Acuson Freestyle Ultrasound System

• K Number: K162417
• Device Name: Acuson Freestyle Ultrasound System
• Manufacturer: Siemens Medical Solutions, Inc.
• Date Cleared: 2016-09-28 ( 29 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Device Description

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

Predicate Devices

K100598, K152369

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary does not mention AI, ML, or any related terms, nor does it describe any features or performance metrics typically associated with AI/ML-powered devices.

Therapeutic

No
The device is described as an "ultrasound imaging system" intended for "diagnostic imaging or fluid flow analysis," which indicates a diagnostic rather than a therapeutic purpose.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states "The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body".

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an "ultrasound imaging system" that operates with "linear, curvilinear, array transducers," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the ACUSON Freestyle™ Ultrasound System is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states "diagnostic imaging or fluid flow analysis of the human body". This describes a device used for in vivo (within the living body) imaging, not for testing samples in vitro (outside the body).
• Device Description: The description details an ultrasound imaging system that uses transducers to image the human body. This aligns with in vivo imaging.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside of the body, which are hallmarks of IVD devices.

Therefore, the ACUSON Freestyle™ Ultrasound System is a medical imaging device used for diagnostic purposes within the human body, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX

Device Description

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Intraoperative Neurological, Pediatric, Small Organ (Breast, Testes, Thyroid, Penis), Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

Indicated Patient Age Range

Fetal, Neonatal, Pediatric, Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The ACUSON Freestyle™ Ultrasound System is a class II device, and uses the same technology and operating principle as the predicate devices; clinical data is not required for substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100598, K152369

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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

September 28, 2016

SIEMENS MEDICAL SOLUTIONS, INC. % Mr. MARK JOB THIRD PARTY REVIEWER REGULATORY TECHNOLOGY SERVICES LLC 1394 25TH STREET, NW BUFFALO MN 55313

Re: K162417

Trade/Device Name: Acuson Freestyle Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: August 29, 2016 Received: August 30, 2016

Dear Mr. Job:

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-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.

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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/Resourcesfor You/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 yours.

Michael D'Hara

For

Robert Ochs Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

ACUSON FreestyleTM Ultrasound System

Indications for Use (Describe)

The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

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) Number (if known):

ACUSON FreestyleTM Diagnostic Ultrasound System Device Name:

Diagnostic Imaging or fluid flow analysis of the human body as follows: Intended Use:

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify:
(Note 2)	Other:
Harmonic
Imaging
Opthalmic
Fetal		P				P	P
Abdominal		P				P	P
Intraoperative (Note 1)		P				P	P
Intraoperative Neurological		P				P	P
Pediatric		P				P	P
Small Organ (Note 3)		P				P	P
Neonatal Cephalic		P				P	P
Adult Cephalic
Cardiac		P				P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel		P				P	P
Laparoscopic
Musculo-skeletal
Conventional		P				P	P
Musculo-skeletal Superficial		P				P	P
Other

N=new indication, P = Previously Cleared, Blank: Not Claimed

Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or Cardiac Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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510(k) Number (if known):

L8-3 Linear Transducer Device Name:

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify:
Note 2)	Other:
Harmonic
Imaging
Opthalmic
Fetal		P				P	P
Abdominal		P				P	P
Intraoperative (Note 1)		P				P	P
Intraoperative Neurological		P				P	P
Pediatric		P				P	P
Small Organ (Note 3)		P				P	P
Neonatal Cephalic		P				P	P
Adult Cephalic
Cardiac		P				P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel		P				P	P
Laparoscopic
Musculo-skeletal
Conventional		P				P	P
Musculo-skeletal Superficial		P				P	P
Other

N=new indication, P = Previously Cleared, Blank: Not Claimed

Additional Comments: Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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

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510(k) Number (if known):

Device Name:

L12-5 Linear Transducer

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color	Amplitude
Doppler Doppler	Color
Velocity
Imaging	Combined
(Specify:
Note 2)	Other: Harmonic
Imaging
Opthalmic
Fetal		P				P	P
Abdominal		P				P	P
Intraoperative (Note 1)		P				P	P
Intraoperative Neurological		P				P	P
Pediatric		P				P	P
Small Organ (Note 3)		P				P	P
Neonatal Cephalic		P				P	P
Adult Cephalic
Cardiac		P				P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel		P				P	P
Laparoscopic
Musculo-skeletal Conventional		P				P	P
Musculo-skeletal Superficial		P				P	P
Other

