(302 days)
Not Found
No
The summary describes a mechanical infusion catheter and does not mention any AI or ML components or functionalities.
Yes
This device is intended for the localized infusion of therapeutic solution(s) in the coronary vasculature, indicating a therapeutic purpose.
No
The device is described as an "infusion catheter" for the "localized infusion of therapeutic solution(s)". Its purpose is to deliver solutions, not to diagnose conditions.
No
The device description clearly describes a physical catheter with a microporous membrane, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The e Med's Microfuse Membrane Infusion Catheter is a device used to deliver therapeutic solutions directly into the coronary vasculature. It is an invasive medical device used for treatment, not for testing samples outside the body.
- Intended Use: The intended use clearly states "localized infusion of therapeutic solution(s) in the coronary vasculature." This is a therapeutic action, not a diagnostic test.
Therefore, the function and intended use of this device fall outside the scope of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Microfuse Membrane Infusion Catheter is intended for controlled and selective infusion of therapeutic agents into subselected region(s) within the coronary vasculature.
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.
Prescription Use
(Per 21 CFR 801.109)
Product codes (comma separated list FDA assigned to the subject device)
74 KRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating physician
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
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.
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.
1
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.
2
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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3
Indications for Use
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.
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