(26 days)
Philips CX50 Diagnostic Ultrasound Systems is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Intraoperative Laparoscopic Fetal Abdominal Pediatric Small Organ Adult Cephalic Neonatal Cephalic Trans-vaginal Musculo-skeletal Gynecological Cardiac Adult Cardiac Pediatric Trans-Esoph. (Cardiac) Intracardiac echo Peripheral Vessel Other (Carotid)
Philips Sparq Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical M-mode), Pulse Wave Doppler, Continuous Wave Doppler, Color Doppler, Tissue Doppler Imaging and Harmonics (Tissue and Contrast) modes. It is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic Fetal Abdominal Pediatric Small Organ Adult Cephalic Trans-vaginal Trans-rectal Musculo-skeletal Gynecological Cardiac Adult Trans-Esoph. (Cardiac) Peripheral Vessel
The modified CX50 and Sparq Diagnostic Ultrasound Systems are general purpose, software controlled, diagnostic ultrasound systems. Their function is to acquire ultrasound data and to display the data in various modes of operation. The devices consist of two parts: the system console and the transducers. The system console contains the user interface, a display, system electronics and optional peripherals (ECG, printers). In addition to the physical knobs and buttons of the main control panel. The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 -channel, diagnostic ultrasound imaging system. It is housed in a portable, laptop-style chassis. An optional cart is available that allows the user to place the laptop on the cart for a more mobile application. The Sparq Diagnostic Ultrasound System uses the same technology, but is a cart based mobile system. It provides a capacitive touch user interface and an articulating monitor arm. The removable transducers are connected to the system using a standard technology, multi-pin connectors. The modified CX50 and Sparq systems use standard transducer technology, and support phased, linear, curved linear array, TEE, and non-imaging (pencil) probes. Clinical data storage consists of a local repository as well as off-line image storage via the network, DVR, DVD, and USB storage devices. The images are stored in industry-standard formats (e.g. JPEG, AVI, DICOM) and are intended to be readable using industry-standard hardware and software. On-line review of the images is available. Secure access tools are provided to restrict and log access to the clinical data repository according to HIPAA. The system circuitry generates an electronic voltage pulse, which is transmitted to the transducer. In the transducer, a piezo electric array converts the electronic pulse into an ultrasonic pressure wave. When coupled to the body, the pressure wave transmits through body tissues. The Doppler functions of the system process the Doppler shift frequencies from the echoes of moving targets such as blood to detect and graphically display the Doppler shifts of these tissues as flow. The modified CX50 and Sparq systems give the operator the ability to measure anatomical structures and offer analysis packages that provide information used by competent healthcare professionals to make a diagnosis.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Philips CX50 and Sparq Diagnostic Ultrasound Systems (K162329).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Philips CX50 and Sparq Diagnostic Ultrasound Systems are implicitly defined by compliance with several international and FDA-recognized consensus standards, as well as the FDA's specific guidance for diagnostic ultrasound systems. The reported device performance is that it complies with these standards and guidances, and meets the acceptance criteria.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Performance Standards | IEC 60601-1: Medical electrical equipment. General requirements for basic safety and essential performance. 2005. Amendment 1, 2012 | |
| (General electrical and safety requirements) | Complies | |
| IEC 60601-1-2 Medical Electrical Equipment Part 1-2, General Requirements for Basic Safety and Essential Performance - Collateral Standard Electromagnetic Compatibility, 2007 | ||
| (Electromagnetic Compatibility - EMC) | Complies | |
| IEC 60601-2-37: Medical electrical equipment. Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment, 2007 | ||
| (Specific safety and performance requirements for ultrasound equipment) | Complies | |
| IEC 62359: Ultrasonics Field characterization Test methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, 2010 | ||
| (Acoustic Output Display & FDA Limits: ISPTA max=720 mW/cm², MI max=1.9, MI display, TI display) | Complies; acoustic output levels are within Track 3 FDA limits. | |
| ISO 10993: Biological evaluation of medical devices | ||
| (Biological compatibility of patient contact materials) | Complies; materials have equivalent bio-safety, no new or changed materials. | |
| FDA Guidance | Guidance for Industry and FDA Staff - Information for manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008) | Complies |
| System Level Requirements | Satisfy system level requirements and risk control measures. | Non-Clinical verification testing performed and demonstrates compliance. |
| Intended Use & Claims | Covered intended use and commercial claims as well as usability with representative intended users. | Non-Clinical validation testing performed and demonstrates the device is adequate for its intended use. |
| Substantial Equivalence | The modified CX50 and Sparq Diagnostic Ultrasound Systems are substantially equivalent to the predicate CX50 Diagnostic Ultrasound System (K123754) and reference predicate EPIQ Diagnostic Ultrasound System (K160807) in terms of: |
- Indication for use
- Technological characteristics
- Non-clinical performance testing
- Safety and effectiveness
These devices share the same gray-scale and Doppler capabilities, fundamentally identical scientific technology, same materials (bio-safety), equivalent quality systems, and same electrical and physical safety standards. | This is the primary conclusion of the submission, based on the non-clinical testing, confirming that the device meets the acceptance criteria for substantial equivalence to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The modified CX50 and Sparq Diagnostic Ultrasound Systems did not require clinical data since substantial equivalence to the primary currently marketed predicate CX50 Diagnostic Ultrasound System and reference predicate EPIQ Diagnostic Ultrasound System was demonstrated with the following attributes: • Indication for use; • Technological characteristics; • Non-clinical performance testing; and • Safety and effectiveness." (Page 39)
Therefore, there appears to be no separate clinical test set in the traditional sense for evaluating the performance of the modified device against specific clinical metrics. Instead, the performance was established through non-clinical testing and comparison to legally marketed predicate devices.
The data provenance for the modifications is based on the previously cleared predicate device (CX50, K123754) and reference device (EPIQ/Affiniti, K160807), which would have undergone their own testing. The current submission relies on the established safety and effectiveness of these predicates.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since no clinical test set was required for the modified device, there's no information provided about experts establishing ground truth for a test set. The evaluation was primarily non-clinical and comparative.
4. Adjudication Method for the Test Set
Not applicable, as no dedicated clinical test set with human interpretation was conducted for this specific 510(k) submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No MRMC comparative effectiveness study was mentioned or indicated as being performed for this submission. The submission explicitly states "did not require clinical data."
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
This refers to a diagnostic ultrasound system, which is a hardware device with software, not typically a standalone algorithm like AI software. The performance assessment was based on the system's ability to acquire and display ultrasound data in various modes, complying with established physical and safety standards. Therefore, an "algorithm only" standalone performance study in the context of an AI-driven system is not applicable here.
7. The Type of Ground Truth Used
For the non-clinical testing, the "ground truth" would be established by the engineering and quality control standards defined in the referenced IEC and ISO standards. This includes:
- Engineering specifications and measurements for acoustic output (e.g., ISPTA, MI, TI).
- Compliance with electrical and physical safety requirements.
- Biocompatibility testing against ISO 10993 standards for materials.
- Verification and validation against system requirements and risk controls.
The ground truth for the predicate devices (K123754 and K160807) would have involved comprehensive testing for their initial clearances, which may have included a combination of phantom studies, animal studies, and potentially clinical studies to establish their diagnostic capabilities. However, this submission specifically highlights that additional clinical data was not required due to the substantial equivalence argument.
8. The Sample Size for the Training Set
Not applicable. This device is a diagnostic ultrasound system, not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The system's functionalities are based on established ultrasound physics and engineering principles, not statistical learning from 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.
§ 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.