AcuNav Volume ICE Catheter

K163478 · Siemens Medical Solutions USA, Inc. · OBJ · Feb 9, 2017 · Cardiovascular

Device Facts

• Record ID: K163478
• Device Name: AcuNav Volume ICE Catheter
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: OBJ · Cardiovascular
• Decision Date: Feb 9, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.

Device Story

AcuNav Volume is a 12.5F, 90 cm steerable intracardiac echocardiography (ICE) catheter; provides real-time 3D and 2D ultrasound images of cardiac structures and devices. Used in clinical settings by physicians for imaging guidance during percutaneous cardiac interventions. Catheter features four-way steering; connects to ultrasound system via electrical connector. Provides visual feedback to clinicians to assist in procedural navigation and device placement. Benefits include enhanced visualization of cardiac anatomy and physiology during minimally invasive procedures.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electromagnetic, and mechanical safety testing.

Technological Characteristics

12.5F steerable ultrasound catheter; 90 cm length; four-way steering mechanism. Materials conform to ISO 10993-1. Sterilization via EtO. Complies with UL 60601-1, IEC 60601-2-37, AIUM/NEMA UD-2, and UD-3. Single-use device.

Indications for Use

Indicated for imaging guidance during cardiac interventional percutaneous procedures, intraluminal visualization of great vessel anatomy/physiology, and intracardiac visualization of anatomy, physiology, and devices in 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 V diagnostic ultrasound catheter (K081808)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 9, 2017

Siemens Medical Solutions USA, Inc. Shelly Pearce Director, Regulatory Affairs 685 East Middlefield Road Mountain View, California 94043

Re: K163478

Trade/Device Name: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: January 19, 2017 Received: January 27, 2017

Dear Shelly 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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); medical device reporting (reporting of medical devicerelated 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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# Indications for Use

510(k) Number (if known) K163478

#### Device Name

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

Indications for Use (Describe)

The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 14 510(k) Summary

## SPONSOR'S NAME & ADDRESS

Siemens Medical Solutions USA, Inc. 685 East Middlefield Road Mt. View, CA 94043

## OFFICIAL CORRESPONDENT

Shelly Pearce Director, Regulatory Affairs Phone: [phone] Email: [e-mail]

## SUBMISSION DATE

November 18, 2016

## TRADE NAME

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

## COMMON NAME

Ultrasound Catheter

### CLASSIFICATION NAME/PRODUCT CODE

Intravascular Ultrasound Catheter/OBJ

### CLASSIFICATION

Class II, 21 CFR 870.1200

### PREDICATE DEVICE

The AcuNav Volume is substantially equivalent to the AcuNav V diagnostic ultrasound catheter.

### DESCRIPTION OF MODIFIED DEVICE

The ACUSON AcuNav Volume ICE Catheter is a 12.5F catheter with 90 cm of usable length and four-way steering that provides real-time three-dimensional ultrasound images of anatomical structures and devices, in addition to conventional real-time twodimensional images.

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## INDICATIONS FOR USE

The AcuNav Volume is intended for imaging guidance, not treatment delivery, of cardiac interventional percutaneous procedures; intraluminal visualization of great vessel anatomy and physiology; intracardiac visualization of cardiac anatomy, physiology, and devices within the heart of an adult or a pediatric patient.

## DESCRIPTION OF MODIFICATION

This is the initial release of the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

## SUMMARY OF NONCLINICAL TESTS

To support the design change of the catheter, Design Verification Testing was performed on the modified ACUNAV VOLUME CATHETER.

Safety and Electromagnetic Compliance testing was also performed to support the design changes on the predicate device. The Safety and Electromagnetic compliance testing validates the use of the modified device.

## SUBSTANTIAL EQUIVALENCE CONCLUSION

The AcuNav Volume diagnostic ultrasound catheter is substantially equivalent to the company's own previously cleared Acuson AcuNav V diagnostic ultrasound catheter (K081808) with regard to both intended use and technological characteristics. Both the subject catheter and the predicate catheter functions in the same manner as all diagnostic ultrasound catheters.

| Feature / Characteristic | AcuNav Volume<br>This Submission | AcuNav V<br>K081808 |
|-----------------------------|----------------------------------|---------------------|
| <b>Indications for Use:</b> | | |
| ■ Cardiac | √ | √ |
| ■ Pediatric | √ | √ |
| ■ Intraluminal | √ | √ |
| ■ Intraoperative | √ | √ |
| ■ Intra-cardiac | √ | √ |
| Patient Contact Materials | ISO 10993-1 | ISO 10993-1 |

A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

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The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electromagnetic and mechanical safety and has been found to conform with applicable medical device safety standards. The device complies with the following voluntary standards:

- I UL 60601-1, Safety Requirements for Medical Equipment
- IEC 60601-2-37 Diagnostic Ultrasound Safety Standards I
- I AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- I AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
- I Safety and EMC Requirements for Medical Equipment
- o EN/IEC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
- I ISO 10993-1 Biocompatibility

Cleared patient contact materials and mechanical safety are unchanged.

## A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Because the AcuNav Volume in this submission uses the same technology, patient contact materials and principles as the predicate device, clinical data is not required to establish substantial equivalence.

Intended use and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards. The product is designed to conform to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore it is the opinion of Siemens Medical that the ACUSON AcuNav Volume ICE Catheter is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

## SIMILARITIES TO THE PREDICATE DEVICES

a) The modified ACUNAV VOLUME is identical to the currently cleared ACUNAV V in the following aspects:

- Have the same intended use .
- Use the same operating principle •
- Are manufactured in the same manufacturing facility .
- Use the same fundamental scientific technology .
- . Incorporate the same materials and construction
- Have the same deflection mechanism .
- Catheter body & strain relief have identical assembly process .

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- . Have the same acoustic array location and connection
- Are packaged using the same materials and processes .
- Have the same Electronics; the PCB is inside the Hypertronic connector . and Extension Cable
- Identical magnetic sensor location (not connected to the Printed Circuit . Board (PCB))
- Have the same handle material •
- . Have the same Steering mechanism
- Have identical Hypertronic connector .
- Most of the manufacturing processes are identical .
- . Have the same shelf life
- Use the same sterilization method (EtO sterilization) .
- Are single use devices .

## DIFFERENCES FROM THE PREDICATE DEVICES

Some of the differences between the modified ACUNAV VOLUME CATHETER and the currently cleared ACUNAV V CATHETER are:

- a) Tip dimensions
- b) Distal shaft dimension
- c) Electrical connector
- d) Packaging

| | AcuNav V | AcuNav Volume |
|----------------------------|--------------------------------------------|------------------------------------------------|
| Tip Dimensions | 10F | 12.5F |
| Distal Shaft<br>Dimensions | 10F | 12.5F |
| Electrical<br>Connector | Twist and lock mechanism | Push and lock mechanism |
| Packaging | Paper board tray | Paper board tray |
| | Double Pouch | Single Pouch |
| | Telescoping two-piece CCSBS unit<br>carton | Non-telescoping one-piece CCSBS unit<br>carton |