(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
Fetal OB/GYN
Abdominal
Pediatric
Small Organ (breast, thyroid, testicle)
Neonatal Cephalic
Adult Cephalic
Cardiac
Trans-Rectal
Trans-Vaginal
Peripheral-Vascular
Muscular-Skeletal (Conventional, Superficial)
Typical examinations performed using the system are:
General abdominal and pelvic studies including organ surveys, assessment, and retro-peritoneal cavity studies.
Study of small parts including breasts, shoulders, thyroid, and the abdominal wall.
Pediatric scans of organs and bony structures.
Peripheral vascular applications including carotid arteries, legs, arms, feet, and penile artery.
Monitoring procedures for infertility studies (other than in vitro fertilization).
First, second and third trimester pregnancy studies.
Prostate, prostate biopsy guidance, and rectal wall studies.
Neonatal head studies.
Transcranial studies of middle cerebral arteries, internal carotid artery, and vertebral arteries.
Cardiac studies in adults and children.
Biopsy guidance for tissue or fluid sampling.
Conventional podiatry scans.
The SA600011 scanner is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as B-mode, M-mode, or as a combination of these modes. SA600011 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals.
Five different models of transducers are available and any two may be connected at the same time. 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. More detailed explanations of these functions and controls are included in the Operator's manual, and in the software/firmware documentation included in this 510(k) Notification. Patient contact materials are the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185).
The SA6000II uses digital beamforming technology. The SA6000II supports a variety of Linear and Curved Linear Array 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 2.0 MHz to 10 MHz. These probes can be applied to a variety of fields such as fetal, abdominal, intra-operative, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-rectal, trans-vaginal, peripheral-vascular, muscular-skeletal. The same clinical uses were cleared for the predicate device, SA5500 Ultrasound System (K992761) and SA9900 Ultrasound System (K002185).
SA6000II provides high quality images and various measuring functions. It can measure distances and calculate areas, circumferences and volumes, as well as calculate the date of delivery by using BPD (biparietal diameter), OFD (occipito-frontal diameter), HC (head circumference), AC (abdominal circumference), AD (abdominal diameter), FL (femur length), CRL (crown rump length), APD (anteroposterior abdominal diameter), TTD (transverse trunk diameter), GS (gestational sac), etc.
Biopsy guidelines are provided on screen to assist in the collection of tissue samples, using biopsy guide adapters offered as an optional accessory. The operating Modes of SA6000II are B, M, or as a combination of these modes. M-mode uses the sweep display method that has its images flow from the left to the right on the monitor. The SA6000II supports the Cine function (capable of storing up to 64 frames) and real-time zoom function to the region-of-interest. Management of patient history is possible by an image-filing function. High-resolution images are provided by utilizing a technology called digital dynamic receive focusing.
The provided 510(k) summary for the Medison America, Inc. SA6000II Diagnostic Ultrasound System focuses on demonstrating substantial equivalence to predicate devices (SA5500 and SA9900). It does not present a study with specific acceptance criteria and reported device performance in the manner typically seen for AI/ML-based medical devices or novel diagnostic tools.
Instead, the submission primarily details the device's technical characteristics, intended use, and acoustic output limits, comparing them to established predicate devices. The "acceptance criteria" here are implicitly the FDA's requirements for substantial equivalence, meaning the device's technological characteristics and intended uses are as safe and effective as a legally marketed device.
Therefore, the following information is extracted and presented based on the context of a 510(k) submission for a diagnostic ultrasound system:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from predicate device characteristics) | Reported SA6000II Performance |
|---|---|---|
| Intended Use | Match or be substantially equivalent to predicate devices (SA5500, SA9900) in clinical applications and modes of operation. | All listed clinical applications (e.g., Fetal, Abdominal, Pediatric, Small Organ, etc.) and modes (B, M, Combined B-M) are either "P" (previously cleared in K992761, SA5500) or "P1" (previously cleared in K002185, SA9900). Some transducers introduce "N" (new indication) for certain applications, indicating these are also being cleared as part of this submission, implying they meet the same safety/effectiveness as predicate devices. |
| Technological Characteristics | Digital beamforming technology, a variety of Linear and Curved Linear Array probes, frequencies from 2.0 MHz to 10 MHz. | The SA6000II uses digital beamforming, supports Linear and Curved Linear Array probes, and frequencies from 2.0 MHz to 10 MHz. |
| Acoustic Output Limits | ISPTA: Max 720 mW/cm², MI: Max 1.9 (same as predicate Track I devices). | ISPTA: 720 mW/cm², MI: 1.9. These limits are stated to be "the same as predicate Track I devices." |
| Electromechanical Safety Standards | Compliance with EN 60601-1, UL 2601-1, C22.2 No. 601.1, CEI/IEC 1157:1992, EN 60601-1-2. | The SA6000II has been designed to meet all listed electromechanical safety standards, and is "Compliant with the European Medical Device Directive Certificate issued by TUV." |
| Biocompatibility | Transducer patient contact materials are biocompatible. | Transducer patient contact materials are "the same as those previously cleared in the predicate device, SA5500 Ultrasound System and Transducers (K992761) and SA9900 Ultrasound System and Transducers (K002185)." |
Summary of the "Study" (Demonstration of Substantial Equivalence)
The "study" in this context is a comparison to predicate devices to demonstrate substantial equivalence, rather than a clinical trial measuring diagnostic accuracy or reader performance. The manufacturer, Medison America, Inc., asserts that the SA6000II Ultrasound System is substantially equivalent to the currently marketed SA5500 System (K992761) and SA9900 System (K002185).
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a traditional "test set" in the context of an algorithm or diagnostic performance study. The evaluation for substantial equivalence primarily relies on engineering specifications, technical comparisons, and compliance with recognized standards. There is no mention of a clinical "test set" of patient data used for performance verification in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The submission is a 510(k) for an ultrasound system, not an AI/ML diagnostic algorithm. Ground truth for image interpretation would traditionally be established by the interpreting physician during clinical use, not as part of this specific regulatory submission for the device itself.
4. Adjudication Method for the Test Set
Not applicable. There is no described test set requiring adjudication in this document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this 510(k) summary. This type of study is typically performed for AI-assisted diagnostic devices to measure the impact of AI on human reader performance, which is not the focus of this traditional ultrasound device submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done or described. The SA6000II is a diagnostic ultrasound system that functions by acquiring and displaying data for interpretation by a competent healthcare professional. It is not an AI algorithm intended for standalone diagnosis.
7. The Type of Ground Truth Used
The "ground truth" for the claims in this submission is primarily based on technical specifications, compliance with international safety and performance standards (e.g., IEC, UL, CSA), and the established safety and effectiveness of its predicate devices. For example, acoustic output limits are verified against recognized standards, and biocompatibility is confirmed by using materials identical to those cleared in predicate devices.
8. The Sample Size for the Training Set
Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML algorithm, there is no training set mentioned or described within 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.