The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal (Superficial).

Device Description

The ACUSON Freestyle™ Diagnostic Ultrasound System is a portable ultrasound imaging system where the system operates with linear and curvilinear array transducers. These transducers may be used in a wireless mode or using a probe adaptor cable and is capable of the following modes (these modes below can be operated in combination or individually):

। B-Mode
-Color Doppler Mode
-Amplitude Doppler Mode
The ACUSON Freestyle™ Diagnostic Ultrasound System includes a main unit console with user interface controls, a 15-inch video display, and system electronics. The main unit weighs approximately 10.5 pounds and is 13.2 inches high, 14.7 inches wide, and 5 inches deep. The system may be mounted on a small roll stand, monitor arm, or tabletop. An optional external receiving antenna can be mounted to the unit console, this provides better line of sight to the wireless transducers. The system provides an intuitive and easy-to operate user interface. It has a compact and portable design and offers DICOM archival and networking capability.

AI/ML Overview

The provided text describes the ACUSON Freestyle Diagnostic Ultrasound System (VA41A), a modification of a previously cleared device (ACUSON Freestyle 4.0, VA40A). The document focuses on demonstrating substantial equivalence to the predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.

However, based on the information provided, we can infer the acceptance criteria relate to maintaining equivalence with the predicate device and adhering to established medical device standards. The "study" proving acceptance criteria is a substantial equivalence determination based on comparison and non-clinical testing.

Here's an breakdown based on your request, as much as can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly stated as being substantially equivalent to the predicate device in terms of:

Intended Use and Indications for Use
Technological Characteristics
Safety and Effectiveness

The document does not provide quantitative performance metrics against specific, pre-defined acceptance criteria (e.g., minimum sensitivity, specificity, or image resolution values). Instead, it asserts that the new device, VA41A, maintains the performance and safety profile of the predicate device, VA40A, which was already cleared.

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary of Comparison)
Intended Use	Identical: The device maintains the same intended use: "diagnostic imaging or fluid flow analysis of the human body performed by an appropriately trained healthcare professional in a healthcare setting."
Indications for Use	Modified but Substantially Equivalent: Existing indications (Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal Conventional, Musculoskeletal Superficial) are identical. Some indications (Fetal, Cardiac, Neonatal Cephalic, Intraoperative Neurological) were deleted. The addition of the L17-5 transducer expands capabilities for existing indications but does not introduce new types of clinical applications.
Technological Characteristics	Largely Identical with Minor Modifications/Enhancements:- Imaging modes (B-Mode, Color Doppler, Amplitude Doppler, M-mode, PWD) are identical.- Transducer frequencies are identical for existing transducers (L8-3, L13-5, C5-2).- New Transducer: Introduction of L17-5 (5.0 - 17.0 MHz) with higher frequency for improved near-field resolution.- Imaging functions (Multi-Hertz, Beam-free, Spatial Compounding, Speckle Filter, TGC, Auto Send, Auto Study Management, Needle V, Measurements, Trapezoidal Imaging, Cine Capture) are identical, with new Dual Mode and Split Mode.- Wireless features, FCC compliance, battery operation, connectivity, monitoring, OS, output display, patient contact materials, and UL certification are identical.
Safety and Effectiveness	Confirmed by Compliance: Evaluated for acoustic output, cleaning, disinfection, thermal, electromagnetic, and mechanical safety. Found to conform to applicable medical device safety standards (AIUM/NEMA UD-2, UD-3, ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, IEC 62359, IEC 60601-1-6, IEC 62304, ISO 10993-1, ISO 14971). No new issues of safety or effectiveness are raised.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Since the ACUSON Freestyle Diagnostic Ultrasound System is a class II device and uses the same technology and operating principles as existing predicate device, ACUSON Freestyle Ultrasound System (K162417), therefore clinical studies were not required to support substantial equivalence."

This indicates that there was no dedicated clinical test set for evaluating the performance of the VA41A in human subjects. The assessment relies on a comparison to the predicate device and non-clinical engineering and safety testing. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable here because such a study was not performed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As there was no clinical test set requiring ground truth establishment from human readings, this information is not applicable.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring ground truth establishment from human readings, this information is not applicable.

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

The device described is a diagnostic ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not applicable.

