(269 days)
No
The summary describes a physical catheter device and its performance testing, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is intended for the delivery of contrast media for diagnostic purposes, not for therapeutic intervention.
No
The device is intended for the delivery of contrast media during angiographic procedures, which is a therapeutic or interventional function, not a diagnostic one.
No
The device description and performance studies clearly indicate that this is a physical catheter, a hardware medical device, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "delivery of contrast media to the peripheral and coronary vasculature". This is a procedure performed in vivo (within the living body) for imaging purposes.
- Device Description: The description details a catheter, which is a device used to access internal body structures.
- 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.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve reagents, test kits, or instruments used to analyze these specimens.
The testing described (biocompatibility, tensile strength, leakage, burst pressure, dimensional verification) are all related to the physical and functional performance of a medical device used in vivo, not the analytical performance of an IVD.
N/A
Intended Use / Indications for Use
The Royal Flush Catheters are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.
Product codes
DOO
Device Description
The Royal Flush® Catheter subject of this submission is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Catheter is available in a 3.0 French size and is manufactured in lengths of 30 to 75 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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
The Royal Flush® 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, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI ANSI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
- Tensile Testing of the Hub to Shaft Joint - Testing verified that under proper clinical use of the catheter, the peak load value of the hub-to-shaft connection shall be in accordance with the applicable values of BS EN ISO 10555-1:2013. Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Tip to Shaft Joint Testing verified that under proper . clinical use of the catheter, the peak load value of the tip-to-shaft connection shall be in accordance with the applicable values 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 shall 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 shall 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 devices are within a specified tolerance. The predetermined acceptance criteria were met.
- Tensile Testing of the Sideports Testing verified that under proper clinical use . of the catheter, the peak load values of the sideported area of the catheter shaft shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was 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
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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January 25, 2018
Cook Incorporated Jessica Swafford Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402
Re: K171264
Trade/Device Name: Royal Flush Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: December 22, 2017 Received: December 26, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-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,
Kenneth J. Cavanaugh -S
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) K171264
Device Name Royal Flush Catheter
Indications for Use (Describe)
The Royal Flush Catheters are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.
Type of Use (Select one or both, as applicable)
2 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 WW.COOKMEDICA
K171264 – 510(k) Summary
Royal Flush® Catheter Traditional 510(k) Summary 21 CFR §807.92
Submitter Information
| Applicant: | Cook Incorporated |
|---|---|
| Address: | 750 Daniels Way |
| Bloomington, IN 47404 | |
| Contact: | Jessica P. Swafford |
| Email: | RegSubmissions@cookmedical.com |
| Contact Phone Number: | 812-335-3575 ext. 104260 |
| Contact Fax Number: | 812-332-0281 |
Date Prepared:
25 January 2018
Device Information
| Trade Name: | Royal Flush® Catheter |
|---|---|
| Common Name: | Angiographic Catheter |
| Classification Name: | Catheter, Intravascular, Diagnostic |
| DOO (21 CFR §870.1200) |
Predicate Device
The Royal Flush® Catheter, subject of this submission, is substantially equivalent to the primary predicate Slip-Cath® Beacon® Tip Catheter cleared under 510(k) number K122937 and the secondary predicate Mongoose® Pediatric Angiography Catheters cleared under 510(k) number K113819.
4
Reference Device
Cook has utilized the Sizing Catheters (K162448) as a reference device to support the biocompatibility of the subject device, the Royal Flush® Catheter.
Comparison to Predicates
It has been demonstrated that the subject Royal Flush® Catheter and the predicate devices are substantially equivalent in terms of intended use, duration of use, principles of operation, fundamental technological characteristics, and insertion method. The design, dimensions, manufacture, and materials of the subject device are either similar to the materials of the predicate devices or have been used in other cleared devices. The differences between the subject device and the predicate devices do not raise new questions of safety and effectiveness as demonstrated by performance and biocompatibility testing.
Device Description
The Royal Flush® Catheter subject of this submission is a sterile, single use device designed for use in angiographic procedures. The Royal Flush® Catheter is available in a 3.0 French size and is manufactured in lengths of 30 to 75 centimeters. Each configuration includes a luer lock adapter, connecting cap, and a single lumen shaft.
Intended Use
The Royal Flush® Catheters are intended for the delivery of contrast media to the peripheral and coronary vasculature, not including the neurovasculature.
Test Data
The Royal Flush® 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, and partial thromboplastin time) demonstrated that the device is biocompatible. In conformance with the applicable sections of AAMI ANSI ISO 10993-1:2009(R)2013, the predetermined acceptance criteria were met.
5
- . Tensile Testing of the Hub to Shaft Joint - Testing verified that under proper clinical use of the catheter, the peak load value of the hub-to-shaft connection shall be in accordance with the applicable values of BS EN ISO 10555-1:2013. Annex B. The predetermined acceptance criterion was met.
- Tensile Testing of the Tip to Shaft Joint Testing verified that under proper . clinical use of the catheter, the peak load value of the tip-to-shaft connection shall be in accordance with the applicable values 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 shall 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 shall 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 devices are within a specified tolerance. The predetermined acceptance criteria were met.
- Tensile Testing of the Sideports Testing verified that under proper clinical use . of the catheter, the peak load values of the sideported area of the catheter shaft shall be in accordance with the applicable values of BS EN ISO 10555-1:2013, Annex B. The predetermined acceptance criterion was 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.