Voluson E6, Voluson E8, Voluson E10 by GE Healthcare

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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Submission for GE Healthcare's Voluson E Series ultrasound systems. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed device performance metrics for a new clinical application.

Therefore, many of the requested details about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not available in this document. This submission details an update to existing devices with improved hardware and minor software improvements, asserting that the intended use and performance remain substantially equivalent to the previously cleared predicate.

Here's what can be extracted and what is not available from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new clinical performance study. The submission focuses on demonstrating substantial equivalence through a comparison of technological characteristics, safety standards, and intended use as described in the "Determination of Substantial Equivalence" section. Implicitly, the acceptance criteria are that the updated device must meet the same safety, effectiveness, and performance levels as its predicate, especially concerning acoustic output, electrical/thermal/mechanical safety, biocompatibility, and software functionality.
Reported Device Performance: No specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are provided in this document as it's not a clinical performance study. The document states:
- "The proposed Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness."
- "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 have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies."
- "The systems have acoustic power levels which are below the applicable FDA limits."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not provided. This submission did not involve a clinical study with a test set of patient data to evaluate performance for a new clinical claim. It's a technical and regulatory review for substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not provided. No clinical ground truth was established as no clinical study was conducted for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not provided. No clinical study was performed.

5. 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. This document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no MRMC study was conducted. Also, the device is a general-purpose ultrasound system with improved hardware and existing software features, not an AI-assisted diagnostic tool discussed in the context of improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This submission is for an ultrasound system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/Not provided. No new clinical ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence primarily relies on technical specifications, adherence to safety standards, and documented equivalence to a legally marketed predicate device's performance, which was presumably established in its original clearance.

8. The sample size for the training set

Not applicable/Not provided. As no new clinical algorithm with a training set is discussed or developed in this submission, this information is not relevant. The software improvements mentioned are to existing features, implying an iterative development process rather than a new AI model requiring a separate training set.

9. How the ground truth for the training set was established

Not applicable/Not provided. No new training set or associated ground truth establishment is described in this document.

Summary

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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

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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

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GE Healthcare 510(k) Premarket Notification Submission

Section 4: Indications for Use Statement

Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10)

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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)

K192159

Device Name Voluson E6, Voluson E8, Voluson E10

Indications for Use (Describe)

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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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 15Zipf, Austria 4871
Primary Contact Person:	Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262)247-5502F:(414)918-8275
Secondary Contact Person:	Roland KuntscherRegulatory Affairs SpecialistGE Healthcare Austria GmbH & Co OGT:(+43)7682-3800-660F:(+43)7682 3800-47
Device Trade Name:	Voluson E6, Voluson E8, Voluson E10Models: 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 forgeneral radiology use and specialized for OB/GYN with particularfeatures for real-time 3D/4D acquisition. They consist of a mobileconsole with keyboard control panel; color LCD/TFT touch panel,color video display and optional image storage and printing devices.

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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

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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: ●

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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).

Regulation Number and Section

§ 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.