(344 days)
Not Found
No
The document describes a standard angiographic catheter for delivering contrast media and does not mention any AI/ML components or functionalities.
No
The device is intended for delivering contrast media for diagnostic imaging, not for treating a disease or condition.
No
The device is an angiographic catheter intended for delivering contrast media, which is a procedural device, not one that directly diagnoses a condition.
No
The device description clearly outlines a physical catheter with various components (shaft, tip, luer connector, etc.) designed for delivering contrast media, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The Ursa™ angiographic catheter is used to deliver contrast media directly into the patient's vascular system inside the body. It is an invasive device used for imaging procedures, not for analyzing samples.
- Intended Use: The intended use clearly states "delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature." This is a procedural function, not a diagnostic test performed on a sample.
The device description and performance studies further support that this is a catheter used for a medical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
Product codes (comma separated list FDA assigned to the subject device)
DQO
Device Description
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39 different curve shapes and three sizes of 4. 5 and 6F. Each device consists of a catheter with luer connector; strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
Performance testing was conducted on the Ursa™ Angiographic Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993.
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
510K SUMMARY IV.
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.
| Submitter: | Curative Medical Technology Inc .
198 Xiangjiang Road
New District, Suzhou 215011
P. R. China |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person:
Phone:
Email: | Ms. Jessica Chiu, General Manager
011-86-13651894673
jmbchiu@devicetechinc.com |
| Date of Summary: | September 25, 2009 |
| Device Name: | UrsaTM Angiographic Catheter |
| Device Classification Name: | Diagnostic Intravascular Catheter (74DQO)
21 CFR 870.1200 |
| Predicate Device: | Infiniti Angiographic Catheter manufactured by
Cordis, K970854 (September 30, 1997).
Jography Angiographic Catheter manufactured by
Abbott, K000825 (September 21, 2000) |
Device Description:
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39 different curve shapes and three sizes of 4. 5 and 6F. Each device consists of a catheter with luer connector; strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
Intended Use:
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
1
Summary of Technological Characteristics in Comparison to Predicate Device:
The Ursa™ Angiographic Catheter has the same intended use and employs a similar method of operation and design as compared to the predicate devices. Both the new and predicate devices consist of a proximal connector, shaft, and distal tip. Both the new and predicate devices are comprised of similar materials and serve as passive conduits for the delivery of contrast media under high pressure.
Performance Data:
Performance testing was conducted on the Ursa™ Angiographic Catheter to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional and functional testing. Additionally, the catheters were subjected to biocompatibility testing per ISO 10993.
Conclusion:
The information and data provided in this 510(k) Notification establish that the Ursa™ Angiographic Catheter is substantially equivalent to the legally marketed predicate device.
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 features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized depiction of an eagle or bird-like figure, with its wings outstretched and its body forming a flowing, ribbon-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Curative MedicaL Technology, Inc. c/o Ms. Amy E. McKinney, MS, RAC Regulatory Affairs Consultant 102 Mistletoe Street Lake Jackson, TX 77566
Re: K090427
JAN 2 9 2010
Trade/Device Name: Ursa™ Angiographic Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: DQO Dated: January 15, 2010 Received: January 19, 2010
Dear Ms. McKinney:
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.
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.
3
Page 2 - Ms. Amy E. McKinney, MS. RAC
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/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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
ura R. hilmer
Image /page/3/Picture/8 description: The image shows a close-up of a handwritten symbol or character. It appears to be a cursive letter or a stylized mark, possibly part of a signature or a unique identifier. The character has a loop at the top and a curved line extending downwards, ending in a sharp point.
^ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K090427
Device Name: Ursa™ Angiographic Catheter
Indications For Use:
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only.
This device is not intended for use in the neurovasculature.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sumar D. Vines
Olvision Sian-Off) vision of Cardiovascular Devices
:10(k) Number_K690427
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