(56 days)
No
The document does not mention AI, ML, or related terms, nor does it describe any features or studies indicative of AI/ML functionality.
No.
The device is a diagnostic ultrasound system intended for imaging, measurement, display, and analysis of the human body and fluid, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is a "general-purpose diagnostic ultrasound system."
No
The device description clearly states it is a "full-featured Track 3 ultrasound system" consisting of a "mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices." It also mentions utilizing "a variety of linear, curved linear, matrix phased array transducers." These are all hardware components, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Voluson S Series is a diagnostic ultrasound system. It uses sound waves to create images of the inside of the body. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This is in vivo (within the living body) imaging, not in vitro (in glass/outside the body) analysis.
The document describes a medical imaging device, not a device that performs tests on biological samples.
N/A
Intended Use / Indications for Use
Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics: Abdominal (including renal and GYN/Pelvic): 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, AMM, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes. All probes on the subject device have been previously cleared on the predicate K180374 with the exception of the IC9b-RS which was previously cleared on predicate K201828. All probes available as accessories for the subject systems Voluson are used unchanged from the cleared predicates. They are made of the same materials and their shape is unchanged The primary differences between the difference models are the Voluson S10 Expert/S10 and S8t have a touch panel in the user interface and the S8 and S6 do not. Additionally, the Voluson S10 Expert is the highest configuration offering all the features and probes available on the S Series and the other models offer a subset of them.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Human body and fluid (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)).
Indicated Patient Age Range
Adult and Pediatric
Intended User / Care Setting
Qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices. The users may or may not be working under supervision or authority of a physician. Intended to be used in a hospital or medical clinic.
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)
The subject of this premarket submission, Voluson S Series did not require clinical studies 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.
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.
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
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUATOSA WI 53226
January 13, 2022
Re: K213642
Trade/Device Name: Voluson S6, Voluson S8, Voluson S10, Voluson S10, Voluson S10 Expert Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 17, 2021 Received: November 18, 2021
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/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
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Indications for Use
510(k) Number (if known)
Device Name
Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert
Indications for Use (Describe)
Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are a general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional that are legally authorized or licensed by law in the country, state or other local municipality in which he or she practices for ultrasound imaging, measurement, display and analysis of the human body and fluid. The users may or may not be working under supervision or authority of a physician. Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert clinical applications include: Fetal/Obstetrics: Abdominal (including renal and GYN/Pelvic): 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, AMM, PW Doppler, CW Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD-Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S10 / Voluson S10 Expert are intended to be used in a hospital or medical clinic.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| --------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------- |
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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by three stylized water droplets, also in blue, which give the impression of movement or flow around the central letters.
510(k) Summary K213642
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 17, 2021 |
| Submitter: | GE Medical Systems Ultrasound and Primary care Diagnostics, LLC |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Ultrasound Korea, Ltd. |
| 9, Sunhwan-ro 214beon-gil, Jungwon-gu, | |
| Seongnam-si, Gyeonggi-do, Republic of Korea | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262) 247-5502 | |
| Alternate Contact Person: | Jiyeon Park |
| Senior Regulatory Affairs Leader | |
| GE Healthcare | |
| T: +82 317406307 | |
| Device Trade Name: | Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Primary Predicate Device: | K180374 Voluson S series Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Reference Device(s): | K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN (primary), IYO, ITX (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN; | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO; | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Device Description: | The systems are full-featured Track 3 ultrasound systems, primarily for |
| general radiology use and specialized for OB/GYN with particular | |
| features for real-time 3D/4D acquisition. They consist of a mobile | |
| console with keyboard control panel; color LCD/TFT touch panel, color | |
| video display and optional image storage and printing devices. They | |
