(20 days)
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.
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.
The provided text describes the ACUSON Redwood Diagnostic Ultrasound System and its substantial equivalence to predicate devices. However, it explicitly states that clinical studies were not required to support substantial equivalence because the device uses the same technology and principles as existing devices. Therefore, the document does not contain information about acceptance criteria, device performance from a study, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details.
The document focuses on non-clinical tests demonstrating compliance with safety and performance standards.
Here's a breakdown of what cannot be provided based on the input text:
- Table of acceptance criteria and reported device performance: No clinical performance data is presented, and therefore no acceptance criteria related to such performance are defined or met by a specific study. The text largely refers to compliance with safety standards.
- Sample size used for the test set and the data provenance: No clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical test set was used.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical test set was used.
- 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: No MRMC study was done, and the device is an ultrasound system, not an AI-assisted diagnostic tool in the sense of requiring such a study to demonstrate improved human reader performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as the device is an ultrasound system, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical test set was used to establish a ground truth.
- The sample size for the training set: Not applicable as no clinical training set was mentioned for algorithm development in this context.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding non-clinical acceptance:
The device has been evaluated for and found to conform to various medical device safety standards. These can be considered the "acceptance criteria" for the non-clinical aspects.
Non-Clinical Acceptance Criteria and Study Findings (as per the document):
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance / Study Finding (Met) |
|---|---|
| Acoustic output evaluation | Conforms |
| Biocompatibility evaluation | Conforms |
| Cleaning and disinfection effectiveness evaluation | Conforms |
| Thermal safety evaluation | Conforms |
| Electrical safety evaluation | Conforms |
| Electromagnetic safety and EMC requirements (IEC 60601-1-2 Ed. 4.0 2014-02) | Conforms |
| Mechanical safety evaluation | Conforms |
| IEC 62359: Edition 2.1 2017-09 (Ultrasonics - Field characterization - Test methods for thermal and mechanical indices) | Conforms |
| AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Medical electrical equipment - General requirements for basic safety and essential performance) | Conforms |
| IEC 60601-1:2005 (Medical electrical equipment Part 1: General requirements for basic safety and essential performance) | Conforms |
| IEC 60601-2-18: Edition 3.0 2009-08 (Medical electrical equipment Part 2-18: Particular requirements for basic safety and essential performance of endoscopic equipment) | Conforms |
| IEC 60601-2-37 Edition 2.1 2015 (Medical electrical equipment Part 2-37: Particular requirements for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) | Conforms |
| ISO 10993-1 Fifth edition 2018-08-01 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process) | Conforms |
| UL 60601-1 Certified | Certified |
| 21 CFR 820 Quality System Regulation | Conforms |
| ISO 13485:2016 quality system standards | Conforms |
Summary of Clinical Study Absence:
The crucial piece of information for your request is found in Section 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."
Therefore, there is no clinical study, test set, expert ground truth, adjudication method, MRMC study, or standalone performance data to report from this document. The substantial equivalence determination was based on the technological similarity to previously cleared predicate devices and compliance with non-clinical performance and safety standards.
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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, 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
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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
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Indications for Use
510(k) Number (if known)
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.
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| 510(k) Summary | K210743 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Date: | January 15, 2021 | ||||||||||||
| 1. Sponsor: | Siemens Medical Solutions USA, Inc.Ultrasound Division22010 South East 51st StreetIssaquah, Washington 98029 | ||||||||||||
| Contact Person: | Sulgue ChoiTel: (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 KoreaSiemens 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).
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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
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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 RedwoodThis Submission | ACUSON P200K191922Primary | ACUSON SequoiaK201462Reference | ACUSON S FamilyK172162Reference |
|---|---|---|---|---|
| Predicate device | Predicate device | Predicate device |
Indications for Use:
| • Fetal | √ | √ | - | - |
|---|---|---|---|---|
| • Abdominal | √ | √ | - | - |
| • Pediatric | √ | √ | - | - |
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Siemens Medical Solutions USA, Inc.
