(58 days)
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); Pediatic; 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 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 highly accurate real-time three-dimensional imaging supporting all standard acquisition modes.
This is a 510(k) premarket notification for the GE Healthcare Voluson E6, Voluson E8, and Voluson E10 ultrasound systems. The document states that clinical studies were not required to support substantial equivalence. Therefore, there is no information about specific acceptance criteria related to a study proving device performance, sample sizes for test or training sets, data provenance, expert ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.
The document focuses on demonstrating substantial equivalence to predicate devices (K162269 Voluson E6_E8_E10 Diagnostic Ultrasound System and K150087 Vivid E80/E90/E95 Diagnostic Ultrasound System) through technological characteristics, intended use, imaging capabilities, safety, and compliance with recognized standards.
Table of Acceptance Criteria and Reported Device Performance:
Since no clinical studies were performed, there are no specific performance metrics reported for the device against acceptance criteria in the traditional sense of a clinical trial. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices and compliance with safety and performance standards.
| Acceptance Criterion Type | Description from Document | Reported Device Performance |
|---|---|---|
| Intended 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 proposed Voluson E Series and predicate Voluson E Series systems have the same clinical intended use. The proposed Voluson E Series adds one new transducer M5Sc-D to the system, but its applications are within the indications for use of the predicate system. No change to system indications for use. |
| Technological Characteristics | The Voluson E Series (Voluson E6 / Voluson E8 / Voluson E10) employs the same fundamental scientific technology as its predicate devices. | The proposed Voluson E Series and predicate Voluson E Series systems have the same imaging modes and equivalent transducers. The proposed Voluson E Series adds an improved version of existing software feature IOTA LR2 model called IOTA Simple Rules, a Post processing analysis tool from TomTec called Fetal Heart Analysis, a 3D Analysis feature of the endometrial cavity called SonoMetrium, and a Fetal Cardio preset to the new M5Sc-D transducer (already implemented and cleared with other probes). |
| Safety | Systems are manufactured with materials evaluated and found to be safe; acoustic power levels are below FDA limits; designed in compliance with approved electrical and physical safety standards. | Complies with voluntary standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, NEMA UD 2, ISO14971. Transducer materials and other patient contact materials are biocompatible. |
| Performance | Similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies. Systems undergo risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, safety testing, and final acceptance testing. | The system has similar capabilities to the predicate with added software features for improved analysis (IOTA Simple Rules, Fetal Heart Analysis, SonoMetrium). |
Specific Information Regarding Studies:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- No clinical test set was used, as clinical studies were not required for this 510(k) submission. Non-clinical tests were performed to ensure compliance with standards.
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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, as no clinical test set requiring expert ground truth was utilized.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable due to the absence of a clinical test set.
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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 MRMC comparative effectiveness study was conducted or reported. The submission focuses on substantial equivalence of the ultrasound system itself, not on specific AI assistance features that would require such a study for performance evaluation. While new software features like "IOTA Simple Rules," "Fetal Heart Analysis," and "SonoMetrium" are mentioned, their specific performance metrics requiring MRMC studies are not detailed or were not deemed necessary for this 510(k) due to claimed substantial equivalence.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable, as the device is a diagnostic ultrasound system, not a standalone algorithm. The mentioned software features are integrated into the system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical studies with ground truth were conducted. Compliance with safety and performance standards was demonstrated through non-clinical testing.
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The sample size for the training set:
- Not applicable, as no clinical studies were conducted, and therefore no training set was explicitly mentioned. The development of software features would involve internal datasets, but details are not provided in this regulatory document.
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How the ground truth for the training set was established:
- Not applicable, for the reasons stated above.
§ 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.