(28 days)
Not Found
No
The description focuses on mechanical features and operator control, with no mention of AI or ML.
No
The device is intended to assist in the delivery of diagnostic and therapeutic agents, but it is not a therapeutic agent itself. It is a diagnostic intravascular catheter.
No
The "Intended Use / Indications for Use" states the device is "intended to assist in the delivery of diagnostic agents... and therapeutic agents." The "Device Description" also labels it as a "diagnostic intravascular catheter," but its primary function described is delivering agents and manipulating the catheter tip, not performing a diagnostic assessment itself.
No
The device description clearly describes a physical catheter with a shapeable tip controlled by a knob, indicating it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to assist in the delivery of diagnostic and therapeutic agents into the body (peripheral, coronary, and neuro vasculature). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The device is described as a diagnostic intravascular catheter, which is a tool used within the body.
- 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 specifically designed to be used in vitro (outside the body) on biological samples. This device is clearly designed for use in vivo.
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 (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Micrus® Courier Enzo™ Microcatheter 0.0190" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±90° from the an m-110 shapedere up was @ Courier Enzo™ Microcatheter 0.0190"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping while anovired. This design feature allows the clinician to adjust the catheter tip shape to toor to require variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.
The accessories for the Micrus Courier Enzo Microcatheter 0.0190", which are not supplied as Phe development of the sales to those for the Micrus Courier Pre-Shaped Microcatheters and include:
- Guiding catheter (generally, 5-7F) ●
- Guidewire compatible with the microcatheter ●
- Rotating Hemostatic Valves (RHV); two (2) required .
- 3-way stopcock ●
- 1-way valve .
- Femoral sheath .
- Continuous Saline Flush Set-ups with Pressure Bags, one as a flush for the guiding . catheter and the other as a flush for 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)
Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0190" demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to diagnostic intravascular catheters when used in accordance with its Instructions for Use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
OCT 5 2007
510(k) Summary
Micrus Endovascular Corporation Micrus® Courier Enzo™ Microcatheter 0.0190''
This 510(k) summary for the Micrus® Courier Enzo™ Microcatheter 0.0190"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, California 95131
Phone: (408) 433-1400
Est. Registration No. 2954740 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | R. Michael Crompton
Vice President, Regulatory / Clinical Affairs
& Quality |
| Date Prepared: | September 6, 2007 |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | Micrus® Courier Enzo™ Microcatheter 0.0190" |
| Generic/Common Name: | Diagnostic intravascular catheter (21 CFR § 870.1200) |
PREDICATE DEVICE
Micrus® Courier Enzo™ Microcatheter 0.0170" (reference: K070456)
.
ﻴﺔ
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, gorionary, and neuro vasculature.
1
DEVICE DESCRIPTION
The Micrus® Courier Enzo™ Microcatheter 0.0190" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±90° from the an m-110 shapedere up was @ Courier Enzo™ Microcatheter 0.0190"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping while anovired. This design feature allows the clinician to adjust the catheter tip shape to toor to require variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.
The accessories for the Micrus Courier Enzo Microcatheter 0.0190", which are not supplied as Phe development of the sales to those for the Micrus Courier Pre-Shaped Microcatheters and include:
- Guiding catheter (generally, 5-7F) ●
- Guidewire compatible with the microcatheter ●
- Rotating Hemostatic Valves (RHV); two (2) required .
- 3-way stopcock ●
- 1-way valve .
- Femoral sheath .
- Continuous Saline Flush Set-ups with Pressure Bags, one as a flush for the guiding . catheter and the other as a flush for the microcatheter
SUBSTANTIAL EQUIVALENCE
The Micrus® Courier Enzo™ Microcatheter 0.0190"is substantially equivalent to the predicate device identified previously. The Micrus® Courier Enzo™ Microcatheter 0.0190"is substantially equivalent to the predicate device with regard to intended use, shape of distal tip angle, materials, design, and function.
Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0190" demonstrates the device is substantially equivalent to the predicate device and does not raise new questions regarding safety and effectiveness with respect to diagnostic intravascular catheters when used in accordance with its Instructions for Use.
CONCLUSION
As described in this 510(k) Summary, Micrus Endovascular Corporation considers the Micrus® Courier Enzo™ Microcatheter 0.0190" substantially equivalent to the Micrus® Courier Enzo™ Microcatheter 0.0170" based on a comparison of intended uses and the results of in-virro tests.
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 with three stripes forming its wing and three wave-like shapes below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micrus Endovascular Corporation .OCT 5 * 2007 c/o Mr. R. Michael Crompton Vice President, Regulatory/Clinical Affairs & Quality 821 Fox Lane San Jose, CA 95131
Re: K072526
Trade/Device Name: Micrus® Courier Enzo™ Microcatheter 0.0190" Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: September 6, 2007 Received: September 7, 2007
Dear Mr. Crompton:
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.
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
3
Page 2 - Mr. Crompton
forth in the quality systems (OS) 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 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 postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Singerely Nours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Statement of Indications for Use
510(k) Number (if known): K
Device Name: Micrus® Courier Enzo™ Microcatheter - 0.0190"
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 × (Per 21 C.F.R. 801 Subpart D) AND/OR
Over-the-Counter Use (21 C.F.R. 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)
Division of Cardiovascular Device
510(k) Nubber
K072526
Page 1 of 1