(23 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and its performance characteristics, with no mention of software, algorithms, image processing, or AI/ML terms.
Yes
The "Intended Use / Indications for Use" section explicitly states the device's intention to deliver "therapeutic agents such as occlusion coils." The "Device Description" also mentions its use for "therapeutic purposes."
No
The device description states it is for diagnostic and therapeutic purposes, but its function is to assist in the delivery of agents, not to diagnose. The diagnostic agents are delivered by the device, but the device itself does not perform the diagnostic function.
No
The device description clearly indicates it is a physical, tubular device (microcatheter) designed for insertion into the cardiovascular system, which is hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for assisting in the delivery of agents into the vasculature (peripheral, coronary, and neuro). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description reinforces this by stating it's designed for insertion into the cardiovascular system.
- 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.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on samples taken from the body to diagnose conditions, monitor treatments, or screen for diseases. This device is a delivery tool used directly within the body.
N/A
Intended Use / Indications for Use
The Micrus “Courier” microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
Product codes
DQO
Device Description
The Micrus Microcatheters are tubular devices with a single lumen designed for insertion into the cardiovascular system for diagnostic and therapeutic purposes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary, and neuro vasculature
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
Non-clinical testing performed by Micrus Endovascular Corporation. The Micrus "Courier Pre-Shaped" microcatheters had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
510(k) Summary Micrus Microcatheters "Courier Pre-Shaped"
The Assigned 510(k) number is: K061963
| Submitter Name and
Address: | Micrus Endovascular Corp.
821 Fox Lane
San Jose, CA 95131 | AUG - 4 2006 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Name: | Patrick Lee, Regulatory Affairs Specialist
Phone: 408-433-1428
Fax: 408-433-1401
Email: plee@micruscorp.com | |
| Preparation Date: | August 1, 2006 | |
| Device Name and
Classification: | Micrus Microcatheter “Courier Pre-Shaped”
170–45°, 170–90°, 190–45°, & 190–90°
Common Name: Courier Pre-Shaped Microcatheter
Classification Name: Microcatheter, intravascular, diagnostic
Regulatory Class II | |
| Predicate Device: | Micrus Microcatheter, “Courier” Straight,
510(k) number K060116
Boston Scientific, Excelsior 1018 and SL-10 Microcatheters,
510(k) number K042568 | |
| Device Description: | The Micrus Microcatheters are tubular devices with a single
lumen designed for insertion into the cardiovascular system for
diagnostic and therapeutic purposes. | |
| Device Intended Use | The Micrus “Courier” microcatheters are intended to assist in
the delivery of diagnostic agents, such as contrast media, and
therapeutic agents such as occlusion coils, into peripheral,
coronary, and neuro vasculature. | |
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Comparison to Predicate Device:
The Micrus "Courier Pre-Shaped" microcatheters are substantially equivalent to the predicate device Micrus "Courier Straight" microcatheters in terms of design, materials. and function. They are both made of the same materials and coated with the same hydrophilic coating, they have the same shaft design with the same radiopaque markers: they have the same proximal and distal inner diameters and same outer diameters: the have the same effective shaft lengths. The Micrus Courier Pre-Shaped microcatheters have tips that are already shaped to either a 45° or 90° whereas the predicate Courier Straight microcatheters have straight tips. The tips of both types of microcatheters can be further steam-shaped by the physician at the time of use.
The Micrus "Courier Pre-Shaped" microcatheters are also substantially equivalent to the predicate device Boston Scientific Excelsior 1018 and SL-10 microcatheters (both of which have 90° tips) in terms of its ability to track through a tortuous path with minimal force. The Micrus "Courier Pre-Shaped" microcatheters had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10.
Conclusion:
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Endovascular Corporation, it is concluded that the Microcatheter, "Courier" with Pre-Shaped tip is substantially equivalent to the predicate devices in safety and effectiveness.
2
Image /page/2/Picture/2 description: The image shows the seal for the Department of Health and Human Services, USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 4 2006
Micrus Endovascular Corp. c/o Mr. Patrick Lee Regulatory Affairs Specialist 821 Fox Lane San Jose, CA 95131
Re: K061963 Micrus Microcatheter "Courier Pre-Shaped" Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular, Diagnostic Regulatory Class: Class II (two) Product Code: DQO Dated: July 11, 2006 Received: July 12, 2006
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 – Mr. Patrick Lee
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dima R. Vachner
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name:
Model #s: MPS170045-00, MPS170090-00, MPS190045-00, MPS190090-00
Indications For Use:
The Micrus Courier microcatheters are intended to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents such as occlusion coils, into peripheral, coronary, and neuro vasculature.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
una R. Vachner
(Division Sign-C Division of Cardiovascular Devices
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