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

This refers to an AI algorithm's performance in isolation. As the device is an ultrasound system and not an AI algorithm for image interpretation, this is not applicable. The "device" itself is the imaging system, and its performance is evaluated through engineering and safety standards, and equivalence to a predicate, not as an AI algorithm.

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

For the non-clinical testing and comparison to standards, the "ground truth" would be established by:

Engineering specifications and measurements: For acoustic output, thermal properties, electromagnetic compatibility, and mechanical safety.
Standard compliance: Adherence to recognized national and international standards (e.g., AIUM/NEMA, ANSI AAMI, IEC, ISO).
Predicate device characteristics: The established performance and safety profile of the legally marketed predicate device (ACUSON Freestyle 4.0, VA40A).

8. The Sample Size for the Training Set

As this is not an AI/ML device, the concept of a "training set" is not applicable.

9. How the Ground Truth for the Training Set was Established

As this is not an AI/ML device, the concept of a "training set" and its ground truth establishment is not applicable.

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 and Human Services seal on the left and the FDA acronym and name on the right. The Department of Health and Human Services seal is a circular emblem with a stylized caduceus in the center. The FDA acronym is in a blue square, and the words "U.S. Food & Drug Administration" are in blue text to the right of the square.

April 10, 2020

Siemens Medical Solutions USA, Inc. % Shruti Arora Regulatory Affairs Specialist 685 East Middlefield Road MOUNTAIN VIEW CA 94043

Re: K200644

Trade/Device Name: ACUSON Freestyle™ Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, OIJ, ITX Dated: March 10, 2020 Received: March 11, 2020

Dear Shruti Arora:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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

for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200644

Device Name

ACUSON Freestyle Diagnostic Ultrasound System

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

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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

510 (k) Number (if known):

Device Name:

ACUSON Freestyle™ Diagnostic Ultrasound System

Intended Use:

Diagnostic imaging or fluid flow analysis of the human body as follows:

ClinicalApplication	B	M	PWD	ColorDoppler	AmplitudeeDoppler
Ophthalmic
Fetal
Abdominal	P			P	P
Intraoperative
IntraoperativeNeurological
Pediatric	P			P	P
Small Organ(Note 1)	P			P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P			P	P
Laparoscopic
Musculo-skeletalConventional	P	P	P	P	P
Musculo-skeletalSuperficial	P	P	P	P	P
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

Additional Comments:
Note 1

B-mode and PWD mode or Color Doppler and PW mode Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

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

510 (k) Number (if known):

Device Name:	L8-3 Linear Array Transducer
Intended Use:	Diagnostic imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)(Note 2)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P				P	P
Intraoperative
IntraoperativeNeurological
Pediatric		P				P	P
Small Organ(Note 1)		P				P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P				P	P
Laparoscopic
Musculo-skeletalConventional		P				P	P
Musculo-skeletalSuperficial		P				P	P
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

Note 1 For example: breast, testes, thyroid, penis etc.

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)__

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

510 (k) Number (if known):

Device Name: L13-5 Linear Array Transducer Intended Use: Diagnostic imaging or fluid flow analysis of the human body as follows: Mode of Operation Combined Color Color Amplitude Other CWD Clinical Application A B M PWD Velocity (Specify) Doppler Doppler (Specify) lmaging (Note 2) Ophthalmic Fetal P P P Abdominal Intraoperative

IntraoperativeNeurological
Pediatric	P	P	P
Small Organ(Note 1)	P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel	P	P	P
Laparoscopic
Musculo-skeletalConventional	P	P	P
Musculo-skeletalSuperficial	P	P	P
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc. Note 1

Note 2 B-mode and PWD mode or Color Doppler and PW mode

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

{6}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:		L17-5 Linear Array TransducerDiagnostic imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)(Note 2)	Other(Specify)
Ophthalmic
Fetal
Abdominal		N				N	N
Intraoperative
IntraoperativeNeurological
Pediatric		N				N	N
Small Organ(Note 1)		N				N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N				N	N
Laparoscopic
Musculo-skeletalConventional		N				N	N
Musculo-skeletalSuperficial		N				N	N
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc.
B-mode and PWD mode or Color Doppler and PW mode Note 1

Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

{7}------------------------------------------------

510 (k) Number (if known):

