REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10

K092425 · Ascent Healthcare Solutions · OWQ · Oct 21, 2009 · Cardiovascular

Device Facts

• Record ID: K092425
• Device Name: REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10
• Applicant: Ascent Healthcare Solutions
• Product Code: OWQ · Cardiovascular
• Decision Date: Oct 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.

Device Story

Reprocessed 3D diagnostic ultrasound catheter; 10 French, 90 cm length. Distal tip contains ultrasound transducer for 2D imaging and location sensor for 3D mapping. Sensor consists of three orthogonal micro-machined coils detecting external electromagnetic fields. Handle contains pre-amplifier circuit board. Used in clinical settings for cardiac/great vessel visualization. Physician operates catheter; steering mechanism rotates tip and provides variable deflection. Location data transmitted to CARTO® XP EP Navigation System to calculate tip position/orientation. Real-time ultrasound images and 3D mapping assist physician in navigation and device placement within heart. Benefits include enhanced anatomical visualization and guidance during electrophysiology procedures.

Clinical Evidence

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

Technological Characteristics

10F, 90cm diagnostic ultrasound catheter. Features acoustic array and location sensor (three orthogonal micro-machined coils). Includes handle-integrated pre-amplifier circuit board. Energy source: electromagnetic field (for location sensing). Connectivity: wired interface to CARTO® XP EP Navigation System. Sterilization: validated reprocessing process.

Indications for Use

Indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy, physiology, and other devices in the heart. Used with CARTO® XP EP Navigation System (v9+).

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

• SOUNDSTAR™ 3D Ultrasound Catheter, Model M-5723-05 (K070242)

Reference Devices

• ACUSON AcuNav 10F Diagnostic Ultrasound Catheter

Submission Summary (Full Text)

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K092425

# SECTION 5: 510(k) SUMMARY

| Submitter: | Ascent Healthcare Solutions<br>10232 South 51st Street<br>Phoenix, Arizona 85044 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Contact: | Amanda Babcock<br>Regulatory Affairs Specialist<br>[phone] (o)<br>[phone] (f)<br>[e-mail] | OCT 21 2009 |
| Date of preparation: | August 5, 2009 | |
| Name of device: | Trade/Proprietary Name: Reprocessed 3D Diagnostic<br>Ultrasound Catheters<br>Classification Name: Catheter, Angiography, Reprocessed | |
| Predicate Device<br>K070242 | 510(k) Title<br>SOUNDSTAR™ 3D Ultrasound<br>Catheter, Model M-5723-05 | Manufacturer<br>Biosense Webster, Inc. |
| Device description: | 3D Diagnostic Ultrasound Catheters are specially designed<br>catheters that provide two-dimensional imaging using an<br>ultrasound transducer and three-dimensional location<br>information using a location sensor. The ultrasound transducer<br>and location sensor are at the distal tip of the catheter and can<br>be positioned for ultrasound imaging and 3D mapping by a<br>steering mechanism that rotates the catheter tip and variable<br>deflection. 3D Diagnostic Ultrasound Catheters incorporate a<br>handpiece, a flexible shaft and a distal tip section containing an<br>ultrasound transducer and a location sensor. The SOUNDSTAR™<br>3D Diagnostic Ultrasound Catheter 3-D location sensor provides<br>location information to the CARTO® XP EP Navigation System<br>(mapping system). The SOUNDSTAR™ 3D Diagnostic Ultrasound<br>Catheter is 10 French with a 90 cm insertion length. | |
| Indications for Use: | Reprocessed 3D Diagnostic Ultrasound Catheters are indicated<br>for intracardiac and intraluminal visualization of cardiac and<br>great vessel anatomy and physiology as well as visualization of<br>other devices in the heart. The 3D Diagnostic Ultrasound<br>Catheter provides location information when used with the<br>CARTO® XP EP Navigation System Version 9 or greater. | |
| Technological<br>characteristics: | The SOUNDSTAR™ 3D Diagnostic Ultrasound Catheter is a<br>90cm 10F IntraCardiac diagnostic ultrasound catheter with an<br>acoustic array identical to the ACUSON AcuNav 10F Diagnostic<br>Ultrasound Catheter. The catheter has a location sensor<br>(providing location information to the CARTO® | EP XP |

Ascent Healthcare Solutions
Reprocessed 3D Diagnostic Ultrasound Catheters
Reprocessed 3D Diagnostic Ultrasound Catheters
Traditional 510(k)

Page 18 OF2

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Navigation System) and an ultrasound transducer (acquiring real time ultrasound images) embedded in the tip. It also has a pre-amplifier circuit board inside the handle that amplifies the signals from the location sensor. The location sensor consists of a set of three micro-machined coils that act as pick up coils when placed in an external electromagnetic field created by external field generator coils. The sensor coils are positioned orthogonal to each other inside the sensor assembly. The coils pick up signals from the field in response to their position and orientation with respect to a frame of reference. The signals are processed by a system to calculate the position and orientation of the tip of the catheter. The associated circuitry for the sensor consists of pre-amplifier circuits for each coil.

### Performance data:

Bench and laboratory testing was conducted to demonstrate performance (safety and effectiveness) of Reprocessed 3D Diagnostic Ultrasound Catheters. This included the following tests:

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

Performance testing demonstrates that Reprocessed 3D Diagnostic Ultrasound Catheters perform as originally intended.

#### Conclusion:

Ascent Healthcare Solutions concludes that the modified devices (Reprocessed 3D Diagnostic Ultrasound Catheters) are safe, effective, and substantially equivalent to the predicate devices as described herein.

Ascent Healthcare Solutions Reprocessed 3D Diagnostic Ultrasound Catheters Traditional 510(k)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ascent Healthcare Solutions c/o Ms. Amanda Babcock Regulatory Affairs Specialist 10232 South 51st Street Phoenix, AZ 85044

## OCT 21 2009

Re: K092425

> Trade/Device Name: Reprocessed 3D Ultrasound Catheter (See Enclosed Model) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II (two) Product Code: NLI Dated: August 5, 2009 Received: August 7, 2009

Dear Ms. Babcock:

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. Amanda Babcock

Please bé 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 yours,

Duna R. Richter

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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Page 3 – Ms. Amanda Babcock

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Original model found to be SE SE SE SE SOUNDSTAR™ 3D Ultrasound Catheter, Model M-5723-05

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### SECTION 4: INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K092425

Device Name: Reprocessed 3D Diagnostic Ultrasound Catheters

### Indications For Use:

Reprocessed 3D Diagnostic Ultrasound Catheters are indicated for intracardiac and intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart. The 3D Diagnostic Ultrasound Catheter provides location information when used with the CARTO® XP EP Navigation System Version 9 or greater.

Prescription Use × (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)

W.M.P.

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K092425

CONFIDENTIAL

Ascent Healthcare Solutions Reprocessed 3D Diagnostic Uitrasound Catheters Traditional 510(k)