ACUSON ACUNAV 8F ULTRASOUND CATHETER

K042593 · Siemens Medical Solutions USA, Inc. · OBJ · Oct 15, 2004 · Cardiovascular

Device Facts

• Record ID: K042593
• Device Name: ACUSON ACUNAV 8F ULTRASOUND CATHETER
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

The ACUSON AcuNav™ 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.

Device Story

The ACUSON AcuNav 8F is a single-use, disposable, 8 Fr diameter, 110 cm long ultrasound-tipped catheter. It features a phased-array imaging transducer and a four-way steering mechanism capable of deflection in two orthogonal planes (160° range). The device connects to a reusable system cable and is used with compatible ultrasound systems (e.g., Cypress, Sequoia) to perform intra-cardiac and intra-luminal imaging. It captures ultrasound signals to visualize cardiac/great vessel anatomy, physiology, and other devices within the heart. The physician operates the catheter, manipulating the steering mechanism to position the transducer. The ultrasound system processes the signals to produce real-time images and blood flow data (Doppler modes) on a display. These images assist clinicians in assessing cardiac structures and guiding interventions, potentially improving diagnostic accuracy and procedural outcomes.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1, IEC 60601-2-37), electromagnetic compatibility (CISPR 11, IEC 61000 series), acoustic output measurements (AIUM/NEMA UD-2, UD-3), and biocompatibility/sterilization validation (ISO 10993, ISO 11135).

Technological Characteristics

8 Fr diameter, 110 cm length, single-use disposable phased-array ultrasound transducer. Four-way steering mechanism. Connectivity via reusable system cable to ultrasound host. Standards: UL 60601-1, IEC 60601-2-37, ISO 10555-1, ISO 10993-1/7, ISO 11135, ISO 14971. Sterilization: Ethylene oxide.

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. No specific age or gender contraindications provided.

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

• ACUSON AcuNav 90/10 Diagnostic Ultrasound Catheter (K033650)
• ACUSON AcuNav Diagnostic Ultrasound Catheter (K992631)
• Cypress Ultrasound System with AcuNav Diagnostic Ultrasound Catheter (K010950)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, with the profiles overlapping each other. The profiles are arranged in a way that they also resemble a bird in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 4 2007

Siemens Medical Solutions USA, Inc. c/o Dr. Iskra Mrakovic Manager, Regulatory Affairs 1230 Shorebird Way P.O. Box 7393 Mountain View, CA 94039

Re: K042593

Trade/Device Name: ACUSON AcuNav 8F Ultrasound Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: II Product Code: OBJ Dated: September 22, 2004 Received: September 23, 2004

Dear Dr. Mrakovic:

This letter corrects our substantially equivalent letter of October 15, 2004.

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 - Dr. Mrakovic

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 v

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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Siemens Medical Solutions USA. Inc. Ultrasound Division

ACUSON AcuNav™ 8F Ultrasound Catheren 510(k) Submission

| 510(k) Number (if known): | K042593 |
|---------------------------|---------|
|---------------------------|---------|

Device Name: ACUSON AcuNav™ 8F Ultrasound Catheter

Indications for Use:

The ACUSON AcuNav™ 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.

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

Over-The-Counter Use _ (21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

4.2593
(Division Sign-Off) Bhaminuma

Division of Cardiovascular Devices 510/k) Number

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# Diagnostic Ultrasound Indications for Use Form Cypress Ultrasound System

| 510(k) Number: | K042593 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ACUSON AcuNav™ 8F Ultrasound Catheter |
| Indications for Use: | The AcuNav™ Ultrasound Catheter is intended for intra-cardiac and<br>intra-luminal visualization of cardiac and great vessel anatomy and<br>physiology as well as visualization of other devices in the heart. |
| Ultrasound System: | Cypress |
| Transducer: | AcuNav 8F Ultrasound Catheter |

| | 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* | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intra-Luminal | | 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* | |

the FDA under premarket notification K992631. DV

Additional Comments:

*The Cypress Ultrasound System does not provide combined modes where more than one scanning mode is netive simultancously

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

Prescription Use (Per 21 CFR SO 1.109)

**510(k) Number** k042593

.. . . . . . .

Section 6

Indications for Use Form

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### Diagnostic Ultrasound Indications for Use Form Sequoia Diagnostic Ultrasound System

| 510(k) Number: | K042593 |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | ACUSON AcuNav m 8F Ultrasound Catheter |
| Indications for Use: | The AcuNav TM 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. |
| Ultrasound System:<br>Transducer: | Sequoia<br>AcuNav 8F Ultrasound Catheter |

| 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 under premarket notification K992631.

