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K Number
K200707
Device Name
ACUSON Sequoia Diagnostic Ultrasound System
Manufacturer
Siemens Medical Solutions USA, Inc
Date Cleared
2020-04-15

(28 days)

Product Code
IYNITXIYOOIJ
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
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.
More Information

K193257, K172162

K172162

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device using traditional ultrasound technology and processing methods.

No
The device is described as a "diagnostic ultrasound system" intended to provide "images of, or signals from, inside the body" and "measure anatomical structures" for clinical diagnosis purposes, not for treating any condition or disease.

Yes
The "Device Description" explicitly states, "The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." The "Intended Use / Indications for Use" also mentions that the system's calculation packages "provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes."

No

The device description explicitly states it is a "multi-purpose mobile, software controlled, diagnostic ultrasound system" and describes its function as transmitting and receiving ultrasound echo data, which requires hardware components (transducers, processing units, etc.) beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body ("in vitro").
  • Device Function: The ACUSON Sequoia ultrasound system is described as a device that transmits and receives ultrasound echo data to create images and signals from inside the body. This is an in vivo (within the living body) diagnostic method.
  • Intended Use: The intended use clearly states it provides images and signals from inside the body for various anatomical sites.
  • Device Description: The description details the ultrasound technology and how it functions to display images and data based on echoes from within the body.

Therefore, the ACUSON Sequoia ultrasound system is an in vivo diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

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.

Product codes

IYN, IYO, ITX, OIJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts (breast, testes, thyroid, penis, prostate, etc.), OB/GYN (ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal, Peripheral Vascular, Transrectal, Transvaginal.

Indicated Patient Age Range

Adult, Pediatric, Neonatal Fetal.

Intended User / Care Setting

appropriately trained healthcare professional in a clinical setting

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

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.

Key Metrics

Not Found

Predicate Device(s)

K193257, K172162

Reference Device(s)

K172162

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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

1

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

2

Indications for Use

510(k) Number (if known) K200707

Device Name

ACUSON Sequoia Diagnostic Ultrasound System

Indications for Use (Describe)

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, 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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FORM FDA 3881 (7/17)

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

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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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDC
AbdominalPPPPPPBMDC
Intraoperative
Intraoperative
Neurological
PediatricPPPPPPPBMDC
Small Organ
(Note 1)PPPPPPBMDC
Neonatal CephalicPPPPPPBMDC
Adult CephalicNNNNNNBMDC
CardiacPPPPPPPBMDC
Trans-esophageal
TransrectalPPPPPPBMDC
TransvaginalPPPPPPBMDC
Transurethral
Intravascular
Peripheral vesselPPPPPPBMDC
Laparoscopic
Musculo-skeletal
ConventionalPPPPPPBMDC
Musculo-skeletal
SuperficialPPPPPPBMDC
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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPPBMDC
AbdominalPPPPPPBMDC
Intraoperative
Intraoperative
Neurological
PediatricPPPPPPBMDC
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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: 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

| Intraoperative

Neurological
PediatricPPPPPBMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|-------------------|---|-----|-----|------------------|----------------------|------------------------|-----------------------|--------------------|
| | | Mode of Operation | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | 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 | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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)

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

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510 (k) Number (if known):

| Device Name:
Intended Use: | 9C3 Curved Array Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|--------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | P | P | P | | P | P | | BMCD | |
| Abdominal | | P | P | P | | P | P | | BMCD | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| 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-skeletal
Conventional | | P | P | P | | P | P | | BMCD | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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)

