The catheter is intended for intracardiac 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. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

Device Description

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 two-dimensional images. Modifications include the clarification to the indications for use statement and the update of labeling. There are no new indications for use in this modification.

AI/ML Overview

This document is a 510(k) premarket notification for the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter. It seeks to establish substantial equivalence to a previously cleared device (K163478).

Based on the provided text, there are no acceptance criteria, device performance results, or a study explicitly proving the device meets these criteria in the typical sense of a clinical or analytical performance study with specific metrics. The submission focuses on substantial equivalence based on technological characteristics and a clarification of the Indications for Use.

Here's an breakdown of the requested information based on the document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/device algorithm. Instead, the "acceptance criteria" for this submission appear to be demonstrating substantial equivalence to the predicate device. This is primarily established by showing the new device has the same intended use, technological characteristics, and safety profile as the predicate.
Reported Device Performance: No specific quantitative performance metrics (e.g., sensitivity, specificity) are reported. The document states that the device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electromagnetic, and mechanical safety, and found to conform with applicable medical device safety standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This submission does not describe a clinical test set with human or animal subjects that would require a sample size for performance evaluation. The evaluation is based on non-clinical testing for safety and technological equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. Since no clinical performance study with a test set is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. This submission is for an intracardiac echocardiography catheter, which is a diagnostic imaging device, not an AI algorithm intended to assist human readers or perform automated interpretations. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

No. This device is not an algorithm that operates in a standalone manner. It is a physical catheter that provides imaging guidance to a clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided in the context of a performance study. For the safety and performance evaluations mentioned (acoustic output, biocompatibility, etc.), the "ground truth" would be established by compliance with recognized standards and verified through established testing methodologies.

8. The sample size for the training set

Not applicable/Not provided. This device does not employ machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. No training set is described.

Summary of the Study:

The submission for the ACUSON AcuNav Volume Intracardiac Echocardiography Catheter relies on demonstrating substantial equivalence to a predicate device (ACUSON AcuNav Volume ICE Catheter, K163478). The key arguments for substantial equivalence are:

Same Intended Use: The indications for use are the same as the predicate, with only a clarification in wording for this submission. The catheter is for intracardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, and visualization of other devices, for imaging guidance during cardiac interventional percutaneous procedures in adult and pediatric patients.
Same Technological Characteristics: The device shares the same technology, patient contact materials, and principles as the predicate device. It is a 12.5F catheter with 90 cm usable length and four-way steering, providing real-time 3D and 2D ultrasound images.
Non-Clinical Testing: The device underwent non-clinical testing to ensure safety and compliance with various standards, including:
- Acoustic output (AIUM/NEMA UD-3, UD-2)
- Biocompatibility (ISO 10993-1)
- Cleaning and disinfection effectiveness
- Thermal, electromagnetic, and mechanical safety (UL 60601-1, IEC 60601-2-37, EN/IEC 60601-1, EN/IEC 60601-1-2)

The submission explicitly states: "Because the ACUSON AcuNav Volume ICE catheter 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." This indicates that no new clinical study was performed or required for this 510(k) submission.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION".

December 19, 2017

Siemens Medical Solutions USA, Inc. Hyunjung Lee Regulatory Technical Specialist 685 East Middlefield Road Mountain View, California 94043

Re: K173618

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: November 21, 2017 Received: November 22, 2017

Dear Hyunjung Lee:

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. Iisting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{1}------------------------------------------------

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerelv.

M.A. Hillebrenner
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K173618

Device Name

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

SPONSOR'S NAME & ADDRESS

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

OFFICIAL CORRESPONDENT

HyunJung Lee Regulatory Technical Specialist Phone: (425) 281-5061 Email: hyunjung.lee@siemens-healthineers.com

SUBMISSION DATE

November 21, 2017

TRADE NAME

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

COMMON NAME

Ultrasound Catheter

CLASSIFICATION NAME/PRODUCT CODE

Diagnostic Intravascular Catheter/ OBJ

CLASSIFICATION

Class II, 21 CFR 870.1200

PREDICATE DEVICE

#K163478, ACUSON AcuNav Volume ICE Catheter

DESCRIPTION OF MODIFIED DEVICE

{4}------------------------------------------------

INDICATIONS FOR USE

The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

SUBSTANTIAL EQUIVALENCE CONCLUSION

The ACUSON AcuNav Volume ICE catheter is substantially equivalent to the company's own previously cleared AcuNav Volume ICE catheter (K163478) with regard to both intended use and technological characteristics. Both the subject catheters and the predicate catheters function in the same manner as all diagnostic ultrasound catheters.

Feature / Characteristic	AcuNav Volume ICEThis Submission	AcuNav Volume ICEK163478
Indications for Use:
■ Cardiac	√	√
■ Pediatric	√	√
■ Intra-luminal	√	√
■ 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.

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
l IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
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/EC 60601-1
- o EN/IEC 60601-1-2
I ISO 10993-1 Biocompatibility

Cleared patient contact materials and mechanical safety are unchanged.

{5}------------------------------------------------

A SUMMARY DISCUSSION OF THE CLINICAL TESTS SUBMITTED, REFERENCED, OR RELIED ON FOR A DETERMINATION OF SUBSTANTIAL EQUIVALENCE.

Because the ACUSON AcuNav Volume ICE catheter 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.

SUMMARY

Intended use and other key features are consistent with traditional clinical practice and FDA guidelines. Changes to the currently cleared AcuNav Volume ICE catheter include 1) a clarification to the indications for use statement and 2) update on labeling. There are no new Indications for Use in this device modification. 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.

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
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.(b)
Classification. Class II (performance standards).