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510(k) Data Aggregation
(27 days)
Sonosite LX Ultrasound System
The Sonosite LX Ultrasound System is a general-purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include:
- Abdominal
- Adult Cephalic
- Neonatal Cephalic
- Cardiac Adult
- Cardiac Pediatric
- Dermatological
- Fetal OB/GYN
- Musculo-skeletal (Conventional)
- Musculo-skeletal (Superficial)
- Ophthalmic
- Pediatric
- Peripheral vessel
- Small Organ (breast, thyroid, testicles, prostate)
- Transesophageal (cardiac)
- Transrectal
- Transvaginal
- Needle Guidance
Modes of operation include: B Mode (B), M-Mode (M) (including simultaneous M-mode and anatomical M Mode), PW Doppler (PWD) (including Pulsed Wave Tissue Doppler), Continuous Wave Doppler (CWD), Color Power Doppler (including Velocity Color Doppler), Tissue Harmonic Imaging (THI), Tissue Doppler Imaging (TDI), and Combined modes, including Triplex imaging: B+M, B+PWD, B+CWD, B+C, (B+C)+PWD, (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX Ultrasound System is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The Sonosite LX 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 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.
The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
The provided FDA 510(k) clearance letter for the Sonosite LX Ultrasound System (K251830) describes a general-purpose ultrasound system. As such, the clearance does not detail specific acceptance criteria for diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be associated with AI-powered diagnostic devices. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical characteristics and compliance with general safety and performance standards.
However, based on the information provided, we can infer some "acceptance criteria" related to the device's technical specifications and safety, and how the study addresses them.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a general-purpose ultrasound system and not an AI/diagnostic algorithm, the acceptance criteria are not in the form of diagnostic performance metrics. Instead, they are related to equivalence with predicate devices, safety, and general performance standards.
| Acceptance Criteria (Inferred from Substantial Equivalence and Safety Standards) | Reported Device Performance / Assessment Method |
|---|---|
| Intended Use Equivalence | Reported: "The Sonosite LX Ultrasound System (this submission) and the predicate device is diagnostic ultrasound imaging or fluid flow analysis of the human body." |
| Evaluation: "The intended use of the Sonosite LX is identical to the predicate and reference devices." | |
| Indications for Use Equivalence | Reported: Covers a broad range of clinical applications (Abdominal, Cardiac, OB/GYN, Musculoskeletal, etc.), with the addition of a "Dermatological" indication via the new UHF46-20 transducer. This new indication was previously cleared on the reference device (Vevo MD Imaging system K190476). |
| Evaluation: "The Indications for Use are similar as what was cleared on Sonosite LX Ultrasound system (primary predicate- K233597). The dermatological indication introduced with Sonosite LX in this submission is previously cleared on the reference device, Vevo MD Imaging system (K190476). The dermatological indication on UHF46-20 supports vessel and superficial exam types and is an extension of the dermatological indication on UHF48 (K190476)." | |
| Technological Characteristics Equivalence | Reported: Similar transducer types, modes of operation, DICOM support, transmit/receive channels, system characteristics (form factor, beamformer, screen, ports, dimensions, weight, battery, ratings, measurement packages). The primary differences noted are the addition of the UHF46-20 transducer, which is equivalent to the UHF48 transducer from the reference device. |
| Evaluation: "The technological characteristics are unchanged from the primary predicate Sonosite LX (K233597) and reference device, Vevo MD imaging system (K190476). The Sonosite LX Ultrasound System employs the same fundamental scientific characteristics as the currently marketed predicate devices." | |
| Acoustic Output within FDA Limits | Reported: Global Maximum Outputs including Ispta.3, TI Type, TI Value, MI, Ipa.3@MI Max values are provided (e.g., Ispta.3: 607 mW/cm^2, MI: 1.72). MI & TI are always displayed. |
| Evaluation: "Acoustic output is within the FDA established limits and same as the primary predicate." and "MI & TI are always displayed, and a power management system ensures that they never exceed the derated FDA limits." | |
| Patient Contact Materials Biocompatibility | Reported: Materials used for transducers and needle guides are listed. The new material Rexolite (for the UHF46-20 lens) is highlighted. |
| Evaluation: "Rexolite is introduced as lens material for the UHF46-20 on the Sonosite LX system, This UHF48-20 has passed biocompatibility testing per ISO 10993-1. The rexolite material used for the lens is also the same as the one used on Vevo MD's UHF48 and UHF70 transducers (K190476). The rest of the ultrasound material is the same as the material used on the previously cleared transducers under (K233597)." | |
| "All patient contact materials are biocompatible." | |
| Electrical, Thermal, Mechanical, EMC Safety | Reported: The new transducer UHF46-20 was evaluated for these aspects. |