Device Name:Intended Use:	C5-2 Curvilinear Array TransducerDiagnostic imaging or fluid flow analysis of the human body as follows:
	Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	ColorVelocityImaging	Combined(Specify)(Note 2)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P				P	P
Intraoperative
IntraoperativeNeurological
Pediatric		P				P	P
Small Organ(Note 1)		P				P	P
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P				P	P
Laparoscopic
Musculo-skeletalConventional		P				P	P
Musculo-skeletalSuperficial		P				P	P
Other (specify)

N = new indication; P = previously cleared by K162417, Blank = Not Claimed

Additional Comments:

For example: breast, testes, thyroid, penis etc.
B-mode and PWD mode or Color Doppler and PW mode Note 1

Note 2

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off - Office of In Vitro Diagnostic Devices 510(k)_

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the text 'K200644' in a simple, sans-serif font. The text is black and appears to be on a white background. The letters and numbers are evenly spaced and of uniform size, creating a clear and legible sequence.

Image /page/8/Picture/2 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots arranged in a circular pattern.

510(K) SUMMARY

This summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21CFR §807.92.

Date:	March 10th, 2020
1. Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Shruti AroraTel: (425) 375-6890
2. Device Name:	ACUSON Freestyle™ Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:IIReview Category:Tier IIClassification Panel:Radiology	Regulatory Class:	II	Review Category:	Tier II	Classification Panel:	Radiology
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology
	Ultrasonic Pulsed Doppler Imaging System892.155090-IYNUltrasonic Pulsed Echo Imaging System892.156090-IYO90-OIJDiagnostic Ultrasound Transducer892.157090-ITX	Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN	Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO90-OIJ	Diagnostic Ultrasound Transducer	892.1570	90-ITX
Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO90-OIJ
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Manufacturing Site:	Siemens Medical Solutions USA, Inc.5168 Campus DrivePlymouth Meeting, PA 19462, UNITED STATES

3. Legally Marketed Predicate Devices

The ACUSON Freestyle Diagnostic Ultrasound System; v4.1 (VA41A) is a portable ultrasound imaging system with accessories and proprietary software. This subject device VA41A is a modification to the predicate device and is substantially equivalent to the company's legally marketed device, ACUSON Freestyle 4.0 (VA40A) previously cleared as represented below:

Predicate Device	510(k) Number	Clearance Date
ACUSON Freestyle™Ultrasound System (v4.0)	K162417	09/28/2016

{9}------------------------------------------------

Image /page/9/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

4. Device Description

। B-Mode
-Color Doppler Mode
-Amplitude Doppler Mode

The ACUSON Freestyle™ Diagnostic Ultrasound System includes a main unit console with user interface controls, a 15-inch video display, and system electronics. The main unit weighs approximately 10.5 pounds and is 13.2 inches high, 14.7 inches wide, and 5 inches deep. The system may be mounted on a small roll stand, monitor arm, or tabletop. An optional external receiving antenna can be mounted to the unit console, this provides better line of sight to the wireless transducers. The system provides an intuitive and easy-to operate user interface. It has a compact and portable design and offers DICOM archival and networking capability.

The ACUSON Freestyle Ultrasound System is intended for diagnostic imaging or fluid flow analysis performed by an appropriately trained healthcare professional in a healthcare setting for the following conditions: Abdominal, Pediatric, Small Organ, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial. The system also provides the ability to measure anatomical structures using distance, ellipse and area measurements. This information may be used adjunctively with other medical data obtained by a physician for clinical diagnostic purposes.

5. Intended Use and Indications for Use Statement

6. Comparison of Technological Characteristics with the Predicate Device

The modified ACUSON Freestyle Diagnostic Ultrasound System is substantially equivalent to the company's own previously cleared ACUSON Freestyle. VA40A (K162417) with regard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound system function in the same manner as all diagnostic ultrasound systems and transducers.

The submission device differs from the predicated devices as following:

. The modified ACUSON Freestyle Diagnostic Ultrasound System includes the addition of the L17-5 transducer. The L17-5 transducer is substantially equivalent to the L13-5 in its indications for use and fundamental scientific technology where L13-5 was cleared as a part of the ACUSON Freestyle VA40A (v4.0) under K162417 . L17-5 is a modified version of L13-5 with higher frequency capability to improve near field resolution.
The modified ACUSON Freestyle Diagnostic Ultrasound System updated the indications for use statement (Intended use) to delete the following indications: Fetal, Cardiac, Neonatal Cephalic. Intraoperative neurological and rephrased to include

{10}------------------------------------------------

Image /page/10/Picture/1 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

the operator qualification and device use setting (previously cleared on the predicate device under K162417).

