Search Results
Found 2 results
510(k) Data Aggregation
(20 days)
The DC-7 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in abdominal, cardiac, small organ (breast, testes, thyroid, etc.), peripheral vascular, fetal, transvaginal, pediatric, transcranial (adult cephalic and neonatal cephalic), musculoskeletal (conventional and superficial), intraoperative, and urology exams.
The DC-7 Diagnostic Ultrasound System is a general purpose, portable, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, M-mode, Color mode, Color M mode, CW mode, CW mode, Power/DirPower mode, TDI mode or the combined mode (i.e. B/M Mode). This system is a Track 3 device that employs an array of probes that include linear array probe, convex array probe, phased array probe and volume probe with a frequency range of approximately 1.8 MHz to 12.0 MHz. This modification will provide users with 3 additional transducers, some additional optional features called STIC, Stress Echo, iPage, and etc. These modifications all lead to overall quality and image enhancement.
The DC-7 Diagnostic Ultrasound System is a general purpose ultrasound system with various transducers and modes of operation. The provided text is a 510(k) summary for this device, seeking substantial equivalence to predicate devices, and outlines its intended use, non-clinical tests, and technological characteristics. The document does not contain specific acceptance criteria and a study proving the device meets those criteria in the way typically expected for an AI/CADe device.
Instead, the document details the Indications for Use (IFU) for the DC-7 Diagnostic Ultrasound System and its various transducers across different clinical applications and modes of operation. The "acceptance criteria" here are implicitly that the new system and its transducers can perform these functions ("P" for previously cleared, "N" for new indications) safely and effectively, demonstrating substantial equivalence to the listed predicate devices.
Here's a breakdown based on your request, interpreting "acceptance criteria" as the claimed capabilities and "study" as the information provided for regulatory clearance:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) clearance for a general-purpose ultrasound system and not a specific AI/CADe algorithm with performance metrics like sensitivity/specificity, the "acceptance criteria" are the claimed modes of operation and clinical applications for each transducer. The "reported device performance" is that the system and transducers are capable of these indicated uses, demonstrating substantial equivalence to predicate devices.
The tables for each transducer (e.g., 3C5A, C5-2, V10-4, L12-4, P7-3, etc.) list the following "acceptance criteria" (indicated by 'P' for previously cleared or 'N' for new) and their reported performance (the presence of 'P' or 'N' in the table signifies the device meets these criteria for the given transducer):
| Clinical Application | B Mode | M Mode | PWD | CWD | Color Doppler | Amplitude Doppler | Combined Mode | Other Features |
|---|---|---|---|---|---|---|---|---|
| Ophthalmic | ||||||||
| Fetal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Abdominal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,5,6,7 |
| Intraoperative (includes abdominal, thoracic, vascular) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Small Organ (breast, testes, thyroid) | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Neonatal Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Adult Cephalic | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,5,6,7 |
| Trans-rectal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Trans-vaginal | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,3,4,6,7 |
| Musculoskeletal Conventional | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Musculoskeletal Superficial | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Cardiac Adult | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Cardiac Pediatric | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,5,6,7 |
| Peripheral Vascular | P / N | P / N | P / N | P / N | P / N | P / N | P / N | Note 1,2,4,6,7 |
| Other (Urology) | N | N | N | N | N | N | N | Note 1,2,4,6,7 |
Notes:
- Tissue Harmonic Imaging: The feature does not use contrast agents.
- Smart3D: (Likely a 3D imaging feature)
- 4D (Real-time 3D): (Real-time 3D imaging)
- iScape: (Likely an extended field of view imaging feature)
- TDI (Tissue Doppler Imaging): (Cardiac function assessment)
- Color M: (Color M-mode)
- Biopsy Guidance: (Assistance for biopsy procedures)
P = Previously cleared by FDA; N = New indication (for this specific K-number, it implies new to this device or transducer combination)
Entries are filled based on the collective information from all transducer tables where "P" or "N" is indicated for at least one transducer. Some specific cells might be blank for certain transducers, meaning that mode/application is not indicated for that specific transducer.
