(60 days)
The SonoSite Maxx™ Series Ultrasound System is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications include: Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Intra-operative (Neuro.), Pediatric, Small Organ (breast, thyroid, testicle, prostate), Neonatal Cephalic, Trans-Rectal, Trans-Vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Cardiac Pediatric, Trans-esophageal (cardiac), Peripheral Vessel.
The SonoSite Maxx Series Ultrasound System is a full featured, general purpose, software controlled, diagnostic ultrasound system used to acquire and display high-resolution, real-time ultrasound data in a number of exam types and clinical applications. The SonoSite Maxx Series is a design that readily lends itself to be configured to specific ultrasound imaging applications through physical packaging adaptations and system feature selections. Maxx Series can operate on either battery or AC power.
The provided document is a 510(k) summary for the FUJIFILM SonoSite Maxx™ Series Ultrasound System and its associated transducers. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing novel clinical studies to establish new acceptance criteria. Therefore, the document primarily lists the features and performance of the device and compares them to the predicate devices, rather than defining specific acceptance criteria for performance metrics and studies to prove they are met.
Based on the document, here's the information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance
The document does not define specific quantitative "acceptance criteria" for the device's imaging performance (e.g., sensitivity, specificity, accuracy). Instead, it establishes substantial equivalence by demonstrating that the device's technological characteristics, intended use, and indications for use are comparable to legally marketed predicate devices and that it complies with relevant safety and performance standards.
The "reported device performance" is implicitly that it performs equivalently to the predicate devices for the listed applications and modes. The tables provided (Table 1.3-1 to 1.3-17) list the clinical applications and modes of operation for the main system and each transducer. "P" indicates that these indications and modes were "previously cleared" for the predicate devices, which implies the current device meets existing performance expectations for these.
| Feature/Metric | Acceptance Criteria (Implicitly met by Predicate Equivalence) | Reported Device Performance (Implicitly Equivalent to Predicate) |
|---|---|---|
| Intended Use | Diagnostic ultrasound imaging or fluid flow analysis of the human body | Same as predicate devices (SonoSite Maxx™ Series Ultrasound System, SonoSite Edge Ultrasound System, Terason t3000 Ultrasound System) |
| Indications for Use (System) | Ophthalmic, Fetal - OB/GYN, Abdominal, Intraoperative, Pediatric, Small Organ, Neonatal/Adult Cephalic, Trans-Rectal/Vaginal, Musculo-skeletal, Cardiac, Peripheral Vessel, Biopsy/Needle guidance, etc. | Same as predicate devices, with some minor additions/modifications (e.g., this submission includes "Cardiac Adult" and "Trans-esophageal (cardiac)" for the main system, and specific transducer tables indicate which modes are available for each application, marked "P" for previously cleared in predicate K082098, K113156). Specific modes are B, M, PWD, CWD, Color Doppler, Combined. |
| Transducer Types | Linear Array, Curved Linear Array, Intracavitary | Same as most predicate devices (Terason T3000 only lists Linear and Curved Linear Array, but other SonoSite predicates include Intracavitary). |
| Transducer Frequency | 1.0-15.0 MHz | Same as SonoSite Maxx Series (K082098, K101757) and SonoSite Edge Ultrasound System (K113156). |
| Modes of Operation | B-mode, 3D/4D, Tissue Harmonic, M-mode, Anatomical M-Mode, Color M-Mode, Color Power Doppler, Zoom, Combination Modes, PW Doppler, CW Doppler, SonoRes/SonoHD Noise Reduction, SonoMB Image Compounding, Steered CW Doppler, Velocity Color Doppler, Color TDI, Elastography, Strain Rate Imaging, ECG, DICOM (3.0), IMT Measurement | Same as SonoSite Maxx Series (K082098, K101757) and SonoSite Edge Ultrasound System (K113156), with the Terason t3000 having a slightly different set of named features. |
| Electrical, Thermal, Mechanical, EMC Safety | Conformance to applicable mandatory medical device safety standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.) | Found to conform to all applicable mandatory medical device safety standards. |
| Biocompatibility | Conformance to AAMI/ANSI/ISO 10993 series | All patient contact materials are biocompatible, conforming to AAMI/ANSI/ISO 10993 series. |
| Acoustic Output | Conformance to NEMA UD 2-2004, NEMA UD 3-2004, AIUM MUS | Evaluated and found to conform to these standards. |
| Quality System | Conformance to 21 CFR 820, ISO 9001, ISO 13485 | Product development process conforms to these quality systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "The SonoSite Maxx Series Ultrasound System and transducers did not require clinical studies to support the determination of substantial equivalence." This means there was no specific "test set" of patient data used for clinical performance validation as would be the case for a new or significantly modified device. The data provenance is therefore not applicable in the context of clinical performance testing.
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)
Since no clinical studies were performed, there was no "test set" or explicit "ground truth" establishment by experts for performance metrics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical studies with test sets were performed.
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 device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical imaging device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical studies with specific performance endpoints requiring ground truth were performed. The "ground truth" for this 510(k) submission relies on demonstrating substantial equivalence to predicate devices that have an established history of safety and effectiveness, meaning their performance was already accepted by regulatory bodies.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device that requires a training set and ground truth for it.
In summary:
The submission for the SonoSite Maxx™ Series Ultrasound System is a 510(k) premarket notification. This type of submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. For such submissions, extensive new clinical performance studies are often not required if the device is sufficiently similar to existing ones.
In this case, the manufacturer has established substantial equivalence by:
- Comparing the Intended Use and Indications for Use of the new device and its transducers to those of predicate devices (K082098, K101757, K113156, K112953). The tables indicate that almost all applications and modes ("P" for previously cleared) are identical or highly similar to those cleared for the predicate devices.
- Detailing the Technological Characteristics (e.g., transducer types, frequency, modes of operation, system specifications) and showing they are equivalent to or improve upon predicate devices without introducing new safety or effectiveness concerns.
- Demonstrating compliance with a comprehensive list of national and international safety and performance standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility, NEMA UD series for acoustic output). These standards define a baseline of acceptable performance and safety for such devices.
- Explicitly stating that clinical studies were not required, as the equivalence was demonstrated through non-clinical testing and comparison to predicates.
§ 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.