The modified ACUSON Freestyle Diagnostic Ultrasound System incorporates other device usability enhancements and improved imaging features: Dual screen capability (viewing two imaging areas side by side), Import/export system settings, inclusion of digital video output (to support use of the device in interventional suites without the need for video converters), product data security (prevent unauthorized access to system or patient data) and software updates to enhance the user workflow and security requirements..
The foundation of the ACUSON Freestyle (this submission) is the ACUSON Freestyle (K162417) which will be updated with the VA41A software version supporting all transducers (L8-3, C5-2, L13-5 and L17-5) and all device clinical application. The ACUSON Freestyle with software version VA41A is substantially equivalent to the predicate device with regard to both the intended use, indications for use and technological characteristics. The table below compares the technological characteristics between the submission device and the predicate devices.

		Predicate Device (K162417)		Proposed/Submission Device
Feature /Characteristic	ACUSONFreestyle VA40A(v4.0)	ACUSON FreestyleElite VA40A (v4.0)	ACUSON FreestyleVA41A (v4.1)	ACUSONFreestyle EliteVA41A (v4.1)	SE ComparativeConclusion
Device Classification(Regulation, DeviceClass, Product codeand panel)	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, RadiologyUltrasonic Pulsed DopplerImaging System; 21 CFR #892.1550Product Code: IYNUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: IYOUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: OIJDiagnostic UltrasoundTransducer; 21 CFR # 892.1570Product Code: ITX	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, RadiologyUltrasonic Pulsed DopplerImaging System; 21 CFR #892.1550Product Code: IYNUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: IYOUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: OIJDiagnostic UltrasoundTransducer; 21 CFR # 892.1570Product Code: ITX	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, RadiologyUltrasonic Pulsed DopplerImaging System; 21 CFR #892.1550Product Code: IYNUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: IYOUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: OIJDiagnostic UltrasoundTransducer; 21 CFR # 892.1570Product Code: ITX	Regulatory Class: IIReview Category: Tier IIClassification Panel: 90, RadiologyUltrasonic Pulsed DopplerImaging System; 21 CFR #892.1550Product Code: IYNUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: IYOUltrasonic Pulsed Echo ImagingSystem; 21 CFR # 892.1560Product Code: OIJDiagnostic UltrasoundTransducer; 21 CFR # 892.1570Product Code: ITX	IDENTICAL
Indications for Use:
■ Fetal	√	√	-	-	MODIFIED(Indication deleted)
■ Abdominal	√	√	√	√	IDENTICAL
■ Pediatric	√	√	√	√	IDENTICAL
■ Small Organ¹	√	√	√	√	IDENTICAL
■ Cardiac	√	√	-	-	MODIFIED(Indication deleted)
		Predicate Device (K162417)		Proposed/Submission Device
Feature /Characteristic	ACUSONFreestyle VA40A(v4.0)	ACUSON FreestyleElite VA40A (v4.0)	ACUSON FreestyleVA41A (v4.1)	ACUSONFreestyle EliteVA41A (v4.1)	SE ComparativeConclusion
■Intraoperative	√	√	-	-	MODIFIED(Indication deleted)
■IntraoperativeNeurological	√	√	-	-	MODIFIED(Indication deleted)
■Peripheral vessel	√	√	√	√	IDENTICAL
■Musculo-skeletal(conventional)	√	√	√	√	IDENTICAL
■Musculo-skeletal(superficial)	√	√	√	√	IDENTICAL
