond this general statement.
- Biocompatibility testing: Performed on the predicate 5 French Fountain Infusion Catheter according to ISO 10993-1-1994 and FDA G95-1. The conclusion was that the device was "biocompatible, nontoxic and acceptable for its intended use." Crucially, the 4 French catheter (the subject of this 510(k)) was not independently tested for biocompatibility but was deemed biocompatible because it is "manufactured from the same materials as the predicate device."
- Clinical Testing: No clinical testing was performed for this 510(k) submission, relying instead on the similarities to the predicate device.
In essence, this 510(k) relies on a demonstration of technological equivalence and material equivalence to a previously cleared predicate device, supported by in-vitro functional testing and leveraging the predicate's biocompatibility data due to shared materials. It does not present new, extensive clinical study data or involve AI/software performance evaluation.
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February 3, 2022
Merit Medical Systems, Inc. Chester McCoy Regulatory Affairs Engineer 1600 West Merit Pkwy. South Jordan, Utah 84095
Re: K992231
Trade/Device Name: FOUNTAIN Infusion Catheter and Occluding Guide Wire Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Chester McCoy:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 23, 1999. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Digitally signed by Gregory W. Gregory W. O'connell O'connell -S Date: 2022.02.03 14:40:16 -05'00'
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
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 23 1999
Mr. Chester McCoy Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan, UT 84095
Re : K992231 The FOUNTAIN™ Infusion Catheter and Occluding Guide Wire Requlatory Class: II (two) Product Code: 74 KRA Dated: June 25, 1999 Received: July 2, 1999
Dear Mr. McCoy:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Chester McCoy
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Cal ahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k)Number(if Known) | K992231 |
|---|---|
| Device Name | FOUNTAINT™ Infusion Catheter and Occluding Guide Wire |
| Indications forUse | The FOUNTAINTM Infusion Catheter and Occluding Guide Wire isintended to administer infusions of various therapeutic solutionsinto the peripheral vasculature of a patient |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Oristopher M. Al for Callahan
Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices
Prescription Use
✓
OR
510(k) Number ..
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
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JUL 2 3 1999
Attachment 4
1) 510(k) summary
510(k) Summary
SAFETY AND EFFECTIVENESS SUMMARY
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Submitted by Name/Address: | Chester McCoyRegulatory Affairs EngineerMerit Medical Systems, Inc.1600 West Merit ParkwaySouth Jordan, UT 84095(801) 253-1600 ext. 404(801) 253-1684 fax |
|---|---|
| Contact Person: | Same as above |
| Date Summary Prepared: | June 4, 1999 |
| Device Name: | 4 French FOUNTAINTM Catheterand Occluding/Guide Wire |
| Common Name: | Infusion Catheter andOccluding/Guide Wire |
| Trade Name: | FOUNTAINTM Infusion System |
| Classification (if known): | Intravascular Catheter |
| Predicate Device: | 5 French FOUNTAINTM Infusion CatheterOccluding Guide Wire (K974067) & K991619Fountain Infusion System |
Device Description:
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This device is a 4 French infusion catheter and system.
Intended Use:
The Fountain™ Infusion System is intended to administer infusions of various therapeutic solutions into the peripheral vasculature of a patient.
Device Use:
The Fountain™ Infusion Catheter will be placed in the peripheral vasculature of a patient over a 0.035 inch outer diameter diagnostic guide wire. The infusion segment of the catheter will be positioned at the intended delivery site. The infusion segment is identified by radiopaque marker bands, and may be visualized under fluoroscopy by the clinician. The diagnostic guide wire will then be removed, while maintaining the position of the catheter. The Occluding Wire will be advanced through the catheter and hemostasis valve until the cap on the wire snaps into the hemostasis valve. The use of the occluding wire enhances controlled, localized dispersion of therapeutic solution through the infusion holes of the catheter.
Infusion of therapeutic solutions is made via the syringes, a hemostasis valve and a dual check valve or the squirt™ fluid delivery system. The therapeutic solution can be either infused by slow, continuous infusion or pulse infusion. Continuous infusion is the uninterrupted flow of infusion therapy over a period of time. Typically, the therapeutic solution is administered from an IV pump at a very low flow rate. Infusion by pulsing is the administration of small and quick injections of therapeutic solution delivered at repeated intervals. At the completion of the infusion therapy, the occluding wire and infusion catheter are removed.
Technology Comparison:
The Merit 4 French Fountain Infusion Catheter are technologically comparable to the predicate devices (Merit 5F Fountain) in construction and physical specifications. Also, design, manufacturing, and sterilization procedures are representative of current industry practices.
Test Summary, In-vitro:
Functional testing was performed on the Merit 4 French Fountain Infusion Catheter to evaluate the integrity and performance of the device. Based upon the results of this testing. Merit has determined that the device is safe and effective and is acceptable in design and construction for its intended use.
Test summary, In-vivo:
Clinical testing was not performed on the subject catheter due to the similarities to the predicate device.
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Test Summary, Biocompatibility:
Biocompatibility testing was performed on the Merit 5 French Fountain Infusion Catheter in accordance with the requirements specified in International Standards Organization (ISO) 10993-1-1994 Biological Evaluation of Medical Devices - Part 1: Guidance on Selection of Tests and the FDA General Program Memorandum No. G95-1. The Merit 5 French Fountain Infusion Catheter was found to biocompatible, nontoxic and acceptable for its intended use. The Merit 4 French Fountain Infusion Catheters are manufactured from the same materials as the predicate device so they have also been found to be biocompatible, nontoxic and acceptable for their intended use.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).