(28 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, submaxillar, gland, testes and breast.), Peripheral Vascular, Trans-vaginal, Trans-rectal, 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 and 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 and 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 510(k) K123616 submission for the SonoScape A6 Portable Ultrasonic Diagnostic System and its associated transducers concerns a traditional substantial equivalence determination. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often by showing it has the same technological characteristics and intended use, or that any differences do not raise new questions of safety or effectiveness.
Crucially, this document explicitly states: "No clinical testing was required." This means there was no study performed to directly test the diagnostic performance of the device against a set of acceptance criteria in a clinical setting. The acceptance criteria for this device are primarily related to meeting established medical device safety and performance standards for ultrasound systems, rather than diagnostic accuracy metrics like sensitivity or specificity.
Therefore, many of the requested points below about specific study details (like sample size for test sets, number of experts, adjudication methods, MRMC studies, or standalone performance) cannot be answered from this document because such clinical performance studies were not conducted.
Here's a breakdown of the information that can be extracted or inferred from the provided text, particularly in the context of device acceptance:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of traditional 510(k), acceptance criteria are typically met by adherence to recognized standards and by demonstrating that the device functions according to its technical specifications and intended use without raising new safety or effectiveness concerns compared to the predicate. The "reported device performance" is essentially that it meets these standards and functions as intended, similar to the predicate.
| Acceptance Criteria Category | Specific Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness (General) | Substantial Equivalence to Predicate Device (SonoScape A6, K101337) | The device is determined to be Substantially Equivalent (SE) to the predicate device in respect of safety and effectiveness. |
| Technological Characteristics | Same fundamental technology as the predicate device. | The A6 Portable Ultrasonic Diagnostic System with added transducer incorporates the same fundamental technology as the predicate device. |
| Acoustic Output Measurements | NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004 | Acoustic output is measured and calculated per NEMA UD 2 Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment: 2004. All transducers used with the A6 are track 1 (meaning their acoustic output is within specified Track 1 limits). |
| Electrical, Thermal, Mechanical Safety | IEC 60601-1: 2005 (General Requirements for Safety), IEC 60601-1-2: 2007 (EMC), IEC 60601-2-37: 2008 (Specific for Ultrasonic Equipment) | The device has been found to conform to applicable medical device safety standards in regards to thermal, mechanical and electrical safety. |
| Biocompatibility | Implied standard for patient contact materials. | All patient contact materials are biocompatible. |
| Design Specifications | Internal design specifications for the device and added transducers. | Laboratory testing was conducted to verify that the A6 Portable Ultrasonic Diagnostic System with added transducer met all design specification. |
| Intended Use | Consistent with predicate device's intended use across various anatomical regions and patient populations. | The intended uses for the system and each transducer (Abdomen, Cardiac, Small Organ, Peripheral Vascular, Transvaginal, Transrectal, Musculo-skeletal, Pediatric, Fetal, OB/Gyn and Urology for adult, pregnant woman, pediatric, and neonate) are considered substantially equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / No specific clinical test set: The submission explicitly states, "No clinical testing was required." The acceptance was based on engineering and performance verification against recognized standards and comparison to a predicate device, not on diagnostic performance in a test set of patient data.
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 testing was required, there was no test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable: As no clinical testing was required, there was no test set requiring adjudication.
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 was not a comparative effectiveness study involving human readers or AI. It's a 510(k) for an ultrasound system, comparing it to a previous version of the same system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: The device is an ultrasonic diagnostic system, requiring a human operator (qualified physician) for its intended use. It is not an algorithm for standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- No clinical ground truth used: For the purposes of this 510(k), ground truth was established by adherence to technical specifications, engineering measurements against industry standards (e.g., NEMA UD 2, IEC 60601 series), and verification that the device's technical characteristics and intended use were substantially equivalent to the predicate device.
8. The sample size for the training set
- Not applicable: As no clinical testing was required and this is not an AI/algorithm-based submission, there was no training set in the conventional sense for diagnostic performance.
9. How the ground truth for the training set was established
- Not applicable: No training set was used.
§ 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.