Voluson SWIFT, Voluson SWIFT+

K201828 · GE Medical Systems Ultrasound and Primary Care Diagnostics · IYN · Oct 11, 2020 · Radiology

Device Facts

• Record ID: K201828
• Device Name: Voluson SWIFT, Voluson SWIFT+
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: IYN · Radiology
• Decision Date: Oct 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiaς (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/ Prostate) (TR): Transvaginal (TV). Mode of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/ Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.

Device Story

Mobile diagnostic ultrasound system; provides real-time 2D, 3D/4D imaging, and Doppler analysis. Inputs: ultrasound signals from linear, curved linear, and matrix phased array transducers. Processing: digital acquisition, image processing, and analysis; includes automated features like SonoLyst (auto-selection of Scan Assistant items based on frozen image analysis). Outputs: visual display of anatomical structures and fluid flow; DICOM-compatible digital images/reports. Used in hospitals/clinics by trained clinicians. Benefits: facilitates diagnostic evaluation, measurement, and clinical decision-making for OB/GYN and general radiology applications.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/electromagnetic/mechanical safety testing per AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and ISO 10993-1.

Technological Characteristics

Mobile console with touch monitor; supports linear, curved linear, and matrix phased array transducers. Energy: ultrasonic pulsed Doppler/echo. Connectivity: DICOM-compliant networking. Safety standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, ISO 10993-1, ISO 14971, IEC 62359. Biocompatible patient-contact materials.

Indications for Use

Indicated for qualified healthcare professionals to perform ultrasound imaging, measurement, and analysis of the human body and fluid across fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transrectal, and transvaginal applications.

Regulatory Classification

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.

Predicate Devices

• Voluson P series Diagnostic Ultrasound System (K180535)

Reference Devices

• Voluson S series Diagnostic Ultrasound System (K180374)
• Voluson E10 Diagnostic Ultrasound System (K192159)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226

Re: K201828

Trade/Device Name: Voluson SWIFT, Voluson SWIFT+ Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: September 14, 2020 Received: September 15, 2020

Dear Mr. Behn:

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/cfpmp/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

October 11, 2020

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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 ([e-mail]) or phone [phone] 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) K201828

Device Name Voluson SWIFT, Voluson SWIFT+

#### Indications for Use (Describe)

The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiaς (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/ Prostate) (TR): Transvaginal (TV).

Mode of operation include: B, M, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/ Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.

| 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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## K201828

## 510(k) Summary

| | In accordance with 21 CFR 807.92 the following summary of information is provided: |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | June 30, 2020 |
| Submitter: | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Manufacturer: | GE Ultrasound Korea, Ltd.<br>9, Sunhwan-ro 214beon-gil, Jungwon-gu,<br>Seongnam-si, Gyeonggi-do, Republic of Korea |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Director<br>GE Healthcare<br>T:[phone] |
| Alternate Contact Person: | Jiyeon Park<br>Senior Regulatory Affairs Leader<br>GE Healthcare<br>T: [phone] |
| Device Trade Name: | Voluson SWIFT, Voluson SWIFT+ |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN (primary), IYO, ITX (secondary)<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN;<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO;<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary Predicate Device: | K180535 Voluson P series Diagnostic Ultrasound System |
| Reference Device(s): | K180374 Voluson S series Diagnostic Ultrasound System<br>K192159 Voluson E10 Diagnostic Ultrasound System |
| Device Description: | The subject device is a Track 3 device, primarily intended for general-<br>purpose radiology evaluation and specialized for OB/GYN with particular<br>features for real-time 3D/4D acquisition. The Voluson SWIFT, Voluson<br>SWIFT+ provide digital acquisition, processing and display capability.<br>Voluson SWIFT, Voluson SWIFT+ consist of a mobile console with<br>control panel, full touch monitor, optional image storage and printing<br>devices. It provides high-performance ultrasound imaging and analysis<br>and have comprehensive networking and DICOM capability. It utilizes a<br>variety of linear, curved linear, matrix phased array transducer including<br>mechanical and electronic scanning transducers which provide accurate |

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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative swirls, giving the logo a classic and recognizable appearance.

real-time three-dimensional imaging supporting all standard acquisition modes.

The Voluson SWIFT, Voluson SWIFT+ is a general-purpose diagnostic Intended Use: ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Voluson SWIFT, Voluson SWIFT+ clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal(including Urology/Prostate) (TR); Transvaginal (TV). Mode of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson SWIFT / Voluson™ SWIFT+ are intended to be used in a hospital or medical clinic.

> The Voluson SWIFT, Voluson SWIFT+ employs the same fundamental scientific technology as its predicate device(s).

Technology:

Determination of Substantial Equivalence:

The proposed Voluson SWIFT, Voluson SWIFT+ is a new platform substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed Voluson SWIFT, Voluson SWIFT+ and the predicate Voluson P Series (K180535).

Comparison to Predicates

- . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson P ● Series systems have the same clinical intended use.
- The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson P Series systems have the similar imaging modes. Voluson SWIFT, Voluson SWIFT+ have additional Elastography mode cleared in Voluson S series (K180374).
- The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device.
- The systems have acoustic power levels which are below the applicable FDA limits.
- The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson P Series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.

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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and there are decorative swirls around the outside of the circle. The logo is simple and recognizable, and it is associated with a well-known company.

- The Voluson SWIFT, Voluson SWIFT+ and predicate Voluson P ● Series systems have been designed in compliance with approved electrical and physical safety standards.
- The probes supported in proposed Voluson SWIFT, Voluson o SWIFT+ and predicate Voluson P series are identical except: - The following probes have been migrated from Voluson S Series(K180374): RAB6-RS, C1-5-RS - The addition of one new transducer IC9B-RS (similar to IC9-RS/E8C-RS on predicate Voluson P Series)
- The following software features have been migrated from Voluson ● E Series(K192159): SonoCNS, IDEA Assessment, IOTA Adnex, IETA Tool.
- The following software features have been migrated from Voluson o S Sereis(K180374): Elastography, Scan Assistant and VOCAL.
- The proposed Voluson SWIFT, Voluson SWIFT+ adds a feature o of automatically selecting Scan Assistant List items based on the analysis of a frozen ultrasound image called SonoLyst.

## Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The Voluson SWIFT, Voluson SWIFT+ complies with voluntary standards:

- AAMI/ANSI ES60601-1. Medical Electrical Equipment Part 1: ● General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General ● Requirements for Basic Safety and Essential Performance -Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.0, 2014
- IEC 60601-2-37, Medical Electrical Equipment Part 2-37: ● Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, Edition 2.1, 2015
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: ● Evaluation and Testing Within A Risk Management Process, Fourth edition, 2009
- o ISO 14971. Application of risk management to medical devices, 2007
- NEMA PS 3.1 3.20, Digital Imaging and Communications in o Medicine (DICOM) Set. (Radiology), 2016

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The frame has decorative swirls or flourishes around the perimeter. The logo is presented in a light blue color.

- IEC 62359, Ultrasonics Field characterization Test methods for ● the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
The following quality assurance measures are applied to the development of the system:

- o Risk Analysis
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification) ●
- Safety testing (Verification) ●

Transducer materials and other patient contact materials are biocompatible.

### Summary of Clinical Tests:

The subject of this premarket submission. Voluson SWIFT, Voluson SWIFT+, did not require clinical studies to support substantial equivalence.

- Conclusion: GE Healthcare considers the Voluson SWIFT, Voluson SWIFT+ to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).