(35 days)
Not Found
Not Found
No
The summary describes a physical medical device (microcatheter) and its performance testing, with no mention of software, algorithms, image processing, or AI/ML terms.
No
The device is described as an "infusion catheter" for diagnostic and interventional procedures, not directly for therapy or treatment.
No
Explanation: The device description states that the microcatheter is "designed for use...for diagnostic and interventional procedures," indicating it can be used for both. However, the performance studies primarily emphasize its function as an "infusion catheter" and testing related to its mechanical performance and biocompatibility for that purpose, rather than diagnostic capabilities. There is no mention of diagnostic output, image processing, or metrics typically associated with diagnostic devices (e.g., sensitivity, specificity). Therefore, it serves primarily as an interventional tool that can also be used during diagnostic procedures, but it is not inherently a diagnostic device itself.
No
The device description clearly describes a physical medical device (microcatheter) with specific dimensions, materials (hydrophilic coating), and intended uses involving physical intervention. The performance studies also focus on physical properties like tensile strength, burst pressure, and biocompatibility.
Based on the provided text, the Mira-Flex™ 18 microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the device as being used in vivo (within the body) for diagnostic and interventional procedures in small vessels. IVD devices are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels for infusion. This is consistent with an in vivo medical device, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with IVD devices.
Therefore, the Mira-Flex™ 18 microcatheter is an invasive medical device used for procedures within the body, not an IVD.
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. Supplied sterile in peel-open packages. Intended for one-time use.
# Product codes (comma separated list FDA assigned to the subject device)
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 will be available with a 2.5 French shaft, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be supplied sterile, 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 (neuro, peripheral, or coronary use)
# 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
Not Found
# Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- 1. Tensile tests
- 2. Burst and pressure tests
- 3. Biocompatibility tests
- 4. Leakage tests
- 5. 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.
# Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
# Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
# Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
# Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
K 060224
MAR 6 2006
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
27 January 2006
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 technological characteristics to 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, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including neuro, peripheral, or coronary use. This device will be available with a 2.5 French shaft, and is compatible with 0.018" embolization coils and appropriately-sized embolization particles. The device will be supplied sterile, 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 Assurance Program. The 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
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms or lines extending upwards, representing growth and vitality. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is written around the circumference of the circle.
mar 6 2006
2006
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
Re: K060224 Mira-Flex™ 18 Microcatheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous flush catheter Regulatory Class: II Product Code: KRA Dated: February 16, 2006 Received: February 17, 2006
Dear Ms. Brine:
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, F12A may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Thalia Brine
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I DTT 8 local.org complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any redelal statutes and regulations and using, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 007); adoling (21 CFR Part 820); and if application (21 CFR Part 820); and if application (200 forth in the quarty by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control po begin marketing your device as described in your Section 510(k) I mis letter wif anow you to ough finding of substantial equivalence of your device to a legally premarket notification. "The PDF and on 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 If you desire specific ac no and (240) 276-0120. Also, please note the regulation entitled, Connact the Office of Ocharket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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,
surve R. V. Amer
GA_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): _ KOGO224
Mira-Flex™ 18 microcatheter Device Name:
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. Supplied sterile in peel-open packages. 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 ﺔ ﺍﻟﻤﺘﺤﺪﺓ of the Devices 510(k) Number_