(50 days)
The SonoSite Series Ultrasound Systems are 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 and exam types include: Ophthalmic, Fetal/OB; Abdominal; Intra-operative (abdominal organs and vascular); Laparoscopic; Pediatric; Small Organ (breast, thyroid, testicles, prostate); Neonatal Cephalic; Adult Cephalic; Trans-recta;, Trans-vaginal; Musculo-skeletal (Conventional); Musculo-skeletal (Superficial); Cardiac Adult; Cardiac Pediatric; Trans-esophageal (cardiac); Peripheral Vessel.
Cardiac Imaging Applications: This system allows the clinician to perform focused cardiac studies. This system transmits ultrasound energy into the thorax of adult and pediatric patients to obtain 2D, PowerMap, DCPD, M-mode (where available), Tissue Harmonic Imaging, or PW and CW Doppler images of the heart, great vessels, and anatomic or pathologic structure. This system can be used to assess overall cardiac performance and size, determine the presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis procedures, and visualize blood flow through cardiac valves. Also the system can be used to access the presence and extent of some injuries and diseases. The ECG (where available) is used for accurate timing of diastolic and systolic function. The ECG trace is not used to diagnose cardiac rhythms and is not designed for long term cardiac rhythm monitoring.
SonoSite ultrasound systems are highly portable, software-controlled ultrasound systems used to acquire and display high resolution, real-time ultrasound data in a variety of modes and clinical settings.
Here's a breakdown of the acceptance criteria and the study information based on the provided document.
Acceptance Criteria and Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria for device performance in the traditional sense of a study testing performance metrics against predefined thresholds. Instead, the "acceptance criteria" are implied by the device's conformance to established industry standards and its substantial equivalence to previously cleared devices. The study detailed is a demonstration of conformance to these standards, not a performance study with numerical criteria.
Note: The tables in the document (Tables 1.3-1 to 1.3-6) list "Clinical Application" and "Mode of Operation" and indicate whether these were "previously cleared by FDA" ("P"). This signifies that the intended uses and technological characteristics were already deemed acceptable based on prior 510(k) clearances. This submission is for an expansion of marketing claims for existing cleared devices, not for a new device requiring novel performance testing.
Therefore, the "acceptance criteria" for this specific 510(k) submission are that the device (with its expanded indications for use) still conforms to the safety and performance standards demonstrated in previous clearances, and that the expanded indications do not introduce new technology, software, or hardware changes that would necessitate new performance studies.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Effectiveness Standards Conformance: Device develops and operates in compliance with recognized regulatory and industry standards. | "SonoSite performs testing in order to verify compliance with the standards." (Refers to AAMI/ANSI/ISO 10993 series, IEC 60601-1, IEC 60601-2-37, NEMA UD 2-2004, NEMA UD 3-2004, ISO 9001:2008, 21 CFR Part 820, EN ISO 13485:2003, EN ISO 14971:2000, RTCA D160E). "SonoSite development records demonstrate compliance and are maintained in the Device History Record, in compliance with 21 CFR 820." "The device conforms to applicable electromedical device safety standards with compliance verified through independent evaluation and ongoing factory audits." |
| New Technology/Software/Hardware: Expanded indications do not introduce new technologies, software, or hardware that would require new performance studies. | "This 510(k) premarket notification includes no changes, including no new system functions or technology changes, to the ultrasound systems, transducers, or accessories that were the subjects of the above-referenced submissions." "This update required no new technology, no new software, and no new instructions for use." "As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission." |
| Substantial Equivalence: The device remains substantially equivalent to previously cleared predicate devices. | "SonoSite, Inc., believes that the SonoSite Ultrasound Systems described in this Submission, and previously cleared on 510(k)'s K071134, K082098 and K092058 are substantially equivalent to the SonoSite 180 Hand Carried Ultrasound System (K014116)." "It is the opinion of SonoSite, Inc. that the SonoSite Series Ultrasound System is substantially equivalent with regard to safety and effectiveness to other devices already cleared for marketing." |
| Clinical Application Extension: The expanded clinical applications (specifically identifying "Presence and location of fluid around the heart and lungs, aid in pericardialcentesis and pleuralcentesis and visualize bloodflow through cardiac valves") are consistent with current clinical practice and FDA guidelines. | "This clinical application and intended use is consistent with current clinical practice and FDA guidelines. Ultrasound is commonly used to visualize existing landmarks in the anatomy, and the use of diagnostic ultrasound for the evaluation of fluid flow in the cardiac system, including lung is well established. Specific clinical application to the discrimination of Lung anatomy, including other types of anatomical detail, adds no significant risk to the general indication for use." |
Study Information
The document explicitly states that no new testing was performed for this specific 510(k) submission. This submission solely focuses on expanding marketing claims for already cleared devices without any changes to the technology, software, or hardware. Therefore, information regarding sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, and ground truth for new studies is not applicable to this 510(k) submission.
The "study" referenced in the document is the prior verification and validation performed during the original clearances of the predicate devices (K071134, K082098, K092058, and ultimately K014116 as the base predicate). The current submission relies on the established safety and effectiveness of those prior clearances and the fact that no changes have been made that would invalidate those prior assessments.
Below is a breakdown based on the general nature of such a submission when relying on previous clearances, noting that specific details for those prior clearances are not provided in this document.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable to this submission. The document states, "As this submission is in support of expanding marketing claims only, there have been no changes to technology, software or hardware. As such no additional testing was performed in support of this submission." The clinical applications ("P" for previously cleared) were established in prior 510(k)s (K092058, K071134, K082098, K014116). The specific details of the test sets for those prior submissions are not described here.
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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):
- Not applicable to this submission. See point 1. The document does not describe any new clinical studies requiring ground truth establishment by experts for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable to this submission. See point 1.
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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-based interpretation or diagnostic aid. No MRMC study is described. The submission extends indications for a human-operated imaging device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a diagnostic ultrasound system intended for human operation, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable to this submission. For the prior clearances that established the "P" (previously cleared) indications, it's generally understood that diagnostic ultrasound systems are evaluated based on their ability to produce clinically acceptable images that allow trained clinicians (experts) to make diagnoses. The ground truth for such systems typically relies on established clinical evaluation by medical professionals, potentially corroborated by other diagnostic modalities or pathology where relevant. However, this specific document does not detail how ground truth was established for the prior clearances.
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The sample size for the training set:
- Not applicable. This is a hardware/software diagnostic ultrasound system, not an AI model that requires a "training set" in the machine learning sense. The "development records" mentioned refer to product design and testing, not AI model training.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.