(58 days)
Vscan with Dual Probe is general purpose diagnosic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications:
Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e,g. Iower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines, upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, amniocentesis), Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics
Its pocket-sized portability and simplified user integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during, triage assessments, and procedural guidance for adults and pediatrics.
Vscan with Dual Probe is a pocket-sized, battery powered general purpose, track 3, diagnostic ultrasound system. The system consists of a handheld unit with a flip up 3.5 inch LCD display and a permanently attached dual ended (phased and linear) transducer operating B and color modes with digital acquisition, processing and display capability. The user interface control panel is composed of a navigation wheel that allows for intuitive thumb control.
The battery can be charge either in the system or alone. The system contains a Docking Station, charger with cable and soft bag. Capabilities also include distance measurements, voice recordings and storage of files. Additional Vscan gateway software can be loaded on a personal computer to allow the user to review, annotate and create reports with the image, video and voice files once files are transferred using the included USB cable.
Vscan with Dual Probe is general purpose diagnostic ultrasound imaging system for use by qualified and trained health care professionals enabling visualization and measurement of anatomical structures and fluid. With a single probe solution, the dual headed probe integrates both linear and phased array transducers that allows for a wide range of clinical applications: Cardiac: Abdominal: Renal: OB/GYN: Urology: Fetal, Evaluation of Presence of Fluid; Peripheral Vascular Imaging(e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels(e.g. central lines. upper extremity); Imaging Guidance for Needle/Catheter Placement(e.g. paracentesis, thoracentesis. amniocentesis); Thoracic/Lung(e.g. pleural motion/sliding, line artifacts); Thyroid and other Small Organs; Long Bone; Hip and Knee Joints; and Pediatrics
Its pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, triage assessments, and procedural guidance for adults and pediatrics.
The medical device, Vscan with Dual Probe, is a general-purpose diagnostic ultrasound imaging system.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not contain specific numerical acceptance criteria or quantitative performance metrics for the Vscan with Dual Probe. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means its "performance" is implicitly accepted if it performs similarly to or better than the already cleared predicate devices for its intended uses.
The reported "performance" is qualitative, asserting that the device is substantially equivalent in terms of:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence | The Vscan with Dual Probe system is substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics, and safety and effectiveness. The Vscan with Dual Probe and predicate Vscan system have the same clinical intended use, with exceptions. The exceptions (Small Organ, Musculo-skeletal conventional, Vascular access, and Nonvascular access) are substantially equivalent to other listed predicate devices (Vivid e and Venue 40). |
| Technological Characteristics Equivalence | Vscan with Dual Probe and predicate Vscan have the same imaging modes, system display size, and are battery-powered. The deep scanning end of the transducer on Vscan with Dual Probe is similar to the probe on Vscan (K092756). The shallow scanning end of the transducer on Vscan with Dual Probe is similar to an 8L-RS probe used on and cleared with Vivid e (K113690). |
| Safety and Effectiveness (Materials & Acoustic Output) | Systems are manufactured with materials evaluated and found safe. Acoustic power levels are below applicable FDA limits. |
| Functional Equivalence (Measurements, Review, Reporting) | Vscan with Dual Probe and predicate Vscan have similar capability in terms of performing measurements, capturing digital images, reviewing, and reporting studies. |
| Compliance with Safety Standards | The Vscan with Dual Probe complies with approved electrical and physical safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 3, ISO10993-1, ISO14971, NEMA UD 2). |
| Quality Assurance Measures | Risk analysis, requirements reviews, design reviews, unit-level testing (module verification), integration testing (system verification), performance testing (verification), and safety testing (verification) were applied. |
| Biocompatibility | Transducer materials are biocompatible. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Summary of Clinical Tests: The subject of this premarket submission, Vscan with Dual Probe, did not require clinical studies to support substantial equivalence."
Therefore, there is no test set sample size and no data provenance as no clinical studies were performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical studies were performed, there were no experts used to establish ground truth for a test set.
4. Adjudication Method for the Test Set
As no clinical studies were performed, there was no adjudication method for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case comparative effectiveness study was not done. The submission explicitly states no clinical studies were required or performed. Therefore, there's no reported effect size regarding human readers improving with or without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
The Vscan with Dual Probe is a diagnostic ultrasound system, not an AI-powered algorithm in the sense of software interpreting images independently. It is a human-operated imaging device. Therefore, a standalone performance study in the context of an algorithm's diagnostic accuracy was not applicable and not performed.
7. The Type of Ground Truth Used
Given that no clinical studies were performed to establish diagnostic accuracy against a ground truth, there is no specified type of ground truth (e.g., expert consensus, pathology, outcomes data) used for the device's validation. The device's "ground truth" for regulatory clearance is based on its substantial equivalence to predicate devices, which implies that if the predicate devices were considered safe and effective, and this device is similar, it is also safe and effective.
8. The Sample Size for the Training Set
The Vscan with Dual Probe is a physical ultrasound imaging device, not a machine learning model that requires a "training set" in the conventional AI sense. Therefore, there is no training set sample size. Any internal calibration or development testing would not be referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI/ML device requiring a training set, the question of how ground truth for a training set was established is not applicable.
§ 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.