(23 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 Microcatheters are tubular devices with a single lumen designed for insertion into the cardiovascular system for diagnostic and therapeutic purposes.
This 510(k) summary (K061963) for the Micrus Microcatheters "Courier Pre-Shaped" describes the device and its intended use, and makes a claim of substantial equivalence to predicate devices based on design, materials, function, and non-clinical testing. However, it does not provide the specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets those criteria in the way you've outlined for medical AI/software performance.
Here's an analysis based on the information provided and how it relates to your requested points:
1. A table of acceptance criteria and the reported device performance:
This document does not contain a quantitative table of acceptance criteria and reported device performance. The comparison to predicate devices is qualitative and states that the "Micrus Courier Pre-Shaped microcatheters had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10." This suggests mechanical testing was done, but no specific values or acceptance thresholds are provided.
2. Sample size used for the test set and the data provenance:
No information provided. This document describes a medical device (a microcatheter), not a software or AI device that would typically use "test sets" of data. The "testing" referred to is likely mechanical and bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a physical medical device, not an AI/software product.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For a physical device like a microcatheter, the "ground truth" for performance would be derived from engineering specifications, material properties, and mechanical test results (e.g., tensile strength, flexibility, lubricity measurements).
8. The sample size for the training set:
Not applicable. As a physical device, there's no "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is provided vs. what is requested:
The provided document is a 510(k) summary for a physical medical device (microcatheter). The questions you've asked are predominantly tailored for the evaluation of medical AI or software as a medical device (SaMD), which requires different types of studies and performance metrics (e.g., sensitivity, specificity, AUC, human reader studies).
For this 510(k) submission, the "study" proving the device meets acceptance criteria is implied to be a series of non-clinical bench and mechanical tests. These tests would likely compare properties such as:
- Mechanical properties: Tensile strength, pushability, trackability, torqueability, flexibility, kink resistance.
- Dimensional accuracy: Inner/outer diameters, length, tip shape.
- Material compatibility: Biocompatibility (though typically covered by material predicate).
- Coating integrity/lubricity.
- Radiopacity.
The document states that the new device "had lower peak and lower average tension / compression than the predicate Excelsior 1080 and SL-10," indicating that specific mechanical tests were performed to demonstrate mechanical performance metrics (like force required to traverse a tortuous path). However, the specific acceptance criteria (e.g., "force must be less than X N" or "within Y% of predicate device") and the detailed quantitative results of these non-clinical studies are not included in this high-level 510(k) summary. These details would typically be found in the full 510(k) submission and the internal test reports of the manufacturer.
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510(k) Summary Micrus Microcatheters "Courier Pre-Shaped"
The Assigned 510(k) number is: K061963
| Submitter Name andAddress: | Micrus Endovascular Corp.821 Fox LaneSan Jose, CA 95131 | AUG - 4 2006 |
|---|---|---|
| Contact Name: | Patrick Lee, Regulatory Affairs SpecialistPhone: 408-433-1428Fax: 408-433-1401Email: plee@micruscorp.com | |
| Preparation Date: | August 1, 2006 | |
| Device Name andClassification: | Micrus Microcatheter “Courier Pre-Shaped”170–45°, 170–90°, 190–45°, & 190–90°Common Name: Courier Pre-Shaped MicrocatheterClassification Name: Microcatheter, intravascular, diagnosticRegulatory Class II | |
| Predicate Device: | Micrus Microcatheter, “Courier” Straight,510(k) number K060116Boston Scientific, Excelsior 1018 and SL-10 Microcatheters,510(k) number K042568 | |
| Device Description: | The Micrus Microcatheters are tubular devices with a singlelumen designed for insertion into the cardiovascular system fordiagnostic and therapeutic purposes. | |
| Device Intended Use | The Micrus “Courier” microcatheters are intended to assist inthe delivery of diagnostic agents, such as contrast media, andtherapeutic 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.
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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.
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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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12061765 510(k) Number_
§ 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).