(59 days)
The EchoSure diagnostic ultrasound system and its transducer are in clinical examinations of blood vessels that are marked with an EchoMark LP implant. The system provides measurements and information about blood flow.
The system is intended for use by trained medical health care professionals in support of clinical diagnosis.
EchoSure is a portable diagnostic ultrasound system which applies the latest technologies to produce optimal images and provide information about blood flow in vessels. Various image parameter adjustments, dual high-resolution displays, and a custom probe are configured to provide clear and stable images. The system operates in B-Mode and Color Flow Doppler Mode. EchoSure is comprised of the EchoSure Ultrasound, the EchoSure Application, and the EchoSure Probe.
This document describes the Sonavex EchoSure Diagnostic Ultrasound System, which is intended for clinical examinations of blood vessels marked with an EchoMark or EchoMark LP implant. The system provides measurements and information about blood flow and is intended for use by trained medical healthcare professionals in support of clinical diagnosis.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with corresponding performance metrics as would typically be seen for a new device claiming improved performance. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K173265, WinProbe UltraVision 2 Diagnostic Ultrasound System) by outlining similar technical characteristics and adherence to relevant safety and performance standards.
The table below summarizes key comparisons between the EchoSure and its predicate, acting as implicit "acceptance criteria" through comparative equivalence:
| Feature | Acceptance Criteria (Predicate Device K173265) | Reported Device Performance (EchoSure) |
|---|---|---|
| Intended Use | Clinical examinations of vessels for evaluating blood flow and echogenicity of soft tissue (thyroid, breast, testicles, peripheral vessel, abdominal, superficial muscular skeletal diagnosis). | Clinical examinations of blood vessels marked with EchoMark or EchoMark LP implants, providing blood flow measurements and information. (More limited scope than predicate) |
| Principle of Operation | Same fundamental scientific technologies | Same fundamental scientific technologies (B-mode and Color Flow Doppler-mode operations) |
| Power Supply Voltage | 90-264 V AC | 100 – 264 V AC |
| Power Supply Frequency | 50/60 Hz | 47-63 Hz |
| Installation & Use | Portable equipment, mobile with cart | Portable equipment, mobile with cart |
| Mode of Operation | Continuous operation | Continuous operation |
| Dimensions (WxHxD) | 400x50x250 mm | 400x55x250 mm |
| Weight | ~10 lbs (4.5 kg) | ~13 lbs (5.9 kg) |
| Operating Temperature | 0°C to 40°C | 0°C to 40°C |
| Operating Humidity | Not for high humidity | 0% - 90% relative humidity (Allows for higher humidity than predicate's implied acceptance) |
| Safety Classification | Class II, Type BF | Class II, Type BF |
| EMC Compliance | IEC 60601-1-2 | IEC 60601-1-2 |
| Acoustic Output Std. | IEC 61157 AIUM/NEMA UD-2 | IEC 61157 AIUM/NEMA UD-2 |
| Biocompatibility | ISO 10993-1 | ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 (More extensive testing than predicate's implied acceptance) |
| Monitor Display | 15 inch LCD flat panel, 2800x1800 pixels | 15.6 inch IGZO, 3200x1800 pixels (Higher resolution than predicate) |
| General Imaging Mode | B, M, Color Flow Doppler, Shear, PW Doppler, E | B mode, Color Flow Doppler mode (More limited modes than predicate) |
| Scanning Method | Linear | Linear |
| Displayed Depth | 20 mm to 300 mm | 10 mm – 80 mm (More limited depth range) |
| Gray Scales | 256 | 256 |
| TGC | 8 segments | 8 segments |
| Probe Type | Linear (L14-4) | Linear (4DML12-5) |
| Probe Freq. Bandwidth | 5 - 15 MHz | 5 – 12 MHz (More limited bandwidth than predicate) |
| Probe # Elements | 256 | 192 |
| Probe Modes | B, E, M, CFD, PWD | B and CFD (More limited modes than predicate) |
| Mechanical Index (MI) | 0.82 | 0.8 |
| ISPTA (mW/cm²) | 75 | 106 |
| Pr (MPa) | 2.142 | 2.75 |
| Frequency (MHz) | 7.55 | 6.85 |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Clinical studies are not required to support equivalence for these conventional ultrasound systems." This implies that there was no specific clinical test set used for the EchoSure device itself to prove its performance in human subjects, beyond the non-clinical safety and performance data. The FDA clearance is based on substantial equivalence to a predicate device and adherence to recognized standards.
Therefore, information regarding sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable as no clinical studies were performed for this specific submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
As no clinical test set was required or performed for direct evaluation of the EchoSure device's performance in a clinical setting, there's no information about experts establishing ground truth for a test set. The submission relies on the established safety and performance of the predicate device and compliance with standards.
4. Adjudication Method for the Test Set:
Since a clinical test set was not used to evaluate device performance, an adjudication method for a test set is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No MRMC comparative effectiveness study was done, as confirmed by the statement "Clinical studies are not required."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The EchoSure is a diagnostic ultrasound system, not an algorithm-only device. Its performance is intrinsically tied to human operation and interpretation. Therefore, a "standalone algorithm only" performance study is not applicable in this context. The document emphasizes its use "by trained medical health care professionals."
7. The type of ground truth used:
Given the reliance on substantial equivalence and non-clinical testing, the "ground truth" for the EchoSure's clearance is primarily based on:
- Compliance with recognized electrical, mechanical, safety, EMC, acoustic output, and biocompatibility standards (e.g., ISO 10993, IEC 60601 series). These standards serve as the "ground truth" for ensuring the device meets fundamental safety and engineering performance requirements.
- Demonstrated performance specifications during bench testing. These tests confirm that risk controls were properly implemented, design outputs meet design inputs, and the device is suitable for its intended use within a laboratory/engineering context.
8. The sample size for the training set:
The EchoSure is a conventional diagnostic ultrasound system, not an AI/ML-driven device that requires a "training set" in the machine learning sense. Therefore, information about a training set sample size is not applicable.
9. How the ground truth for the training set was established:
As the device does not utilize a machine learning algorithm requiring a training set, this question is not applicable.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.