(88 days)
Not Found
No
The summary describes a physical catheter and its performance characteristics, with no mention of AI or ML capabilities.
No
The device is a catheter for infusing pharmacologic agents or contrast media, which are the therapeutic or diagnostic tools, not the device itself.
No
The device is an infusion catheter used for delivering pharmacologic agents or contrast media, which is a therapeutic rather than a diagnostic function.
No
The device description clearly describes a physical catheter with a lumen, hydrophilic coating, luer lock adapter, and radiopaque marker, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "controlled selective infusion of physician specified pharmacologic agents or contrast media into the distal vasculature." This describes a therapeutic or interventional procedure performed directly on the patient's body.
- Device Description: The description details a catheter designed for navigation and infusion within blood vessels. This is consistent with a device used for direct patient treatment.
- 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 compatibility testing.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This device is clearly intended for use inside the body for therapeutic or diagnostic imaging purposes (infusion of contrast media).
N/A
Intended Use / Indications for Use
The catheter is intended to be used for the controlled selective infusion of physician specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy.
Product codes
KRA
Device Description
The Flow Rider Flow Directed Micro Catheter is a single lumen infusion catheter designed to be flow directed into the distal vasculature. The Flow Directed Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal vasculature of the peripheral and neuro anatomy
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
Biocompatibility testing was performed on the Flow Directed Micro Catheter in accordance with the International Standard for the Biological Evaluation of Medical Devices. Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)). Results of the tests showed that the device passed Biocompatibility testing and is suitable for its application.
Physical testing of the product included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. All testing of the product yielded acceptable results.
Animal studies were performed to assess the performance of the Flow Rider Catheter. The studies demonstrated that the Flow Rider Catheter is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Target Spinnaker™ Flow Directed Infusion Catheter, K965189, Balt Magic™ Infusion Catheter, K923368
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PR 10 1998
Image /page/0/Picture/2 description: The image shows the logo for Micro Therapeutics, Inc. The logo consists of the letters "MTI" in a bold, sans-serif font. To the left of the letters, there is a series of small squares that appear to be arranged in a grid-like pattern. Below the letters, the words "MICRO THERAPEUTICS, INC." are written in a smaller, serif font.
510(k) Summary of Safety and Effectiveness Flow Rider™ Flow Directed Micro Catheter
Prepared January 8, 1998
| Trade Name: | Flow RiderTM Flow Directed Micro Catheter | ||
|---|---|---|---|
| Generic Name: | Percutaneous Intravascular Catheter | Classification: | Class II |
| Submitted By: | Micro Therapeutics, Inc. | ||
| 1062-F Calle Negocio | |||
| San Clemente, CA 92673 | Contact: | Tom Daughters | |
| Regulatory Affairs | |||
| (714) 361-0610 |
Predicate Devices
Target Spinnaker™ Flow Directed Infusion Catheter, K965189 Balt Magic™ Infusion Catheter, K923368
Device Description
The Flow Rider Flow Directed Micro Catheter is a single lumen infusion catheter designed to be flow directed into the distal vasculature. The Flow Directed Micro Catheter has a hydrophilic coating to provide lubricity for navigation of vessels. A standard luer lock adapter on the proximal hub is used for the attachment of accessories. The catheter tip is indicated by a radiopaque marker to facilitate fluoroscopic visualization.
Intended Use
The catheter is intended to be used for the controlled selective infusion of physician specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy.
Testing
Biocompatibility testing was performed on the Flow Directed Micro Catheter in accordance with the International Standard for the Biological Evaluation of Medical Devices. Part 1: Guidance on Selection of Tests (ISO 10993-1:1992(E)). Results of the tests showed that the device passed Biocompatibility testing and is suitable for its application.
Physical testing of the product included dimensional inspection, tensile strength tests, burst pressure tests, flow rate tests, torque tests and performance under simulated conditions. All testing of the product yielded acceptable results.
Animal studies were performed to assess the performance of the Flow Rider Catheter. The studies demonstrated that the Flow Rider Catheter is substantially equivalent to the predicate devices.
Summary of Substantial Equivalence
The Flow Rider Flow Directed Micro Catheter is substantially equivalent to the predicate devices in intended use and principles of operation.
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 stylized eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 1998
Mr. Tom Daughters Requlatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673
Re: K980104 Flow Rider™ Flow Directed Micro Catheter Trade Name: Requlatory Class: II Product Code: KRA Dated: January 9, 1998 January 13, 1998 Received:
Dear Mr. Daughters:
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 Requlations, 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any
2
Page 2 - Mr. Tom Daughters
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.
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) 594-4618. 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. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known):
Device Name:
Flow Rider™ Flow Directed Micro Catheter
Indications for Use:
The catheter is intended to be used for the controlled selective infusion of physician specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuro anatomy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over the Counter Use _________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
| 510(k) Number | K980604 |
|---|---|
| --------------- | --------- |
Exhibit 6, Page 4