Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms like deep learning or neural networks in the device description or intended use. While it mentions "UltraArt Universal Image processing," this is a general term for image enhancement and doesn't necessarily imply AI/ML. The lack of information on training/test sets and performance metrics also suggests the absence of AI/ML components.

Therapeutic

No.
The device is described as a "diagnostic ultrasound imaging system" that "provides images of, or signals from, inside the body" for "clinical diagnosis purposes," which indicates it is used for diagnosis rather than treatment.

Diagnostic

Yes

Explanation: The "Device Description" explicitly states, "The ACUSON Redwood Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system." It also mentions "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."

SaMD (Software as a Medical Device)

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.) in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, the ACUSON Redwood ultrasound imaging system 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.
ACUSON Redwood Function: The ACUSON Redwood system uses ultrasound technology to create images of structures inside the body. It transmits and receives ultrasound waves and displays the resulting echoes as images.
Intended Use: The intended use clearly states that the system is used to "provide images of, or signals from, inside the body." It is used for visualization and measurement of anatomical structures in vivo.
No Sample Analysis: There is no mention of the system analyzing samples taken from the body.

Therefore, the ACUSON Redwood is a diagnostic imaging system that operates in vivo, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ACUSON Redwood 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, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) 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 (comma separated list FDA assigned to the subject device)

IYN, IYO, ITX, OIJ

Device Description

The ACUSON Redwood 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

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

Indicated Patient Age Range

Adult, Pediatric and Neonatal

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

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

K191922

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.

K201462, K172162

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

0

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol of the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of "ADMINISTRATION".

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

Re: K210743

Trade/Device Name: ACUSON Redwood 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 11, 2021 Received: March 12, 2021

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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

April 1, 2021

1

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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)

K210743

Device Name

ACUSON Redwood Diagnostic Ultrasound System

Indications for Use (Describe)

The ACUSON Redwood 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, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) 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.

Mode of operation: 2D-mode 2D-mode with Harmonics imaging Color flow Doppler Color (velocity) Power (energy) Doppler Tissue Imaging Pulsed Wave Doppler Pulsed Wave Doppler Tissue Imaging High Pulsed Repetition Frequency Pulsed Wave Doppler Continuous Wave Doppler Steerable Continuous Wave Doppler for phased array transducers Auxiliary Continuous Wave Doppler for pencil transducers M-mode M-mode with Harmonics imaging Anatomical M-mode Volume Imaging Combined Modes 2D-mode with color 2D-mode with power 2D/Doppler 2D/Doppler with color 2D/Doppler with power 2D/M-mode 2D/M-mode with color 2D/Anatomical M-mode 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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	510(k) Summary	K210743
Date:	January 15, 2021
1. Sponsor:	Siemens Medical Solutions USA, Inc.
Ultrasound Division
22010 South East 51st Street
Issaquah, Washington 98029
Contact Person:	Sulgue Choi
Tel: (425) 281-9898
2. Device Name:	ACUSON Redwood Diagnostic Ultrasound System
Common Name:	Diagnostic Ultrasound System with Accessories
Classification:	Regulatory Class:IIReview Category:Tier IIClassification Panel:Radiology	Regulatory Class:	II	Review Category:	Tier II	Classification Panel:	Radiology
Regulatory Class:	II
Review Category:	Tier II
Classification Panel:	Radiology
	Ultrasonic Pulsed Doppler Imaging System892.155090-IYNUltrasonic Pulsed Echo Imaging System892.156090-IYODiagnostic Ultrasound Transducer892.157090-ITXBiopsy Needle Guide Kit892.156090-OIJ	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
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 Healthineers, Ltd.
2 nd ~ 3 rd Floor, 143, Sunhwan-ro, Jungwon-gu, Seongnam-si,
Gyeonggi-do, Republic of Korea

Siemens Medical Solutions USA, Inc.
22010 South East 51st Street,
Issaquah, Washington 98029, UNITED STATES | | | | | | | | | | | | |

3. Legally Marketed Predicate Devices

The ACUSON Redwood 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 P200 (K191922) which is a primary predicated device, Sequoia (K201462) and the ACUSON S family (K172162).

