URSA ANGIOGRAPHIC CATHETER

K123818 · Curative Medical Technology, Inc. · DQO · Mar 4, 2013 · Cardiovascular

Device Facts

• Record ID: K123818
• Device Name: URSA ANGIOGRAPHIC CATHETER
• Applicant: Curative Medical Technology, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Mar 4, 2013
• Decision: SESE
• Submission Type: Special
• 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. The device is for single use only. The device is not intended for use in the neurovasculature.

Device Story

Ursa™ angiographic catheter is a sterile, single-use, disposable device; functions as a passive conduit for delivering radiopaque contrast media to coronary and peripheral vascular sites. Device comprises a proximal luer connector, strain relief, catheter shaft, soft extension, and soft distal tip. Available in various curve shapes and 4F, 5F, and 6F sizes; accepts guidewires up to 0.038". Sideholes may be included for contrast injection. Operated by clinicians in a clinical setting to access vascular anatomies for diagnostic imaging. Output is the targeted delivery of contrast media, enabling visualization of the vasculature during procedures. Benefits include facilitating diagnostic imaging of coronary and peripheral vessels.

Clinical Evidence

Bench testing only. Performance testing included dimensional and functional testing of the new catheter shapes to verify substantial equivalence to the predicate device.

Technological Characteristics

Passive diagnostic intravascular catheter. Materials: identical to predicate. Dimensions: 4F, 5F, 6F sizes; accepts 0.038" guidewires. Features: luer connector, strain relief, catheter shaft, soft extension, soft distal tip, optional sideholes. Sterilization: not specified. Connectivity: none.

Indications for Use

Indicated for delivery of radiopaque contrast media to coronary and peripheral vasculature. Not for use in neurovasculature. Single use only.

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

• Ursa™ Angiographic Catheter (K090427)

Submission Summary (Full Text)

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Curative Medical Technology

### K123818, Page 1 of 2

## Section 5. 510(k) Summary

### 510(k) SUMMARY TEMPLATE

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

#### Submitter:

Curative Medical Technology Inc . 198 Xiangjiang Road New District, Suzhou 215011 P. R. China

Ms. Jessica Chiu, General Manager Company Contact Person:

> Phone: 011-86-13651894673 Email: [e-mail]

| Date of Summary: | December 11, 2012 |
|-----------------------------|--------------------------------------------------------------|
| Device Name: | Ursa™ Angiographic Catheter |
| Device Classification Name: | Diagnostic Intravascular Catheter (74DQO)<br>21 CFR 870.1200 |
| Predicate Device: | Ursa™ Angiographic Catheter (K090427) |

#### 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 39different curve shapes and three sizes of 4, 5 and 6F. This Special 510(k) adds sixteen (16) new shapes to the current commercially available selection of catheters. 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. The device is for single use only. The device is not intended for use in the neurovasculature.

#### Summary of Performance Data and Substantial Equivalence:

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

Special 510(k) – Ursa™ Angiographic Catheter – Additional Shapes

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#### Curative Medical Technology

consist of a proximal connector, shaft, and distal tip. Both the new and predicate devices are comprised of identical materials and serve as passive conduits for the delivery of contrast media under high pressure. The sixteen (16) new shapes have indications, same basic catheter design, same materials, same manufacturing methods, and the same packaging and sterilization method as the predicate devices.

Additionally, performance testing was conducted on the new shapes of 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.

#### Conclusion:

The information and data provided in this Special 510(k) establish that the Ursa™ Angiographic Catheter is substantially equivalent to the legally marketed predicate device.

Special 510(k) - Ursa™ Angiographic Catheter - Additional Shapes

Page 12 of 28

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of the human form.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 4, 2013

Curative Medical Technology Inc. C/O Amy E. McKinney 6518 Tamarind Sky Ln Fulshear, TX 77441 United States

Re: K123818

Trade Name: Ursa™ Angiographic Catheters Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DQO Dated: December 11, 2012 Received: December 12, 2012

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. 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

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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 yours,

# Matthew G. Hillebrenner

for 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):

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)

# Matthew G¶¼illebrenner