(82 days)
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a software-based imaging system and accessories intended for use by qualified physicians and healthcare professionals who has the ability to conduct ultrasound scan process for evaluation by ultrasound imaging system or fluid flow analysis of the human body. The modes of operation include B mode, PWD mode, Color Doppler (CD) mode, Power Doppler mode, and the combined mode (B+M, B+CD, B+PWD). Specific clinical applications and exam types including:
LU700L
General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic, Musculoskeletal (conventional),Musculosketal (superficial),Peripheral vessel ,Other (Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)
LU710L
Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic.Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other
(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)
LU710LH
Ophthalmic, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Neonatal cephalic,Musculoskeletal (conventional),Musculoskeletal (superficial),Peripheral vessel ,Other
(Carotid),Pulmonary,interventional guidance (free hand needle/ catheter)
LU700C
General abdominal imaging,Musculoskeletal (conventional),Musculoskeletal (superficial),OB/Gyn,Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710C
Fetal.General abdominal imaging.Small organ (thyroid, prostate, scrotum, breast).Urology.Musculoskeletal (conventional),OB/Gyn,Cardiac (pediatric),Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710M
Fetal,General abdominal imaging,Pediatric,Small organ (thyroid, prostate, scrotum, breast),Neonatal cephalic. Urology. Musculoskeletal (conventional), OB/Gyn. Cardiac (pediatric), Peripheral vessel ,interventional guidance (free hand needle/ catheter)
LU710PA
Fetal, General abdominal imaging, Pediatric, Cardiac (adult), Cardiac (pediatric), Pulmonary
LU710E
Fetal, General abdominal imaging, Pediatric, Small organ (thyroid, prostate, scrotum, breast), Transvaginal,Urology,OB/Gyn,interventional guidance (free hand needle/ catheter)
The clinical environments where the system can be used include physician offices, clinics, and clinical point-of-care for diagnosis of patients.
The Leltek Ultrasound Imaging System (Model: LU700 Series) is a portable, software controlled, handheld ultrasound system used to acquire and display hi-resolution, real-time ultrasound data through a commercial off-the-shelf (COTS) mobile device.
- I. The imaging system software runs as an app on a mobile device.
- II. The imaging system software can be download to a commercial off-the-shelf (COTS) mobile device and utilizes an icon touch-based user interface.
- III. The imaging system consists of a series of wireless transducers employing Wi-Fi-based technology to communicate with traditional tablet/smartphone devices via direct Wi-Fi. This allows the user to export ultrasound images and display them across a range portable personal device.
- IV. The imaging system houses a built-in battery, multichannel beamformer, prescan converter and Wi-Fi components
The provided text describes the Leltek Ultrasound Imaging System (Model: LU700 Series) seeking 510(k) clearance from the FDA. Based on the document, here's a breakdown of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not provide a specific table of quantitative acceptance criteria and reported device performance in terms of diagnostic accuracy metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are generally based on compliance with international safety and performance standards for medical electrical equipment and the device demonstrating "substantially equivalent" safety and effectiveness to predicate devices.
The reported device performance is primarily described as:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Safety and Performance Standards Compliance | The device has been designed, manufactured, tested, and certified to comply with the following internationally recognized standards: |
| - AAMI/ANSI ES60601-1 (2009 & 2012): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | |
| - IEC 60601-1-2 (2014): Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | |
| - IEC 60601-1-6 (2013): Medical electrical equipment Part 1-6 General requirements for basic safety and essential performance Collateral standard Usability | |
| - IEC 60601-2-37/AMD1 (2008 & 2015): Medical electrical equipment - Part 2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | |
| - IEC 62133 (2012): Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications | |
| - IEC 62304 (2014): Medical device software - Software life-cycle processes | |
| - IEC 62366-1 (2015): Medical devices -- Part 1: Application of usability engineering to medical devices | |
| - ISO 10993-1 (2009 & 2018): Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | |
| - ISO 10993-5 (2009): Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity | |
| - ISO 10993-10 (2010): Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization | |
| - ISO 13485 (2016): Medical devices - Quality management systems - Requirements for regulatory purposes | |
| - ISO 14971 (2019): Medical devices - Application of risk management to medical devices | |
| - ISO 15223-1 (2016): Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements | |
| Device Performance Specifics (as mentioned for new models/changes) | - Acoustic output: The new models (LU710L, LU710LH) were tested and determined to be in full compliance. The maximum acoustic output level is under the FDA recommended limit, and the power level is displayed all the time. |
| - Biocompatibility: The new models were tested and determined to be in full compliance. | |
| - Cleaning and disinfection effectiveness: The new models were tested and determined to be in full compliance. | |
| - Wireless, thermal, electrical, electromagnetic and mechanical safety: The system has been evaluated and found to conform with applicable medical device safety standards. | |
| Substantial Equivalence | The device is deemed "substantially equivalent" to predicate devices, meaning it has "no pragmatic detriments" compared to the cleared device (K210432) and other reference devices (K202035). All safety and performance tests meet essential requirements. |
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 Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This indicates that no test set involving patient data was used for a clinical performance study. The evaluation was based on compliance with performance standards and comparison with predicate devices.
Therefore, information regarding sample size, country of origin, and retrospective/prospective nature of a test set is not applicable as no clinical test set was used.
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, as no clinical test set was used and therefore no ground truth needed to be established by experts for a performance evaluation study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
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. The document states "The Leltek Ultrasound Imaging System did not require clinical testing to establish substantial equivalence." This implies no clinical performance study, including an MRMC study with AI assistance, was conducted or required for this 510(k) submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The Leltek Ultrasound Imaging System is an ultrasound imaging system, not an AI algorithm. It provides imaging data for qualified physicians and healthcare professionals to conduct ultrasound scans and fluid flow analysis. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated on its ability to produce safe and effective ultrasound images, not on an AI's diagnostic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a clinical performance study for an AI algorithm. The device itself is an imaging tool. Its "ground truth" for regulatory purposes revolves around its technical specifications, safety, and ability to generate images comparable to legally marketed predicate devices, as demonstrated through engineering tests and adherence to standards.
8. The sample size for the training set
Not applicable. The Leltek Ultrasound Imaging System is an imaging device, not an AI algorithm that requires a training set of data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.