(30 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional: Urology (including prostate), Transesophageal; Transrectal (TR); and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid 7 Diagnostic Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console approximately 65 cm wide, 96 cm deep and 139 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls and a color video CRT or LCD display. This modification offers improved performance and productivity for users.
The GE Vivid 7 Diagnostic Ultrasound System with EchoPAC BT06 is a medical device for diagnostic ultrasound imaging and fluid flow analysis. The device is an update to the already marketed GE Vivid 7 Diagnostic Ultrasound System. No clinical tests were required for this 510(k) submission, as the manufacturer states that "intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination." The submission relies on non-clinical testing and the established safety and effectiveness of Diagnostic Ultrasound.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance (Reference) |
|---|---|
| Acoustic Output | Conforms with applicable medical device safety standards (Section b.1) |
| Biocompatibility | Conforms with applicable medical device safety standards (Section b.1) |
| Cleaning and Disinfection Effectiveness | Conforms with applicable medical device safety standards (Section b.1) |
| Electromagnetic Compatibility | Conforms with applicable medical device safety standards (Section b.1) |
| Thermal Safety | Conforms with applicable medical device safety standards (Section b.1) |
| Electrical Safety | Conforms with applicable medical device safety standards (Section b.1) |
| Mechanical Safety | Conforms with applicable medical device safety standards (Section b.1) |
| Quality Systems | Conforms with 21 CFR 820, ISO 9001:2000, and ISO 13485 (Section b.3) |
| Overall Safety and Effectiveness | Substantially equivalent to predicate device (GE Vivid 7) (Section b.3, Section a.6) |
2. Sample Size Used for the Test Set and the Data Provenance:
No specific test set data (e.g., patient cases) was provided or mandated for this submission. The "test set" for this device's acceptance relied on adherence to established medical device safety standards and the substantial equivalence to a predicate device. Therefore, there is no sample size or data provenance in the traditional sense of a clinical study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. As no clinical tests were required, there was no "ground truth" derived from expert consensus on patient data for this submission. The ground truth for safety and performance was based on conformance to engineering and quality standards, and the history of safe and effective performance of diagnostic ultrasound.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set requiring adjudication was used for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Tests: None required" (Section b.2).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable, as this device is a diagnostic ultrasound system intended for use by a qualified physician. Its performance is inherently linked to human operation and interpretation. The submission does not detail any standalone algorithmic performance studies.
7. The Type of Ground Truth Used:
The ground truth used for this submission primarily revolved around:
- Conformance to internationally recognized medical device safety standards (e.g., acoustic output limits, electrical safety, biocompatibility).
- Compliance with quality system regulations (21 CFR 820, ISO 9001:2000, ISO 13485).
- Substantial equivalence to a legally marketed predicate device (GE Vivid 7), meaning its indications for use, fundamental technology, and safety/effectiveness profile are comparable.
- The established history of safe and effective performance of diagnostic ultrasound technology in general.
8. The Sample Size for the Training Set:
Not applicable. This submission does not describe a machine learning algorithm that would typically require a training set of data. The "training" in this context refers to the development and manufacturing processes adhering to quality systems and engineering standards.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. Since there was no machine learning algorithm or training set in the typical sense, there was no ground truth for a training set to be established. The "ground truth" for the device's development was established through adherence to engineering principles, regulatory standards, and manufacturing quality controls.
§ 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.