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510(k) Data Aggregation
(240 days)
CMS600P2 B-Ultrasound Diagnostic System
CMS600P2 B-Ultrasound Diagnostic System in a general-purpose, digital ultrasound diagnostic system for abdomen,gynecology, obstetric, urology,and small-parts application.
The system is intended to use for the following type of studies: fetal organ, abdominal, pediatric, small organs, neonatal cephalic, transvaginal, peripheral vascular,and musculo-skeletal (both conventional and superficial). The device is intended to adult, pregnant woman, pediatric and neonate.
The system is a prescription device intended to be used by or on the order of a physician or similar qualified health care professional.
This device is not intended for home use.
The apparatus is high resolution ultrasound diagnostic system, which adopts digital beam forming(DBF), real-time dynamic aperture(RDA), real-time dynamic beam apodization (DRA), real-time dynamic receive focusing (DRF), digital-control dynamic frequency scanning (DFS), frame correlation etc. technologies. The image is clear, stable, and high resolution.
It adopts embedded operating system, which greatly improve the product security and compatibility, and enhance the data processing ability.
The apparatus is taken more conveniently for its humane operation interface and management system, flexible expansibility and compatibility, pop-up menu and keyboard design.
Users can chose different kinds of display modes,such as:B, 2B, 4B, BM, M. Image real-time, freeze, memory, calling up and large capability cine loop can be realized; the device possesses multilevel scanning depth, dynamic range, sound output power and focus number, focus space, focus position adjusting etc. functions.
With controllable frame correlation, gamma correction, image reversing, histogram, depth advance, zoom magnification, no distortion real-time part magnification etc. image processing functions. It is convenient for choice of optimal diagnostic image with image pigeonhole, browse, management functions. Measure, calculation, and report features are provided to facilitate image measurement.
The device supports linear probe and convex probe. The frequency of the device is 2.0 MHz-10.0 MHz. It has extensive application that is suitable for clinic diagnosis, such as abdomen, obstetrics, gynecology, small organs, cardiology and urology etc. .
The device is consist of three parts: mainframe, transducer(probe), adapter.
The provided text describes the 510(k) submission for the CMS600P2 B-Ultrasound Diagnostic System, asserting its substantial equivalence to a predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device).
Important Note: This document focuses on demonstrating substantial equivalence to a predicate device, as opposed to proving novel performance against specific clinical acceptance criteria through a clinical trial with a human-in-the-loop AI system. Therefore, the information provided will pertain to demonstrating equivalence to an existing medical device's performance, rather than an AI's performance against specific clinical metrics. Many of the requested details, such as "effect size of human readers improving with AI vs. without AI assistance," "standalone (algorithm only) performance," or "adjudication method for the test set," are typically associated with AI/ML-driven devices and are not applicable to this traditional ultrasound system's 510(k) submission.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence)
The acceptance criteria for the CMS600P2 B-Ultrasound Diagnostic System are primarily based on demonstrating substantial equivalence (SE) to a legally marketed predicate device (EMP-2100 Full Digital Ultrasound Diagnostic Device) in terms of:
- Intended Use and Indications for Use
- Technological Characteristics (e.g., imaging modes, frequency range, resolution, safety standards)
- Safety and Effectiveness (demonstrated through non-clinical testing and comparison to predicate)
The performance of the proposed device is assessed against the performance characteristics of the predicate device.
