(20 days)
K181985 Voluson E6_E8_E10 Diagnostic Ultrasound System
Not Found
No
The document explicitly states that "no additional software functions were added in this submission" compared to the predicate device, and there are no mentions of AI, ML, or related terms.
No.
The device is described as a "general-purpose ultrasound system" primarily for "general radiology use" and for "imaging." This indicates a diagnostic rather than a therapeutic purpose.
Yes
The "Intended Use / Indications for Use" section lists various clinical applications, indicating it's used for medical imaging to assess conditions, which is the definition of a diagnostic device. Additionally, the predicate device is explicitly named "Diagnostic Ultrasound System."
No
The device description explicitly states it consists of a mobile console with keyboard control panel, touch panel, video display, image storage/printing devices, and mechanical/electronic scanning transducers, indicating it is a hardware system with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "general-purpose ultrasound system" for various clinical applications involving imaging of anatomical structures. IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis.
- Device Description: The description details a system for generating and displaying ultrasound images of the body. This is consistent with an imaging device, not a device for analyzing biological samples.
- No mention of analyzing biological samples: The text does not mention any functionality related to analyzing blood, urine, tissue, or any other biological specimen.
Therefore, the device described is a diagnostic imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal.
The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
The proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use.
There is no change to the system indications for use.
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. including mechanical and electronic scanning transducers, which highly accurate real-time three-dimensional provide imaging supporting all standard acquisition modes. Voluson E10 is identical in hardware and software compared to the Voluson E8 and Voluson E6 with the exception of scan channels. Voluson E10 has more than Voluson E8 and E6. Voluson E10 also has additional hardware for the 4D electronic probes: eM6C and eM6C G2. The basic software is the same as the predicate and no additional software functions were added in this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB; Abdominal (including GYN, pelvic); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal; Transrectal
Indicated Patient Age Range
Pediatric; Neonatal and Adult
Intended User / Care Setting
Not Found
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 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 to applicable medical device safety standards. The Voluson E Series and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1. Medical Electrical Equipment Part . 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
- . IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: ● Evaluation and Testing- Third Edition, 2009
- ISO14971, Application of risk management to medical devices: ● Second edition 2007
- NEMA PS 3.1 3.20 (2016), Digital Imaging and . Communications in Medicine (DICOM) Set. (Radiology)
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) ●
- Final Acceptance Testing (Validation) ●
Transducer materials and other patient contact materials are biocompatible.
The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), 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.
K181985 Voluson E6_E8_E10 Diagnostic Ultrasound System
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.
Not Found
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text on the right. The symbol on the left is a stylized representation of a human figure. The text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "U.S. FOOD & DRUG" are on the top line, and the word "ADMINISTRATION" is on the bottom line.
August 29, 2019
GE Healthcare c/o Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA, WI 53226
Re: K192159
Trade/Device Name: Voluson E6, Voluson E8, Voluson E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: August 7, 2019 Received: August 9, 2019
Dear Mr. Bryan 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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Image /page/2/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, cursive font in the center. The circle is surrounded by four water droplets, one at each quadrant of the circle. The logo is simple and recognizable, and it is associated with a well-known and established company.
GE Healthcare 510(k) Premarket Notification Submission
Section 4: Indications for Use Statement
Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10)
3
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GE Healthcare 510(k) Premarket Notification Submission
| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|---|
| Food and Drug Administration |
| Indications for Use |
| Form Approved: OMB No. 0910-0120 |
| Expiration Date: 06/30/2020 |
| See PRA Statement below. |
510(k) Number (if known)
Device Name Voluson E6, Voluson E8, Voluson E10
Indications for Use (Describe)
The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral Vascular; Transvaginal (including GYN); Transrectal.
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary
Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10)
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510(k) Premarket Notification Submission
510(k) Summary K192159
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Aug 7, 2019 |
|---|---|
| Submitter: | GE Healthcare [GE Healthcare Austria GmbH & Co OG] |
| Tiefenbach 15 | |
| Zipf, Austria 4871 | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)247-5502 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Roland Kuntscher |
| Regulatory Affairs Specialist | |
| GE Healthcare Austria GmbH & Co OG | |
| T:(+43)7682-3800-660 | |
| F:(+43)7682 3800-47 | |
| Device Trade Name: | Voluson E6, Voluson E8, Voluson E10 |
| Models: Voluson E6 / Voluson E8 / Voluson E10 | |
| Common/Usual Name: | Ultrasound system |
| Classification Names: | Class II |
| Product Code(s): | IYN (primary), IYO, ITX (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN | |
| Primary Predicate Device(s): | K181985 Voluson E6_E8_E10 Diagnostic Ultrasound System |
| Product Code(s): | IYN (primary), IYO, ITX (secondary) |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550, 90-IYN | |
| 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. |
6
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 a stylized font in the center. The letters are surrounded by a swirling design that resembles water droplets or stylized leaves. The logo is simple and recognizable, and it is associated with a well-known and established company.
510(k) Premarket Notification Submission
including mechanical and electronic scanning transducers, which highly accurate real-time three-dimensional provide imaging supporting all standard acquisition modes. Voluson E10 is identical in hardware and software compared to the Voluson E8 and Voluson E6 with the exception of scan channels. Voluson E10 has more than Voluson E8 and E6. Voluson E10 also has additional hardware for the 4D electronic probes: eM6C and eM6C G2. The basic software is the same as the predicate and no additional software functions were added in this submission.
- The device is a general-purpose ultrasound system. Specific clinical Intended Use: applications remain the same as previously cleared: Fetal/OB: Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-Conventional and skeletal Superficial; Peripheral Vascular: Transvaginal (including GYN); Transrectal
- The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) Technology: employs the same fundamental scientific technology as its predicate devices. The updated version of the Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) consists of improved hardware and improvements to existing software features compared to the predicate version.
Determination of Comparison to Predicates Substantial The proposed Voluson E Series (Voluson E6 / Voluson E8 / Voluson Equivalence: E10) is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use.
- The proposed Voluson E Series and predicate Voluson E Series ● systems have the same imaging modes.
- The proposed Voluson E Series and predicate Voluson E Series . systems transducers are equivalent. No new transducers were
7
Image /page/7/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, cursive font. There are four white teardrop shapes surrounding the letters, one in each quadrant of the circle. The logo is simple and recognizable, and it is often used to represent the company's brand.
510(k) Premarket Notification Submission
added to the proposed system.
- . There is no change to the system indications for use.
- 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 E Series and predicate Voluson E Series ● systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The proposed Voluson E Series and predicate systems have ● been designed in compliance with approved electrical and physical safety standards.
- There proposed Voluson E Series and predicate Voluson E ● series Software Features are identical. Some minor improvements to the existing Software features have been implemented into the proposed system.
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 to applicable medical device safety standards. The Voluson E Series and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1. Medical Electrical Equipment Part . 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: . General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2014
- . IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
- ISO10993-1, Biological Evaluation of Medical Devices- Part 1: ● Evaluation and Testing- Third Edition, 2009
- ISO14971, Application of risk management to medical devices: ●
8
Image /page/8/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 script in the center. The circle is surrounded by a series of stylized water droplets or swirls. The blue color is a medium shade, and the overall design is clean and modern.
510(k) Premarket Notification Submission
Second edition 2007
-
NEMA PS 3.1 3.20 (2016), Digital Imaging and . Communications in Medicine (DICOM) Set. (Radiology)
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) ●
-
Final Acceptance Testing (Validation) ●
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10), did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Voluson E Series (Voluson E6 / Voluson Conclusion: E8 / Voluson E10) to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).