(236 days)
No
The device description and intended use are purely mechanical and do not mention any computational or analytical capabilities that would suggest AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No
The device is described as a support catheter to facilitate procedures and deliver substances, not to treat a disease or condition itself.
No
The device is a support catheter used to facilitate interventional procedures and deliver diagnostic contrast agents, but it does not diagnose conditions itself.
No
The device description clearly describes a physical catheter with specific dimensions and materials, intended for insertion into the body. It is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "diagnostic and interventional procedures" within the body ("small vessel or superselective anatomy," "peripheral use"). This involves direct interaction with the patient's anatomy.
- Device Description: The description details a physical catheter designed to be inserted into the body to facilitate procedures, deliver substances, and provide support.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. IVDs are typically reagents, instruments, or systems used for testing samples in vitro.
This device is a medical device used in vivo (within the living body) for diagnostic and interventional purposes, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CXI™ Support Catheter is 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 with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The CXI™ Support Catheter will be available in catheter sizes of 2.6 and 4.0 French and with catheter lengths of 65, 90, 135, and 150 centimeters. The catheters will be supplied sterile and are intended for one-time use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small vessel or superselective anatomy, peripheral
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
Animal Testing - The testing showed that the devices were adequate or better in terms of the following performance parameters: preparation, introduction, pushability, trackability, flexibility, torquability, withdrawal, and inspection after use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 22, 2016
Cook Incorporated Daniel Corbin Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404
Re: K160884
Trade/Device Name: CXI Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: March 29, 2016 Received: March 31, 2016
Dear Mr. Corbin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Brian D. Pullin -S
for 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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Indications for Use
510(k) Number (if known) K160884
Device Name CXI™ Support Catheter
Indications for Use (Describe)
The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| Submitted By: | Daniel J. Corbin |
|---|---|
| Cook Incorporated | |
| 750 Daniels Way | |
| P.O. Box 489 | |
| Bloomington, IN 47402 | |
| Phone: (812) 335-3575 x104018 | |
| Fax: (812) 332-0281 | |
| Date Prepared: October 25, 2016 |
Device:
Trade Name: Common Name: Classification Name: CXI™ Support Catheter Continuous Flush Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)
Indications for Use:
The CXI" Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Predicate Device:
The device, subject of this submission, is substantially equivalent to the predicate device, the CXI" Support Catheter cleared under 510(k) number K072724.
Comparison to Predicate Device:
The CXI" Support Catheter is substantially equivalent to the predicate device, the CXI"" Support Catheter (K072724), in the following characteristics: identical intended use, identical fundamental technological characteristics, identical method of operation, and identical materials of construction. The CXT" Support Catheter (subject of this submission) is available in two French sizes (2.6 and 4.0 French) and in four lengths (65, 90, 135, and 150 centimeters), whereas as the predicate CXI" Support Catheter (K072724) was cleared with 2.6 French and 90 and 150 centimeter lengths. The CXI" Support Catheter may be used coaxially with other CXI™ Support Catheters, i.e. the 2.6 French CXI™ Support Catheter may fit into and be used coaxially with the 4.0 French CXI" Support Catheter. The substantial equivalence of the
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modified device to the predicate device is supported by testing summarized in this submission. Reference devices for this submission of the CXI" Support Catheter (K160884) include the CXI" Support Catheter (K122796) and CXI" TriForce Peripheral Crossing Set (K111263).
Device Description:
The CXI™ Support Catheter with hydrophilic coating is a braided, kink-resistant catheter designed to facilitate wire guide exchange, wire guide support and to provide a conduit for the delivery of saline solutions or diagnostic contrast agents. The CXI" Support Catheter will be available in catheter sizes of 2.6 and 4.0 French and with catheter lengths of 65, 90, 135, and 150 centimeters. The catheters will be supplied sterile and are intended for one-time use.
Test Data:
The following tests were performed to demonstrate that the CXI™ Support Catheter met applicable design and performance requirements and support a determination of substantial equivalence.
- I Animal Testing - The testing showed that the devices were adequate or better in terms of the following performance parameters: preparation, introduction, pushability, trackability, flexibility, torquability, withdrawal, and inspection after use.
In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.