(217 days)
Echo Blaster 128 / Echo Blaster 64 ultrasound imaging systems are intended to be used for applications in fetal, abdominal, pediatric, small organ (breast, thyroid and testicles), cephalic (neonatal and adult), musculoskeletal (conventional), musculoskeletal (superficial), cardiac adult and peripheral vessel (including imaging for needle guidance, see ch.1.3). It is possible to provide diagnostic information (B, B+M and M-mode imaging) outside of an imaging lab, including at the bedside systems, for navigated medical application, in operating rooms/critical care units.
Echo Blaster 128 / Echo Blaster 64 systems are intended for the multipurpose ultrasound examinations, based on electronic linear and convex scanning. Echo Blaster 128 / Echo Blaster 64 system is a combination of proprietary hardware and software that has been designed for real-time imaging and is intended to be a basic diagnostic tool. The System is based on a modular and flexible architecture allowing for both mobile and stationary (installed) configurations. The system is designed for imaging with transducer ranges of 2 to 10 MHz. The devices referenced in this submission represent a transportable, software-controlled, diagnostic ultrasound system with accessories. This submission does not include technology or control feature changes nor deviations from indications for use different from those demonstrated in previously cleared devices operating in ultrasound B-Mode or M-Mode, inclusive of the predicate devices so claimed. The Echo Blaster 128 / Echo Blaster 64 only contains the hardware and firmware, everything else (e.g. ultrasound software, database) is located on a standard PC that is connected to the Echo Blaster 128 / Echo Blaster 64 via USB 2.0. Minimum requirements are given for the PC. The probes are connected to the Echo Blaster 128 / Echo Blaster 64. All Sonograms are saved on the PC and can there be evaluated, printed and archived. The Echo Wave software was especially designed for the Echo Blaster 128 / Echo Blaster 64. Software able to reside in a Windows-based PC. The Echo Blaster 128 / Echo Blaster 64 can be used together with the appropriate probes for the entire ultrasound diagnostic (2MHz to 10MHz probes can work simultaneously for Echo Blaster 128 2Z modifications.
The Telemed Echo Blaster 64 and 128 are ultrasound imaging systems. This 510(k) submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices by demonstrating compliance with safety and performance standards. The information provided does not detail a study involving clinical performance metrics typically associated with AI/algorithm-driven devices, as the product is a general-purpose ultrasound system.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with established international and national safety and performance standards for medical electrical equipment and diagnostic ultrasound, rather than specific clinical performance metrics like sensitivity or specificity. The "reported device performance" is the assertion of full compliance with these standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| IEC 60601-1: 2000 (General safety) | Full compliance with safety requirements as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| IEC 60601-1-2: 2001 (EMC requirements) | Full compliance with EMC requirements as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| IEC 60601-1-4: 1996 (Programmable Medical Systems) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| IEC 60601-2-37: 2007-08 (Specific requirements for ultrasonic medical diagnostic and monitoring equipment) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| NEMA UD 2-2004 (Acoustic Output Measurement Standard) | Maximum acoustic output level is under the FDA recommended limit and power level is displayed all the time. Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| NEMA UD 3-2004 (Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| AIUM MUS: 2002 (Medical Ultrasound Safety) | Acoustic output is in accordance with the ALARA principle. Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| ISO-10993-1, -5, -10, -11 (Biological Evaluation of Medical Devices) | Biocompatibility testing performed and determined to be in full compliance. Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| IEC 62304: 2006 (Medical device software -- Software life cycle processes) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| ISO 14971:2007 (Risk management to medical devices) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| Essential Requirements of Council directive 93/42/EEC (Medical Device Directive) | Full compliance as referenced in DECLARATION OF CONFORMITY (Appendix 06). |
| Cleaning and disinfection effectiveness | Cleaning and disinfection effectiveness testing performed and determined to be in full compliance. |
| Equivalence to predicate devices (Ardent Sound, Inc.; Voyager K050551; Ardent Sound, Inc.; Seeker/Spark K060800; Medison America, Inc: MYSONO 201 K003121) | Device functions and indications are substantially equivalent to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not describe a clinical performance study with a "test set" in the context of an AI/algorithm-driven device. The device is a general-purpose ultrasound system. The "testing" involved compliance with established engineering, safety, and performance standards. Therefore, information about clinical test set sample size, country of origin, or retrospective/prospective nature is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As noted above, this submission doesn't describe a clinical performance study requiring expert-established ground truth for a test set. Evaluation was against technical standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudications for a clinical test set are mentioned.
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. This submission describes a general-purpose ultrasound imaging system, not an AI-assisted diagnostic algorithm. Therefore, no MRMC study comparing human reader performance with and without AI assistance was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a hardware and software system for real-time ultrasound imaging operated by a human, not a standalone algorithm performing diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this type of device (general-purpose ultrasound), "ground truth" relates to compliance with engineering specifications, safety limits and image quality parameters defined by industry standards, rather than clinical diagnostic accuracy against a specific pathology.
8. The sample size for the training set
Not applicable. This device is an ultrasound system; it does not involve AI model training on a "training set" of medical data in the way a diagnostic AI algorithm would.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a "training set" for an AI model in this submission.
§ 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.