e Med's Microfuse Membrane Infusion Catheter is a nondilatation over-the-wire device intended for the localized infusion of therapeutic solution(s) in the coronary vasculature through a microporous membrane. The catheter is intended to be coaxially tracked over a guidewire to access a subselective infusion region in the coronary vasculature. The technique, rate of administration, duration of infusion, and appropriate sizing of the membrane to the arterial diameter is determined by the operating physician. The infusion solution should be used in accordance with the manufacturer's instructions for use.

Device Description

The Microfuse Membrane Infusion Catheter is a non-dilatation, over-thewire infusion device designed for localized delivery of solutions through a microporous membrane. The membrane gently "sweats" solution through its many pores. The device can accommodate a coronary guidewire.

AI/ML Overview

This 510(k) submission for the Microfuse Membrane Infusion Catheter does not contain detailed acceptance criteria and study data on device performance in the way a typical medical device clinical trial report would. Instead, it relies on a declaration of "substantial equivalence" to predicate devices. Therefore, I cannot provide a table of acceptance criteria vs. reported device performance, or details about patient data, expert involvement, or MRMC studies.

Here's an analysis of what is present in the document related to device validation:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics. The overarching criterion for this 510(k) submission is "substantial equivalence" to predicate devices.	The submission states that "Functional and safety testing consisted of examination and function of the device under conditions similar to those found in normal usage, and raise no new issues regarding safety and effectiveness of the device."
Conformance to product specification.	"Test requirements were set to ensure conformance to product specification."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable. The document refers to "Functional and safety testing" but does not specify a test set in terms of patient data or clinical samples. It appears to be bench testing or in-vitro testing. There is no information about data provenance (country of origin, retrospective/prospective).

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 submission does not describe a study involving expert readers or the establishment of ground truth by experts in the context of clinical performance evaluation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. No adjudication method is described as there are no expert readings or clinical evaluations requiring reconciliation.

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. This device is a catheter, not an AI-assisted diagnostic tool. An MRMC study would not be relevant in this context.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device (catheter), not an algorithm or software. Therefore, the concept of "standalone performance" for an algorithm is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not explicitly stated in detail. The document mentions "functional and safety testing" and "conformance to product specification." This suggests that the ground truth for these tests would likely be based on established engineering specifications, mechanical test standards, and potentially in-vitro performance metrics, rather than clinical outcomes or pathology from patients.

8. The sample size for the training set

Not Applicable. This device is a physical catheter, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established

Not Applicable. As there is no training set for a machine learning model, this question is not applicable.

Summary

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KA71619

FES 2 7 1998

510(k) SUMMARY

SUBMITTER: CONTACT PERSON:

DATE PREPARED: TRADE NAME: CLASSIFICATION NAME and NUMBER:

e Med Corp. John Dockter Senior Engineer April 25, 1997 Microfuse Membrane Infusion Catheter Catheter, Infusion 21 CFR, 870.1250

PREDICATE DEVICES:

LocalMed - Kaplan-Simpson InfusaSleeve™ II Catheter, K933549 Scimed - Dispatch Catheter, K932616 Cardiovascular Dynamics Inc. (CDI) BULLETT™ Infusion Catheter, K931027

DEVICE DESCRIPTION:

INTENDED USE:

The Microfuse Membrane Infusion Catheter is intended for controlled and selective infusion of therapeutic agents into subselected region(s) within the coronary vasculature.

FUNCTIONAL & SAFETY TESTING:

Functional and safety testing consisted of examination and function of the device under conditions similar to those found in normal usage, and raise no new issues regarding safety and effectiveness of the device. Test requirements were set to ensure conformance to product specification.

CONCLUSION:

The Microfuse Membrane Infusion Catheter is substantially equivalent to the predicate devices based on the similarities in functional design, materials and indications for use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines that suggest the shape of a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 1998

Mr. John Vanden Hoek Director of Engineering E-Med Corporation 651 Campus Drive St. Paul, MN 55112

Re: K971619 Microfuse Membrane Infusion Catheter Regulatory Class: II (two) Product Code: 74 KRA February 9, 1998 Dated: Received: February 11, 1998

Dear Mr. Hoek:

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 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, Druq, 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 assumptions. Failure to comply with the GMP regulation may result in 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. Dennis (Dan) Reigle

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 regulation (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/dsmamain.html".

Sincerely yours,
Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation

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Indications for Use

Prescription Use
(Per 21 CFR 801.109)

Chistopher Hoa for TJC

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number K971619

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).