(144 days)
The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
The MiraFlex™ High Flow Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available with a 2.8 French shaft and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.
This document describes the MiraFlex™ High Flow Microcatheter and its substantial equivalence to a predicate device, as well as the testing performed to demonstrate its reliable design and performance. However, it does not provide detailed acceptance criteria or numerical performance results in a way that allows for a direct comparison table as requested. The document also does not describe an AI/ML device, a clinical study with human readers, or the establishment of ground truth in the context of an AI/ML model.
Therefore, many of the requested points cannot be answered based on the provided text.
Here's an attempt to answer what can be gleaned from the text, with clear indications of what information is not present:
1. A table of acceptance criteria and the reported device performance
The document lists types of tests performed but does not provide specific numerical acceptance criteria or reported performance values for these tests. For instance, it states "Tensile tests" were performed, but not "Tensile strength > X N" (acceptance criteria) and "Reported tensile strength = Y N" (device performance).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests described are device performance tests, not clinical studies with patients or data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable as this is a device performance testing report, not an AI/ML study involving expert ground truth labeling.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the same reason as point 3.
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
There is no mention of an MRMC study, AI, or human readers in this document. This refers to a medical device's physical and functional performance, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
This is not applicable. The "ground truth" for these tests would be established by validated test methodologies and standards for mechanical, physical, and biocompatibility performance.
8. The sample size for the training set
This information is not applicable as there is no mention of a training set or an AI/ML model.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as point 8.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on Provided Text):
The provided document (a 510(k) Premarket Notification summary) describes the MiraFlex™ High Flow Microcatheter. The "study" in this context refers to a series of engineering and performance tests conducted to demonstrate the device's reliable design and performance and its substantial equivalence to a predicate device (MiraFlex™ 18 Microcatheter, K060224).
The tests performed include:
- Tensile tests
- Burst and pressure tests
- Kink radius and stiffness tests
- Torque response tests
- Flow rate tests
- Embolic particle tests
- Leakage tests
- Shelf life tests
- Biocompatibility tests
The document states, "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use." This indicates that the device met the internal acceptance criteria for each of these tests, leading to the FDA's clearance. However, the specific acceptance criteria and detailed quantitative results are not disclosed in this summary.
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becial 510(k) Premarket Notification iraFlexTM High Flow Microcatheter OK INCORPORATED
510(k) Summary
AUG - 8 2008
Submitted By:
Nathan Simon Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812.339.2235
14 March 2008
Device:
Trade Name: Proposed Classification: MiraFlex™ High Flow Microcatheter Catheter, Continuous Flush KRA
Indications for Use:
The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
Predicate Devices:
The MiraFlex™ High Flow Microcatheter is similar in terms of intended use, materials, and technological characteristics to the predicate MiraFlex™ 18 Microcatheter cleared under 510(k) number K060224.
Device Description:
The MiraFlex™ High Flow Microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures. The device is available with a 2.8 French shaft and is available in 100, 110, 135, and 150 cm lengths. The device is supplied sterile and intended for one-time use.
Substantial Equivalence:
The MiraFlex™ High Flow Microcatheter is substantially equivalent to the predicate MiraFlex™ Microcatheter cleared under 510(k) number K060224.
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K080737 pg 2 of 2
Special 510(k) Premarket Notification MiraFlex™ High Flow Microcatheter COOK INCORPORATED
Test Data:
The MiraFlex™ High Flow Microcatheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were:
-
- Tensile tests
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- Burst and pressure tests
-
- Kink radius and stiffness tests
-
- Torque response tests
-
- Flow rate tests
-
- Embolic particle tests
-
- Leakage tests
-
- Shelf life tests
-
- Biocompatibility tests
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its intended use
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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 symbol resembling a bird or abstract human figure with three curved lines, positioned to the right. Encircling the symbol is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook Incorporated c/o Mr. Nathan Simon 750 Daniels Way P.O. Box 489 Bloomington, IN 47402
110 - 8
Re: K080737
Trade/Device Name: MiraFlex™ High Flow Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Catheter, Continuous Flush Regulatory Class: Class II Product Code: KRA Dated: July 10, 2008 Received: July 11, 2008
Dear Mr. Simon:
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 mov publish further announcements concerning your device in the Eederal 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 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.
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Page 2 - Mr. Nathan Simon
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and my of substantial equivalence of your device of your device to a legally premarket nedicate 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 11 Joa at 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 (210) 270 0128. TRBS) pro 807.97). For questions regarding postmarket surveillance, please contact nouncention (21 er er and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device 240-276-3411: 1 t 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 Shaall oomin other general mional 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
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1
Special 510(k) Premarket Notification MiraFlex™ High Flow Microcatheter COOK INCORPORATED
510(k) Number (if known): _KOB6737
MiraFlex™ High Flow Microcatheter Device Name:
Indications for Use:
The MiraFlex™ High Flow Microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-the-Counter Use
(Per 21 CFR 801 Subpart D)
(Per 21 CFR 807 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 Devices
51
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).