N=new indication, P = Previously Cleared, Blank: Not Claimed

Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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510(k) Number (if known):

Device Name:

C5-2 Curvilinear Transducer

Intended Use:

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

Clinical Application	Mode of Operation
	A	B	M	PWD	CWD	Color
Doppler	Amplitude
Doppler	Color
Velocity
Imaging	Combined
(Specify:
Note 2)	Other:
Harmonic
Imaging
Opthalmic
Fetal		P				P	P
Abdominal		P				P	P
Intraoperative (Note 1)		P				P	P
Intraoperative Neurological		P				P	P
Pediatric		P				P	P
Small Organ (Note 3)		P				P	P
Neonatal Cephalic		P				P	P
Adult Cephalic
Cardiac		P				P	P
Transesophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral Vessel		P				P	P
Laparoscopic
Musculo-skeletal
Conventional		P				P	P
Musculo-skeletal Superficial		P				P	P
Other

N=new indication, P = Previously Cleared, Blank: Not Claimed

Additional Comments:

Note 1: For example Cardiac Note 2: B Mode and PWD mode, or color Doppler and PW Mode Note 3: Breast, Testes, Thyroid, Penis

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

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510(k) Summary

| Sponsor: | Siemens Medical Solutions, Inc.
Ultrasound Division
5168 Campus Drive
Plymouth Meeting, PA 19462 |

----------	-----------------------------------------------------------------------------------------------------------

Contact Person: Primary Contact: Kevin Kong, RAC Telephone: [phone]

Secondary Contact:

Lawrence Engle Telephone: [phone] Ext 102

• Submission Date: July 8, 2016
  ACUSON Freestyle™ Ultrasound System Device Name:

• Common Name: Diagnostic Ultrasound System

• Classification: Regulatory Class: ll

Review Category: Tier II Classification Panel: 90, Radiology

Ultrasonic Pulsed Doppler Imaging System

• 21 CFR # 892.1550 .
• . Product Code IYN

Ultrasonic Pulsed Echo Imaging System

• . 21 CFR # 892.1560
• Product Code IYO ●

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Diagnostic Ultrasound Transducer

• 21 CFR # 892.1570 .
• . Product Code ITX

Legally Marketed Predicate Devices

The ACUSON Freestyle™ Ultrasound System in this 510k is a modification to Penrith Elettra Diagnostic Ultrasound System (Primary predicate), previously cleared in K100598. The secondary predicate device is the ACUSON S2000 as cleared on K152369.

Device Description:

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

Intended Use

The ACUSON Freestyle™ Ultrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal, Abdominal, Intraoperative, Intraoperative Neurological, Pediatric, Small Organ, Neonatal Cephalic, Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

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Substantial Equivalence

The submission device is a modification to Elettra Ultrasound System previously cleared in K100598 with regard use and technological characteristics and is also substantially equivalent to the ACUSON S2000 as cleared in K152369.

Freestyle™ Ultrasound System Substantial Equivalence Table

| Description | ACUSON S2000
(Predicate K152369) | Penrith Elettra
(Predicate
K100598) | ACUSON
Freestyle™ (This
submission) |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Indications for Use
(Clinical Applications) | The ultrasound imaging systems are intended for the following applications: Fetal,
Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac,
Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial
Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal,
abdominal, intraoperative, pediatric, small organ, neonatal cephalic, adult cephalic,
cardiac, trans-esophageal, transrectal, transvaginal, peripheral vessel, musculo-
skeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and
calculation packages that provide information to the clinician that may be used
adjunctively with other medical data obtained by a physician for clinical diagnosis
purposes.

The Arterial Health Package (AHP) software provides the physician with the
capability to measure Intima Media Thickness and the option to reference
normative tables that have been validated and published in peer-reviewed studies.
The information is intended to provide the physician with an easily understood tool
for communicating with patients regarding state of their cardiovascular system.
This feature should be utilized according to the "ASE Consensus Statement; Use
of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate
Cardiovascular Disease Risk: A Consensus Statement from the American
Association of Echocardiography; Carotid Intima-Media Thickness Task Force, | Diagnostic
Imaging or fluid
flow analysis of
the human body
as follows: Fetal,
Abdominal,
Intraoperative
Intraoperative
Neurological,
Pediatric, Small
Organ, Neonatal
Cephalic, Cardiac,
Peripheral Vessel,
Musculo-skeletal
(Conventional),
Musculo-skeletal
(Superficial) | Same as K100598 |