| Evaluation: "The subject ultrasound system Sonosite LX Ultrasound System uses the new transducer UHF46-20, which has been evaluated for electrical, thermal, mechanical, and EMC safety." | |
| Cleaning/Disinfection Effectiveness | Reported: Evaluated for Sonosite LX. |
| Evaluation: "cleaning/disinfection... have been evaluated for Sonosite LX..." | |
| Compliance with Recognized Standards | Reported: Listed compliance with ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-37, IEC 62304, ISO 14971, IEC 62359. |
| Evaluation: "The Sonosite LX Ultrasound System is designed to comply with the following FDA recognized standards." | |
| Quality System Compliance | Reported: Mention of Design Phase Reviews, Risk Assessment, Requirements Development, System and Software Verification, Hardware Verification, Safety Compliance Verification, and Clinical Validation. |
| Evaluation: "Assurance of quality was established by employing the following elements of product development..." and "FUJIFILM SonoSite, Inc. believes that the Sonosite LX Ultrasound System is substantially equivalent with regards to safety and effectiveness to the predicate devices." (implies QS compliance supports this) | |
| Performance in Clinical Environment | Reported: The device with the new transducer was tested. |
| Evaluation: "The Sonosite LX with new transducer UHF46-20 has been successfully tested in a clinical environment and the device performed as expected." |
Regarding specific AI-related questions (2-9), this clearance letter does not pertain to an AI/ML device for diagnostic interpretation. It's for a general-purpose ultrasound system. Therefore, most of these questions are not applicable to the information provided.
However, I will address them to indicate their non-applicability or provide any remotely relevant information.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a general-purpose ultrasound system, not an AI/ML algorithm requiring a specific test set for diagnostic performance. The evaluation was primarily based on engineering testing (electrical, thermal, mechanical, EMC safety, biocompatibility, acoustic output, standards compliance) and comparison to predicate devices, rather than a dataset of patient cases.
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)
- Not Applicable. No ground truth (in the context of diagnostic accuracy) was established for a test set in this submission, as it's not an AI/ML diagnostic algorithm.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set requiring expert adjudication for diagnostic ground truth.
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 is not an AI-assisted diagnostic device, so no MRMC study comparing human readers with and without AI assistance was performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device (ultrasound system), not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. The "ground truth" here relates to engineering specifications and safety standards, such as:
- Biocompatibility confirmed by ISO 10993-1 standards (chemical testing, etc.)
- Acoustic output confirmed by IEC 62359 standards.
- Electrical safety confirmed by IEC 60601-1 standards.
- Functional "ground truth" confirmed by successful testing in a clinical environment, meaning it operates as intended for imaging and fluid flow analysis.
8. The sample size for the training set
- Not Applicable. This clearance is not for an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI/ML device.
In summary, the FDA 510(k) clearance for the Sonosite LX Ultrasound System is focused on demonstrating substantial equivalence to pre-existing, legally marketed predicate ultrasound systems and compliance with international safety and performance standards. The "study" proving it meets acceptance criteria primarily involves comprehensive engineering validation and verification testing (electrical, thermal, mechanical, EMC, acoustic output, biocompatibility, cleaning/disinfection) and documented adherence to a robust Quality System, rather than a clinical study evaluating diagnostic accuracy with a patient dataset or the performance of an AI algorithm.
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(28 days)
Sonosite LX Ultrasound System
The Sonosite LX ultrasound system is a general purpose ultrasound system intended for use by qualified physicians and healthcare professionals for evaluation by ultrasound imaging or the human body. Specific clinical applications and exam types include:
Abdominal Adult Cephalic Neonatal Cephalic Cardiac Adult Cardiac Pediatric Fetal - OB/GYN Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Ophthalmic Pediatric Peripheral vessel Small Organ (breast, thyroid, testicles, prostate) Transesophageal (cardiac) Transrectal Transvaginal Needle Guidance
Modes of operation include: B Mode (M) (including simultaneous M-mode and anatomical M-Mode), PW Doppler (PWD) (including High Pulse Repetition Frequency (HPRF) and simultaneous PWD for certain exam types), Tissue Doppler Imaging (TDI), Continuous Wave Doppler (CWD), Color Power Doppler, Velocity Color Doppler, Color Variance, Tissue Harmonic Imaging (THI), Multi-beam imaging, Steep Needle Profiling, Trapezoid, and combined modes, including duplex and triplex imaging: B+M, B+PWD, B+C, (B+C)+PWD, (B+C)+CWD.
