(203 days)
Not Found
Not Found
No
The description focuses on the physical characteristics and intended use of a catheter for infusion, with no mention of AI or ML capabilities.
No.
The device is described as a catheter for the controlled infusion of therapeutic agents, not as a therapeutic agent itself or as performing a therapeutic function directly, but rather as a delivery mechanism.
No
The device is described as an "infusion catheter" intended for the "controlled infusion of physician specified therapeutic agents and contrast media," which points to a therapeutic function rather than a diagnostic one.
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 infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems." This describes a device used within the body for treatment or imaging, not a device used to examine specimens outside the body to provide diagnostic information.
- Device Description: The description details a catheter designed for insertion into blood vessels. This is consistent with an interventional medical device, not an IVD.
- Input Imaging Modality: Fluoroscopic visualization is used to guide the placement of the catheter within the body. IVDs typically analyze samples like blood, urine, or tissue.
- Anatomical Site: The device is used in the "Neurovascular and peripheral systems," which are parts of the human body. IVDs analyze samples taken from the body.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device is used directly on the patient for therapeutic or imaging purposes.
N/A
Intended Use / Indications for Use
The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.
Product codes
KRA
Device Description
The EASY RIDER® Micro Catheter is a single lumen infusion catheter designed to be introduced over a steerable guide wire into distal vasculature. The EASY RIDER® 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
neurovascular and peripheral systems
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 EASY RIDER 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 vielded acceptable results.
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
JUN 17 1998
Image /page/0/Picture/1 description: The image shows the logo for Micro Therapeutics, Inc. The logo consists of a stylized, black graphic element above the company name. The graphic element appears to be a stylized representation of the letters 'MTI'. The text 'MICRO THERAPEUTICS, INC.' is printed in a simple, sans-serif font.
Image /page/0/Picture/2 description: The image shows a black and white graphic of the word "KMAA13". The letters are stylized and bold, with a slightly rough or hand-drawn appearance. The letters are closely spaced, and the overall impression is one of a logo or a signature.
510(k) Summary of Safety and Effectiveness
EASY RIDER® Micro Catheter
Prepared November 21, 1997
General Information
| Classification | Class II |
|---|---|
| Trade Name | EASY RIDER® Micro Catheter |
| Generic Name | Percutaneous Catheter |
| Submitted By | Micro Therapeutics, Inc. |
| 1062-F Calle Negocio | |
| San Clemente, CA 92673 | |
| Phone: (714) 361-0616 FAX (714) 361-0210 | |
| Contact | Tom Daughters |
| Regulatory Affairs |
Predicate Devices
-
- FasTracker™ -10 Infusion Catheter Target Therapeutics, In.
-
- RapidTRANSIT™ Infusion Catheters Cordis Endovascular Systems, Inc.
-
- JetStream™ Infusion Catheter Micro Interventional Systems, Inc.
Device Description
The EASY RIDER® Micro Catheter is a single lumen infusion catheter designed to be introduced over a steerable guide wire into distal vasculature. The EASY RIDER® 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.
1
Intended Use
The catheter is intended to be used for the controlled infusion of physician specified therapeutic agents and contrast media into the neurovascular and peripheral systems.
Testing
Biocompatibility testing was performed on the EASY RIDER 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 vielded acceptable results.
Summary of Substantial Equivalence
The EASY RIDER Micro Catheter is substantially equivalent to the predicate devices in intended use and principles of operation.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 17 1998
Mr. Tom Daughters Regulatory Affairs Micro Therapeutics, Inc. 1062-F Calle Negocio San Clemente, CA 92673
Re: K974473 EASY RIDER® Micro Catheter Trade Name: Requlatory Class: II Product Code: KRA Dated: June 6, 1998 Received: June 21, 1998
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, qood 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 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
3
Page 2 - Tom Daughters
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" (21CFR 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 Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name:
EASY RIDER® Micro Catheter
Indications for Use:
The catheter is intended to be used for the controlled infusion of physician The catherer is intended to be ad contrast media into the neurovascular and peripheral systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
| Prescription Use | ✓ | OR | Over the Counter Use | |
|---|---|---|---|---|
| ------------------ | ----------------------------------------------------------------- | ---- | ---------------------- | ---------------------------------------------------------------- |
| (Per 21 CFR 801.109) | TWA |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K974473 |
Exhibit 8 Page 3and the state the state of the state of the first of the first of the