(44 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device is a support catheter intended for diagnostic and interventional procedures, assisting in the delivery of other devices, not actively treating a condition itself. The performance studies also indicate its function as a "catheter guide wire."
Yes
The "Intended Use / Indications for Use" section explicitly states "Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures".
No
The device description clearly describes a physical catheter with specific dimensions, materials (hydrophilic coating, radiopaque markers), and mechanical properties (tensile strength, bending). The performance studies also focus on physical characteristics and performance of the catheter itself. There is no mention of software as the primary or sole component of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "diagnostic and interventional procedures including peripheral use" in small vessel or superselective anatomy. This describes a device used within the body for procedures, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be inserted into blood vessels, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is clearly designed for direct interaction with the patient's vascular system.
N/A
Intended Use / Indications for Use
Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including peripheral use.
Product codes
KRA
Device Description
The Cxi Support Catheter consists of a 2.6 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The inner diameter allows acceptance of a 0.018-inch (0.45mm) wire guide. The catheter is available in two lengths, 90 and 150 cm, with a straight or angled distal tip.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small vessel or superselective anatomy
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
The Cxi Support Catheter was subjected to the following tests to assure reliable design and performance under specified testing parameters. These tests were comprised of: - Freedom of Leakage 1. - 2. Burst Pressure - 3. Tensile Strength - 4. Bending - 5. Flow Rate - Biocompatibility 6. 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 a catheter guide wire.
Key Metrics
Not Found
Predicate Device(s)
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).
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NOV @ 9 2007
Special 510(k) Premarket Notification MiraFlex 18 Microcatheter COOK INCORPORATED
510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235
Device:
| Trade Name: |
|---|
| Proposed Classification: |
Cxi Support Catheter Catheter, Continuous Flush KRA (21 CFR §870.1250)
Indications for Use:
Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including peripheral use.
Predicate Devices:
The Cxi Support Catheter is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for use in small vessel or superselective anatomy for diagnostic and interventional procedures.
Device Description:
The Cxi Support Catheter consists of a 2.6 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The inner diameter allows acceptance of a 0.018-inch (0.45mm) wire guide. The catheter is available in two lengths, 90 and 150 cm, with a straight or angled distal tip.
Substantial Equivalence:
The Cxi Support Catheter is similar to catheters in commercial distribution for use in small vessel or superselective anatomy for diagnostics and interventional procedures. The device most similar is the MiraFlex 18 Microcatheter cleared for marketing on December 8, 2005 (D.C.#K052841) and March 6, 2006 (D.C.#K060224).
The similar indications for use, principles of operation, technological characteristics and performance testing results for the Cxi Support Catheter as compared to the predicate device supports a determination of substantial equivalency.
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Test Data:
The Cxi Support Catheter was subjected to the following tests to assure reliable design and performance under specified testing parameters. These tests were comprised of:
- Freedom of Leakage 1.
-
- Burst Pressure
-
- Tensile Strength
-
- Bending
-
- Flow Rate
- Biocompatibility 6.
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 a catheter guide wire.
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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines that suggest a head, body, and legs.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 0 9 2007
Cook Inc. c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489
Re: K072724 CXI Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II (Two) Product Code: KRA Dated: October 31, 2007 Received: November 1, 2007
Dear Ms. Bradburn:
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 - Ms. Karen Bradburn
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 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 notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact 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 Small Manufacturers. International 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,
R. bohner
A 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 MiraFlex 18 Microcatheter COOK INCORPORATED
510(k) Number (if known):
Kozary
Device Name: Cxi Support Catheter
Intended for use in small vessel or superselective anatomy for diagnostic Indications for Use: and interventional procedures including peripheral use.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (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)
suna R. barner (Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K072724
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