(29 days)
Not Found
No
The summary describes a physical catheter and its performance characteristics, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device facilitates diagnostic and interventional procedures by supporting guidewires and delivering solutions, but it does not directly treat a disease or condition itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "diagnostic and interventional procedures." Additionally, the "Device Description" mentions that it can "provide a conduit for the delivery of... diagnostic contrast agents."
No
The device description clearly describes a physical, single lumen intravascular catheter with radiopaque markers and a hydrophilic coating, indicating it is a hardware 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 vascular system. This involves direct interaction with the patient's body for procedures like guiding wires and delivering substances.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. It describes its physical characteristics, such as lumens, radiopaque markers, and coatings, all related to its function within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) in vitro (outside the body) to provide information for diagnostic purposes.
IVD devices are specifically designed to perform tests on biological samples outside the body to diagnose diseases or conditions. This device is an invasive medical device used within the body for procedural support and delivery.
N/A
Intended Use / Indications for Use
The CrossCath 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
CrossCath Support Catheters are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
CrossCath Support Catheters are available in 12 different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating length within the vascular system. The distal radiopaque marker is positioned approximately 3 millimeters from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The distal 40 to 60 centimeters of each configuration are hydrophilically coated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
small vessel or superselective anatomy, vasculature
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 following tests were performed to demonstrate that the modification to the CrossCath Support Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
Flow Rate - Measure flow rates through the device at designated injection pressures using saline and contrast.
In conclusion, the test results provide reasonable assurance to support a determination that the subject device is substantially equivalent to the predicate device.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 29, 2016
Cook Incorporated Jessica Swafford Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402
Re: K161801
Trade/Device Name: CrossCath Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: June 29, 2016 Received: June 30, 2016
Dear Ms. Swafford:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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,
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) K161801
Device Name CrossCath® Support Catheter
Indications for Use (Describe)
The CrossCath 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) |
|---|
| ☑ 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:
Jessica Swafford Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x104260 Fax: (812) 332-0281 Date Prepared: June 29, 2016
COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 MINGTON, IN 47402-0489 U.S.A. WWW.COOKMEDICAL.COM
Device:
Trade Name: Common Name: Classification Name: CrossCath® Support Catheter CXC Support Catheter Catheter, Continuous Flush KRA (21 CFR §870.1210)
Indications for Use:
The CrossCath 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 CrossCath Support Catheters cleared under 510(k) number K093052.
Comparison to Predicate Device:
It has been demonstrated that the CrossCath Support Catheters are comparable to the predicate device. The CrossCath Support Catheters are identical in terms of intended use, principles of operation, and basic technological characteristics to the predicate device. An additional catheter length has been included and the substantial equivalence of the modification is supported by testing. Flow rate information included in the labeling has been updated to reflect this modification.
Device Description:
CrossCath Support Catheters are single lumen intravascular catheters, designed to support a wire guide during access of vasculature, allow for exchange of wire guides, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.
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Special 510(k): Device Modification CrossCath® Support Catheter Cook Incorporated June 29, 2016
CrossCath Support Catheters are available in 12 different configurations. All models have three radiopaque markers spaced equally along the distal shaft to aid in estimating length within the vascular system. The distal radiopaque marker is positioned approximately 3 millimeters from the catheter tip. Each model has a smaller distal portion for passing through smaller vasculature and a larger proximal portion for additional support. The distal 40 to 60 centimeters of each configuration are hydrophilically coated.
Test Data:
The following tests were performed to demonstrate that the modification to the CrossCath Support Catheters met applicable design and performance requirements and support a determination of substantial equivalence.
- . Flow Rate - Measure flow rates through the device at designated injection pressures using saline and contrast.
In conclusion, the test results provide reasonable assurance to support a determination that the subject device is substantially equivalent to the predicate device.