(61 days)
The device is a general-purpose ultrasonic imaging instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic(neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology.
The SonoScape S6 Diagnostic Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The all digital architecture with progressive dynamic receive focusing allows the system to maximize the utility of all imaging transducers to enhance the diagnostic utility and confidence provided by the system. The exam dependent default setting allows the user to have minimum adjustment for imaging the patient, while the in-depth soft-menu control allows the advanced user to set the system for different situations. The architecture allows cost-effective system integration to a variety of upgrade-able options and features. This SonoScape system is a general purpose, software controlled, diagnostic ultrasound system. Its basic function is to acquire ultrasound data and display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Doppler and Power Doppler, or a combination of these modes, 3D/4D.
This is a 510(k) premarket notification for the SonoScape S6 Diagnostic Ultrasound System. The document focuses on establishing substantial equivalence to a predicate device, not on presenting novel acceptance criteria or a dedicated study proving device performance against specific clinical endpoints. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical accuracy (e.g., sensitivity, specificity, AUC) for diagnostic tasks. Instead, it relies on demonstrating substantial equivalence to a predicate device by conforming to recognized safety and performance standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety Standards | IEC 60601-1 (1988), Amendment 1 (1991), Amendment 2 (1995) | Device conforms to this standard. |
| IEC 60601-1-2 (Second Edition, 2001) | Device conforms to this standard. | |
| IEC 60601-2-37 (2004) (2005) Amendment 2 | Device conforms to this standard. | |
| NEMA UD 2-2004 | Acoustic output measured and calculated per NEMA UD 2: 2004 and NEMA UD3: 2004. | |
| ISO 10993-5:1999 (Biological evaluation - In Vitro cytotoxicity) | Device conforms to this standard (biocompatibility). | |
| ISO 10993-10:2002 (Biological evaluation - Irritation/hypersensitivity) | Device conforms to this standard (biocompatibility). | |
| Functional Equivalence | Met all design specifications | Laboratory testing verified that the device met all design specifications and was substantially equivalent to the predicate device. |
| Same fundamental technology as predicate device | The S6 Diagnostic Ultrasound System with added transducer incorporates the same fundamental technology as the predicate device (S20 Digital Doppler Ultrasound System and Transducers - K110510). | |
| Intended Use | (General purpose, multi-application) | Intended for use for Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Cephalic (neonatal and adult), Trans-rectal, Trans-vaginal, Peripheral Vascular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), OB/Gyn and Urology. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The submission describes laboratory testing for engineering characteristics and adherence to standards, not a clinical trial with a "test set" of patients or data in the context of AI performance. The term "test set" as typically used for AI device evaluation is not relevant here.
- Data Provenance: Not applicable. The testing described is primarily laboratory-based (acoustic output, electrical safety, biocompatibility) rather than on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. Ground truth, in the context of clinical diagnostic accuracy, is not discussed as this is a 510(k) for an ultrasound system, not an AI diagnostic algorithm. The evaluation focuses on engineering performance and safety.
- Qualifications of Experts: Not applicable.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
- Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. This is a 510(k) for a diagnostic ultrasound system itself, not an AI algorithm intended to assist human readers. Therefore, an MRMC comparative effectiveness study regarding AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. The device is a diagnostic ultrasound system, which inherently requires a human operator for image acquisition and interpretation. There is no "algorithm only" performance reported in the context of AI.
7. The Type of Ground Truth Used
- Not applicable in the context of clinical diagnostic ground truth. The "truth" for the described testing relies on physical measurements against engineering specifications and adherence to established medical device safety and performance standards (e.g., acoustic output values, electrical impedance, biological reactivity in in-vitro tests).
8. The Sample Size for the Training Set
- Not applicable. The document describes a traditional medical device (an ultrasound machine), not an AI/Machine Learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, the concept of establishing ground truth for it is not relevant to this submission.
§ 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.