■Neonatal cephalic	√	√	-	-	MODIFIED(Indication deleted)
Imaging Modes:
■B	√	√	√	√	IDENTICAL
■Color Doppler	√	√	√	√	IDENTICAL
■Power(Amplitude)Doppler	√	√	√	√	IDENTICAL
TransducerFrequencies
Supported:
■L8-3 (Linear)	√(3.0 - 8.0) MHz	√(3.0 - 8.0) MHz	√(3.0 - 8.0) MHz	√(3.0 - 8.0) MHz	IDENTICAL
■L13-5 (Linear)	√(5.0 - 13.0) MHz	√(5.0 - 13.0) MHz	√(5.0 - 13.0) MHz	√(5.0 - 13.0) MHz	IDENTICAL
■C5-2 (Curvilinear)	√(2.0 - 5.0) MHz	√(2.0 - 5.0) MHz	√(2.0 - 5.0) MHz	√(2.0 - 5.0) MHz	IDENTICAL
■L17-5 (Linear)	-	-	√(5.0 - 17.0) MHzNew	√(5.0 - 17.0) MHzNew	MODIFIED(introduction of L17-5transducer)
Imaging functions,Controls andDisplay:
■Multi-Hertzmultiplefrequencyimaging	√	√	√	√	IDENTICAL
■Beam-freesynthetic apertureand Pixelformerimage	√	√	√	√	IDENTICAL
■SpatialCompounding	√	√	√	√	IDENTICAL
■Speckle Filter	√	√	√	√	IDENTICAL
■Time/Gaincompensationfunction	√	√	√	√	IDENTICAL
■Auto Send	√	√	√	√	IDENTICAL
■Auto StudyManagement	√	√	√	√	IDENTICAL
			Predicate Device (K162417)	Proposed/Submission Device
Feature /Characteristic		ACUSONFreestyle VA40A(v4.0)	ACUSON FreestyleElite VA40A (v4.0)	ACUSON FreestyleVA41A (v4.1)	ACUSONFreestyle EliteVA41A (v4.1)	SE ComparativeConclusion
■	Multiple angleneedlevisualization(Needle V)	√ (Optional)	√	√	√	IDENTICAL
■	Measurements(Distance, Area,Elliptical)	√	√	√	√	IDENTICAL
■	Trapezoidal(Wide) Imaging	√	√	√	√	IDENTICAL
■	Dual Mode	-	-	√ New	√ New	MODIFIED
■	Split Mode	-	-	√ New	√ New	MODIFIED
■	Cine Capture
	- Clip Storelength	Upto 30 secs	Upto 30 secs	Upto 30 secs	Upto 30 secs	IDENTICAL
	- Clip replayonsystem	√	√	√	√	IDENTICAL
■	Artis PatientSynchronization	-	√ (Optional)	-	√	IDENTICAL
■	Artis Access(includes Artispatientsynchronization,external antenna& Freestyle Eliteto Artis LargeDisplay mounting)	-	√ (Optional)	-	√	IDENTICAL
	Wireless Transducer
■	WirelessUltrasound ImageTransmission	B, Color,Amplitude	B, Color, Amplitude	B, Color, Amplitude	B, Color,Amplitude	IDENTICAL
■	Meets FCC Part15 Subpart B:UnintentionalRadiators	√	√	√	√	IDENTICAL
■	Meets FCC Part15 Subpart C:IntentionalRadiators	√	√	√	√	IDENTICAL
■	Meets FCC Part15 Subpart F:Ultra-WidebandOperation	√	√	√	√	IDENTICAL
■	Meets FCC Part95 (WMTS)	-	-	-	-	IDENTICAL
■	Frequency RangeRF Transmitter	7.5-8.5 GHz	7.5-8.5 GHz	7.5-8.5 GHz	7.5-8.5 GHz	IDENTICAL
■	Lithium IonBattery Operation	√	√	√	√	IDENTICAL
	Connectivity
		Predicate Device (K162417)	Proposed/Submission Device
Feature /Characteristic	ACUSONFreestyle VA40A(v4.0)	ACUSON FreestyleElite VA40A (v4.0)	ACUSON FreestyleVA41A (v4.1)	ACUSONFreestyle EliteVA41A (v4.1)	SE ComparativeConclusion
■Wireless network	√	√	√	√	IDENTICAL
■External Antenna	√ (Optional)	√ (Optional)	√ (Optional)	√ (Optional)	IDENTICAL
■DICOMCompatibility(Storage,Commit, MWL,MPPS & Media)	√ (Optional)	√	√ (Optional)	√	IDENTICAL
■Mobile Link App(connection)	√	√	√	√	IDENTICAL
Monitor: 15 inch (38.1cm) high-bright LEDLCD	√	√	√	√	IDENTICAL
Software OperatingSystem (GreenHillsIntegrity RTOS)	√	√	√	√	IDENTICAL
Output DisplayStandard (Track 3)	√	√	√	√	IDENTICAL
Patient ContactMaterials	Tested to ISO10993-1	Tested to ISO 10993-1	Tested toISO 10993-1	Tested toISO 10993-1	IDENTICAL
UL 60601-1 Certified	√	√	√	√	IDENTICAL

List of Technological characteristics and SE comparison

1 Includes Breast, Thyroid, testicles and lymph nodes.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a cluster of orange dots.

