(40 days)
Ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.
The G60S system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software, and is substantially equivalent to our current products that are already cleared for USA distribution under the following 510(k) PreMarket Notification number: K040060 (January 28, 2004) cleared as SONOLINE G50TM and SONOLINE G60 STM Ultrasound Systems. The G60S ultrasound system has been designed to conform to the following product safety standards: UL 2601-1, Safety Requirements for Medical Equipment, CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment, AIUM/NEMA UD-2, 1998, Acoustic Output Measurement Standard for Diagnostic Ultrasound, AIUM/NEMA UD-3, 1998, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment, 93/42/EEC Medical Device Directive, Safety and EMC Requirements for Medical Equipment, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 1157 Declaration of Acoustic Power, ISO 10993 Biocompatibility. The system's acoustic output is in accordance with ALARA principle (as low as reasonably achievable).
The provided document is a 510(k) Pre-Market Notification for the Siemens SONOLINE G60 S™ Ultrasound System, dated November 23, 2005. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding detailed acceptance criteria, study methodologies, sample sizes, expert qualifications, and ground truth establishment is not available in this type of submission.
Instead, the submission asserts that the SONOLINE G60 S™ system, including its transducers, is substantially equivalent to existing cleared devices based on its intended use and technological characteristics. The "performance" in this context refers to meeting established safety and functional standards, and having equivalent clinical applications and operational modes to predicate devices.
Here's a breakdown of the available information and areas where the requested details are not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for substantial equivalence, specific quantitative acceptance criteria and detailed performance metrics of the new device are not explicitly outlined in a typical "acceptance criteria vs. reported performance" table for novel device validation. The "acceptance criteria" here are implicitly meeting the performance and safety standards demonstrated by the predicate devices and applicable industry standards.
The "reported device performance" is the assertion that the SONOLINE G60 S™ performs similarly to the predicate devices for the listed clinical applications and modes of operation. The tables provided in Sections 6-31 indicate the clinical applications and modes of operation for which each transducer is intended, with 'P' signifying "previously cleared by the FDA under # K040060" (the primary predicate device) and 'E' signifying "added under Appendix E" (new or modified applications, which would still be compared to existing equivalent technology).
| Acceptance Criteria (Implicit) | Reported Device Performance (Implicit, based on Substantial Equivalence) |
|---|---|
| Safety: Conformance to recognized standards. | The G60S system has been designed to conform to UL 2601-1, CSA C22.2 No. 601-1, AIUM/NEMA UD-2 & UD-3, 93/42/EEC Medical Device Directive, EN 60601-1, EN 60601-1-1, EN 60601-1-2, IEC 1157, and ISO 10993. Acoustic output is in accordance with ALARA principle. |
| Intended Use: Device performs for stated applications. | The SONOLINE G60 S™ is intended for Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications, providing anatomical measurements and analysis for clinical diagnosis. Transducer-Specific Performance: As indicated in the detailed tables for each transducer (Sections 6-31), each transducer supports specific clinical applications ('P' for previously cleared functionality under K040060, 'E' for added functions in this submission, implying equivalence to other cleared devices). Modes of operation include B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Combined (BMDC). Additional features noted include Ensemble tissue harmonic imaging, 3D imaging, B&W SieScape panoramic imaging, Power SieScape panoramic imaging, and Contrast agent imaging. The assumption is that these functions perform comparably to those on the predicate device(s). |
| Technological Equivalence: Functionally similar to predicate. | The G60S™ is substantially equivalent in its technologies and functionality to the SONOLINE G50™ and SONOLINE G60 S™ Diagnostic Ultrasound Systems (K040060). It functions in the same manner by transmitting ultrasonic energy, processing reflected echoes to generate 2D images, and using Doppler principles for blood flow display. Specialized measurements and calculation functions are also equivalent. |
| Acoustic Output: Within safe limits. | A post-clearance special report is required for acoustic output measurements based on production line devices (Appendix G of September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers"). This ensures acoustic output is within approved levels. This is a post-market requirement to confirm manufacturing consistency, not a pre-market performance study comparing the device to a gold standard. |
2. Sample Size Used for the Test Set and the Data Provenance
This submission does not describe a clinical study with a "test set" in the traditional sense of evaluating a novel algorithm's diagnostic performance against a dataset. The focus is on demonstrating engineering and functional equivalence to existing cleared devices. Therefore, details about sample size and data provenance for a test set are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since a clinical study with a test set is not described, there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
As no test set or clinical performance study is described, there is no adjudication method 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
This document describes a diagnostic ultrasound system, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not applicable and not mentioned in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This submission pertains to a diagnostic ultrasound system and its transducers, which are imaging devices operated by trained medical professionals. It does not describe a standalone algorithm or AI performance.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given that this is a substantial equivalence submission for hardware and basic imaging functionalities, the "ground truth" implicitly refers to the established and accepted clinical utility and image interpretation capabilities of the predicate devices. There is no mention of specific ground truth types in the context of a new efficacy study.
8. The Sample Size for the Training Set
This submission does not describe an AI or machine learning model that would require a "training set." Therefore, no information on training set sample size is provided.
9. How the Ground Truth for the Training Set Was Established
As there is no training set described, there is no information on how its ground truth would have been established.
§ 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.