REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

K033436 · Alliance Medical Corp. · OWQ · Mar 16, 2005 · Cardiovascular

Device Facts

• Record ID: K033436
• Device Name: REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
• Applicant: Alliance Medical Corp.
• Product Code: OWQ · Cardiovascular
• Decision Date: Mar 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Reprocessed Diagnostic Ultrasound Catheters are intended for intravascular or intracardiac ultrasound imaging in order to provide visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart. The device is intended for use in the right heart only.

Device Story

Reprocessed diagnostic ultrasound catheter; 10 French, 90 cm insertion length. Features distal ultrasound transducer for 2D imaging; steering mechanism for tip rotation and variable deflection; handpiece and flexible shaft. Used for intravascular/intracardiac imaging; provides visualization of anatomy/physiology and blood flow measurement. Operated by clinicians in clinical settings. Reprocessing involves cleaning adherent visible soil and functional testing of components prior to packaging/labeling. Device provides real-time imaging to assist healthcare providers in visualizing cardiac structures and guiding other devices within the heart.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation to demonstrate performance equivalent to the original device.

Technological Characteristics

10 French, 90 cm diagnostic ultrasound catheter. Includes ultrasound transducer, steering mechanism, handpiece, and flexible shaft. Identical design and materials to predicate. Sterilization validation performed.

Indications for Use

Indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, and measurement of blood flow. Intended for use in the right side of the heart 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

• AcuNav™ Diagnostic Ultrasound Catheter (K992631)

Submission Summary (Full Text)

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KO33436 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

## MAR 1 6 2005

Alliance Medical Corporation

Submitter:

Image /page/0/Picture/2 description: The image shows a logo with three curved lines above the word "ALLIANCE". The lines are thick and black, and they curve upwards and to the right. The word "ALLIANCE" is written in a simple sans-serif font, and it is located directly below the curved lines. The logo is simple and modern, and it is likely used to represent a company or organization.

ALLIANCE

## SECTION B: 510(k) SUMMARY

10232 South 5 Ist Street Phoenix, Arizona 85044

ILL 480.763.5300
FAX [phone] Tالا Free 888.888.3433 www.alliance-medical.com

| Submitter: | Alliance Medical Corporation<br>10232 South 51 ^st Street<br>Phoenix, Arizona 85044 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Moira Barton<br>Regulatory Affairs Manager<br>[phone] (o)<br>[phone] (f)<br>[e-mail] |
| Date of preparation: | October 3, 2003 |
| Name of device: | Trade/Proprietary Name: Reprocessed Ultrasound Catheter<br>Common or Usual Name: Diagnostic Ultrasound Transducer Catheter<br>Classification Name: Catheter, Intravascular, Diagnostic |
| Predicate device: | AcuNav™ Diagnostic Ultrasound Catheter |
| K992631 | |
| Device description: | Diagnostic ultrasound catheters are specially designed<br>ultrasonic catheters that provide two-dimensional imaging using<br>an ultrasound transducer. The ultrasound transducer is at the<br>distal tip of the catheter and can be positioned for ultrasound<br>imaging by a steering mechanism that rotates the catheter tip<br>and variable deflection. Diagnostic ultrasound catheters<br>incorporate a handpiece, a flexible shaft and a distal tip section<br>containing an ultrasound transducer. The ultrasound catheter is<br>10 French with 90 cm insertion length. |
| Intended use: | Reprocessed Diagnostic Ultrasound Catheters are intended for<br>intravascular or intracardiac ultrasound imaging in order to<br>provide visualization of vascular anatomy, cardiac and great<br>vessel anatomy and physiology, or other devices in the heart.<br>The device is intended for use in the right heart only. |
| Indications statement: | Reprocessed Diagnostic Ultrasound Catheters are indicated for<br>visualization of vascular anatomy, cardiac and great vessel<br>anatomy and physiology, or other devices in the heart, as well<br>as measurement of blood flow. The Reprocessed Diagnostic<br>Ultrasound Catheter is intended for use in the right side of the<br>heart only. |
| Technological characteristics: | The design, materials, and intended use of Reprocessed<br>Ultrasound Catheters are identical to the predicate devices. The |

Alliance Medical Corporation
Reprocessed Ultrasound Catheters
Traditional 510(k)10

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mechanism of action of Reprocessed Ultrasound Catheters is mechanism of dotion of dotion of that the same standard luentical to the prodicate cals and sizes are utilized. There are mochaniour doolig intended use, clinical applications, no changes to the claim ance specifications, or method of operation.

Alliance Medical Corporation's reprocessing of ultrasound Allianoo Moules removal of adherent visible soil and catheters indiados rom individual ultrasound catheter is tested for appropriate function of its components prior to packaging and labeling operations.

Bench and laboratory testing was conducted to demonstrate Performance data: performance (safety and effectiveness) of the Reprocessed Ultrasound Catheters.

- Biocompatibility .
- Validation of reprocessing .
- Sterilization Validation .
- Function test(s) .
- Packaqing Validation ●

Performance testing demonstrates that Reprocessed Ultrasound Catheters perform as originally intended.

## Conclusion:

Alliance Medical Corporation concludes that the modified device (the Reprocessed Ultrasound Catheter) is safe, effective and substantially equivalent to the predicate devices as described herein.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

SEP - 6 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alliance Medical Corporation c/o Ms. Moira Barton Regulatory Affairs Manager 10232 South 51st Street Phoenix, Arizona 85044

Re: K033436

Trade/Device Name: Reprocessed Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II (Two) Product Code: NLI Dated: January 19, 2004 Received: January 21, 2005

Dear Ms. Barton:

This letter corrects our substantially equivalent letter of March 16, 2005.

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 (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. Moira Barton

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); 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.

This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

B. Bimiena for

Bram D. Zuckerman, M.D. Director Divison of Cardioascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (2)

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Page 3 - Ms. Moira Barton

| Original model found to be SE | |
|-------------------------------------------------|--|
| AccuNavTM Diagnostic Ultrasound Catheter, Model | |
| 08255790 | |

:

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## Indications for Use Statement 2.

510(k) Number (if known): KO33434

Device Name: Alliance Medical Corporation Reprocessed Ultrasound Catheter

Indications for Use: Reprocessed Diagnostic Ultrasound Catheters are Indications for Use: Replocessed Diagnosus Cardiac and great vessel anatomy
indicated for visualization of vascular anatomy, cardiac mazurement of blood indicated for visualization of vascular analy, barantes, as well as measurement of blood
and physiology, or other devices in the heart, as well as measurement of blood and physiology, or other devices in the nearly as well as work in the first in the right side of the heart only.

Prescription Use _ (per 21 CFR 801.109) ਾ

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Cardiovascular Devices 510(k) Numbər _