The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transvaqinal, peripheral vessel, musculoskeletal 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.

Device Description

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

AI/ML Overview

Based on the provided text, here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The provided document is a 510(k) Pre-Market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting specific acceptance criteria and performance data for new functions. The "acceptance criteria" here are implicitly the existing performance and safety characteristics of the predicate devices. The "reported device performance" is essentially that the ACUSON Sequoia Diagnostic Ultrasound System performs equivalently to its predicate devices.

Acceptance Criteria Category	Reported Device Performance
Intended Use Equivalence	The ACUSON Sequoia system's intended uses are consistent with its predicate devices (ACUSON Sequoia K193257 and ACUSON S family K172162). It provides images/signals for Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN, Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications, and measures anatomical structures for various clinical diagnosis purposes, matching the predicates. It also adds new indications for Adult Cephalic and incorporates specific transducers (CW5, 11M3, 7L2) and a needle guide for 7L2, which were cleared under previous 510(k)s.
Technological Characteristics Equivalence	The modified ACUSON Sequoia Ultrasound System shares the same technology and principles as the predicate ACUSON Sequoia (K193257) and the ACUSON S family (K172162). It transmits and receives ultrasound echo data and displays it in various modes (B-Mode, M-Mode, PW Doppler, CW Doppler, Color Doppler, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, combined modes, and Harmonic Imaging). Features, frequencies, modes, and other characteristics (e.g., monitor, touch screen, patient contact materials, safety certifications) are either identical to or within the established range of the predicate devices.
Safety and Effectiveness	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety. It conforms to applicable medical device safety standards (IEC 62359:2010, AAMI ES60601-1:2005, IEC 60601-1-2 Ed 4.0 2014-02, IEC 60601-2-18: Ed 3.0 2009-08, IEC 60601-2-37 Ed 2.1 2015, ISO 10993-1). The manufacturer's design and development process conforms to 21 CFR 820 Quality System Regulation and ISO 13485:2016 quality system standards.

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

The document explicitly states: "Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." This indicates that no specific "test set" of clinical data was used for this 510(k) submission to demonstrate performance with acceptance criteria, as the claim is based on equivalence to previously cleared devices.

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, as no new clinical studies or test sets with ground truth establishment by experts were conducted for this submission.

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

Not applicable, as no new clinical studies or test sets requiring adjudication were conducted for this submission.

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 is a submission for a diagnostic ultrasound system, not an AI-enabled device requiring a comparative effectiveness study in the context of human reader improvement.

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

Not applicable. This is not an AI algorithm. The submission is for a diagnostic ultrasound system.

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

Not applicable, as no new clinical studies were conducted to establish ground truth for new performance claims. The "ground truth" for the device's capabilities relies on the established safety and efficacy of its predicate devices, which would have undergone their own validation processes during their initial clearance.

8. The sample size for the training set

Not applicable, as there is no mention of a training set, indicating that this is not an AI/machine learning device that performs a diagnostic task for which it needs to be "trained."

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

Not applicable, as there is no training set mentioned.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

April 15, 2020

Re: K200707

Trade/Device Name: ACUSON Sequoia Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX, OIJ Dated: March 17, 2020 Received: March 18, 2020

Dear Prithul Bom:

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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 mediation-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.

For

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

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Indications for Use

510(k) Number (if known) K200707

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use (Describe)

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510 (k) Number (if known):

Device Name: Intended Use:

ACUSON Sequoia Diagnostic Ultrasound System Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC
Abdominal	P	P	P	P		P	P		BMDC
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P		BMDC
Small Organ(Note 1)	P	P	P	P		P	P		BMDC
Neonatal Cephalic	P	P	P	P		P	P		BMDC
Adult Cephalic	N	N	N	N		N	N		BMDC
Cardiac	P	P	P	P	P	P	P		BMDC
Trans-esophageal
Transrectal	P	P	P	P		P	P		BMDC
Transvaginal	P	P	P	P		P	P		BMDC
Transurethral
Intravascular
Peripheral vessel	P	P	P	P		P	P		BMDC
Laparoscopic
Musculo-skeletalConventional	P	P	P	P		P	P		BMDC
Musculo-skeletalSuperficial	P	P	P	P		P	P		BMDC
Other (specify)

N = new indication; P = previously cleared by K193257

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

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

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510 (k) Number (if known):

Device Name:	4V1 Phased Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMDC
Abdominal	P	P	P	P		P	P		BMDC
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P		P	P		BMDC
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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510 (k) Number (if known):

