(106 days)
The SonoScape S30/S40 system is a general-purpose ultrasonic instrument intended for use by a qualified physician for evaluation of Fetal, Abdominal, Pediatric, Small Organ (breast, thyroid), Cephalic (neonatal and adult), Transrectal, Trans-vaginal, Peripheral Vascular, Muscular, Musculo-skeletal (Conventional and Superficial), Cardiac (neonatal and adult), Trans-esoph.(Cardiac), Laparoscopic, OB/Gyn and Urology.
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (specify: breast, thyroid, testes), Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Musculo-skeletal (Conventional), Musculo-skeletal (Superficial), Other (Ob/GYN), Other (Urology), Cardiac Adult, Cardiac Pediatric, Trans-esoph.(Cardiac), Peripheral vessel, Cerebral vascular, Laparoscopic.
This SonoScape S30/S40 Digital Color Doppler Ultrasound System is an integrated preprogrammed color ultrasound imaging system, capable of producing high detail resolution intended for clinical diagnostic imaging applications. The basic principle is that system transmits ultrasonic energy into patient body and implements post processing of received echoes to generate onscreen display of anatomic structures and fluid flow within the body. This system is a Track 3 device that employs a wide array of probes that include linear array, convex array and phased array with a frequency range of 2.0 MHz to 15.0 MHz. This system consists of a mobile console with touch screen and keyboard control panel, power supply module, color LCD monitor and optional probes. This system is a mobile, general purpose, software controlled, color diagnostic ultrasound system. Its basic function is to acquire ultrasound data and to display the image in B-Mode (including Tissue Harmonic Image), M-Mode, TDI, Color-Flow Doppler, Pulsed Wave Doppler, Continued Wave Doppler and Power Doppler, or the combination of these modes, Elastography, 3D/4D. The subject of this submission is the addition of new indications, new probes and special function to original SonoScape S30 and the addition of S40 model.
This submission describes the SonoScape S30/S40 Digital Color Doppler Ultrasound System and its substantial equivalence to previously cleared predicate devices. The document does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as one would typically find for a new, non-substantially equivalent device or an AI/ML product requiring performance evaluation. Instead, the submission focuses on demonstrating that the S30/S40 system is substantially equivalent to existing devices.
Therefore, many of the requested categories cannot be filled as they pertain to a performance study that was not conducted or detailed in this 510(k) summary. The submission relies on the concept of "substantial equivalence" to previously cleared devices.
Here's a breakdown of the information that can be extracted or is explicitly stated as not applicable from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission is a 510(k) for substantial equivalence, not a performance study against predefined metrics. The "performance" is implicitly deemed equivalent to the predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific test set or data provenance for a performance study is described. The submission focuses on technical comparisons and compliance with standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth for a performance study is not established or reported.
4. Adjudication Method for the Test Set
Not applicable. No performance study is detailed that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This submission does not describe an MRMC study or any AI components that would suggest one was performed. The device is an ultrasound system with various imaging modes, not an AI-powered diagnostic tool. The "AI" concept isn't mentioned in the context of improving human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This document describes an ultrasound system, not an AI algorithm.
7. Type of Ground Truth Used
Not applicable. As no clinical performance study for new capabilities is presented, no ground truth is discussed. The "clearance" is based on substantial equivalence to existing devices with established clinical use.
8. Sample Size for the Training Set
Not applicable. This document describes an ultrasound system, not an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This document describes an ultrasound system, not an AI algorithm with a training set.
Information that is provided in the document related to device evaluation:
The study that "proves the device meets the acceptance criteria" (in the context of a 510(k) for substantial equivalence) is the Non-Clinical Tests section, which confirms compliance with recognized standards and similarity to predicate devices.
Non-Clinical Tests (from Section 7):
- Evaluation Focus: Electrical, mechanical, thermal and electromagnetic compatibility safety, biocompatibility, and acoustic output.
- Strain Elastography Function: Laboratory tests were conducted to verify that the S30/S40 system and its strain Elastography function met all design specifications.
- Standards Conformance: The S30/S40 system was designed and manufactured to meet the following standards:
- IEC 60601-1
- IEC 60601-1-2
- IEC 60601-2-37
- ISO 10993-5
- ISO 10993-10
- UD2
- UD3
Clinical Test (from Section 8):
- Requirement: "No clinical testing was required." This indicates that the FDA considered the non-clinical tests and comparison to predicate devices sufficient to demonstrate substantial equivalence, and no new clinical performance claims were being made that would necessitate a clinical study.
Substantial Equivalence Conclusion (from Section 9):
- The manufacturer concludes that the S30/S40 Digital Color Doppler Ultrasound System is substantially equivalent to the predicate devices (SonoScape S30 K132527, SonoScape S40 K131213, and SonoScape S9 K142710) with regard to safety and effectiveness, based on the non-clinical tests and comparisons.
Summary of Device Performance (Implied by Substantial Equivalence):
The device is expected to perform comparably to the predicate devices mentioned (SonoScape S30 K132527, S40 K131213, and S9 K142710) for its specified indications for use across various probes and modes. The addition of new probes (C345, C613, 2P2, 3P1, 5P2, 8P1, 6V1A, CWD2.0, CWD5.0, PWD2.0, and LAP7) and the special function of Elastography were evaluated through non-clinical testing and also found to be substantially equivalent or not to raise new risks. The new indications for Cerebral Vascular and Laparoscopic use were also evaluated within this framework.
§ 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.