(62 days)
The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. This device is intended for one-time use.
The Mira-Flex™ 18 microcatheter is an infusion catheter with a hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including neuro, peripheral, or coronary use. This device has a small inner lumen, a tapered tip, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be sterilized and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the supporting study.
It's important to note that 510(k) summaries, especially for devices like microcatheters, often do not include the granular detail you're asking for, particularly concerning AI/machine learning specific metrics like sample sizes for test/training sets, expert qualifications, or MRMC studies. The document focuses on demonstrating substantial equivalence to a predicate device through engineering tests and general performance.
Acceptance Criteria and Device Performance for the Mira-Flex™ 18 Microcatheter
The provided 510(k) summary for the Mira-Flex™ 18 Microcatheter does not explicitly list quantitative acceptance criteria in a table format alongside specific numerical performance results for the device. Instead, it describes types of tests conducted to ensure "reliable design and performance." The implicit acceptance criterion for these tests is that the device performed adequately or within engineering specifications to demonstrate substantial equivalence to the predicate device.
The document indicates that the device's performance was considered acceptable as the FDA granted 510(k) clearance, implying that the results of the conducted tests provided "reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use."
1. Table of Acceptance Criteria and Reported Device Performance
| Test Type | Acceptance Criteria (Implicit from 510(k) Clearance) | Reported Device Performance (Implicit from 510(k) Clearance) |
|---|---|---|
| Tensile tests | Device withstands specified tensile forces without failure. | Performed reliably; results supported intended use. |
| Burst and pressure tests | Device withstands specified internal pressures without bursting or leaking. | Performed reliably; results supported intended use. |
| Biocompatibility tests | Device materials are biocompatible and do not cause adverse biological reactions. | Materials are biocompatible (implied by clearance). |
| Leakage tests | Device mainains integrity and does not leak under specified conditions. | Performed reliably; results supported intended use. |
| Acute animal study | Device performs safely and effectively in vivo, demonstrating features for intended use. | Demonstrated reliable design and performance in a live animal model. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document only lists the types of tests performed (e.g., Tensile, Burst, Leakage, Biocompatibility, Acute Animal Study). Typical sample sizes for these types of engineering and animal studies are not detailed in 510(k) summaries.
- Data Provenance: Not explicitly stated, but engineering tests are usually conducted in a laboratory setting, and biocompatibility tests would follow ISO standards. The "Acute animal study" would have been conducted in an animal facility. The country of origin for the data is implicitly the United States, given the submitting company (Cook Incorporated, Bloomington, IN) and the FDA submission. The studies are prospective in nature, as they are conducted specifically to support the device's clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified. For engineering tests, "ground truth" would be established by validated test methodologies and specifications. For the animal study, veterinarians and potentially veterinary pathologists would be involved, but their number and specific qualifications are not detailed.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable or not specified. For engineering and biocompatibility tests, results are typically objective measurements against a standard, not subject to subjective adjudication. For the animal study, observations and assessments would have been made by the research team, but a formal adjudication method (like 2+1 or 3+1 for clinical endpoints) is not mentioned or typically required for an acute animal study supporting a 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a microcatheter, a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are used for evaluating diagnostic software or imaging systems where human interpretation is a critical component.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This device does not involve an algorithm or AI component.
7. Type of Ground Truth Used
- Ground Truth Type:
- For Tensile, Burst, Pressure, and Leakage tests: Engineering specifications, validated measurement equipment, and standardized test methods.
- For Biocompatibility tests: ISO standards (e.g., ISO 10993) and laboratory assays.
- For Acute animal study: Direct physiological observations, potentially necropsy findings, and expert veterinary assessment.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a physical medical device and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not applicable, as there is no training set for this type of device.
Summary of Limitations Based on Document Content:
The provided 510(k) summary is typical for a physical medical device. It focuses on demonstrating substantial equivalence through a series of standard engineering and biocompatibility tests, along with an acute animal study. It does not contain the detailed information related to AI/machine learning model development, validation, or human reader studies, as those concepts are irrelevant to this particular device submission. The "acceptance criteria" and "performance" are framed in terms of general reliability and conformance to requirements rather than specific quantitative thresholds for each test, implying that the raw data and detailed reports were provided to the FDA but are not part of the public summary.