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

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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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
PediatricPPPPPBMCD
Small Organ
(Note 1)PPPPPBMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMCD
Musculo-skeletal
SuperficialPPPPPBMCD
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:14L5 Linear Array Transducer
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
PediatricPPPPPBMCD
Small Organ
(Note 1)PPPPPBMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMCD
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMCD
Musculo-skeletal
SuperficialPPPPPBMCD
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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
FetalPPPPPBMCD
AbdominalPPPPPBMCD
Intraoperative
Intraoperative
Neurological
PediatricPPPPPBMCD
Small Organ
(Note 1)PPPPPBMCD
Neonatal CephalicPPPPPBMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselPPPPPBMCD
Laparoscopic
Musculo-skeletal
ConventionalPPPPPBMCD
Musculo-skeletal
SuperficialPPPPPBMCD
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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
TransrectalPPPPPPBMCD
TransvaginalPPPPPPBMCD
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|---|--------------------------------------------------------------------------------------------------------|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|--|
| | | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) | |
| Ophthalmic | | | | | | | | | | | |
| Fetal | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | | |
| 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-skeletal
Conventional | | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | | |
| 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
AbdominalPPPPPBMCD
Intraoperative
Intraoperative
Neurological
PediatricPPPPPPBMCD
Small Organ
(Note 1)
Neonatal CephalicPPPPPBMCD
Adult Cephalic
CardiacPPPPPPBMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows: | | | | | | | | | |
|----------------------------------|-----------------------------------------------------------------------------------------------------------|---|---|-----|-----|------------------|----------------------|------------------------------|-----------------------|--------------------|
| | Mode of Operation | | | | | | | | | |
| Clinical Application | A | B | M | PWD | CWD | Color
Doppler | Amplitude
Doppler | Color
Velocity
Imaging | Combined
(Specify) | Other
(Specify) |
| Ophthalmic | | | | | | | | | | |
| Fetal | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Intraoperative | | | | | | | | | | |
| Intraoperative
Neurological | | | | | | | | | | |
| Pediatric | | | | | P | | | | | |
| Small Organ
(Note 1) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | P | | | | | |
| Trans-esophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transurethral | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Peripheral vessel | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
| Musculo-skeletal
Conventional | | | | | | | | | | |
| Musculo-skeletal
Superficial | | | | | | | | | | |
| 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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
PediatricPPPPPPBMCD
Neonatal CephalicPPPPPBMCD
Adult Cephalic
CardiacPPPPPPBMCD
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)PPPPPBMCD
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
SuperficialPPPPPBMCD
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:CW5 Continuous Wave Transducer
Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
Pediatric
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselN
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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 ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
AbdominalNNNNNBMCD
Intraoperative
Intraoperative
Neurological
PediatricNNNNNBMCD
Small Organ
(Note 1)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vesselNNNNNBMCD
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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:11M3 Curved Array Transducer
Intended Use:Ultrasound imaging or fluid flow analysis of the human body as follows:
Mode of Operation
Clinical ApplicationABMPWDCWDColor
DopplerAmplitude
DopplerColor
Velocity
ImagingCombined
(Specify)Other
(Specify)
Ophthalmic
Fetal
Abdominal
Intraoperative
Intraoperative
Neurological
PediatricNNNNNBMCD
Small Organ
(Note 1)
Neonatal CephalicNNNNNBMCD
Adult Cephalic
Cardiac
Trans-esophageal
Transrectal
Transvaginal
Transurethral
Intravascular
Peripheral vessel
Laparoscopic
Musculo-skeletal
Conventional
Musculo-skeletal
Superficial
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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K200707510(k) Summary
-------------------------
Date:March 04, 2020
1. Sponsor:Siemens Medical Solutions USA, Inc.,
Ultrasound Division
685 East Middlefield Road
Mountain View, California 94043
Contact Person:Sulgue Choi
Tel: (425) 281-9898
2. Device Name:ACUSON Sequoia Diagnostic Ultrasound System
Common Name:Diagnostic Ultrasound System with Accessories
Classification:Regulatory Class: II
Review Category: Tier II
Classification Panel: Radiology
Ultrasonic Pulsed Doppler Imaging System892.155090-IYN
Ultrasonic Pulsed Echo Imaging System892.156090-IYO
Diagnostic Ultrasound Transducer892.157090-ITX
Biopsy Needle Guide Kit892.156090-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

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.