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+Pawer Doppler

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Concurrence of CDRH, Office of Device Evaluation (ODE)

WODELMAN

Prescription Use (Per 21 CFR 801.109)

Division of Cardiovascular Devices

510(k) Number L042593

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ACUSON AcuNay™ 8F 510(k) Submission

# OCT 15 2004

# SECTION 11

# 510(k) Summary of Safety and Effectiveness

| Sponsor: | Siemens Medical Solutions USA, Inc., Ultrasound Division<br>1230 Shorebird Way<br>P.O. Box 7393<br>Mountain View, California 94039-7393 |
|------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Iskra Mraković<br>Manager of Regulatory Affairs<br>Telephone: [phone]<br>Fax: [phone] |
| Submission Date: | September 22, 2004 |
| Device Name: | ACUSON AcuNav 8F Ultrasound Catheter |
| Common Name: | Intracardiac/Intravascular Ultrasound Catheter |

Classification:

Regulatory Class: II Review Category: Tier II

| | FR # | Product Code |
|-----------------------------------|----------|--------------|
| Diagnostic Intravascular Catheter | 870.1200 | 74-DQO |
| Diagnostic Ultrasound Transducer | 892.1570 | 90-ITX |

## Predicate Devices:

- # K033650 (February 24, 2004), cleared as ACUSON AcuNav® 90/10 Diagnostic . Ultrasound Catheter.
- # K992631 (November 8, 2001), cleared as ACUSON AcuNav® Diagnostic . Ultrasound Catheter.
- #K010950 (June 27, 2001), cleared as Cypress Ultrasound System with AcuNav . Diagnostic Ultrasound Catheter.

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# Device Description:

The AcuNav catheter is comprised of a single-use, disposable ultrasonic phasedarray imaging transducer and a catheter which is 8 Fr in diameter and 110 cm in insertable length.

The device is capable of imaging at multiple frequencies and obtaining blood flow data in multiple ultrasound modes. The distal portion of the catheter can be deflected in four directions in two orthogonal planes: left-right (in a plane perpendicular to the image rour directions in two over of the a plane coincident with the image plane). The range of pume) and a 160° in each direction. The AcuNav catheter is comprised of three major components: (1) the catheter itself; (2) the steering mechanism; and (3) the reusable system cable.

The AcuNav 8F ultrasound catheter is substantially equivalent to our current product that is already cleared for USA distribution under the following 510(k) PreMarket Notification numbers:

- # K033650 (February 24, 2004), cleared as ACUSON AcuNav 90/10 Diagnostic ● Ultrasound Catheter.
- # K992631 (November 8, 2001), cleared as ACUSON AcuNav Diagnostic . Ultrasound Catheter.
- #K010950 (June 27, 2001), cleared as Cypress Ultrasound System with AcuNav . Diagnostic Ultrasound Catheter.

The AcuNav 8F Ultrasound Catheter has been designed to conform to the following product safety standards [as required by 21 CFR § 807.87(j)]:

- UL 60601-1, Safety Requirements for Medical Equipment .
- EN 60601-1: 1990+A1 (1992) +A2 (1995) .
- IEC 60601-2-37: 2001+AM1 (2004) .
- CAN/CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment ●
- CISPR 11, Class A .
- ISO 10555-1: 1995+AM1 (1999) .
- EN 60601-1-2: 2001 ●
- EN 55011:1991 (Radiated and Conducted Emissions) Class A or B, Group 1 .
- EN 61000-3-2, edition 2.1 (Harmonic Current Emissions) .
- EN 61000-3-3:1994, plus AM1 (2001) (Voltage Fluctuations, Flicker Emissions) .
- IEC 61000-4-2, edition 1.2 (ESD) .
- IEC 61000-4-3, edition 2.1 (Radiated RF) .
- IEC 61000-4-4:1995, plus AM1 (2000) and AM 2 (2001) (EFT/Burst) .
- IEC 61000-4-5, edition 1.1 (Surge) ●

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- IEC 61000-4-6, edition 2.0 (Conducted RF Immunity) ◆
- IEC 61000-4-8, edition 1.1 (PF Magnetic Fields) .
- IEC 61000-4-11, edition 1.1 (Voltage Dips and Interruptions) �
- AIUM/NEMA UD-2: 1998: Acoustic Output Measurement Standard for . Diagnostic Ultrasound
- AIUM/NEMA UD-3: 1998: Standard for Real Time Display of Thermal and . Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- Declaration of Acoustic Power . IEC 1157:
- Biological evaluation of medical devices Part 1: ISO 10993-1, 2003: . Evaluation and Testing
- Biological evaluation of medical devices Part 7: Ethylene ISO 10993-7, 1995: . oxide sterilization residuals
- Sterilization (Medical devices-Validation and routine ISO 11135, 1994: . control of ethylene oxide sterilization)
- Medical Devices -- Application of Risk Management to Medical ISO 14971: . Devices
- Medical Device Directive . 93/42/EEC

### Indications for Use:

The AcuNav™ 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.

## Technological Comparison to Predicate Device:

The AcuNav 8F Ultrasound Catheter is substantially equivalent in its technologies and functionality to the AcuNav 90/10 Diagnostic Ultrasound Catheter that is already cleared under 510(k) premarket notification numbers K033650 (Feb. 24, 2004), K992631 (Nov. 8, 2001), and K010950 (June 27, 2001).

Both, AcuNav 8F and AcuNav 90/10 catheters are ultrasound-tipped catheter devices used directly within the vasculature and/or the heart for intravascular or intracardiac ultrasound imaging, as well as for the measurement of blood flow.

Devices are specifically indicated 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.