Device Name: DAX Curved Array Transducer Intended Use: Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Color Color Amplitude Combined Other CWD Clinical Application A B M PWD Velocity Doppler Doppler (Specify) (Specify) Imaging Ophthalmic Fetal P P P P P BMCD Abdominal P P P P P BMCD Intraoperative

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

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:Intended Use:	5C1 Curved Array TransducerUltrasound imaging or fluid flow analysis of the human body as follows:
		Mode of Operation
Clinical Application	A	B	M	PWD	CWD	ColorDoppler	AmplitudeDoppler	Color Velocity Imaging	Combined(Specify)	Other(Specify)
Ophthalmic
Fetal	P	P	P	P		P	P		BMCD
Abdominal	P	P	P	P		P	P		BMCD
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P		P	P		BMCD
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:Intended Use:	9C3 Curved Array TransducerUltrasound 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)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMCD
Abdominal		P	P	P		P	P		BMCD
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMCD
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMCD
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:	18L6 Linear Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMCD
Small Organ(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMCD
Musculo-skeletalSuperficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:		14L5 Linear Array Transducer
Intended Use:		Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMCD
Small Organ(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMCD
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMCD
Musculo-skeletalSuperficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:	10L4 Linear Array Transducer
Intended Use:		Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal		P	P	P		P	P		BMCD
Abdominal		P	P	P		P	P		BMCD
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P		P	P		BMCD
Small Organ(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		P	P	P		P	P		BMCD
Laparoscopic
Musculo-skeletalConventional		P	P	P		P	P		BMCD
Musculo-skeletalSuperficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name: Intended Use:

9EC4 Endocavity Transducer

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

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:Intended Use:		5V1 Phased Array TransducerUltrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric	P	P	P	P	P	P	P		BMCD
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic		N	N	N		N	N		BMCD
Cardiac	P	P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:	8V3 Phased Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal		P	P	P		P	P		BMCD
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMCD
Small Organ(Note 1)
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:Intended Use:	CW2 Continuous Wave TransducerUltrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric					P
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac					P
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:	10V4 Phased Array Transducer
Intended Use:		Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric		P	P	P	P	P	P		BMCD
Neonatal Cephalic		P	P	P		P	P		BMCD
Adult Cephalic
Cardiac		P	P	P	P	P	P		BMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:	18H6 Linear Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)		P	P	P		P	P		BMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial		P	P	P		P	P		BMCD
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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

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510 (k) Number (if known):

Device Name:Intended Use:						CW5 Continuous Wave Transducer
	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel					N
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

(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)_

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510 (k) Number (if known):

Device Name:	7L2 Linear Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal		N	N	N		N	N		BMCD
Intraoperative
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMCD
Small Organ(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel		N	N	N		N	N		BMCD
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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510 (k) Number (if known):

Device Name:	11M3 Curved Array Transducer
Intended Use:	Ultrasound 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)	Other(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
IntraoperativeNeurological
Pediatric		N	N	N		N	N		BMCD
Small Organ(Note 1)
Neonatal Cephalic		N	N	N		N	N		BMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletalConventional
Musculo-skeletalSuperficial
Other (specify)

N = new indication; P = previously cleared by K193257

Additional Comments:

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

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

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K200707	510(k) Summary
---------	----------------

Date:	March 04, 2020
1. Sponsor:	Siemens Medical Solutions USA, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Sulgue ChoiTel: (425) 281-9898
2. Device Name:	ACUSON Sequoia Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class: IIReview Category: Tier IIClassification Panel: Radiology

Ultrasonic Pulsed Doppler Imaging System	892.1550	90-IYN
Ultrasonic Pulsed Echo Imaging System	892.1560	90-IYO
Diagnostic Ultrasound Transducer	892.1570	90-ITX
Biopsy Needle Guide Kit	892.1560	90-OIJ

Manufacturing Site:	Siemens Medical Solutions USA, Inc.22010 S.E. 51st Street,Issaquah, WA, 98029, UNITED STATES
---------------------	------------------------------------------------------------------------------------------------------

3. Legally Marketed Predicate Devices

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to the company's own products, the ACUSON Sequoia (K193257) which is primary predicated device and the ACUSON S family (K172162).

The additional predicates are the indications for Adult Cephalic and CW5, 11M3, 7L2 transducers and Needle guide for 7L2 which are cleared under ACUSON Sequoia (K193257) and ACUSON S family (K172162) as described in the table of section 6 Summary of Technological Characteristics.

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4. Device Description

5. Intended Use/Indications for Use

6. Summary of Technological Characteristics

The modified ACUSON Sequoia Ultrasound System is the same as the company's own previously cleared ACUSON Sequoia (K193257) and the ACUSON S family (K172162) with regard to both intended use and technological characteristics. Both the modified ultrasound system under this review and the predicate ultrasound systems function in the same manner as all diagnostic ultrasound systems and transducers.