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Special 510(k) Premarket Notification Mira-Flex microcatheter COOK INCORPORATED
2005 DEC 8
510(k) Summary
Submitted By:
Thalia Brine Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 812.339.2235
5 October 2005
Device:
Trade Name: Proposed Classification: Mira-Flex™ 18 Microcatheter Catheter, Continuous Flush KRA
Predicate Devices:
The Mira-Flex™ 18 microcatheter is similar in terms of intended use, materials, and The Milla-Fica - 10 mirrocans the predicate device reviewed as a device for the delivery of thrombolytic therapy or embolic devices in tortuous or superselective anatomy.
Device Description:
The Mira-Flex™ 18 microcatheter is an infusion catheter with a hydrophilic coating, The Mira-1 lex - To inferesanteer superselective anatomy for diagnostic and interventional designed for use in small volser of eapon or coronary use. This device with a saal procedures, moturing nower possible the tip, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be cilloonzation cons and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.
Substantial Equivalence:
This device will be manufactured according to specified process controls and a Quality This device will bo maxe device will undergo packaging similar to the devices currently marketed and distributed by Cook Incorporated. This device will undergo sterilization similar to devices currently marketed and distributed as well. Being similar with respect to indications for use, materials, and physical construction to the predicate device, this device meets the requirements for section 510(k) substantial equivalence.
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Test Data:
The Mira-Flex™ 18 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
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- Biocompatibility tests
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- Leakage tests
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- Acute animal study
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as an infusion catheter in tortuous or superselective anatomy.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features the department's name encircling a symbol. The symbol is a stylized representation of human form, with three figures connected at the top and flowing downward.
DEC 8 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cook, Incorporated c/o Ms. Thalia Brine Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
K052841 Mira-Flex™ 18 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: II Product Code: KRA Dated: November 8, 2005 Received: November 17, 2005
Dear Ms. Brine:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becared the device is substantially equivalent (for the indications ferenced a o re and and sure) to legally marketed predicate devices marketed in interstate for associated in the enactment date of the Medical Device Amendments, or to commerce provision of they 2012) 2011 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 I va raly) and sprovisions 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 Please be advised that FDA's issuance of a substanted other requirements of the Act
that FDA has made a determination that your device also about one one . You must that FDA has made a determination that your as read by other Federal agencies. You must and listing or any Federal statutes and regulations adminiser of registration and listing (2)
comply with all the Act's requirements, including, but not the requirements as set comply with all the Act s requirements, including, barufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); end if capped if capolicable, the ele CFR Part 807), labeling (21 CFR Fall on ), good manastali: gdd if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Path 820); and if applicable forth in the quality systems (QS) regulation (21 -51 x 4 x 8 x 8 x 8 x 1 0 x 1 x 1 000-1050.
product radiation control provisions (Sections 53 1-542 of the Action Section 5 product radiation control provisions (Scettons 35 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a leval This letter will allow you to begin makemig your article as walnee of your device to a legally
premarket notification. The FDA finding of substantial equipacioned thus, perm premarket notification. The FDA inding of substanced by 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
r the results of the man and 120 m the support the reculation entitled If you desire specific advice for your ac not on on on on Also, please note the regulation entitled,
contact the Office of Compliance at (240) 276-0120. ↑ Also, please note t contact the Office of Comphalled at (2 t of 2 t 8 and (21CFR Patt 807.97). You may obtain "Misbranding by relerence to prematict nonlineaus. The Act from the Division of Small
other general information on your responsibilities under the 4 this from pumber (800) 63 other general information on your responsion.com its toll-free number (800) 638-2041 or 1 Manufacturers, International and Consumer Assistance as to very industry/support/index.html.
Sincerely yours,
Duna R. Vochner
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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Special 510(k) Premarket Notification Mira-Flex microcatheter COOK INCORPORATED
510(k) Number (if known): __ KOSZ84 |
Mira-Flex™ 18 microcatheter Device Name:
Indications for Use:
The Mira-Flex™ 18 microcatheter is designed for use in small vessel or superselective I he Mira-Fiex™ To increatically is designed for and uding neuro, peripheral, or
anatomy for diagnostic and interventional procedures including and time vec anatomy for diagnostic and mich ventional provenance intended for one-time 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)
| Muna R. Vochner | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) number | K052841 |
§ 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).