5

4. Device Description

The ACUSON Redwood 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 Redwood 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, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus, and other pelvic structures), Adult, Pediatric and Neonatal Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The systems also provide the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, neonatal cephalic, cardiac (adult, pediatric and neonatal), trans-esophageal, transrectal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) 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.

Mode of operation

2D-mode 2D-mode with Harmonics imaging Color flow Doppler Color (velocity) Power (energy) Doppler Tissue Imaging Pulsed Wave Doppler Pulsed Wave Doppler Tissue Imaging High Pulsed Repetition Frequency Pulsed Wave Doppler Continuous Wave Doppler Steerable Continuous Wave Doppler for phased array transducers Auxiliary Continuous Wave Doppler for pencil transducers M-mode M-mode with Harmonics imaging Anatomical M-mode Volume Imaqinq Combined Modes 2D-mode with color 2D-mode with power 2D/Doppler 2D/Doppler with color 2D/Doppler with power 2D/M-mode 2D/M-mode with color 2D/Anatomical M-mode

6

Ultrasound Division

6. Summary of Technological Characteristics

The modified ACUSON Redwood Ultrasound System is the company's own previously cleared ACUSON P200 (K191922), ACUSON Sequoia (K201462) 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 submission device differs from the predicated devices as following:

. The modified ACUSON Redwood Ultrasound System includes the addition of the 9VE4 transducer previously cleared on the ACUSON Sequoia (K201462).
. The modified ACUSON Redwood Ultrasound System includes the addition of the 18H6 transducer previously cleared on the ACUSON Sequoia (K201462).
. The modified ACUSON Redwood Ultrasound System includes the addition of the 7VC2 transducer, which is substantially equivalent to the 7CF2 transducer previously cleared on the ACUSON S family (K172162).
. The modified ACUSON Redwood Ultrasound System includes the addition of the 3D/4D feature, which is substantially equivalent to the 3D/4D feature previously cleared on the ACUSON Sequoia (K201462).
The modified ACUSON Redwood Ultrasound System includes the addition of the Freehand 3D . feature, which is substantially equivalent to the 3-Scape real-time 3D Imaging option previously cleared on the ACUSON S family (K172162).

All other hardware and software features of the ACUSON Redwood Diagnostic Ultrasound device remain unchanged. The foundation of the ACUSON Redwood (this submission) is the ACUSON P200(K191922) with features and transducers integrated with the ACUSON P200(K191922) hardware and the ACUSON Redwood (this submission) reuse software developed for P200(K191922) mainly as well as 9VE4 transducer, 18H6 transducer and 3D/4D feature from Sequoia (K201462).

The submission device is substantially equivalent to the predicates with regards to both intended use and technological characteristics.

| Feature /
Characteristic | ACUSON Redwood
This Submission | ACUSON P200
K191922
Primary | ACUSON Sequoia
K201462
Reference | ACUSON S Family
K172162
Reference |
|-----------------------------|-----------------------------------|-----------------------------------|----------------------------------------|-----------------------------------------|
| | | Predicate device | Predicate device | Predicate device |

Indications for Use:

• Fetal	√	√	-	-
• Abdominal	√	√	-	-
• Pediatric	√	√	-	-

7

Siemens Medical Solutions USA, Inc.