5. Intended Use/Indications for Use

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.

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 Sequoia
This Submission | ACUSON Sequoia
K# 193257
Predicate device | ACUSON S family
S1000/S2000/S3000
K# 172162
Reference device | |
|----------------------------------------------|-------------------------------------------------|-------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------|
| Indications for Use: | | | | |
| ■ Fetal | √ | √ | | |
| ■ Abdominal | √ | √ | | |
| ■ Pediatric | √ | √ | | |
| ■ Small Organ | √ | √ | | |
| ■ Cardiac | √ | √ | | |
| ■ Transrectal | √ | √ | | |
| ■ Transvaginal | √ | √ | | |
| Feature / Characteristic | | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 193257
Predicate device | ACUSON S family
S1000/S2000/S3000
K# 172162
Reference device |
| ■ | Peripheral vessel | √ | √ | |
| ■ | Musculo-skeletal
(conventional) | √ | √ | |
| ■ | Musculo-skeletal
(superficial) | √ | √ | |
| ■ | Neonatal cephalic | √ | √ | |
| ■ | Adult cephalic | √ | √ | √ |
| Frequencies Supported: | | (1.0MHZ18MHz) | (1.0MHZ18MHz) | (2.0MHz~17MHz) |
| | Modes: | | | |
| ■ | B | √ | √ | |
| ■ | M | √ | √ | |
| ■ | PWD (Pulsed Wave
Doppler) | √ | √ | |
| ■ | CWD (Continuous Wave
Doppler) | √ | √ | |
| ■ | PW DTI (Doppler Tissue
Image) | √ | √ | |
| ■ | Color Doppler | √ | √ | |
| ■ | Power Doppler | √ | √ | |
| ■ | Combined (BMDC) | √ | √ | |
| Features: | | | | |
| ■ | Harmonic imaging | √ | √ | |
| ■ | Panoramic imaging | √ | √ | |
| ■ | Color Panoramic imaging | √ | √ | |
| ■ | Auto TEQ | √ | √ | |
| ■ | Cardiac Imaging
physiological signal display | √ | √ | |
| ■ | eSie OB | √ | √ | |
| ■ | Compounding | √ | √ | |
| ■ | Contrast imaging | √ | √ | |
| ■ | Clarify | √ | √ | |
| ■ | Virtual Touch - Strain | √ | √ | |
| ■ | syngo ® Velocity Vector
Imaging | √ | √ | |
| ■ | eSie Calc | √ | √ | |
| ■ | Speed of Sound | √ | √ | |
| ■ | Fusion | √ | √ | |
| ■ | Virtual Touch – pSWE | √ | √ | |
| ■ | Virtual Touch – SWE | √ | √ | |
| ■ | UltraArt | √ | √ | |
| ■ | Modality Compare | √ | √ | |
| ■ | HD Zoom | √ | √ | |
| ■ | Protocols | √ | √ | |
| Feature / Characteristic | ACUSON Sequoia
This Submission | ACUSON Sequoia
K# 193257
Predicate device | ACUSON S family
S1000/S2000/S3000
K# 172162
Reference device | |
| ■ InFocus | √ | √ | | |
| ■ Flash sequencing | √ | √ | | |
| ■ Gesture control | √ | √ | | |
| ■ TeamViewer | √ | √ | | |
| ■ Motion Stabilized
Persistence | √ | √ | | |
| ■ DICOM | √ | √ | | |
| ■ DICOM SR | √ | √ | | |
| ■ Slow Flow Color Doppler
State | √ | √ | | |
| ■ 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 | √ | √ | | |

22

Siemens Medical Solutions USA, Inc. Ultrasound Division

ACUSON Sequoia Diagnostic Ultrasound System 510(k) Submission

23

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

24

  • 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.