This device is indicated for Prescription Use Only.
The Sonosite LX system is intended to be used in medical practices, clinical environments, including Healthcare facilities, Hospitals, Clinics and clinical point-of-care for diagnosis of patients.
The system is used with a transducer attached and is powered either by battery or by AC electrical power. The clinician is positioned next to the patient and places the transducer onto the patient's body where needed to obtain the desired ultrasound image.
The Sonosite LX 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 2D, M Mode, Pulsed Wave (PW) Doppler, Continuous Wave (CW) Doppler, Color Power Doppler (CPD), and color Doppler (Color) or in a combination of these modes. The Sonosite LX is designed as an integrated unit with its kiosk-style stand.
The system includes a variety of accessories including needle guide starter kits. The system includes USB host support for peripherals such as input devices, storage devices, and an Ethernet port. Input devices include wired and wireless devices. The system also includes an ECG-specific port to support the ECG feature. The non-diagnostic ECG module provides ECG tracing of the cardiac signal synchronized with the ultrasound image.
The provided text is a 510(k) summary for the FUJIFILM SonoSite LX Ultrasound System. It details the device's characteristics and compares it to predicate devices to establish substantial equivalence. However, it explicitly states that no clinical studies were required to support the determination of substantial equivalence for this device. Therefore, the device's acceptance criteria and studies proving it meets those criteria based on clinical performance metrics (like sensitivity, specificity, or reader improvement) are not detailed in this document.
The "acceptance criteria" discussed in the document are primarily related to technical and safety standards compliance rather than clinical performance based on a study.
Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available:
1. Table of Acceptance Criteria and Reported Device Performance
As no clinical study was conducted for performance claims, there is no direct table of acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy) and corresponding reported device performance from such a study.
The provided document focuses on compliance with recognized medical device safety and performance standards. The "acceptance criteria" in this context are adherence to these standards, and the "reported device performance" is a statement of compliance.
| Acceptance Criteria (Standards Compliance) | Reported Device Performance |
|---|---|
| ISO 10993-1:2018 (Biological evaluation of medical devices) | All patient contact materials are biocompatible. Materials used have undergone identical biocompatibility testing to predicate devices. |
| IEC 60601-1 (General requirements for basic safety and essential performance) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-2 (Electromagnetic disturbances) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-1-6 (Usability) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 60601-2-37 (Basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| IEC 62304 (Medical device software - Software life cycle processes) | Device conforms to applicable medical device safety standards. Compliance verified through independent evaluation. |
| ISO 14971 (Application of risk management to medical devices) | Assured quality by employing Design Phase Reviews, Risk Assessment. |
| IEC 62359 (Test methods for determining thermal and mechanical indices for diagnostic ultrasonic fields) | Acoustic output is less than FDA established limits. MI & TI values are always displayed, and a power management system ensures they never exceed derated FDA limits. |
| FDA Guidance: "Marketing Clearance of Diagnostic Ultrasound Systems and Transducers" | Intended uses and other key features are consistent with traditional clinical practice and FDA guidance. |
| ISO 13485 and 21 CFR 820 (Quality system) | Device is manufactured using the same ISO 13485 and 21 CFR 820 quality system as predicates. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not available as no clinical studies were performed. The non-clinical tests involved evaluations against engineering standards and internal verification processes, not a dataset of patient cases.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not available as no clinical studies were performed requiring expert ground truth establishment for a test set.
4. Adjudication Method for the Test Set
This information is not available as no clinical studies were performed requiring an adjudication method for a test set.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "The Sonosite LX Ultrasound System and transducers, subject of this submission, did not require clinical studies to support the determination of substantial equivalence." This device is a general-purpose ultrasound system, not an AI-powered diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device is an ultrasound system, not a standalone algorithm, and no clinical studies were conducted for substantial equivalence.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not available as no clinical studies were performed requiring a type of ground truth. For the non-clinical tests, the "ground truth" was adherence to established engineering and safety standards.
8. The Sample Size for the Training Set
This information is not available as no clinical studies were performed. The device is an ultrasound system with software, but the document does not indicate it uses machine learning/AI models that would require a dedicated "training set" in the diagnostic performance sense. The software development follows IEC 62304 standards, which involve verification and validation but not necessarily clinical "training sets."
9. How the Ground Truth for the Training Set Was Established
This information is not available as no training set (in the context of clinical performance for an algorithm) was discussed or used in the provided documentation for establishing substantial equivalence.
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