(27 days)
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.
§ 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.