(40 days)
Not Found
No
The summary describes a physical catheter used for delivering contrast media and guiding sheaths. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies focus on physical properties and biocompatibility.
No
The device is used to deliver radiopaque media and guide a sheath, which are diagnostic or procedural aid functions, not therapeutic ones.
No
The device is an angiographic catheter used to deliver radiopaque media and aid in percutaneous peripheral procedures. Its function is to facilitate the delivery of contrast for imaging, not to independently diagnose a condition.
No
The device description clearly describes a physical catheter, a hardware component, and the performance studies focus on physical properties and testing of this hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver radiopaque media to selected sites in the vascular system." This is an in vivo procedure, meaning it's performed within a living organism (the patient's body).
- Device Description: The description details a catheter used for angiographic procedures, which are also performed within the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) outside of the body, which is the defining characteristic of an IVD. The device is used to visualize structures within the body.
Therefore, the Cohen Crossover Catheter is a medical device used for interventional procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Cohen Crossover Catheter is intended to be used to deliver radiopaque media to selected sites in the vascular system, including the lower extremities using a contralateral approach.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Cohen Crossover Catheters are angiographic catheters used to aid in percutaneous peripheral procedures. The catheters guide an introducer sheath across the illiac bifurcation and perform a standard angiogram. The catheters are available in three sizes (6 F, 7 F, and 8 F) and taper to a radiopaque, 5 F modified hook configuration on the distal end. Side holes are located at the distal end of the catheters for contrast media injections. The catheters are compatible with 0.035" guidewires.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular system, including the lower extremities
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 device design has been qualified through the following tests:
- Simulated anatomy/concomitant device use
- Straightener removal force
- Flow rate
- Liquid leak
- Dynamic/static high pressure rating
- Aspiration
- Tensile
- Torque
- Dimensional Verification
- Biocompatibility
Results of the verification testing and biomaterial assessments did not raise new safety or performance questions.
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
2 510(k) Summary
JUL 1 9 2010
Date Prepared: June 8, 2010
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court Minneapolis, MN 55369 USA Tel: 763-656-4300; Fax: 763-656-4250 Establishment Registration # 2134812
Contact Person Jennifer Ruether Sr. Regulatory Affairs Associate
General Information
| Trade Name | Cohen Crossover Catheter |
|---|---|
| Common / Usual Name | Diagnostic intravascular catheter |
| Classification Name | 870.1200; DQO; Diagnostic intravascular catheter; Class II |
| Predicate Devices | K000659 Performa Angiographic Catheters (Merit Medical) |
| K091329 Pinnacle Destination Peripheral Guiding | |
| Sheath/Dilator (Terumo Interventional Systems) |
Device Description
The Cohen Crossover Catheters are angiographic catheters used to aid in percutaneous peripheral procedures. The catheters guide an introducer sheath across the illiac bifurcation and perform a standard angiogram. The catheters are available in three sizes (6 F, 7 F, and 8 F) and taper to a radiopaque, 5 F modified hook configuration on the distal end. Side holes are located at the distal end of the catheters for contrast media injections. The catheters are compatible with 0.035" guidewires.
Intended Use / Indications
The Cohen Crossover Catheter is intended to be used to deliver radiopaque media to selected sites in the vascular system, including the lower extremities using a contralateral approach.
1
Technological Characteristics
The Cohen Crossover Catheter is similar in device design and performance to the predicate devices. The Cohen Crossover Catheter and the Performa Angiographic Catheter utilize similar materials of construction, the distal tips share the same shape (modified hook), have side holes, and are used for contrast delivery at a rate of up to 1200 psi. The Cohen Crossover Catheter and the Pinnacle Destination dilator have similar diameters and wall thickness. The three devices are available in similar lengths and sizes, and are compatible with similar guidewire sizes.
Substantial Equivalence and Summary of Studies
The Cohen Crossover Catheter is substantially equivalent to the specified predicate devices based on comparisons of the device functionality, technological characteristics, and Indications for Use. The device design has been qualified through the following tests:
- Simulated anatomy/concomitant device use ●
- Straightener removal force .
- Flow rate .
- Liquid leak .
- Dynamic/static high pressure rating .
- Aspiration .
- Tensile .
- Torque .
- Dimensional Verification .
- Biocompatibility t
Results of the verification testing and biomaterial assessments did not raise new safety or performance questions.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 1 9 2010
Vascular Solutions, Inc. c/o Ms. Jennifer Ruether Sr. Regulatory Affairs Associate 6464 Sycamore Court Minneapolis, MN 55369
Re: K101625
Cohen Crossover Catheter Regulation Number: 21 CFR§ 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (Two) Product Code: DOO Dated: June 8. 2010 Received: June 10, 2010
Dear Ms. Ruether:
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 provisions of inc. Act.
Include of the Act include requirements for annual registration, Insting 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 lo contract to contract mating
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 of ecting 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.
3
Page 2 - Ms. Jennifer Ruether
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.
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/ReportalProblem/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,
Jane R. Palmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K 10 \ (62 \ 6
Device Name: Cohen Crossover Catheter
Indications for Use:
The Cohen Crossover Cutheter is intended to be used to deliver radiopaque media to selected sites in the vascular system, including the lower extremitties using a contralateral approach.
Preseription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I (Posted November 13, 2003)
una R. Vilmer
ardiovascular Devices
510(k) Number K101625