(40 days)
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.
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.
Here's an analysis of the provided text regarding the Cohen Crossover Catheter, structured according to your request.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes verification testing for a medical device (Cohen Crossover Catheter) rather than a software algorithm or AI. Therefore, the "acceptance criteria" are the successful completion of these engineering and safety tests, and the "reported device performance" is that the device met these criteria. There are no quantitative performance metrics (like sensitivity, specificity, etc.) that would typically be associated with AI/software performance.
| Acceptance Criterion (Test Type) | Reported Device Performance |
|---|---|
| Simulated anatomy/concomitant device use | Results of verification testing did not raise new safety or performance questions. |
| Straightener removal force | Results of verification testing did not raise new safety or performance questions. |
| Flow rate | Results of verification testing did not raise new safety or performance questions. |
| Liquid leak | Results of verification testing did not raise new safety or performance questions. |
| Dynamic/static high pressure rating | Results of verification testing did not raise new safety or performance questions. |
| Aspiration | Results of verification testing did not raise new safety or performance questions. |
| Tensile | Results of verification testing did not raise new safety or performance questions. |
| Torque | Results of verification testing did not raise new safety or performance questions. |
| Dimensional Verification | Results of verification testing did not raise new safety or performance questions. |
| Biocompatibility | Biomaterial assessments did not raise new safety or performance questions. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes the premarket notification (510(k)) for a physical medical device (catheter), not an AI algorithm. Therefore, there isn't a "test set" in the context of data used to evaluate an AI model's performance. The "tests" mentioned are engineering and laboratory verification tests conducted on the physical device itself. The document does not specify the number of devices or components tested for each criterion, nor does it refer to data provenance in terms of country of origin or retrospective/prospective data collection as would be relevant for clinical data informing an AI.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is for a physical device, not an AI or diagnostic algorithm, so there is no "ground truth" established by experts in the context of diagnostic accuracy. The "truth" for these engineering tests is defined by the test specifications and whether the device's physical properties meet them.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI or diagnostic algorithm evaluation requiring expert consensus on outputs, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance for diagnostic tasks. This document concerns a physical device, not an AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is for a physical device. There is no algorithm to run in a standalone fashion.
7. The Type of Ground Truth Used
Not applicable in the context of AI. For the engineering tests, the "ground truth" would be established by the specifications of the device and standard engineering testing protocols (e.g., a specific tensile strength requirement, a specific flow rate, etc.).
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device; there is no "training set" as understood in machine learning. Its design and manufacturing are based on engineering principles and existing predicate devices, not data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for a physical medical device.
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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 GuidingSheath/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.
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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.
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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.
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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
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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
§ 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).