(126 days)
Not Found
No
The device description focuses on the mechanical properties and physical design of the microcatheter, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device aids in the delivery of therapeutic agents but is not a therapeutic device itself.
Yes
The device is intended to aid in the delivery of diagnostic agents, such as contrast media, which are used to diagnose medical conditions.
No
The device description clearly details a physical catheter with various material properties, coatings, and physical markers, indicating it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, to provide information for diagnostic, monitoring or compatibility purposes.
- Device Function: The Micrus Courier Flex Microcatheter is a device used within the body (in vivo) to deliver other agents (diagnostic or therapeutic) into blood vessels. It is a tool for accessing and navigating the vasculature, not for analyzing samples taken from the body.
- Intended Use: The intended use clearly states it's for aiding in the delivery of agents into the vasculature.
Therefore, based on the provided information, the Micrus Courier Flex Microcatheter is an in vivo medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
Product codes
DQO
Device Description
Micrus Courier Flex Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neurovasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
MAY - 6 2009
Micrus Endovascular Corporation Micrus® Courier® Flex™ Microcatheter
This 510(k) Summary for the Micros Courier Flex Microcatheter is submitted in accordance with the requirements of 21 C.F.R. § 807.92.
GENERAL INFORMATION
Manufacturer:
Micrus Endovascular Corporation 821 Fox Lane San Jose, CA 95131 Phone: 408-433-1400 Est. Registration No. 2954740
Contact Person:
Patrick Lee Manager, Regulatory Affairs Phonc: (408) 433-1428 Fax: (408) 433-1585 plee@micruscorp.com
Date Prepared:
December 29, 2008
DEVICE CLASSIFICATION
Classification: Class II
Trade Name:
Micrus Courier Flex Microcatheter
Trade Name:
Product Code: DQO
Catheter, Intravascular, Diagnostic (21CFR § 870.1200) Generic/Common Name:
PREDICATE DEVICES
- . 510(k) no. K060116, Courier Microcatheter, May 12, 2006
INTENDED USE
Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
1
DEVICE DESCRIPTION
Micrus Courier Flex Microcatheters are variable stiffness, single lumen catheters designed to aid the physician in accessing small, tortuous vasculature when used with a guiding catheter and steerable guide wire. Multiple levels of stiffness ranging from a highly flexible tip to a semi-rigid proximal section along the length of the catheter are designed to aid the physician in tracking over guide wires without displacement of the wire. The microcatheters have an outer hydrophilic coating that reduces friction during manipulation in the vessel. The lubricious PTFE-coated inner lumen is designed to facilitate movement of guide wires and other devices. A shaft marker, located 90 cm from the distal tip, is provided to expedite microcatheter insertion to the depth of standard guide catheters (90 cm long). Two marker bands, one at the catheter tip and another 3 cm proximal to the tip, are radiopaque to facilitate fluoroscopic visualization. A luer fitting located on the end of the catheter hub can be used to attach accessories. All microcatheters are packaged with a steam shaping mandrel accessory.
SUBSTANTIAL EQUIVALENCE
The Micrus Courier Flex Microcatheter is substantially equivalent to the Micrus Courier Microcatheter in terms of intended use, design, specifications, and materials. The microcatheter is intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature. The Micrus Courier Flex Microcatheter uses the same methods and materials in construction, packaging, and sterilization as its predicates. The modification to the device has not altered the fundamental technology of the predicate devices.
CONCLUSION
As described in this 510(k) Summary, Micrus Endovascular Corporation considers the Micrus Courier Flex Microcatheter to be substantially equivalent to the predicate devices.
2
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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
MAY - 6 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Endovascular Corporation c/o Mr. Patrick Lee Manager, Regulatory Affairs 821 Fox Lane San Jose, CA 95131
Re: K083922
Trade/Device Name: Micrus® Microcatheter, Courier® Flex Regulation Number: 21 CFR 870.1200 Regulation Name: Catheter Intravascular, Diagnostic Regulatory Class: II Product Code: DQO Dated: April 7, 2009 Received: April 8, 2009
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 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.
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); medical device reporting (reporting of medical
3
Page 2 - Mr. Patrick Lee
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _
Micrus Microcatheter "Courier Flex" Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Micrus Courier Flex Microcatheters are intended to aid in the delivery of diagnostic agents, such as contrast media, as well as therapeutic agents, such as occlusion coils, into the peripheral, coronary and neurovasculature.
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)
(Division Sign-Off)
B Zuckerman
5/5/09
Division of Cardiovascular Devices
510(k) Number
83922
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