ACUNAV V ULTRASOUND CATHETER

K081808 · Siemens Medical Solutions USA, Inc. · OBJ · Sep 26, 2008 · Cardiovascular

Device Facts

• Record ID: K081808
• Device Name: ACUNAV V ULTRASOUND CATHETER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Sep 26, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Acuson AcuNav V Ultrasound Catheter is intended for intra-cardiac and intraluminal 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 V is a 10F diagnostic ultrasound catheter; used for intra-cardiac and intra-luminal imaging. Device captures ultrasound signals to visualize cardiac/great vessel anatomy, physiology, and other devices within the heart. Operated by clinicians in a clinical setting; requires compatibility with cleared ultrasound systems. Output is real-time ultrasound imagery displayed on the host system; assists physicians in visualizing cardiac structures and interventional devices during procedures. Benefits include enhanced anatomical visualization for diagnostic or interventional guidance.

Clinical Evidence

No clinical data provided. Performance verified and validated via bench testing and design control processes.

Technological Characteristics

10F diagnostic ultrasound catheter. Complies with UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-2/UD-3, and ISO 10993-1 (biocompatibility). Supports multiple imaging modes including B, M, PWD, CWD, Color Doppler, Power Doppler, and combined modes. Terminally sterilized.

Indications for Use

Indicated for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy, physiology, and other devices in the heart for 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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K081808
pg # 1 of 2

SEP 2 6 2008

# SECTION 11

#### 510(k) Summary Prepared June 24, 2008

Sponsor: Siemens Medical Solutions USA, Inc., Ultrasound Division 1230 Shorebird Way Mountain View, California 94043

Contact Person: Shelly Pearce Telephone: [phone] Fax: [phone]

Submission Date: June 24, 2008

Modified Device Name: AcuNav V Ultrasound Catheter

Common Name: Diagnostic Ultrasound Catheter

#### Classification:

Regulatory Class: ============================================================================================================================================================================== Review Category: Tier 11 Classification Panel: Radiology Ultrasonic Imaging Catheter ; 21C FR # 892.1200; Product Code OBJ

#### A. Legally Marketed Predicate Devices

The modified AcuNav Diagnostic Ultrasound Catheter is substantially equivalent to the original AcuNav Ultrasound Imaging Catheter.

#### B. Device Description:

The AcuNav V has been designed to meet the following product safety standards:

- UL 60601-1, Safety Requirements for Medical Equipment
- I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
- 피 CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- 93/42/EEC Medical Devices Directive
- I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- EN/IEC 60601-1-1 o
- EN/IEC 60601-1-2 o
- IEC 61157 Declaration of Acoustic Power
- 프 ISO 10993-1 Biocompatibility
- ISO 14971 Risk Management
- I ISO 11607 Packaging for terminally sterilized medical devices

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K0818e8
pg # 2 of 2

The AcuNav V catheter is to be used only on systems with which it has been tested and found compatible. Each of these system/transducer combinations shall be cleared through the 510(k) process and have a subsequent special report submitted.

#### C. Intended Use

The Acuson AcuNav V Ultrasound Catheter is intended for 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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Image /page/2/Picture/12 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 6 2008

Siemens Medical Solutions USA, Inc. c/o Ms. Shelly Pearce Regulatory Affairs P.O. 7393 1230 Shorebird Way Mountain View, CA 94039

Re: K081808

Trade Name: ACUSON AcuNav V 10F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: September 5, 2008 Received: September 5, 2008

Dear Ms. Pearce:

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.

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

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#### Page 2 - Ms. Shelly Pearce

systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic 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 vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact . CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

uma R.bacher

A 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 6 Diagnostic Ultrasound Indications for Use Form

510(k) Number: KQ81803

### Device Name: ACUSON AcuNav V 10F Ultrasound Catheter

Indications for Use: The AcuNav™ V Ultrasound 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.

| | Mode of Operation | | | | | | | | | |
|----------------------------------|-------------------|---|---|-----|-----|------------------|---------------------------------|------------------------------|-----------------------|-------------------------------|
| Clinical Application | A | B | M | PWD | CWD | Color<br>Doppler | Power<br>(Amplitude)<br>Doppler | Color<br>Velocity<br>Imaging | Combined<br>(Specify) | Other:<br>Harmonic<br>Imaging |
| Ophtalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative<br>(Vascular) | | | | | | | | | | |
| Intraoperative<br>(Neurological) | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ<br>(Specify)** | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | P | P | P | P | P | P | | P* | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | P | P | P | P | P | P | | P* | |
| Peripheral Vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal<br>Conventional | | | | | | | | | | |
| Musculo-skeletal<br>Superficial | | | | | | | | | | |
| Other (Intra-Cardiac) | | P | P | P | P | P | P | | P* | |

P=Previously cleared by the FDA.

ﻟﻠﺘﻌﻠﻴﻤﻴﺔ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﺘﺎﺭﻳﺦ ﺍﻟﻤﺘﻮﺳﻴ AdditIonal Comments: *Combinations include: B+M, B+PWD, B+CWD, B+Color Doppler, B+M+ Color Doppler, B+PWD+Color Doppler, B+CWD+Color Doppler, B+Power Doppler, B+M+Power Doppler, B+PWD+Power Doppler, B+CWD+Power Doppler

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NECESSARY)

(PLESE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109)

Donna R. Vachner

(Division Sian of Cardiovascular Devices

510(k) Number

Page 12 of 23
Page 1 of 2

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## SECTION 7 Intended Use of the Device

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: AcuNav V Ultrasound Catheter, 10F

Indications For Use:

The Acuson AcuNav V Ultrasound Catheter is intended for intra-cardiac and intraluminal 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 × (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)

Duma R. Sohner

(Division Sign-Off Division of Cardiovascular Devices

510(k) Number