Ultrasound Division

ACUSON Redwood Diagnostic Ultrasound System

510(k) Submission

| Feature /
Characteristic | | ACUSON Redwood
This Submission | ACUSON P200
K191922
Primary
Predicate device | ACUSON Sequoia
K201462
Reference
Predicate device | ACUSON S Family
K172162
Reference
Predicate device |
|-------------------------------------------|------------------------------------------|-------------------------------------------------------|------------------------------------------------------------|-------------------------------------------------------------|-------------------------------------------------------------|
| ■ | Small Organ | √ | √ | - | - |
| ■ | Cardiac | √ | √ | - | - |
| ■ | Neonatal Cephalic | | | - | - |
| ■ | Trans-esophageal | | | - | - |
| ■ | Transrectal | √ | √ | - | - |
| ■ | Transvaginal | √ | √ | - | - |
| ■ | Peripheral vessel | √ | √ | - | - |
| ■ | Musculo-skeletal
(conventional) | √ | √ | - | - |
| ■ | Musculo-skeletal
(superficial) | √ | √ | - | - |
| Frequencies
Supported: | | √ | √ | | |
| | | (1.0MHZ~~18MHz) | (1.0MHZ~~18MHz) | | |
| | Modes: | | | | |
| ■ | B | √ | √ | - | - |
| ■ | M | √ | √ | - | - |
| ■ | PWD (Pulsed Wave
Doppler) | √ | √ | - | - |
| ■ | CWD (Continuous
Wave Doppler) | √ | √ | - | - |
| ■ | PW DTI (Doppler
Tissue Image) | √ | √ | - | - |
| ■ | Color Doppler | √ | √ | - | - |
| ■ | Power Doppler | √ | √ | - | - |
| ■ | Combined (BMDC) | √ | √ | - | - |
| | | | ACUSON P200 | ACUSON Sequoia | ACUSON S Family |
| Feature /
Characteristic | | ACUSON Redwood | K191922 | K201462 | K172162 |
| | | This Submission | Primary
Predicate device | Reference
Predicate device | Reference
Predicate device |
| | Features: | | | | |
| ■ | Harmonics | √ | √ | - | - |
| ■ | Compounding | √ | √ | - | - |
| ■ | UltraArt Universal
Image processing | √ | √ | - | - |
| ■ | Tissue Equalization
(TEQ) | √ | √ | - | - |
| ■ | Biopsy | √ | √ | - | - |
| ■ | Clarify | √ | √ | - | - |
| ■ | Cardiac Imaging | √ | √ | - | - |
| ■ | Speed of Sound | √ | √ | - | - |
| ■ | Protocols | √ | √ | - | - |
| ■ | DICOM | √ | √ | - | - |
| ■ | eSie Calcs | √ | √ | - | - |
| ■ | Wireless | √ | √ | - | - |
| ■ | Virtual Touch Strain
Imaging | √ | √ | - | - |
| ■ | Virtual Touch Point
Shear Wave (VTIQ) | √ | √ | - | - |
| | Contrast Agent
Imaging | √ | √ | - | - |
| ■ | eSie OB | √ | √ | - | - |
| ■ | eSie Left Heart | √ | √ | - | - |
| ■ | eSie Measure | √ | √ | - | - |
| ■ | eSie Follicle | √ | √ | - | - |
| ■ | Panoramic Imaging | √ | √ | - | - |
| Feature /
Characteristic | ACUSON Redwood
This Submission | ACUSON P200
K191922
Primary
Predicate device | ACUSON Sequoia
K201462
Reference
Predicate device | ACUSON S Family
K172162
Reference
Predicate device | |
| Stress Echo | √ | √ | - | - | |
| Syngo Velocity
Vector Imaging
(VVI) | √ | √ | - | - | |
| eSieLink | √ | √ | - | - | |
| DICOM SR | √ | √ | - | - | |
| Wireless | √ | √ | - | - | |
| 3D/4D | √ | - | √ | - | |
| Freehand 3D
Imaging | √ | - | - | √ | |
| Monitor (OLED) | √ (22") | √ (22") | - | - | |
| Touch Screen:
adjustable display | √ (13.3") | √ (13.3") | - | - | |
| 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 | √ | √ | - | - | |

8

Siemens Medical Solutions USA, Inc.

Ultrasound Division

ACUSON Redwood

Diagnostic Ultrasound System

510(k) Submission

9

Siemens Medical Solutions USA, Inc.

Ultrasound Division

ACUSON Redwood 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:

l IEC 62359: Edition 2.1 2017-09, Ultrasonics - Field characterization - Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields / Combines IEC 62359 (2010-10) and AMD 1 (2017-09)
" Safety and EMC Requirements for Medical Equipment

10

AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 o (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 for O 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: General O requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
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: Particular o requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment
ISO 10993-1 Fifth edition 2018-08-01. Biological evaluation of medical devices Part 1: ■ Evaluation and testing within a risk management process / Corrected and reprinted in 2018-10

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

Since the ACUSON Redwood 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 Redwood system is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.