(65 days)
The DC-40/DC-35/DC-45/DC-40S/DC-40 Pro diagnostic ultrasound system is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in fetal, abdominal, pediatric, small organ(breast, thyroid, testes), neonatal cephalic.adult cephalic.trans-rectal, trans-vaginal, musculo-skeletal(supertional), musculo-skeletal(superficial), cardiac adult, cardiac pediatric and peripheral vessel exams.
DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasound diagnostic system. Its function is to acquire and display ultrasound images in B-mode, PW-mode, PW-mode, CW mode, Color-mode, Power/Dirpower mode, THI mode, 3D/4D mode, iScape mode, TDI mode, Color M mode, Biopsy Guidance, Elastography, 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, convex array and phased array with a frequency range of approximately 3 MHz to 10.0MHz.
The provided text is a 510(k) summary for the Shenzhen Mindray Bio-Medical Electronics Co., Ltd. DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System. It describes the device's intended use and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that clinical studies were not required or performed to demonstrate substantial equivalence for this device. Therefore, a study proving the device meets specific acceptance criteria based on clinical performance data is not detailed in this document.
The acceptance criteria mentioned are general safety and performance standards rather than specific clinical performance metrics. The document instead focuses on demonstrating that the new device is substantially equivalent to previously cleared devices through non-clinical testing.
Here's a breakdown of the requested information based on the provided text, with a clear indication when the information is not present or not applicable due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission asserting substantial equivalence based on non-clinical testing and comparison to predicates, the "acceptance criteria" are compliance with recognized standards and similarity to predicate devices. Specific performance metrics (e.g., sensitivity, specificity for a particular clinical task) are not provided as acceptance criteria for this type of submission.
| Acceptance Criteria (General Safety and Performance) | Reported Device Performance (Compliance Claimed) |
|---|---|
| Intended Use Equivalence to Predicate Device (DC-N3 K140030) | The device's intended uses (fetal, abdominal, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal, cardiac adult, cardiac pediatric, and peripheral vessel exams) are stated to be the same as the predicate device (DC-N3 K140030), with the exception of "urology" which is an "other use" for the subject device. |
| Patient Contact Materials Biocompatibility | Tested under ISO 10993-1. |
| Acoustic Power Levels within FDA Limits | Acoustic power levels are below FDA limits, which are the same as the predicate device DC-N3 (K140030). |
| Electrical and Physical Safety Standards Compliance | Designed in compliance with FDA recognized electrical and physical safety standards, which are the same as the predicate device DC-N3 (K140030). |
| Imaging Modes Equivalence | Has the same imaging modes as the predicate devices. |
| Functions Equivalence | All functions are the same as the predicate devices. |
| Transducer Equivalence | Has the same transducers as the predicate devices. |
| Compliance with Specific Recognized Standards: | |
| - AAMI/ANSI ES60601-1 (Medical electrical equipment basic safety) | Compliance claimed. |
| - AAMI/ANSI/IEC 60601-1-2 (Electromagnetic compatibility) | Compliance claimed. |
| - IEC 60601-2-37 (Ultrasonic medical diagnostic equipment) | Compliance claimed. |
| - IEC 62304 (Medical device software life cycle processes) | Compliance claimed. |
| - IEC 62366 (Usability engineering) | Compliance claimed. |
| - IEC 60601-1-6 (Usability for basic safety and essential performance) | Compliance claimed. |
| - ISO 14971 (Risk management) | Compliance claimed. |
| - UD 2 (Acoustic Output Measurement Standard) | Compliance claimed. |
| - UD 3 (Real Time Display of Thermal and Mechanical Acoustic Output | Compliance claimed. |
| Indices) | |
| - ISO 10993-1 (Biological evaluation of medical devices) | Compliance claimed. |
2. Sample size used for the test set and the data provenance
- Not applicable for clinical performance data. The submission states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence."
- For non-clinical tests (acoustic output, biocompatibility, electrical safety, etc.), the sample sizes are not specified in this summary. Data provenance would be from internal lab testing conducted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set with ground truth established by experts is mentioned in this 510(k) summary.
4. Adjudication method for the test set
- Not applicable. No clinical test set and thus no adjudication method is mentioned.
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, an MRMC comparative effectiveness study was not done. The document explicitly states "Not applicable. The subject of this submission... does not require clinical studies to support substantial equivalence." This device is a Diagnostic Ultrasound System, not an AI-assisted diagnostic tool that would typically undergo such studies.
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; performance is inherently "human-in-the-loop" as it requires a trained operator to acquire and interpret images. There is no mention of a standalone algorithm's performance.
7. The type of ground truth used
- Not applicable for clinical performance. For non-clinical tests (e.g., electrical safety, acoustic output), ground truth is established by recognized standards and calibrated measurement equipment.
8. The sample size for the training set
- Not applicable. There is no mention of a "training set" for an algorithm, as this is a diagnostic ultrasound imaging system, not an AI/ML-based diagnostic device in the context of this submission.
9. How the ground truth for the training set was established
- Not applicable. No training set for an algorithm is mentioned.
In summary, this 510(k) submission establishes substantial equivalence for a diagnostic ultrasound system primarily through a comparison to predicate devices and adherence to recognized non-clinical safety and performance standards. It does not involve clinical performance studies with specific acceptance criteria, test sets, expert ground truth, or AI algorithm validation.
§ 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.