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

Device Description

The AcuNav catheters are, disposable, and licensed for single use only. The catheter is optimized for intracardiac scanning. With the catheter, the physician can maneuver the imaging plane located inside the catheter tip to see the region of interest. The physician can steer the catheter to optimize tissue visualization.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens AcuNav Diagnostic Ultrasound Catheter 8F, 10F. It states that the device is substantially equivalent to a previously cleared predicate device (AcuNav Diagnostic Ultrasound Catheter 8F, 10F, K071234) and therefore does not provide information on acceptance criteria or a study proving that the device meets those criteria through clinical data.

The summary explicitly states: "Because the AcuNav catheters 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."

Instead, the submission relies on the substantial equivalence to a predicate device and non-clinical tests to demonstrate safety and effectiveness.

Here is a breakdown of the information that can be extracted or deduced from the document, along with an explanation of why other requested information is not available:

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

Since no clinical study demonstrating performance against specific acceptance criteria was required or provided, this table cannot be populated from the given document. The document focuses on demonstrating that the new device shares the same "Features/Characteristic" of the predicate, implying that if the predicate performed acceptably, so will the new device.

Feature/Characteristic	Acceptance Criteria (Not explicitly stated for new device performance)	Reported Device Performance (Implied by Substantial Equivalence to Predicate)
Indications for use:	Equivalent to predicate	Cardiac, Pediatric, Intra-luminal, Intra-cardiac visualization
- Cardiac	Equivalent to predicate	√
- Pediatric	Equivalent to predicate	√
- Intra-luminal	Equivalent to predicate	√
- Intra-cardiac	Equivalent to predicate	√
Mode of operation:	Equivalent to predicate	2D, C, D, CW
- 2D	Equivalent to predicate	√
- C	Equivalent to predicate	√
- D	Equivalent to predicate	√
- CW	Equivalent to predicate	√
Patient contact materials	ISO 10993-1 compliance	ISO 10993-1 compliant

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. As no clinical study demonstrating performance of the new device was conducted, there are no test sets, data provenance, or sample sizes associated with such a study in this document. The submission relies on the established safety and effectiveness of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical test set data was provided for the new device.

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

Not applicable. No clinical test set data was provided for the new device.

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:

Not applicable. This device is a diagnostic ultrasound catheter, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.

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

Not applicable. This device is not an algorithm, but rather a medical hardware device.

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

Not applicable. No clinical test set data was provided for the new device.

8. The sample size for the training set:

Not applicable. No training set for an algorithm for the new device was mentioned. The device is a hardware component.

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

Not applicable. No training set for an algorithm for the new device was mentioned.

Summary of Non-Clinical Tests:

The document mentions that the device has been evaluated for:

Acoustic output
Biocompatibility
Cleaning and disinfection effectiveness
Thermal, electrical, electromagnetic, and mechanical safety

And has been found to conform with applicable medical device safety standards, including:

UL 60601-1
IEC 60601-2-37
AIUM/NEMA UD-3
AIUM/NEMA UD-2
EN/IEC 60601-1, 60601-1-1, 60601-1-2
ISO 10993-1 (Biocompatibility)

These non-clinical tests serve as the basis for demonstrating the safety of the device, implying that meeting these standards is an "acceptance criteria" for the non-clinical aspects, but they do not relate to clinical performance criteria for diagnosis or imaging quality against a ground truth.

Summary

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Public Health Service

Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three human profiles facing to the right, stacked on top of each other.

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

June 15, 2017

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

Re: K170263

Trade/Device Name: AcuNav Diagnostic Ultrasound Catheter 8F, 10F Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ Dated: May 2, 2017 Received: May 23, 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 device

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related 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.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

MA. Hillebrand

for 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)

K170263

Device Name

AcuNav Diagnostic Ultrasound Catheter 8F, 10F

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)

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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: 650-279-0134 Email: shelly.pearce@siemens.com

SUBMISSION DATE

Mav 2, 2017

TRADE NAME

AcuNav Diagnostic Ultrasound Catheter 8F, 10F

COMMON NAME

Ultrasound Catheter

CLASSIFICATION NAME/PRODUCT CODE

Intravascular Ultrasound Catheter/OBJ

CLASSIFICATION

Class II, 21 CFR 870.1200

PREDICATE DEVICE

#K071234, ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10

DESCRIPTION OF MODIFIED DEVICE

The catheters are to be used only on systems with which they have 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.

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INDICATIONS FOR USE

SUBSTANTIAL EQUIVALENCE CONCLUSION

The AcuNav 8F, 10F ultrasound catheters are substantially equivalent to the company's own previously cleared AcuNav Diagnostic Ultrasound Catheter 8F, 10F (K071234) 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 8F, 10FThis Submission	AcuNav 8F, 10FK071234
Indications for use:
- Cardiac	√	√
- Pediatric	√	√
- Intra-luminal	√	√
- Intra-cardiac	√	√
Mode of operation:
- 2D	√	√
- C	√	√
- D	√	√
- CW	√	√
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, electrical, 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/EC 60601-1
- o EN/IEC 60601-1-1
- o EN/IEC 60601-1-2
I ISO 10993-1 Biocompatibility

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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 catheters 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. 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 AcuNav Diagnostic Ultrasound Catheters are 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).