(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal - OB/GYN, Abdominal, Small Organs (breast, thyroid, testicle), Pediatric, Neonatal Cephalic, Trans-Vaginal, Trans-Rectal, Peripheral Vascular. Typical examinations performed using the system are: General abdominal and pelvic studies including organ surveys. assessment, and retroperitoneal cavity studies. Study of small parts and superficial structures including breasts, shoulders, thyroid, and the abdominal wall. Pediatric scans of organs, superficial, and bony structures. Monitoring procedures for infertility studies (other than in vitro fertilization). First, second and third trimester pregnancy studies. Neonatal head studies. Podiatry scans of superficial structures including muscles, tendons and bones. Prostate, bladder and rectum visualization. Tissue Harmonic Imaging (THI) is a B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts caused by interaction of certain tissue types and low frequency soundwaves. Seven of the twelve probes offered with the system will be indicated for Tissue Harmonic Imaging (THI-Mode). The THI-Mode will be used for fetal, abdominal, pediatric, and small organ clinical applications.
The Combison® 530/Voluson® 530D scanner is a multiple-mode, multipleapplication ultrasound imaging system. The cart-mounted console contains an ultrasound generator/receiver offering a full complement of conventional operating modes, software-based parameter controls, and recording. The selection of twelve transducers offered with the system permits a wide range of clinical applications. In addition to the initial operational settings for each transducer preprogrammed in the system, user-customized parameter settings for each transducer may be inserted by the operator and stored for recall as needed via the system control panel. Customization includes transmit focusing, filtering, image enhancement processing, dynamic window curve selection. Controls are also provided to select display format (single and various combinations), to activate zoom features, and to utilize the cine loop function. The Combison® 530/Voluson® 530D uses digital beamforming technology. The Combison® 530/Voluson® 530D supports a variety of linear and convex probes for wide variety of applications. It is an ultrasound scanner, which provides high resolution, high penetration performance, and various measurement functions. Probes are supported in frequencies from 3.5 MHz to 7.5 MHz. The Combison® 530/Voluson® 530D provides high quality images and various measuring functions. Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. Operating Modes of the Combison® 530/Voluson® 530D are B, B/B, B/M, M and, Doppler, Volume and Power Doppler Mode. Management of patient history is possible by image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing. The Tissue Harmonic Imaging (THI-Mode) Option consists of a software add-on.
This 510(k) Premarket Notification is for the addition of a Tissue Harmonic Imaging (THI-Mode) option to the Combison® 530/Voluson® 530D Diagnostic Ultrasound System. The submission claims substantial equivalence to the Medison SA8800/HDI 1500 System (K974269), which also features THI-Mode.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria or reported device performance in the typical sense of quantitative metrics. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device (Medison SA8800/HDI 1500 System with THI-Mode, K974269) by showing that:
- Intended Use is the same: The THI-Mode is intended for fetal, abdominal, pediatric, and small organ clinical applications, which aligns with the predicate device.
- Technological Characteristics are similar: The device operates identically to predicate devices in principle (piezoelectric material, sound wave reflection, electrical signal conversion) and the THI-Mode is a software add-on.
- Acoustic Output Limits are within acceptable ranges:
- TIS/TIB/TIC: 0.0 - 4.0 (Range)
- ISPTA.3: 720 mW/cm² (Maximum)
- MI: 1.9 (Maximum)
These limits are stated to be the same as "predicate Track 3 devices." This implicitly means the reported performance in terms of acoustic output meets the established safety limits for such devices, which is a form of acceptance criteria for safety.
- New Indications for Use (with THI) are cleared: The FDA clearance explicitly lists several transducers (S-AB, S-ACP 3-5, S-ACP 4-7, S-NLP, S-VAW 3-5, S-VAW 4-7, S-VNW) for which Tissue Harmonic Imaging (N) is a new indication, indicating that the device has been found safe and effective for these applications when using THI.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not provide information on a specific test set, its sample size, or data provenance (country of origin, retrospective/prospective). The submission relies on demonstrating substantial equivalence to an already cleared device, implying that the safety and effectiveness of THI technology were established with the predicate device (K974269).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. As there is no explicitly defined "test set" and a study demonstrating performance is not detailed, there is no mention of experts for ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not provided. Given the absence of a detailed study with a test set, adjudication methods are not discussed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI (THI-Mode in this case) assistance was not conducted or reported in this document. The submission focuses on substantial equivalence based on the technological characteristics and safety data of the device and its predicate.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The document describes the THI-Mode as a "software add-on" that is a "B-Mode imaging technique that enables a dramatic reduction in naturally occurring artifacts." While this describes the algorithmic function, the submission does not present a standalone performance evaluation of the algorithm separate from the overall ultrasound system and its clinical use by a human operator. The focus is on the integrated system's safety and intended use.
7. The Type of Ground Truth Used:
Ground truth for the performance of the THI-Mode itself is not explicitly defined or used within the context of a dedicated performance study in this document. The approval seems to be based on the established safety and effectiveness of the existing THI technology (as demonstrated by the predicate device K974269) and the physical and technical specifications being within acceptable ranges. The "ground truth" for the overall device's safety and effectiveness implicitly comes from established medical practice for diagnostic ultrasound and previous FDA clearances for the base system and the predicate THI-enabled system.
8. The Sample Size for the Training Set:
The document does not mention a training set or its sample size. The THI-Mode is described as a "software add-on," implying an algorithmic approach. However, there's no detail provided on how this algorithm was developed or "trained."
9. How the Ground Truth for the Training Set Was Established:
This information is not provided, as there is no mention of a training set in the document.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.