(86 days)
No
The document does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as a "general-purpose diagnostic ultrasound system" and its intended use is for "imaging, measurement, display and analysis," which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "general-purpose diagnostic ultrasound system."
No
The device description explicitly states it consists of a mobile console with keyboard control panel, color LCD display, and utilizes various transducers, indicating it is a hardware-based ultrasound system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "general-purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional... for ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes a device used for in vivo (within the living body) imaging and diagnosis, not for testing samples in vitro (outside the body).
- Device Description: The description details a mobile console with transducers used for generating ultrasound images of the body. This aligns with in vivo imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This ultrasound system operates by sending sound waves into the body and interpreting the reflected echoes to create images, which is a fundamentally different diagnostic approach.
N/A
Intended Use / Indications for Use
Voluson P6 / Voluson P8 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 P6 / Voluson P8 clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including Urology/Prostate) (TV),
Product codes
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 display, 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
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, Pediatric, Neonatal (Cephalic), Fetal
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.
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 P Series did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K180535 Voluson P Series Diagnostic Ultrasound System
Reference Device(s)
K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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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 is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA WI 53226
February 17, 2022
Re: K213689
Trade/Device Name: Voluson P6, Voluson P8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: November 23, 2021 Received: November 23, 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/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
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,
Jessica Lamb, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch 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)
K213689
Device Name Voluson P6, Voluson P8
Indications for Use (Describe)
Voluson P6 / Voluson P8 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 P6 / Voluson P8 clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN/Pelvic); Pediatric; Small Organ (Breast, Testes, Thyroid, etc.); Neonatal Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (including UrologyProstate) (TV),
Mode of operation include: B, M, AMM, PW Doppler, CW Doppler, Color M Doppler, Color M Doppler, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/Pwwer/ PWD. The Voluson P6 / Voluson P8 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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Image /page/3/Picture/0 description: The image shows the logo for GE (General Electric). The logo is a blue circle with the letters "GE" in white inside. The letters are stylized and connected, and the circle is surrounded by a series of white swirls. The logo is simple and recognizable, and it is often used to represent the company's brand.
510(k) Summary
K213689
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 23, 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: | |
| Common/Usual Name: | |
| Classification Names: | |
| Product Code: | Voluson P6, Voluson P8 |
| Diagnostic Ultrasound System | |
| Class II | |
| 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: | |
| Reference Device(s): | K180535 Voluson P Series Diagnostic Ultrasound System |
| K201828 Voluson SWIFT, Voluson SWIFT+ Diagnostic Ultrasound System | |
| 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 display, 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. |
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Image /page/4/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 a pattern of curved lines, resembling water droplets or stylized leaves, also in blue. The logo is simple, recognizable, and has been used by GE for many years.
Intended Use: Voluson P6 / Voluson P8 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 P6 / Voluson P8 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, HD-Flow, Harmonic Imaging, 3D/4D Imaging mode, Contrast and Combined modes: B/M, B/Color, B/PWD, B/Power/PWD. The Voluson P6 / Voluson P8 are intended to be used in a hospital or medical clinic. The Voluson P6 / Voluson P8 employs the same fundamental scientific Technology: technology as its predicate device(s). Determination of Comparison to Predicates Substantial Equivalence: The proposed Voluson P6 / Voluson P8 is substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed Voluson P6 / Voluson P8 and the predicate Voluson P Series (K180535). ● The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. ● The proposed Voluson P Series and predicate Voluson P Series systems have the same clinical intended use. The proposed Voluson P Series and predicate Voluson P 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. ● The systems have acoustic power levels which are below the applicable FDA limits. The proposed Voluson P Series and predicate Voluson P Series ● systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. The proposed Voluson P Series and predicate Voluson P Series ●
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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 a stylized font in the center. There are decorative swirls around the letters. The logo is simple and recognizable.
systems have been designed in compliance with approved electrical and physical safety standards.
- The probes supported in proposed Voluson P Series and predicate Voluson P Series systems are identical except - The following probe has been migrated from Voluson SWIFT, Voluson SWIFT+ (K201828): IC9B-RS
- The following software features have been migrated from Voluson . SWIFT, Voluson SWIFT+(K201828): Sonobiometry Brain
- The following minor improvements have been made: IDEA ● Assessment, IOTA ADNEX, IETA Tool, Sono FHR, OS update, Security update, Measurement package updates, Refresh of connectivity, Omniview 1 Line.
- The following features is being removed: SonoMetrium ●
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 P 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
- 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
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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 flourishes resembling water droplets or stylized leaves. The logo is presented in a blue color scheme.
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 P Series did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Voluson P Series to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).