(29 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML.
No.
The device is intended for diagnostic and interventional procedures, acting as a support catheter for wire guides, rather than directly providing therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheter is "intended for use... for diagnostic and interventional procedures."
No
The device description clearly outlines a physical catheter with specific dimensions, materials (hydrophilic coating, radiopaque markers), and mechanical properties tested (tensile strength, burst pressure, flow rate). These are all characteristics of a hardware medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 catheter designed to be inserted into the body, used with wire guides, and visualized with fluoroscopy. This is a medical device used in vivo (within a living organism).
- IVD Definition: In Vitro Diagnostics (IVDs) are devices used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. They are used in vitro (outside of a living organism).
This device is a medical device used for procedures performed directly on a patient, not for testing samples outside the body.
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 (comma separated list FDA assigned to the subject device)
KRA
Device Description
The CXI™ Support Catheter consists of a 2.3, 2.6, or 4.0 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The 2.3, 2.6, or 4.0 French catheters allow acceptance of a 0.014 inch diameter (0.36 millimeters) wire guide, a 0.018 inch diameter (0.45 millimeters) wire guide, or a 0.035 inch diameter (0.89 millimeters) wire guide, respectively. The catheter is available in four lengths: 65, 90, 135, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
- Tensile Strength Testing: shows the tensile strength during proper clinical use should not fracture or rupture the catheter. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Liquid Leakage Testing: shows there would be no liquid leakage from the catheter during proper clinical use. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Static Burst Testing: shows the pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter, and should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- Dynamic Burst Testing: shows the pressures reached during proper clinical use (maximum pressure at maximum flow rate) are less than the dynamic burst pressure of the catheter, and should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- Flow Rate Testing: shows the pressure exerted at the maximum flow rate during proper clinical use should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- Biocompatibility Testing: (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, pyrogen, partial thromboplastin time, and complement activation) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
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.
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
KI22796
Special 510(k): Device Modification CXITM Support Catheter Cook Incorporated 11 September 2012
OCT 1 1 2012
510(k) SUMMARY
| Submitted By: | Molly Busenbark, MA, RAC
Cook Incorporated
750 Daniels Way
Bloomington, IN 47404 |
|---------------|-------------------------------------------------------------------------------------------|
| Device: | |
Trade Name: Proposed Classification: CXI™ Support 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:
Cook Incorporated's CXI™ Support Catheter is identical in terms of intended use and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate devices. The device, subject of this submission, is substantially equivalent to the CXI™ Support Catheter and the CrossCath™ Support Catheter, manufactured by Cook Incorporated, which are cleared under 510(k) numbers K072724 and K093052, respectively.
Comparison to Predicate Device:
It has been demonstrated that the CXITM Support Catheter is comparable to the predicate devices in terms of design, intended use, materials, fundamental technology, and principal of operation.
Device Description:
The CXI™ Support Catheter consists of a 2.3, 2.6, or 4.0 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The 2.3, 2.6, or 4.0 French catheters allow acceptance of a 0.014 inch diameter (0.36 millimeters) wire guide, a 0.018 inch diameter (0.45 millimeters) wire guide, or a 0.035 inch diameter (0.89 millimeters) wire
1
Special 510(k): Device Modification CXI™ Support Catheter Cook Incorporated 11 September 2012
guide, respectively. The catheter is available in four lengths: 65, 90, 135, and 150 cm, with a straight or angled distal tip.
Test Data:
The following tests were performed to demonstrate that the CXI™ Support Catheter meets applicable design and performance requirements and supports a determination of substantial equivalence. Additionally, appropriate engineering tests were also performed on aged product to ensure that the CXI™ Support Catheter meets the performance requirements throughout the duration of shelf life.
- Tensile Strength Testing shows the tensile strength during proper clinical use . should not fracture or rupture the catheter. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Liquid Leakage Testing shows there would be no liquid leakage from the . catheter during proper clinical use. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
- Static Burst Testing shows the pressures reached during proper clinical use . (maximum pressure at maximum flow rate) are less than the static burst pressure of the catheter, and should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- Dynamic Burst Testing shows the pressures reached during proper clinical use . (maximum pressure at maximum flow rate) are less than the dynamic burst pressure of the catheter, and should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- Flow Rate Testing shows the pressure exerted at the maximum flow rate during . proper clinical use should not fracture or rupture the catheter. The predetermined acceptance criteria were met.
- . Biocompatibility - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, pyrogen, partial thromboplastin time, and complement activation) shows the device is biocompatible. In conformance with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.
In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate devices and supports a determination of substantial equivalence.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002
OCT 11 2012
Cook Incorporated c/o Molly Busenbark Regulatory Affairs Specialist 750 Daniels Way Bloomington, IN 47402-0489
Re: K122796
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: September 11, 2012 Received: September 12, 2012
Dear Ms. Busenbark:
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. However, we remind you 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
3
Page 2 – Ms. Molly Busenbark
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
4
Special 510(k): Device Modification CXI™ Support Catheter Cook Incorporated 11 September 2012
Indications for Use
510(k) Number (if known):
K12วา96
4
CXI™ Support Catheter Device Name:
Indications for Use for the CXI™ Support Catheter:
The CXI™ Support Catheter is intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures, including peripheral use.
Prescription Use XX (Part 21 CFR 801 Subpart D)
Concurrence e
OR Over-the-Counter Use (21 CFR 801 Subpart C)
Office of Device Evaluation (ODE)
Devices
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH
510(k) Number
(Division Sign-Off)
Division of Cardlovascul