Ultrasound Division
ACUSON Redwood Diagnostic Ultrasound System
510(k) Submission
| Feature /Characteristic | ACUSON RedwoodThis Submission | ACUSON P200K191922PrimaryPredicate device | ACUSON SequoiaK201462ReferencePredicate device | ACUSON S FamilyK172162ReferencePredicate device | |
|---|---|---|---|---|---|
| ■ | Small Organ | √ | √ | - | - |
| ■ | Cardiac | √ | √ | - | - |
| ■ | Neonatal Cephalic | - | - | ||
| ■ | Trans-esophageal | - | - | ||
| ■ | Transrectal | √ | √ | - | - |
| ■ | Transvaginal | √ | √ | - | - |
| ■ | Peripheral vessel | √ | √ | - | - |
| ■ | Musculo-skeletal(conventional) | √ | √ | - | - |
| ■ | Musculo-skeletal(superficial) | √ | √ | - | - |
| FrequenciesSupported: | √ | √ | |||
| (1.0MHZ~18MHz) | (1.0MHZ~18MHz) | ||||
| Modes: | |||||
| ■ | B | √ | √ | - | - |
| ■ | M | √ | √ | - | - |
| ■ | PWD (Pulsed WaveDoppler) | √ | √ | - | - |
| ■ | CWD (ContinuousWave Doppler) | √ | √ | - | - |
| ■ | PW DTI (DopplerTissue Image) | √ | √ | - | - |
| ■ | Color Doppler | √ | √ | - | - |
| ■ | Power Doppler | √ | √ | - | - |
| ■ | Combined (BMDC) | √ | √ | - | - |
| ACUSON P200 | ACUSON Sequoia | ACUSON S Family | |||
| Feature /Characteristic | ACUSON Redwood | K191922 | K201462 | K172162 | |
| This Submission | PrimaryPredicate device | ReferencePredicate device | ReferencePredicate device | ||
| Features: | |||||
| ■ | Harmonics | √ | √ | - | - |
| ■ | Compounding | √ | √ | - | - |
| ■ | UltraArt UniversalImage processing | √ | √ | - | - |
| ■ | Tissue Equalization(TEQ) | √ | √ | - | - |
| ■ | Biopsy | √ | √ | - | - |
| ■ | Clarify | √ | √ | - | - |
| ■ | Cardiac Imaging | √ | √ | - | - |
| ■ | Speed of Sound | √ | √ | - | - |
| ■ | Protocols | √ | √ | - | - |
| ■ | DICOM | √ | √ | - | - |
| ■ | eSie Calcs | √ | √ | - | - |
| ■ | Wireless | √ | √ | - | - |
| ■ | Virtual Touch StrainImaging | √ | √ | - | - |
| ■ | Virtual Touch PointShear Wave (VTIQ) | √ | √ | - | - |
| Contrast AgentImaging | √ | √ | - | - | |
| ■ | eSie OB | √ | √ | - | - |
| ■ | eSie Left Heart | √ | √ | - | - |
| ■ | eSie Measure | √ | √ | - | - |
| ■ | eSie Follicle | √ | √ | - | - |
| ■ | Panoramic Imaging | √ | √ | - | - |
| Feature /Characteristic | ACUSON RedwoodThis Submission | ACUSON P200K191922PrimaryPredicate device | ACUSON SequoiaK201462ReferencePredicate device | ACUSON S FamilyK172162ReferencePredicate device | |
| Stress Echo | √ | √ | - | - | |
| Syngo VelocityVector Imaging(VVI) | √ | √ | - | - | |
| eSieLink | √ | √ | - | - | |
| DICOM SR | √ | √ | - | - | |
| Wireless | √ | √ | - | - | |
| 3D/4D | √ | - | √ | - | |
| Freehand 3DImaging | √ | - | - | √ | |
| Monitor (OLED) | √ (22") | √ (22") | - | - | |
| Touch Screen:adjustable display | √ (13.3") | √ (13.3") | - | - | |
| Output DisplayStandard (Track 3) | √ | √ | - | - | |
| Patient ContactMaterials | Tested to ISO10993-1 | Tested to ISO10993-1 | - | - | |
| UL 60601-1 Certified | √ | √ | - | - | |
| Indications for Use | √ | √ | - | - |
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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
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- 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.
§ 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.