The "study" proving these criteria are met is the "Non-clinical Tests" and the demonstration of "Technological Characteristics" being substantially equivalent to predicate devices.
2. Sample Size Used for the Test Set and the Data Provenance
- The 510(k) summary does not describe a specific "test set" in terms of patient data for a clinical study comparing performance metrics.
- Instead, the submission relies on non-clinical tests (acoustic output, biocompatibility, cleaning/disinfection, thermal/electrical/mechanical safety) and comparison of technological characteristics to predicate devices to establish substantial equivalence.
- Data provenance: Not applicable in the context of a clinical test set from patient data. The provenance for the non-clinical tests would be internal laboratory testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This is a clearance for a general diagnostic ultrasound system based on technological equivalence and safety standards, not an AI/CADe device requiring expert-established ground truth for a clinical performance study.
4. Adjudication Method for the Test Set
- Not applicable, as no clinical test set requiring expert adjudication is described in the provided summary.
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
- Not applicable. This is not an AI/CADe device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI/CADe device.
7. The Type of Ground Truth Used
- Not applicable. The clearance is based on adherence to medical safety standards (IEC, ISO), acoustic output, biocompatibility, and demonstrated technological equivalence to legally marketed predicate devices, rather than comparison to a clinical ground truth like pathology or outcomes data for a specific diagnostic task.
8. The Sample Size for the Training Set
- Not applicable. This is a hardware/software system, not an AI/CADe algorithm requiring a training set from patient data in the context of medical imaging.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, this is not an AI/CADe algorithm with a training set.
In summary: The provided 510(k) summary for the Mindray DC-7 Diagnostic Ultrasound System is for a general-purpose diagnostic imaging device, not an AI or CADe product. Therefore, the "acceptance criteria" and "study" described align with the requirements for establishing substantial equivalence for such a device, focusing on safety, performance, and technological similarity to already cleared predicate devices, rather than detailed performance metrics from clinical trials or AI algorithm validation.
Ask a specific question about this device
(30 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics, 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, Transvaginal (TV), and Intraoperative (abdominal, thoracic, & vascular).
The GE Vivid E9 Ultrasound is a full featured echocardiography imaging and analysis system. It consists of a mobile console with multiple electronic array transducers that provides digital acquisition, processing and display capability. The user interface includes a floating and variable height user control panel with specialized controls, high resolution LCD display and separate LCD touch panel. This modification offers improved performance and productivity for users in a smaller and lighter weight package.
This document describes the Summary of Safety and Effectiveness for the GE Vivid E9 Ultrasound system, prepared in accordance with 21 CFR Part 807.92(c).
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (GE Vivid 7 Diagnostic Ultrasound) rather than establishing specific quantitative acceptance criteria for device performance. The "acceptance criteria" are implied to be adherence to medical device safety standards and comparable performance to the predicate.