| provide high performance ultrasound imaging and analysis and have | |
| comprehensive networking and DICOM capability. They utilize a variety | |
| of linear, curved linear, matrix phased array transducers including | |
| mechanical and electronic scanning transducers, which provide accurate | |
| real-time three-dimensional imaging supporting all standard acquisition | |
| modes. All probes on the subject device have been previously cleared on | |
| the predicate K180374 with the exception of the IC9b-RS which was | |
| previously cleared on predicate K201828. All probes available as | |
| accessories for the subject systems Voluson are used unchanged from the | |
| cleared predicates. They are made of the same materials and their shape | |
| is unchanged | |
| The primary differences between the difference models are the Voluson | |
| S10 Expert/S10 and S8t have a touch panel in the user interface and the | |
| S8 and S6 do not. Additionally, the Voluson S10 Expert is the highest | |
| configuration offering all the features and probes available on the S | |
| Series and the other models offer a subset of them. | |
| Intended Use: | Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 |
| Expert are a general-purpose diagnostic ultrasound system intended for | |
| use by a qualified and trained healthcare professional that are legally | |
| authorized or licensed by law in the country, state or other local | |
| municipality in which he or she practices for ultrasound imaging, | |
| measurement, display and analysis of the human body and fluid. The | |
| users may or may not be working under supervision or authority of a | |
| physician. Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / | |
| Voluson S10 Expert 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, AMM, PW Doppler, CW Doppler, | |
| Color Doppler, Color M Doppler, Power Doppler, Tissue Doppler, HD- | |
| Flow, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, | |
| Elastography, B-Flow, Contrast and Combined modes: B/M, B/Color, | |
| B/PWD, B/Power/PWD. The Voluson S6 / Voluson S8 / Voluson S8t/ | |
| Voluson S10 / Voluson S10 Expert are intended to be used in a hospital | |
| or medical clinic. | |
| Technology: | The Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson |
| S10 Expert employs the same fundamental scientific technology as its | |
| predicate device(s). | |
| Determination of | |
| Substantial Equivalence: | Comparison to Predicates |
| The proposed Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / | |
| Voluson S10 Expert is substantially equivalent to the predicate devices. | |
| The following is an overview of the differences between the proposed | |
| Voluson S6 / Voluson S8 / Voluson S8t / Voluson S10 / Voluson S10 | |
| Expert and the predicate Voluson S Series (K180374). | |
| The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The proposed Voluson S Series and predicate Voluson S series systems have the same clinical intended use. The proposed Voluson S Series and predicate Voluson S series systems have the same imaging modes. The systems are manufactured with materials which have been evaluated and found to be safe for the intended use of the device. |
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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' in a stylized, cursive font, enclosed within a blue circle. There are decorative swirls or flourishes around the outer edge of the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet distinctive, and is widely recognized as the symbol of the General Electric company.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves. The logo is rendered in a blue color.
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Image /page/6/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. There are three white water droplets around the circle. The logo is simple and recognizable.
- The systems have acoustic power levels which are below the ● applicable FDA limits.
- The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The proposed Voluson S Series and predicate Voluson S series systems have been designed in compliance with approved electrical and physical safety standards.
- The probes supported in proposed Voluson S Series and predicate ● Voluson S series systems are identical - The following probe has been migrated from Voluson SWIFT, Voluson SWIFT+ (K201828): IC9B-RS - The C2-9-RS probe has been expanded to Voluson S10, Voluson S8t, Voluson S8 and Voluson S6.
- The following software features have been migrated from . Voluson SWIFT, Voluson SWIFT+(K201828): SonoCNS, Uterine Trace, Sonobiometry Brain.
- The following minor improvements have been made IDEA ● Assessment, IOTA ADNEX, IETA Tool, Sono FHR, SonoAVCantral20, OS update, Security update, Measurement package updates, Refresh of connectivity.
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 S Series 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
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo, which is a circular emblem with a stylized "GE" monogram in the center. The monogram is surrounded by a circular border, and there are three stylized water droplets or flourishes evenly spaced around the outer edge of the circle. The logo is rendered in a blue color.
- ISO 10993-1, Biological Evaluation of Medical Devices-Part 1: . Evaluation and Testing Within A Risk Management Process, Fourth edition, 2009
- ISO 14971, Application of risk management to medical devices, 2019
- NEMA PS 3.1 3.20, Digital Imaging and Communications in ● Medicine (DICOM) Set. (Radiology), 2016
- 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:
- 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 S Series did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the Voluson S Series to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).