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

Substantial Equivalence Conclusion: From the information provided in table above; it is understood that the subject device does not introduce any new technology and/or indications of use; therefore, ACUSON Freestyle VA41A is considered substantially equivalent to the predicate device; the ACUSON Freestyle VA40A.

{14}------------------------------------------------

Image /page/14/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

7. Summary of Design Control Activities and Performance Data

The ACUSON Freestyle Diagnostic Ultrasound System is verified and validated according to the design control requirements of 21 CFR 820 and ISO 13485:2016 quality system standards. The subject device had been subjected to extensive safety and performance testing before release to ensure the device meets all its specifications. The quality assurance measures applied to the design and development of the subject device include, but not limited to risk analysis, verification and validation, product specifications and design reviews.

Software Verification and Validation Testing:

Software documentation for a Moderate Level of Concern software per FDA's guidance document "Guidance for the Content of Premarket Submission for Software contained in Medical Devices" issued on May 11, 2005 is included as part of this submission.

Non-Clinical/Clinical Testing Summary:

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

-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
-Refer to the table below for the Safety/EMC and Biocompatibility standards.

RecognitionNumber	Product Area	Title of Standard	PublicationDate	Standarddevelopmentorganization
19-4	General II (ES/EMC)	ANSI AAMI ES60601-1:2005/(R)2012 andA1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated text)Medical electrical equipment - Part 1:General requirements for basic safety andessential performance (IEC 60601-1:2005,MOD)	07/09/2014	ANSI AAMI
19-8	General II (ES/EMC)	IEC 60601-1-2 Edition 4.0 2014-02 -Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests	09/17/2018	ANSI AAMIIEC
12-293	Radiology	IEC 60601-2-37 Edition 2.1 2015 Medicalelectrical equipment - Part 2-37: Particularrequirements for the basic safety andessential performance of ultrasonic medicaldiagnostic and monitoring equipment	06/27/2016	IEC
12-316	Radiology	IEC 62359 Edition 2.1 2017-09Consolidated Version - Ultrasonics - Fieldcharacterization – Test methods for thedetermination of thermal and mechanicalindices related to medical diagnosticultrasonic fields	06/07/2018	IEC
5-89	General I (QS/RM)	IEC 60601-1-6 Edition 3.1 2013-10Medical electrical equipment - Part 1-6:General requirements for basic safety and	06/27/2016	IEC

Compliance Summary to Voluntary Standards

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots of varying sizes.

		essential performance - CollateralStandard: Usability
13-79	Software/Informatics	IEC 62304 Edition 1.1 2015-06Consolidated Version Medical devicesoftware - Software life cycle processes.	01/14/2019	IEC
2-220	Biocompatibility	ISO 10993-1 Fourth edition 2009-10-15,Biological evaluation of medical devices -Part 1: Evaluation and testing within a riskmanagement process [Including: TechnicalCorrigendum 1 (2010)]	07/26/2016	ISO

Since the ACUSON Freestyle Diagnostic Ultrasound System is a class II device and uses the same technology and operating principles as existing predicate device, ACUSON Freestyle Ultrasound System (K162417), therefore clinical studies were not required to support substantial equivalence.

Further the device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis which identifies potential hazards and is conducted according to ISO 14971:2007 standard. These potential hazards are controlled during development, verification and validation testing for each of the device modifications. The complete risk analysis is available in the device risk hazard analysis report included as part of this submission.

9. Summary

Based on the information provided here in the summary and from the comparison of the device with predicate in table above; ACUSON Freestyle Diagnostic Ultrasound System (VA41A) has the same intended use (indications for use) as the predicate device; incorporates technological features of the predicate device cleared through premarket notification and performance testing indicates that no new issues of safety or effectiveness are raised.

Siemens Medical Solutions USA, Inc. considers the ACUSON Freestyle Diagnostic Ultrasound System VA41A (v4.1) to be substantially equivalent with respect to safety and effectiveness to the previously cleared predicate device for the U.S. market.

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.