URSA ANGIOGRAPHIC CATHETER

K090427 · Curative Medical Technology, Inc. · DQO · Jan 29, 2010 · Cardiovascular

Device Facts

• Record ID: K090427
• Device Name: URSA ANGIOGRAPHIC CATHETER
• Applicant: Curative Medical Technology, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Jan 29, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

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.

Device Story

Ursa™ angiographic catheter; sterile, single-use, disposable device. Delivers radiopaque contrast media to coronary and peripheral vasculature. Features luer connector, strain relief, catheter shaft, soft extension, and soft distal tip. Available in 39 curve shapes; 4F, 5F, and 6F sizes. Accepts guidewires up to 0.038". Sideholes optional for contrast injection. Used by clinicians to access vascular anatomies for diagnostic imaging. Passive conduit for high-pressure contrast delivery. Benefits patient by enabling visualization of vascular structures during angiography.

Clinical Evidence

Bench testing only. No clinical data provided. Performance established via dimensional and functional testing per international standards and in-house requirements. Biocompatibility testing conducted per ISO 10993.

Technological Characteristics

Diagnostic intravascular catheter; 4F, 5F, 6F sizes; 39 curve configurations. Passive conduit design. Materials biocompatible per ISO 10993. Accepts 0.038" guidewires. Sterile, single-use. No electronic components or software.

Indications for Use

Indicated for delivery of radiopaque contrast media to coronary and peripheral vasculature sites. Single use only. Contraindicated for neurovasculature use.

Regulatory Classification

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.

Predicate Devices

• Infiniti Angiographic Catheter (K970854)
• Jography Angiographic Catheter (K000825)

Submission Summary (Full Text)

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#### 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 .<br>198 Xiangjiang Road<br>New District, Suzhou 215011<br>P. R. China |
|---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person:<br>Phone:<br>Email: | Ms. Jessica Chiu, General Manager<br>011-86-13651894673<br>[e-mail] |
| Date of Summary: | September 25, 2009 |
| Device Name: | UrsaTM Angiographic Catheter |
| Device Classification Name: | Diagnostic Intravascular Catheter (74DQO)<br>21 CFR 870.1200 |
| Predicate Device: | Infiniti Angiographic Catheter manufactured by<br>Cordis, K970854 (September 30, 1997).<br>Jography Angiographic Catheter manufactured by<br>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.

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# 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.

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#### 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.

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

ura R. hilmer

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^ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# 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)

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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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