(270 days)
No
The summary describes a physical catheter and its performance characteristics, with no mention of software, image processing, AI, or ML.
No.
The "Intended Use / Indications for Use" states that the device is intended for the "delivery of contrast media and therapeutic agents", but it does not perform a therapeutic function itself. It is a delivery tool, not a therapeutic device.
No
The device is a high-flow catheter intended for the delivery of contrast media and therapeutic agents, not for diagnosis. While contrast media is used for diagnostic imaging, the catheter itself is a delivery device, not a diagnostic one.
No
The device description clearly describes a physical catheter with specific dimensions, materials (implied by biocompatibility testing), and mechanical properties (tensile strength, leakage, burst pressure). The performance studies focus on the physical characteristics and safety of the hardware. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the Royal Flush® Plus High-Flow Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the delivery of substances (contrast media and therapeutic agents) to the vasculature. This is an interventional procedure performed in vivo (within the living body).
- Device Description: The description details a catheter, which is a medical device used for accessing and delivering substances within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the living body) to provide information for diagnosis, monitoring, or screening. IVD devices typically involve analyzing biological samples like blood, urine, or tissue.
Therefore, the Royal Flush® Plus High-Flow Catheter is a medical device used for therapeutic and diagnostic procedures performed directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Royal Flush® Plus High-Flow Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Royal Flush® Plus High-Flow Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Plus High-Flow Catheter is available in 5.0 and 6.0 French sizes and is manufactured in lengths of 25 to 110 centimeters. Each configuration includes a luer lock adapter and a single lumen shaft. For catheters with a labeled length 110 cm or longer, the length is measured from the proximal end of the strain relief to the distal end of the catheter (with pigtail curled if present). For other sizes, the length is measured from the distal end of the strain relief to the distal end of the catheter (with pigtail curled if present).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, carotid, and coronary vasculature, not including the neurovasculature
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 Royal Flush® Plus High-Flow Catheter, subject of this submission, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time) demonstrated that the device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
- Tensile Testing of the Hub-to-Shaft Bond - Testing verified that under proper clinical use of the catheter, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Tip-to-Shaft Bond - Testing verified that under proper clinical use of the catheter, the peak load value of the tip-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Liquid Leakage Testing - Testing verified that under proper clinical use of the catheter, there will be no liquid leakage when tested in accordance with BS EN ISO 10555-1:2013. Annex C. The predetermined acceptance criterion was met.
- Air Leakage Testing - Testing verified that under proper clinical use of the catheter, there will be no air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- Static Burst Testing - Testing successfully characterized the catastrophic failure pressure for the catheter is accordance with BS EN ISO 10555-1:2013, Annex F.
- Dimensional Verification Testing - Testing verified that the dimensional requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met.
- Hub Pressure Testing – Testing successfully characterized the hub pressure, when tested at maximum flow rate, and to verify that it does not exceed the static burst pressure.
In conclusion, the results of these tests support a determination of substantial equivalence.
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.
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).
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October 5, 2018
Cook Incorporated Jessica Swafford Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402
Re: K180054
Trade/Device Name: Royal Flush Plus High-Flow Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: September 4, 2018 Received: September 5, 2018
Dear Jessica 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lydia S. Glaw -S 2018.10.05 10:54:56 -04'00'
- for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180054
Device Name Royal Flush® Plus High-Flow Catheter
Indications for Use (Describe)
The Royal Flush® Plus High-Flow Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
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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COOK INCORPORATED 750 DANIELS WAY BLOOMINGTON, IN 47404 USA 2235 TOLL FREE: 800,457.4500 WWW.COOKMEDICAL.COM
K180054 - 510(k) Summary
Royal Flush® Plus High-Flow Catheter Traditional 510(k) Summary 21 CFR §807.92
Submitter Information
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | David E. Chadwick |
| Email: | RegSubmissions@CookMedical.com |
| Contact Phone Number: | 812-335-3575 ext. 102330 |
| Contact Fax Number: | 812-332-0281 |
| Date Prepared: | 02 October 2018 |
Device Information
| Trade Name: | Royal Flush® Plus High-Flow Catheter |
|---|---|
| Common Name: | Angiographic Catheter |
| Classification Name: | Catheter, Intravascular, Diagnostic |
| DQO (21 CFR §870.1200) |
Predicate Device
The predicate device is the Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937. The predicate device is manufactured in lengths of 60 to 150 centimeters and in diameters of 4.0 to 6.5 French. The shaft of the catheter is compatible with an 0.035 or 0.038 inch wire guide. These catheters are manufactured in a variety of distal tip configurations.
