(23 days)
The CX50 Diagnostic Ultrasound System is intended for diagnostic ultrasound imaging in B (or 2-D), M-mode (including Anatomical --mode), Pulse Wave Doppler, continuous Wave Doppler, color Doppler, tissue Doppler Imaging and Harmonics (Tissue and contrast) modes. The device is indicated for diagnostic ultrasound imaging and fluid flow analysis in the following applications: Ophthalmic, Fetal, Abdominal, Pediatric, Small Organ, Adult Cephalic, Neonatal Cephalic, Trans-vaginal, Musculo-skeletal, Gynecological, Cardiac Adult, Cardiac pediatric, Trans-Esoph. (Cardiac), Peripheral Vessel, Other (Carotid)
The CX50 Diagnostic Ultrasound System is a compact, AC or battery powered, 128 channel, cardiac ultrasound imaging. It uses custom digital electronic and fabrication technologies to provide diagnostic ultrasound information and is housed in a portable, laptop-style chassis. The only changes made in this CX50 510(k) are the additional indications of Cardiac Pediatric and Neonatal Cephalic. There are no new or unique features/technical characteristics introduced with the addition of the new indications.
The Philips CX50 Diagnostic Ultrasound System received clearance for additional indications for Cardiac Pediatric and Neonatal Cephalic applications. This was a 510(k) Premarket Notification based on substantial equivalence to predicate devices (Philips HD11 Diagnostic Ultrasound System, K043535 and earlier CX50 submissions K091804 and K081802). The submission states that no new features or technical characteristics were introduced.
Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly define quantitative "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, resolution) for the new indications. Instead, the "acceptance criteria" for this 510(k) largely revolve around demonstrating substantial equivalence to previously cleared devices for these specific indications and confirming that no new safety or effectiveness concerns arise.
The "device performance" reported is that the CX50 system, with the additional indications, is substantially equivalent in safety and effectiveness to its predicate devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| No new hazards identified with the addition of Cardiac Pediatric and Neonatal Cephalic indications. | "No new hazards were identified with the addition of cardiac pediatric and neonatal cephalic indications." |
| No new testing required to determine safety and efficacy with the new indications. | "No new testing was required to determine safety and efficacy of the CX50 with the new indications." |
| Clinical safety and effectiveness of the system and transducers for the new indications are well accepted and identified in previous submissions. | "The clinical safety and effectiveness of the system and transducers were identified in previous CX50 submissions (K091804 and K081802). The clinical safety and effectiveness of the Neonatal Cephalic and Cardiac Pediatric indications are well accepted for use with ultrasound systems including the predicate device, Philips HD11 (K043535)." The CX50 with additional indications is "substantially equivalent in safety and effectiveness to the predicate identified above." |
| Same gray-scale and Doppler capabilities as predicate devices. | "The predicate devices and CX50 with additional indications have the same gray-scale and Doppler capabilities." |
| Essentially same technologies for imaging, Doppler functions, and signal processing as predicate devices. | "The predicate devices and CX50 with additional indications use essentially the same technologies for imaging, Doppler functions and signal processing." |
| Acoustic output levels below Track 3 FDA limits, equivalent to predicate devices. | "The predicate devices and CX50 with additional indications have acoustic output levels below the Track 3 FDA limits." |
| Manufactured under equivalent quality systems as predicate devices. | "The predicate devices and CX50 with additional indications are manufactured under equivalent quality systems." |
| Manufactured of materials with equivalent biosafety and found to be safe, equivalent to predicate devices. | "The predicate devices and CX50 with additional indications are manufactured of materials with equivalent biosafety. The materials have been evaluated and found to be safe for this application." |
| Designed and manufactured to the same electrical and physical safety standards as predicate devices. | "The predicate devices and CX50 with additional indications are designed and manufactured to the same electrical and physical safety standards." |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data is provided for the new indications with the CX50. The submission explicitly states: "No new testing was required to determine safety and efficacy of the CX50 with the new indications."
Safety and effectiveness were demonstrated through substantial equivalence to existing predicate devices already cleared for these applications, and through previous submissions for the CX50 system itself. Therefore, there is no explicit "sample size used for the test set" or direct "data provenance" for this 510(k) submission regarding the new indications. The reliance is on prior clearances.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no new clinical testing was performed for this specific 510(k) for the new indications, there is no mention of "experts used to establish ground truth for the test set." The substantial equivalence argument relies on the established safety and efficacy of the predicate devices.
4. Adjudication Method for the Test Set
As no specific test set or clinical study was conducted for the new indications in this submission, no adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance
No MRMC comparative effectiveness study was conducted or referenced in this submission. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image interpretation software.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This submission is for a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It is not an "algorithm only" device, and therefore, no standalone algorithmic performance study was conducted.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Given that no new clinical study was performed for the new indications, no specific "type of ground truth" was established or used for this submission pertaining to the new indications. The ground truth for the clinical safety and effectiveness of the predicate ultrasound systems would have been established through methodologies typical for medical device approvals at their time, likely involving assessments by qualified medical professionals (e.g., radiologists, cardiologists) correlating ultrasound findings with patient presentation, other diagnostic tests, or clinical outcomes.
8. The Sample Size for the Training Set
No training set is mentioned as part of this 510(k) submission, as it relates to the addition of new indications to an existing ultrasound system. The device itself is not a machine learning or AI-driven algorithm that would typically require a training set for its core functionality.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in this submission, 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.