The foundation of the ACUSON Sequoia (this submission) is the ACUSON Sequoia(K193257) with features and transducers integrated with the ACUSON Sequoia(K193257) hardware and the ACUSON Sequoia (this submission) reuse software developed for Sequoia(K193257) mainly as well as CW5 transducer from S family. The submission device is substantially equivalent to the predicate with regards to both intended use and technological characteristics.

Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaK# 193257Predicate device	ACUSON S familyS1000/S2000/S3000K# 172162Reference device
Indications for Use:
■ Fetal	√	√
■ Abdominal	√	√
■ Pediatric	√	√
■ Small Organ	√	√
■ Cardiac	√	√
■ Transrectal	√	√
■ Transvaginal	√	√
Feature / Characteristic		ACUSON SequoiaThis Submission	ACUSON SequoiaK# 193257Predicate device	ACUSON S familyS1000/S2000/S3000K# 172162Reference device
■	Peripheral vessel	√	√
■	Musculo-skeletal(conventional)	√	√
■	Musculo-skeletal(superficial)	√	√
■	Neonatal cephalic	√	√
■	Adult cephalic	√	√	√
Frequencies Supported:		(1.0MHZ~18MHz)	(1.0MHZ~18MHz)	(2.0MHz~17MHz)
	Modes:
■	B	√	√
■	M	√	√
■	PWD (Pulsed WaveDoppler)	√	√
■	CWD (Continuous WaveDoppler)	√	√
■	PW DTI (Doppler TissueImage)	√	√
■	Color Doppler	√	√
■	Power Doppler	√	√
■	Combined (BMDC)	√	√
Features:
■	Harmonic imaging	√	√
■	Panoramic imaging	√	√
■	Color Panoramic imaging	√	√
■	Auto TEQ	√	√
■	Cardiac Imagingphysiological signal display	√	√
■	eSie OB	√	√
■	Compounding	√	√
■	Contrast imaging	√	√
■	Clarify	√	√
■	Virtual Touch - Strain	√	√
■	syngo ® Velocity VectorImaging	√	√
■	eSie Calc	√	√
■	Speed of Sound	√	√
■	Fusion	√	√
■	Virtual Touch – pSWE	√	√
■	Virtual Touch – SWE	√	√
■	UltraArt	√	√
■	Modality Compare	√	√
■	HD Zoom	√	√
■	Protocols	√	√
Feature / Characteristic	ACUSON SequoiaThis Submission	ACUSON SequoiaK# 193257Predicate device	ACUSON S familyS1000/S2000/S3000K# 172162Reference device
■ InFocus	√	√
■ Flash sequencing	√	√
■ Gesture control	√	√
■ TeamViewer	√	√
■ Motion StabilizedPersistence	√	√
■ DICOM	√	√
■ DICOM SR	√	√
■ Slow Flow Color DopplerState	√	√
■ Dynamic MultiHertz	√	√
Wireless	√	√
Monitor: 21" FPD (OLED)	√	√
Touch Screen: 15"adjustable Touch Screen	√	√
Output Display Standard(Track 3)	√	√
Patient Contact Materials	Tested to ISO 10993-1	Tested to ISO 10993-1
UL 60601-1 Certified	√	√
Indications for Use	√	√

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

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Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

7. 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 have been found to conform to applicable medical device safety standards. The systems comply with the following voluntary standards:

트 IEC 62359:2010. Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / This document and its separate amendments continue to be valid together with the consolidated version.
트 Safety and EMC Requirements for Medical Equipment
- AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and o A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
- IEC 60601-1:2005, Medical electrical equipment Part 1: General requirements O for basic safety and essential performance / This document and its separate amendments continue to be valid together with the consolidated version
- IEC 60601-1-2 Edition 4.0 2014-02, Medical electrical equipment Part 1-2: O General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

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IEC 60601-2-18: Edition 3.0 2009-08, Medical electrical equipment Part 2-18: O Particular requirements for the basic safety and essential performance of endoscopic equipment
IEC 60601-2-37 Edition 2.1 2015, Medical electrical equipment Part 2-37: o Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1 Fourth edition 2009-10-15, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)]

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

Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence.

9. Summary

Intended uses and other key features are consistent with traditional clinical practice and FDA guidelines. The design and development process of the manufacturer conforms to 21 CFR 820 Quality System Requlation and ISO 13485:2016 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 system has accumulated a long history of safe and effective performance. Therefore, it is the opinion of Siemens Medical Solutions USA, Inc. that the ACUSON Sequoia system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for 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.