ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F

K071234 · Siemens Medical Solutions USA, Inc. · OBJ · Jun 29, 2007 · Cardiovascular

Device Facts

• Record ID: K071234
• Device Name: ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Jun 29, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Device Story

AcuNav Diagnostic Ultrasound Catheter (8F, 10F) is an ultrasound imaging catheter; used for intra-cardiac and intra-luminal visualization of cardiac/great vessel anatomy and physiology; also visualizes other devices within the heart. Operated by clinicians in a clinical setting. Device provides real-time ultrasound images to assist in cardiac procedures; aids healthcare providers in anatomical assessment and device placement; benefits patients by enabling minimally invasive visualization during cardiac interventions.

Clinical Evidence

No clinical data provided; performance verified and validated via design control processes.

Technological Characteristics

Ultrasound imaging catheter; 8F and 10F form factors; biocompatibility per ISO 10993-1.

Indications for Use

Indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices in the heart of adult and pediatric patients.

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 Ultrasound Imaging Catheter (original)

Submission Summary (Full Text)

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K071234

## SECTION 11

| | | 510(k) Summary<br>Prepared April 30, 2007 | | JUN 2 9 2007 |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|--|--------------|
| Sponsor: | Siemens Medical Solutions USA, Inc.,<br>Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 | | | |
| Contact Person: | Sheila W. Pickering Ph.D. | | | |
| | Telephone: | [phone] | | |
| | Fax: | [phone] | | |
| Submission Date: | February 16, 2007 | | | |
| Device Name: | AcuNav Diagnostic Ultrasound Catheter | | | |
| Common Name: | Diagnostic Ultrasound System with Accessories | | | |
| Classification: | | | | |
| Regulatory Class: | II | | | |
| Review Category: | Tier II | | | |
| Classification Panel: | Radiology | | | |
| | Ultrasonic Imaging Catheter ; 21C FR # 892.1550; Product Code DOO | | | |

#### A. Legally Marketed Predicate Devices

The AcuNav Ultrasound Imaging Catheter is substantially equivalent to original AcuNav Ultrasound Imaging Catheter.

#### B. Device Description:

- 활 ISO 10993-1 Biocompatibility
#### C. Intended Use

The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

#### D. Substantial Equivalence

The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.

#### E. Performance Data

The AcuNav modifications are verified and validated according to the company's design control process.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2007

Siemens Medical Solutions USA, Inc. c/o Ms. Sheila Pickering, Ph.D. Senior Director of Regulatory Affairs P.O. Box 7393 1230 Shorebird Way Mountain View, CA 94039

Re: K071234

AcuNav Diagnostic Ultrasound Catheter 8F, 10F Regulation Number: 21 CFR 870.1200 Regulation Name: Intravascular Ultrasound Catheter Regulatory Class: Class II (two) Product Code: OBJ Dated: April 30, 2007 Received: May 3, 2007

Dear Dr. Pickering:

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. Sheila Pickering, Ph.D.

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 rorduct 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 yours,

ura R. lochner

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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# SECTION 7 Intended Use of the Device

510(k) Number (if known):__Ko712-34

Device Name: AcuNav Diagnostic Ultrasound Catheter 8F, 10F

Indications For Use:

The Acuson Acunav Ultrsound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

Prescription Use _ X = 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)

Duma R. Achmes
(Division Sign-Off)

Division of Cardiovascuiar

510(k) Number_k631234

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