(29 days)
The CX50 2.0 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 clinical applications: Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological.
CX50 2.0 is a modification of the CX50 (1.0) compact diagnostic ultrasound system cleared for Philips Ultrasound in K081802. The 2.0 modification adds 4 additional transducers for use with the CX50 system; these transducers and software changes in release 2.0 enable expanded intended uses for the CX50 system. These expanded intended uses are all within the cleared intended uses for the predicate device, Philips iU22 diagnostic ultrasound system cleared in K030455), to which CX50 2.0 is substantially equivalent.
Here’s an analysis of the provided text regarding the Philips CX50 2.0 Diagnostic Ultrasound System, focusing on acceptance criteria and supporting studies.
Important Note: This document describes a 510(k) premarket notification. For ultrasound systems, particularly for updates adding new transducers or expanding indications, the primary "study" proving acceptance criteria is often demonstrating Substantial Equivalence (SE) to a legally marketed predicate device. This typically involves showing that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, without raising new questions of safety or effectiveness. Direct performance metrics like sensitivity, specificity, accuracy, or reader study results, which are common for AI-based or novel diagnostic devices, are usually not extensively detailed in such 510(k) summaries unless a significant new technology or clinical claim (beyond equivalence) is being made.
Therefore, the "acceptance criteria" here largely refers to the criteria for demonstrating substantial equivalence, and the "study" is the comparison made against the predicate devices.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (Claimed Equivalence) |
|---|---|
| Intended Use: Device is indicated for diagnostic ultrasound imaging and fluid flow analysis. Expanded uses remain within the scope of the predicate device. | CX50 2.0: Intended for diagnostic ultrasound imaging and fluid flow analysis in Cardiac (adult), Ophthalmic, Fetal, Abdominal, Pediatric, Musculoskeletal, Peripheral Vessel, Small Organ, Trans-vaginal, Adult Cephalic, and Gynecological applications. |
| Predicate (Philips iU22): Cleared for these intended uses. CX50 2.0's expanded uses (via new transducers/software) are covered by the predicate. | |
| Technological Characteristics: |
- Same gray-scale and Doppler capabilities.
- Essentially same technologies for imaging, Doppler, and signal processing. | CX50 2.0 & Predicate: Both have the same gray-scale and Doppler capabilities. Both use essentially the same technologies for imaging, Doppler functions, and signal processing. |
| Safety: - Acoustic output levels below FDA limits.
- Manufactured under equivalent quality systems.
- Materials with equivalent biosafety and found safe.
- Designed and manufactured to same electrical and physical safety standards. | CX50 2.0 & Predicate:
- Both have acoustic output levels below Track 3 FDA limits.
- Both are manufactured under equivalent quality systems.
- Both are manufactured of materials with equivalent biosafety, found safe.
- Both are designed and manufactured to the same electrical and physical safety standards. |
| Effectiveness: The device performs as effectively as the predicate for its stated indications. | CX50 2.0 & Predicate: Demonstrated substantial equivalence to the Philips iU22 diagnostic ultrasound system (K030455) and the CX50 (1.0 release) (K081802). The new transducers integrate capabilities already cleared on other Philips systems, or are minor modifications of previously cleared transducers. The "Integrated Ultrasound" capability facilitates workflow, which is not a direct diagnostic performance claim but an operational improvement. The FDA's clearance (K091804) indicates acceptance of this demonstrated equivalence. |
Study Details Proving Acceptance Criteria
Given this is a 510(k) for a modification to an existing ultrasound system, the "study" is primarily an equivalence demonstration rather than a traditional performance study with a test set, ground truth, etc., as one would expect for a novel diagnostic algorithm.
2. Sample Size Used for the Test Set and Data Provenance:
- The document does not describe a specific "test set" of patient data for evaluating diagnostic performance in the way a clinical trial might.
- The "test" for this 510(k) is the comparison of the CX50 2.0's design, technology, and indications for use against the cleared predicate devices (Philips iU22 and CX50 1.0). This is inherent in the 510(k) process for demonstrating substantial equivalence.
- Data Provenance: Not applicable in the sense of patient data. The provenance for the comparison comes from the design specifications, technical documentation, and safety testing (e.g., acoustic output, biosafety, electrical/physical safety) of both the new device and the predicate(s). This is retrospective, drawing on existing clearances and design files.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. Ground truth in this context refers to the established safety and effectiveness of the predicate devices, as determined by prior FDA clearances and accepted industry standards. There isn't a "ground truth" established by a panel of experts for a novel diagnostic performance claim within this 510(k) summary. The "ground truth" is the regulatory standard for safety and effectiveness that the predicate device already met.
4. Adjudication Method for the Test Set:
- Not applicable. As there is no specific "test set" of patient cases requiring ground truth, there is no adjudication method described. The FDA reviewer performs the "adjudication" by reviewing the submission and determining if substantial equivalence is met.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done (or at least, not mentioned in this summary). This type of study is usually conducted when a device introduces a new diagnostic capability or significantly alters the interpretation of images, requiring a comparison of human reader performance with and without the device. The CX50 2.0 is an expansion of an existing ultrasound platform, demonstrating equivalence to an already cleared device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- No, a standalone performance study was not done. This device is a diagnostic ultrasound system, which inherently requires a human operator and interpreter. It does not include an "algorithm only" component that would be evaluated in a standalone manner.
7. Type of Ground Truth Used:
- Regulatory Standard of Substantial Equivalence: The "ground truth" is effectively the established safety and effectiveness profile of the predicate devices (Philips iU22 diagnostic ultrasound system K030455 and the CX50 1.0 system K081802). The submission asserts that all new features and indications of CX50 2.0 fall within, or are substantially equivalent to, these previously cleared devices. This includes adherence to FDA guidance, acoustic output limits, biosafety, and electrical/physical safety standards.
8. Sample Size for the Training Set:
- Not applicable. The CX50 2.0 is an ultrasound imaging system, not an AI/ML algorithm that develops its diagnostic capabilities from a "training set" of data. Its performance is based on established ultrasound physics, transducer design, and signal processing.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no "training set" for this type of device, no ground truth was established for it.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.