(97 days)
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.
The Micrus® Courier Enzo™ Microcatheter 0.0170" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±45° to ±90° from the neutral position. The Micrus® Courier Enzo™ Microcatheter 0.0170"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping tool is required. This design feature allows the clinician to adjust the catheter tip shape to accommodate variations in patient anatomy without having to remove the catheter from the patient's body in order to re-shape it.
Acceptance Criteria and Device Performance for Micrus® Courier Enzo™ Microcatheter 0.0170"
The provided 510(k) summary for the Micrus® Courier Enzo™ Microcatheter 0.0170" states that the device is substantially equivalent to its predicate device, the Micrus® Courier™ Pre-Shaped Microcatheter (K061963), with regard to intended use, shape of distal tip angle, and function. The acceptance criteria for this device are implicitly tied to demonstrating this substantial equivalence through verification testing.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list specific numerical acceptance criteria (e.g., in terms of tensile strength, torqueability, or flow rates) for the Micrus® Courier Enzo™ Microcatheter 0.0170". Instead, the performance is evaluated against the predicate device to demonstrate "substantial equivalence."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use | Substantially equivalent to predicate: assist in delivery of diagnostic and therapeutic agents into peripheral, coronary, and neuro vasculature. |
| Shape of Distal Tip Angle | Deflects under operator control at an angle of ±45° to ±90° from neutral. Substantially equivalent to predicate in this aspect. |
| Function | Allows in-vivo adjustment of catheter tip shape without removal, substantially equivalent to predicate. |
| Safety and Effectiveness | Verification testing demonstrates that the device does not raise new questions regarding safety and effectiveness compared to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document states "Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0170" demonstrates the device is substantially equivalent to the predicate device..." However, it does not specify the sample size used for these tests.
The data provenance is not explicitly mentioned (e.g., country of origin). The testing is described as "in-vitro tests," indicating it was conducted in a laboratory setting, not on human subjects (retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish the ground truth for the test set. The evaluation is based on "verification testing" (in-vitro tests) comparing the device's physical and functional characteristics to a predicate device.
4. Adjudication Method for the Test Set
Since human expert review for ground truth establishment is not mentioned, an adjudication method is not applicable or described in this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document presents a 510(k) submission for a medical device (microcatheter), not an AI/software as a medical device (SaMD). Therefore, an MRMC comparative effectiveness study, which typically evaluates the impact of AI on human reader performance, was not performed or described.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
No. As this is not an AI/SaMD product, a standalone algorithm performance study was not applicable and not performed.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of this device is established by comparison to a legally marketed predicate device (Micrus® Courier™ Pre-Shaped Microcatheter) and through in-vitro verification testing. The performance of the new device is considered acceptable if it demonstrates "substantial equivalence" to the predicate without raising new questions of safety and effectiveness.
8. The Sample Size for the Training Set
As this is not an AI/SaMD product, there is no concept of a "training set" in the context of this device's regulatory submission.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
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510(k) Summary
MAY 2 4 2007
Micrus Endovascular Corporation Micrus® Courier Enzo™ Microcatheter 0.0170"
This 510(k) summary for the Micrus® Courier Enzo™ Microcatheter 0.0170"'is submitted in accordance with the requirements of 21 C.F.R. § 807.92.
GENERAL INFORMATION
| Manufacturer: | Micrus Endovascular Corporation821 Fox LaneSan Jose, California 95131Phone: (408) 433-1400Est. Registration No. 2954740 |
|---|---|
| Contact Person: | R. Michael CromptonVice President, Regulatory / Clinical Affairs& Quality |
| Date Prepared: | February 15, 2007 |
| DEVICE DESCRIPTION | |
| Classification: | Class II |
| Trade Name: | Micrus® Courier Enzo™ Microcatheter 0.0170" |
| Generic/Common Name: | Diagnostic intravascular catheter (21 CFR § 870.1200) |
PREDICATE DEVICE
Micrus@ Courier™ Pre-Shaped Microcatheter (reference: K061963)
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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DEVICE DESCRIPTION
The Micrus® Courier Enzo™ Microcatheter 0.0170" in a diagnostic intravascular catheter with an in-vivo shapeable tip which deflects under operator control at an angle of ±45° to ±90° from the neutral position. The Micrus® Courier Enzo™ Microcatheter 0.0170"is designed with a feature which allows the clinician to adjust the catheter tip shape in-vivo by turning a knob. No shaping tool is required. This design feature allows the clinician to adjust the catheter tip shape to accommodate 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 0.0170", which are not supplied as part of the sales unit, are identical 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 0.0170"is substantially equivalent to the predicate device identified previously. The Micrus® Courier Enzo™ Microcatheter 0.0170"is substantially equivalent to the predicate device with regard to intended use, shape of distal tip angle, and function.
Verification testing conducted on the Micrus® Courier Enzo™ Microcatheter 0.0170" 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 0.0170'' substantially equivalent to the Micrus® Courier™ Pre-Shaped Microcatheter based on a comparison of intended uses and the results of in-vitro tests.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image contains a logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles three human profiles or faces stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Micrus Endovascular Corporation c/o Mr. R. Michael Crompton Vice President, Regulatory Clinical Affairs and Quality 821 Fox Lane San Jose, CA 95131
Re: K070456 Micrus® Courier Enzo™ Microcatheter 0.0170" Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (two) Product Code: DQO Dated: May 8, 2007 Received: May 9, 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.
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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 or any x 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) rms lower watification. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dana R. Bachner
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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Statement of Indications for Use
510(k) Number (if known): K070456
Device Name: Micrus® Courier Enzo™ Microcatheter - 0.0170"
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)
R. luchene
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_Ko7 0466
Page 1 of 1
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§ 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).