(141 days)
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Abdomen, Cardiac, Small Organ (Thyroid, parathyroid, parotid, submaxillary gland, testes and breast.), Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal (Conventional and Superficial), Pediatric, Fetal, OB/Gyn and Urology. This device is intended to adult, pregnant woman, pediatric, and neonate.
The A6 Portable Ultrasonic Diagnostic System with added transducer is a general purpose, portable, software controlled, ultrasound diagnostic system. This ultrasonic device is designed to project ultrasound waves into body tissue and to present the returned echo information on the monitor. The resulting information is displayed in B-Mode, M-Mode, THI- Mode or in the combined mode (i.e. B/M-Mode). This system is a Track I device that employs an array of probes that include linear array and convex linear array with a frequency range of approximately 2.0 MHz to 12 MHz.
The provided document describes the SonoScape A6 Portable Ultrasonic Diagnostic System and its associated transducers. The submission is a 510(k) Pre-Market Notification, indicating a device seeking clearance for being substantially equivalent to a legally marketed predicate device, rather than a novel device requiring extensive clinical trials for efficacy.
Here's a breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for its diagnostic performance, nor does it report specific performance metrics for the device in a clinical context. Instead, the acceptance criteria are based on adherence to recognized safety and performance standards for diagnostic ultrasound equipment. The "performance" in this context refers to meeting these established standards, which serve as a proxy for substantial equivalence and safety/effectiveness.
| Acceptance Criterion (Standard Met) | Reported Device Performance |
|---|---|
| Safety Standards | |
| IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Safety | Device found to conform to applicable medical device safety standards for thermal, mechanical, and electrical safety. |
| IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility | Device found to conform to applicable medical device safety standards for electromagnetic compatibility. |
| IEC 60601-2-37: Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment | Device found to conform to applicable medical device safety standards for basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment. |
| Acoustic Output Standards | |
| NEMA UD 2-2004: Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment | Acoustic output is measured and calculated according to this standard, ensuring levels are within safe limits. The device is classified as a Track 1 device, meaning its acoustic output is within "Track 1" limits as defined by FDA guidance, suggesting a presumption of safety given established usage. |
| Biocompatibility Standards | |
| ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for In Vitro cytotoxicity | All patient contact materials are biocompatible, and the device has been tested against this standard. |
| ISO 10993-10: Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity | All patient contact materials are biocompatible, and the device has been tested against this standard, ensuring no irritation or hypersensitivity from patient-contact materials. |
| Substantial Equivalence | The device (A6 Portable Ultrasonic Diagnostic System with added transducer) demonstrates substantial equivalence to legally marketed predicate devices (K070526, K041455, K052042) in terms of intended use, technological characteristics, safety, and efficacy, based on laboratory testing and adherence to recognized standards. No clinical testing was required for this 510(k) clearance. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical testing was required." This means there was no specific "test set" of patient data or samples used in the way one would for a clinical efficacy study. The testing performed was primarily laboratory-based to meet engineering and safety standards. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no clinical testing was required and therefore no clinical "test set" was used, there were no experts establishing ground truth for such a set. The "ground truth" for this device's clearance is its adherence to universally recognized safety and performance standards, verified through laboratory testing.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used for diagnostic performance evaluation or adjudication. The evaluation was primarily against engineering and safety standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
No MRMC comparative effectiveness study was mentioned or required for this 510(k) clearance. The device is a general-purpose ultrasound system, and its clearance relies on proving substantial equivalence to existing predicate ultrasound devices, not on demonstrating improved diagnostic performance with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. It is not an AI algorithm performing diagnostic tasks independently.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the adherence to established international and national standards for medical electrical equipment safety (IEC 60601 series), acoustic output (NEMA UD 2), and biocompatibility (ISO 10993 series). The performance of the device's components and overall system was verified against the requirements outlined in these standards, in comparison to existing legally marketed predicate ultrasound devices.
8. The Sample Size for the Training Set
Not applicable. As a general-purpose diagnostic ultrasound system, this device's functionality is based on established physics and engineering principles of ultrasound imaging, not on machine learning or AI algorithms that require 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 type of device 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.