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| Description | ACUSON S2000
(Predicate K152369) | Penrith Elettra
(Predicate
K100598) | ACUSON
Freestyle™ (This
submission) |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|------------------------------------------------------|
| | Endorsed by the Society for Vascular Imaging. 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 of adult and pediatric patients. | | |
| Product Code(s) | System: IYO, IYN
Transducer: ITX
Catheter: OBJ | -System: IYO, IYN
-Transducers: ITX | -System: IYO, IYN
-Transducers: ITX |
| Transducer Types | -Linear Array
-Phased Array
-Curved Array
-Pencil
-TEE | -Linear Array
-Curvilinear Array | -Linear Array
-Curvilinear Array |
| Description | ACUSON S2000
(Predicate K152369) | Penrith Elettra
(Predicate
K100598) | ACUSON
Freestyle™ (This
submission) |
| Modes of Operation | -B Mode | -B Mode | -B Mode |
| | -M Mode
-Pulsed Wave Doppler (PWD)
-Continuous Wave Doppler (CWD)
-Color Doppler
-Amplitude Doppler
-Combined (BMDC) | -Color Doppler
Mode
-Amplitude
Doppler Mode | -Color Doppler
Mode
-Amplitude
Doppler Mode |
| Functionality with
Siemens ARTIS
System | N/A | N/A | √ |
| Imaging | | | |
| Multi-Hertz multiple
frequency imaging | √ | √ | √ |
| Acoustic output
display standard
compliance | √ | √ | √ |
| Measurements
(Distance, Area,
Elliptical) | √ | √ | √ |
| Trapezoidal (Wide)
Imaging | √ | N/A | √ |
| Description | ACUSON S2000
(Predicate K152369) | Penrith Elettra
(Predicate
K100598) | ACUSON
Freestyle™ (This
submission) |
| Wireless
Transducer | | | |
| Wireless Ultrasound
Image Transmission | N/A | B, Color,
Amplitude | B, Color,
Amplitude |
| Meets FCC Part 15
Subpart B:
Unintentional
Radiators | N/A | Yes | Yes |
| Meets FCC Part 15
Subpart C: Intentional
Radiators | N/A | Yes | Yes |
| Meets FCC Part 15
Subpart F : Ultra
Wideband Operation | N/A | Yes | Yes |
| Meets FCC Part 95
(WMTS) | N/A | No | No |
| Frequency Range RF
Transmitter | N/A | 7.5-8.5 GHz | 7.5-8.5 GHz |
| Lithium Ion Battery
Operation | N/A | Yes | Yes |
| Connectivity | | | |
| Wireless Network
Connectivity | N/A | √ | √ |
| External Antenna | N/A | N/A | √ |
| DICOM Compatibility | √ | √ | √ |

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SIEMENS

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Non-clinical Tests submitted, referenced, or relied on for determination of substantial equivalence

The devices have been evaluated for acoustic output, biocompatibility, cleaning and disinfectiveness as well as thermal, electrical, electromagnetic and mechanical safety and to conform with applicable medical devices safety standards. The systems comply with the following standards:

• · AAMI/ANSI 60601-1: Medical Electrical Equipment Part 1 General Requirements for Basic Safety and Essential Performance
• · IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance: Electromagnetic Compatibility
• · IEC 60601-2-37: Medical Electrical Equipment Part 2-37 For Basic Safety and Essential Performance of Ultrasonic Medical Diagnostic Monitoring Equipment
• IEC 62366: Medical Devices Application of Usability .
• IEC 62304: Medical Device Software Software Life Cycle Process .
• NEMA UD-2: Acoustic Output Measurement Standard for Diagnostic Ultrasound ●
• NEMA UD-3: Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• · ISO 10993-1: Biological Evaluation of Medical Devices

Summary discussion of the clinical tests submitted, referenced, or relied on for determination of substantial equivalence

The ACUSON Freestyle™ Ultrasound System is a class II device, and uses the same technology and operating principle as the predicate devices; clinical data is not required for substantial equivalence.

Conclusion

As shown by the substantial equivalence table above, the ACUSON Freestyle™ is substantially equivalent as the predicate devices; Penrith Elettra Ultrasound System (K100598) and the ACUSON S2000 (K152369).

SIEMENS