Table of Acceptance Criteria and Reported Device Performance (Comparison to Predicate Device)
| Acceptance Criterion (Category / Characteristic) | Predicate Device Performance (EMP-2100) | Proposed Device Performance (CMS600P2) | Substantial Equivalence (SE) / Remark |
|---|---|---|---|
| General | |||
| Device Name | EMP-2100 Full Digital Ultrasound Diagnostic Device | CMS600P2 B-Ultrasound Diagnostic System | / (Different names, but comparable) |
| Classification Name | System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic | System, Imaging, Pulsed Echo, Ultrasonic; Transducer, Ultrasonic, Diagnostic | SE |
| Product Code | IYO, ITX | IYO, ITX | SE |
| Regulation Number | 892.1560, 892.1570 | 892.1560, 892.1570 | SE |
| Intended Use | General-purpose, digital ultrasound diagnostic system for various applications (abdomen, gynecology, obstetric, urology, small-parts, cardiology, etc.) | General-purpose, digital ultrasound diagnostic system for various applications (abdomen, gynecology, obstetric, urology, small-parts, cardiology, etc.) | SE (Similar intended use) |
| Technical Specifications (Probe specific examples) | |||
| C3.5-80R60-A16A (Convex Probe) | Comparable Predicate Data Listed | ||
| Frequency | 3.5MHz (for C128-50 Convex) | 3.5MHz | Analyse 1 (Differences in performance specs, but tested for accuracy and effectiveness) |
| Detect Depth | ≥200 mm (C128-50 Convex) | ≥160 mm | Analyse 1 |
| Resolution (Lateral) | ≤3(depth≤80) ≤4(80 ≤130) (for C128-50 Convex) | ≤3(Depth≤80) ≤4(80≤130) | Analyse 1 |
| Resolution (Axial) | ≤1 (depth≤50) ≤1 (depth≤40) (for C128-50 Convex) | ≤2(Depth≤80) ≤3(80 ≤130) | Analyse 1 |
| L7.5-80L40-A16A (Linear Probe) | Comparable Predicate Data Listed | ||
| Frequency | 6.5MHz (L096-42C Linear) | 7.5MHz | Analyse 1 |
| Detect Depth | ≥90 mm (L096-42C Linear) | ≥50 mm | Analyse 1 |
| Resolution (Lateral) | ≤2(depth≤60) (L096-42C Linear) | ≤2(Depth≤40) | Analyse 1 |
| Resolution (Axial) | ≤0.5(depth≤60) (L096-42C Linear) | ≤1 (Depth≤50) | Analyse 1 |
| E6.5-80R13-A16A (Endo-vaginal Probe) | Comparable Predicate Data Listed | ||
| Frequency | 6.5MHz (C080-13G Micro Convex) | 6.5MHz | Analyse 1 |
| Detect Depth | ≥90 mm (C080-13G Micro Convex) | ≥40 mm | Analyse 1 |
| Resolution (Lateral) | ≤2(depth≤60) (C080-13G Micro Convex) | ≤2(Depth≤30) | Analyse 1 |
| Resolution (Axial) | ≤0.5(depth≤40) (C080-13G Micro Convex) | ≤1 (Depth≤40) | Analyse 1 |
| System Features | |||
| Monitor Size | 10 inch | 10.1 inch | SE |
| Display Mode | B, B+B, B+M, M, 4B | B, 2B, BM, M, 4B | SE (Similar) |
| Image gray scale | 256 level | 256 level | SE |
| Image Storage | 16 | 2048 frame | Analyse 1 (Internal memory difference, but tested functionality) |
| Cine Loop | 256 frame | 600 frame | Analyse 1 (Internal memory difference, but tested functionality) |
| Image Flip | Up/down, left/right | Up/down, left/right, black/white | Analyse 1 (Added capability but main function similar) |
| Image Process | Various | Various | Analyse 1 (Different specific functions, but overall image processing similar) |
| Measurement | Distance, circumference, area, volume, histogram, profile, time velocity heart rate | Distance, circumference, area, volume, heart, pregnant age, fetal weight, expected date | Analyse 1 (Different specific measurements, but overall measurement capability similar) |
| Notation | Date, Time, Name, Sex, Age, Doctor, Hospital name, probe frequency, etc. | Date, time, name, No., sex, age, doctor, hospital name, probe frequency, etc. | SE |
| Net weight | 10kg | 2.3 kg (include probe) | SE (Weight difference not considered to impact safety/efficacy if performance is SE) |
| Power supply | AC 100-240V, 47-60Hz | DC15V; Adapter:100 V~240 V, 50 Hz/60 Hz | Analyse 2 (Difference in power supply, but both passed IEC60601-1 safety test) |
| Dimensions (mm) | 365 (H) X 292 (W) X 380 (D) | 292 (L) × 232 (W) × 45 (H) | SE (Differences in size, but doesn't affect SE of core function) |
| Configuration | mainframe, transducer(probe) | mainframe, transducer(probe), adapter | SE (Both include core components) |
| Safety & Standards Compliance | |||
| Biocompatibility | ISO10993-5 & ISO10993-10 | ISO10993-5 & ISO10993-10 | SE |
