(15 days)
Not Found
No
The device description and summary of performance studies focus on the physical components and intended use of a microcatheter, with no mention of AI or ML technology.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MicroCatheter is intended to assist in the delivery of "therapeutic agents."
No
The device is described as assisting in the delivery of diagnostic agents, but it is not performing the diagnostic function itself. It's a delivery tool, not a diagnostic tool.
No
The device description clearly outlines physical components made of materials like Teflon, stainless steel, and Pebax, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "assist in the delivery of diagnostic agents... and therapeutic agents... into peripheral, coronary, and neuro vasculature." This describes a device used within the body for delivery, not a device used to test samples outside the body to diagnose a condition.
- Device Description: The description details a catheter with a flexible shaft, tip, hub, and coating. This is consistent with a medical device used for insertion into the body, not a laboratory instrument or reagent used for testing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This microcatheter is a delivery tool used directly within the patient's vascular system.
N/A
Intended Use / Indications for Use
The Micrus Microcatheter is 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 Microcatheter consists of 4 major components:
- A flexible shaft with a lubricious liner extruded from Teflon. The liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
- An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- A standard luer hub insert, which is molded onto the flexible shaft.
- A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.
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 (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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
SEP 1 0 2003
K032624
p 1/2
510(k) Safety and Effectiveness Summary l.
Contact Information A.
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation 610 Palomar Avenue Sunnyvale, CA 94085
B. Device Name
Micrus Microcatheter Device: Catheter, Intravascular, Diagnostic Regulation Number: 870.1200 Product Code: DQO Device Class: 2
C. Predicate Device(s)
| Number | Description | Clearance Date |
|---|---|---|
| K960806 | Tracker Excel 14 Microcatheter | 05/02/96 |
D. Device Description
The Micrus Microcatheter consists of 4 major components:
- A flexible shaft with a lubricious liner extruded from Teflon. The ■ liner is reinforced with a metal wire made from stainless steel. The outer shaft jacket is made from Pebax,
- 트 An atraumatic distal flexible tip containing two radiopaque marker bands. The marker bands are useful in tracking catheter tip position and during placement of detachable embolic coils.
- A standard luer hub insert, which is molded onto the flexible shaft. ■
- 보 A hydrophilic coating, which covers the distal 100 centimeters of the Microcatheter.
E. Intended Use
The Micrus Microcatheter is 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.
Intended Use Predicate Device (per products' Instructions for Use) F.
"The Target Therapeutics' 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."
3
1
G. 510(k) Summary of Safety and Efficacy
Based upon the design, materials, function, intended use, comparison with currently marketed devices and the non-clinical testing performed by Micrus Corporation, it is concluded that the Micrus Microcatheter is substantially equivalent to the Boston Scientific/Target Therapeutics Microcatheter in safety and effectiveness.
4
M. Webb
Margaret Webber Director, Regulatory and Clinical Affairs Micrus Corporation June 27, 2003
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three overlapping human profiles, which are meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
SEP 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Corporation c/o Mr. Morten Christensen Underwriters Laboratories, Inc. Office Coordinator 1655 Scott Boulevard Santa Clara, CA 95050-4169
K032624 Micrus Microcatheter Regulation Number: 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II (two) Product Code: DQO Dated: August 25, 2003 Received: August 26, 2003
Dear Mr. Christensen:
Re:
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. Morten Christensen
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 (301) 594-4646. 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 Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Device Name:
510(k) Number (if known):
Micrus Microcatheter
Indications for Use:
The MicroCatheter is 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)
Over the Counter Use: or Prescription Use: (Per 21 CFR 801.109)
Veleton
andigation)
of Cardiovascular Devices 510(k) Number_