The table below summarizes the claimed performance characteristics and indications for use, noting that these are "previously cleared by FDA" (P) or "new indication" (N) for specific transducers. The core acceptance criterion for the device itself is its safety and effective performance, which is stated to be consistent with traditional clinical practice and FDA guidelines.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with applicable medical device safety standards. | The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, electromagnetic compatibility, as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards. |
| Consistent with traditional clinical practice and FDA guidelines | Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. |
| Substantial equivalence to predicate device (GE Vivid 7) | The GE Vivid E9 is of a comparable type and substantially equivalent to the current GE Vivid 7 with overall enhanced performance in a smaller and more compact package. It has the same overall characteristics, key safety and effectiveness features, physical design, general overall construction, and materials, and has the same intended uses and operating modes as the predicate device. |
| Indications for Use (Per Transducer) | (Each "P" or "N" in the following tables indicates claimed performance for that mode/application) |
| GE Vivid E9 Ultrasound System (Overall) | Clinical applications: Ophthalmic, Fetal/Obstetrics, Abdominal (including renal and GYN), Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Urology (including prostate), Transesophageal, Transvaginal, Intraoperative (abdominal, thoracic, & vascular). All listed modes (B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, Harmonic Imaging, Coded Pulse, RT3D Mode) are claimed as 'P' for most applications, except for harmonic imaging, which is not universally 'P' across all applications. Notably, Intraoperative is 'N' for Coded Pulse. |
| GE Vivid E9 with 4C-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Peripheral Vascular (P), Urology (P). All listed modes except CW Doppler are 'P' for these applications. Harmonic Imaging is 'P' for all except Urology, which is blank for Harmonic. |
| GE Vivid E9 with 9L-D Transducer | Pediatric (P), Small Organ (P), Peripheral Vascular (P), Musculo-skeletal Conventional (P). All listed modes except CW Doppler are 'P' for these applications. |
| GE Vivid E9 with 11L-D Transducer | Pediatric (N), Small Organ (N), Peripheral Vascular (N), Musculo-skeletal Conventional (N), Intraoperative (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with M4S-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Adult Cephalic (P), Cardiac (P), Other[Urology/Prostate] (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with M5S-D Transducer | Fetal/Obstetrics (N), Abdominal (N), Pediatric (N), Adult Cephalic (N), Cardiac (N), Other[Urology/Prostate] (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with 6S-D Transducer | Fetal/Obstetrics (N), Abdominal (N), Pediatric (N), Neonatal Cephalic (N), Cardiac (N). All listed modes including CW Doppler are 'N' for these applications. |
| GE Vivid E9 with 3V-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Pediatric (P), Adult Cephalic (P), Cardiac (P), Other [Urology/Prostate] (P). All listed modes including CW Doppler, RT3D Mode, Combined Modes, Harmonic, and Coded Pulse are 'P' for these applications. |
| GE Vivid E9 with E8C-D Transducer | Fetal/Obstetrics (P), Abdominal (P), Other[Urology/Prostate] (P), Transrectal (P), Transvaginal (P). All listed modes except CW Doppler and Harmonic Imaging are 'P' for these applications. |
| GE Vivid E9 with 6T or 6Tc Transducer | Cardiac (P), Transesophageal (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with 9T Transducer | Cardiac (P), Transesophageal (P). All listed modes including CW Doppler are 'P' for these applications. |
| GE Vivid E9 with P2D Transducer | Cardiac (P) and Peripheral Vascular (P) for PW Doppler and CW Doppler modes only. Other modes are not specified. |
| GE Vivid E9 with P6D Transducer | Cardiac (P) and Peripheral Vascular (P) for PW Doppler and CW Doppler modes only. Other modes are not specified. |
Study Details:
A formal clinical study to prove the device meets acceptance criteria was not required or performed for this 510(k) submission.
-
1. A table of acceptance criteria and the reported device performance: See table above.
-
2. 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 tests were stated as "None required."
- Therefore, no sample size, data provenance, or retrospective/prospective nature of the data is reported.
-
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, as no clinical test set was utilized and no ground truth was formally established for direct comparison of the new device's performance against clinical outcomes. The equivalence relies on the established safety and efficacy of diagnostic ultrasound and its predicate.
-
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set was utilized.
-
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 MRMC comparative effectiveness study was done. This submission is for an ultrasound imaging system, not an AI-powered diagnostic aid. The device is a diagnostic ultrasound system, and the submission emphasizes its substantial equivalence to a predicate device and adherence to safety standards, not an improvement in human reader performance through AI assistance.
-
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a diagnostic ultrasound system that requires human operation, not a standalone AI algorithm.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No new ground truth for performance evaluation was established for this submission, as clinical tests were not required. The "ground truth" for the device's acceptable safety and effectiveness is implied through its adherence to established medical device safety standards and the long history of safe and effective performance of diagnostic ultrasound as a modality.
-
8. The sample size for the training set:
- Not applicable. This device is a hardware/software system, not a machine learning model requiring a training set in the typical sense.
-
9. How the ground truth for the training set was established:
- Not applicable, as no training set for a machine learning model was used.
Ask a specific question about this device
Page 1 of 1