4
Reference Device
Cook has utilized the Angiodynamics Soft-Vu® Angiographic Catheter (K161596) as a reference device, which is available in lengths of 25 to 140 centimeters, to support the shorter lengths (25 and 30 centimeters) of the subject device, the Royal Flush® Plus High-Flow Catheter.
Comparison to Predicate(s)
It has been demonstrated that the subject Royal Flush® Plus High-Flow Catheter and the predicate device are substantially equivalent in terms of intended use, duration of use, principles of operation, fundamental technological characteristics, and insertion method. The design, dimensions, manufacturing methods, and materials of the subject device are similar to those of the predicate device. The differences between the subject device and the predicate device do not raise new questions of safety and effectiveness as demonstrated by performance and biocompatibility testing.
Device Description
The Royal Flush® Plus High-Flow Catheter, subject of this submission, is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Plus High-Flow Catheter is available in 5.0 and 6.0 French sizes and is manufactured in lengths of 25 to 110 centimeters. Each configuration includes a luer lock adapter and a single lumen shaft. For catheters with a labeled length 110 cm or longer, the length is measured from the proximal end of the strain relief to the distal end of the catheter (with pigtail curled if present). For other sizes, the length is measured from the distal end of the strain relief to the distal end of the catheter (with pigtail curled if present).
Intended Use
The Royal Flush® Plus High-Flow Catheter is intended for the delivery of contrast media and therapeutic agents to the peripheral, carotid, and coronary vasculature, not including the neurovasculature.
5
Test Data
The Royal Flush® Plus High-Flow Catheter, subject of this submission, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:
- . Biocompatibility testing - Testing (i.e., cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, in vivo thrombogenicity, and partial thromboplastin time) demonstrated that the device is biocompatible for the intended use. In conformance with the applicable sections of ANSI AAMI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
- Tensile Testing of the Hub-to-Shaft Bond Testing verified that under proper . clinical use of the catheter, the peak load value of the hub-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Tip-to-Shaft Bond Testing verified that under proper . clinical use of the catheter, the peak load value of the tip-to-shaft connection is in accordance with the methods of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was met.
- Liquid Leakage Testing Testing verified that under proper clinical use of the . catheter, there will be no liquid leakage when tested in accordance with BS EN ISO 10555-1:2013. Annex C. The predetermined acceptance criterion was met.
- Air Leakage Testing Testing verified that under proper clinical use of the . catheter, there will be no air leakage when tested in accordance with BS EN ISO 10555-1:2013, Annex D. The predetermined acceptance criterion was met.
- . Static Burst Testing - Testing successfully characterized the catastrophic failure pressure for the catheter is accordance with BS EN ISO 10555-1:2013, Annex F.
- . Dimensional Verification Testing - Testing verified that the dimensional requirements of the subject device are within a specified tolerance. The predetermined acceptance criteria were met.
6
Cook Incorporated Royal Flush® Plus High-Flow Catheter Traditional 510(k) 04 September 2018
- . Hub Pressure Testing – Testing successfully characterized the hub pressure, when tested at maximum flow rate, and to verify that it does not exceed the static burst pressure.
In conclusion, the results of these tests support a determination of substantial equivalence.