REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER

K063076 · Ascent Healthcare Solutions · OWQ · Mar 29, 2007 · Cardiovascular

Device Facts

• Record ID: K063076
• Device Name: REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER
• Applicant: Ascent Healthcare Solutions
• Product Code: OWQ · Cardiovascular
• Decision Date: Mar 29, 2007
• 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 length. Features distal tip with ultrasound transducer; handpiece; flexible shaft; steering mechanism for tip rotation and deflection. Provides 2D ultrasound imaging. Used by clinicians for intravascular/intracardiac imaging of right heart anatomy, physiology, and other devices. Reprocessing involves removal of visible soil, decontamination, and functional testing of components prior to repackaging. Device functions as original predicate.

Clinical Evidence

Bench testing only. Testing included biocompatibility, validation of reprocessing, sterilization validation, functional testing, and packaging validation to demonstrate safety and effectiveness.

Technological Characteristics

10 French, 90 cm diagnostic ultrasound catheter. Includes ultrasound transducer at distal tip, handpiece, and steering mechanism. Mechanical design, materials, and size are identical 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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K06a3076

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## SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | MAR 2 9 2007 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Contact: | Jenn Selvey<br>Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | |
| Date of preparation: | September 28, 2006 | |
| Name of device: | Trade/Proprietary Name: Reprocessed Diagnostic Ultrasound<br>Catheter<br>Classification Name: Diagnostic Intravascular Catheter | |
| Predicate Device<br>K992631 | 510(k) Title<br>AcuNav™ Diagnostic Ultrasound<br>Catheter | Manufacturer<br>Acuson Corp. |
| 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. | |
| Indications for 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. | |
| Technological<br>characteristics: | The design, materials, and intended use of Reprocessed<br>Diagnostic Ultrasound Catheters are identical to the predicate<br>devices. The mechanism of action of Reprocessed Diagnostic<br>Ultrasound Catheters is identical to the predicate devices in that<br>the same standard mechanical design, materials, and size are<br>utilized. There are no changes to the claims, intended use,<br>clinical applications, patient population, performance<br>specifications, or method of operation. In addition, Ascent<br>Healthcare Solutions's reprocessing of Ultrasound Catheters<br>includes removal of adherent visible soil and decontamination.<br>Each individual Ultrasound Catheter is tested for appropriate | |
| CONFIDENTIAL | Ascent Healthcare Solutions<br>Reprocessed Ultrasound Catheter<br>Traditional 510(k) | Page 11 |

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function of its components prior to packaging and labeling operations.

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

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

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

## Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.

CONFIDENTIAL

Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)

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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" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 2007

Ascent Healthcare Solutions c/o Ms. Katie Bray Regulatory Affairs Engineer 10232 South 51st Street Phoenix, Arizona 85044

Re: K063076

Trade Name: Reprocessed Diagnostic Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II (two) Product Code: NLI Dated: March 2, 2007 Received: March 5, 2007

Dear Ms. Bray:

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 such 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. Katie Bray

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 begin 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/industry/support/index.html.

Sincerely vours.

B/himmerman for

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

Enclosure

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## SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K063076

Device Name: Reprocessed AcuNav Ultrasound Catheter

Indications For Use: Reprocessed Diagnostic Ultrasound Catheters are indicated for visualization of vascular anatomy, cardiac and great vessel anatomy and physiology, or other devices in the heart, as well as measurement of blood flow. The Reprocessed Diagnostic Ultrasound Catheter is intended for use in the right side of the heart only.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

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)

B. Hemmema

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K063076

CONFIDENTIAL

Ascent Healthcare Solutions Reprocessed Ultrasound Catheter Traditional 510(k)

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