(62 days)
KRA
Not Found
No
The 510(k) summary describes a physical medical device (a microcatheter) and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is a microcatheter designed for diagnostic and interventional procedures, including the delivery of therapeutic agents (infusion catheter) or embolization devices, but it is not itself a therapeutic device. It is a tool for delivering therapy, not the therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the microcatheter is designed for "diagnostic and interventional procedures." Additionally, the "Device Description" reiterates its use for "diagnostic and interventional procedures."
No
The device description clearly describes a physical catheter with specific dimensions, materials, and physical tests (tensile, burst, biocompatibility, leakage, animal study). There is no mention of software as the primary component or function.
Based on the provided information, the Mira-Flex™ 18 microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for diagnostic and interventional procedures within the body (in vivo), specifically in small vessel or superselective anatomy. IVDs are used to examine specimens outside the body (in vitro), such as blood, urine, or tissue samples, to diagnose diseases or conditions.
- Device Description: The description details a catheter designed for infusion and delivery of substances or devices into the body. This is consistent with an interventional medical device, not an IVD.
- Testing: The performance studies listed (tensile, burst, biocompatibility, leakage, animal study) are typical for medical devices used in vivo, not for IVDs which would focus on analytical performance with biological samples.
The Mira-Flex™ 18 microcatheter is a medical device used for procedures performed directly on a patient, not for testing biological samples in a lab.
N/A
Intended Use / Indications for Use
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.
Product codes
KRA
Device Description
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 internal lumen at the tip, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be sterilized by ethylene oxide and is intended for one-time use. The Mira-Flex™ 18 will be available in 100, 110, 135, and 150 cm lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small vessel or superselective anatomy including neuro, peripheral, or coronary
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
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
-
- Burst and pressure tests
-
- Biocompatibility tests
-
- Leakage tests
-
- Acute animal study
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KRA
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
-
- Burst and pressure tests
-
- Biocompatibility tests
-
- Leakage tests
-
- 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.
2
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.
3
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
4
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 |