| Electrical Safety | IEC60601-1 | IEC60601-1 | SE |
| EMC | IEC60601-1-2 | IEC60601-1-2 | SE |
| Performance Standards | UD2 | IEC 60601-2-37; IEC61157 | Analyse 1 (Different specific standards, but both demonstrate performance) |
| Acoustic Output | Meet the requirements of Track 1 | Meet the requirements of Track 3 | Analyse 1 (Different tracks, but both demonstrate compliance) |
| Skin Contacted Material | Probe Cover (ABS), Acoustic Lens (Silicone elastomer) | Probe Cover (ABS), Acoustic Lens (Silicone elastomer) | SE |
| Operation Environment | Temperature 5°C -40°C, RH up to 90%RH, Air pressure 70-106Kpa | Temperature: +10°C~ +40°C, RH: 30%~ 75%, Atmosphere pressure: 700 hPa ~ 1060 hPa | SE (Within acceptable ranges) |
| Storage environment | Temperature -5-40°C, RH up to 90%RH (no water drop), Air pressure 70-106Kpa | Temperature: -10°C~+55°C, RH: ≤93%, no condensation, Atmosphere pressure: 700 hPa ~ 1060 hPa | SE (Within acceptable ranges) |
| Sterile | No | No | SE |
| Single Use | No | No | SE |
Study Proving Acceptance Criteria Met: Non-Clinical Testing and Comparison
The study proving the device meets the acceptance criteria is primarily a non-clinical testing and comparison study against a predicate device, as explicitly stated in the document.
1. Sample Size Used for the Test Set and Data Provenance:
- Test Set: No separate "test set" in the sense of a distinct dataset for an algorithm's performance evaluation is mentioned, as this is a physical diagnostic device, not an AI/ML product. The "test set" would implicitly refer to the device itself undergoing various performance and safety tests.
- Data Provenance: Not applicable in the context of imaging data. The provenances are the device specifications and direct measurements from non-clinical tests conducted on the proposed device and compared to the predicate's known specifications and performance.
- Retrospective/Prospective: Not specified for the "data" as it pertains to device testing against engineering specifications and regulatory standards. The non-clinical tests were conducted on the proposed device.
2. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. This submission is for a traditional ultrasound diagnostic system, not an AI/ML-driven device requiring expert consensus for image interpretation or "ground truth" establishment beyond the standard physical and electrical performance measurements. The "ground truth" here is the adherence to engineering specifications and safety standards, as well as the established performance of the predicate device.
3. Adjudication Method for the Test Set:
- Not applicable. No human interpretation or adjudication of diagnostic outputs from the device is described for the purpose of establishing clinical ground truth for a test set. Adjudication methods are typically relevant for studies evaluating human reader performance, especially with AI assistance.
4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC study was not conducted. The submission explicitly states: "No clinical study is included in this submission." This type of study is common for AI-assisted diagnostic tools to show improvement in human reader performance, which is not the scope of this 510(k) for a basic ultrasound system.
5. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. It is an ultrasound diagnostic system where the user (physician) interprets the images.
6. The Type of Ground Truth Used:
- For the non-clinical tests (e.g., electrical safety, EMC, performance parameters like resolution and depth): The "ground truth" is established by engineering specifications, international consensus standards (IEC, ISO), and the documented performance characteristics of the legally marketed predicate device.
- For biocompatibility: The "ground truth" is established by ISO 10993 series standards for in vitro cytotoxicity, irritation, and delayed-type hypersensitivity.
7. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a "training set" of data.
8. How the Ground Truth for the Training Set Was Established:
- Not applicable. As no training set for an AI/ML algorithm is involved, this question is irrelevant.
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