(78 days)
EPIQ: The intended use of EPIQ Ultrasound Diagnostic System is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), intra-luminal, intra-cardiac echo, Musculoskeletal (Conventional), Musculoskeletal (Superficial), Ophthalmic, Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung. When integrated with Philips EchoNavigator, the systems can assist the interventionalist and surgeon with image guidance during treatment of cardiovascular disease in which the procedure uses both live X-ray and live echo guidance.
Affiniti: The intended use of Affiniti Series Diagnostic Ultrasound Systems is diagnostic ultrasound imaging and fluid flow analysis of the human body, with the following indications for use: Abdominal, Cardiac Adult, Cardiac Other (Fetal), Cardiac Pediatric, Cerebral Vascular, Cephalic (Adult), Cephalic (Neonatal), Fetal/Obstetric, Gynecological, Intraoperative (Vascular), Intraoperative (Cardiac), Musculoskeletal (Conventional), Musculoskeletal (Superficial), Other: Urology, Pediatric, Peripheral Vessel, Small Organ (Breast, Thyroid, Testicle), Transesophageal (Cardiac), Transrectal, Transvaginal, Lung.
The purpose of this Traditional 510(k) Pre-Market Notification is to introduce Remote Software Management (RSM) software feature onto the EPIQ and Affiniti Series Diagnostic Ultrasound Systems. The proposed EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound Systems with new RSM software feature, which is a workflow-enhancement software feature, is equivalent to predicate device, K242020. The Philips RSM feature provides the capabilities to remotely upgrade EPIQ/Affiniti Systems, with the existing RSM capabilities, only patch upgrade was possible, and full upgrade (including OS components) was not supported. The full RSM feature provides the capabilities to perform a remote upgrade to EPIQ/Affiniti Systems. The RSM feature is capable of deploying following packages onto the system: OS Packages, Device Drivers, Printer Drivers, BIOS/UEFI version, Application Packages, Service Application Packages, Automatic backup/restore of existing system settings. Along with the above functionalities, it also supports Automatic and Scheduled software downloads/Installation. No hardware changes to the EPIQ or Affiniti Systems are required when using RSM software feature, and existing, commercialized Philips transducers are used for the RSM software feature. The feature is supported by EPIQ and Affiniti models running software version 12.0.
The provided FDA 510(k) clearance letter (K250177) describes the Philips EPIQ and Affiniti Series Diagnostic Ultrasound Systems with a new feature: Remote Software Management (RSM). The submission focuses on demonstrating substantial equivalence to a predicate device (K242020), specifically highlighting the enhancements to the RSM feature.
Here's an analysis of the acceptance criteria and study information, based on the provided document:
Acceptance Criteria and Device Performance
The document describes the acceptance criteria in terms of the RSM feature's capabilities and its performance in comparison to the predicate device's existing RSM. The key acceptance criteria revolve around the ability to perform comprehensive remote software upgrades without compromising safety or effectiveness.
Table 1: Acceptance Criteria and Reported Device Performance for Remote Software Management (RSM)
| Acceptance Criteria (Derived from "Application Description" and "Application performance" under Comparison) | Reported Device Performance (as stated in the document) |
|---|---|
| Ability to remotely upgrade to major software releases (full upgrade including OS components). | The full RSM feature provides the capabilities to perform a remote upgrade to EPIQ/Affiniti Systems, including OS Packages, Device Drivers, Printer Drivers, BIOS/UEFI version, Application Packages, and Service Application Packages. |
| Support for automatic backup/restore of existing system settings during upgrades. | Supports "Automatic backup/restore of existing system settings." |
| Support for automatic and scheduled software downloads/installation. | "Along with the above functionalities, it also supports Automatic and Scheduled software downloads/Installation." |
| User interface facilitates download and installation process. | "The user can go into Philips Support Connect and navigate the download and installation process for system updates and upgrades. Additionally, Remote Software Management supports automatic and scheduled software downloads and installations." |
| Verification of retention of all system settings and customizations post-installation. | "Remote Service Engineer performs verification post installation, verify all settings and customizations are retained." |
| Installation verification via Philips Remote Service portal. | "Installation is verified through the Philips Remote Service portal." |
| Overall application performance is equivalent to the predicate device. | "Verification and Validation Testing has been conducted on the RSM feature to support the Application performance is equivalent to the predicate device." |
Study Details for Demonstrating Equivalence and Meeting Criteria
The provided document does not describe a clinical study or a comparative diagnostic performance study in the traditional sense, as the submission focuses on a software workflow enhancement feature (Remote Software Management). Instead, the "study" for this feature is a series of non-clinical performance tests and a demonstration of substantial equivalence.
1. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size of patient data or images. The "test set" in this context refers to the simulated testing environments or actual ultrasound systems used to validate the RSM feature.
- Data Provenance: Not applicable in the context of diagnostic image data. The validation would have involved testing the software functionality on the EPIQ and Affiniti platforms. The document mentions "Philips Internal Procedures" for testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this submission is for a software management feature, not a diagnostic algorithm that requires ground truth established by medical experts. The validation would have been performed by software/system engineers and subject matter experts in software deployment and system functionality.
3. Adjudication method for the test set:
- Not applicable for this type of submission. The "adjudication" would be internal verification and validation against functional and performance requirements by the development and quality assurance teams.
4. 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:
- No MRMC comparative effectiveness study was done. This submission is for a Remote Software Management feature, which is a workflow enhancement for system maintenance, not a diagnostic AI tool that assists human readers.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- The "standalone" performance here refers to the RSM feature functioning correctly on its own in deploying software updates. The document states:
- "All software verification tests met the acceptance criteria."
- "Results of these tests show that the proposed Remote Software Management software feature meets the intended use."
- This implies that the algorithm/feature was tested to ensure it performs its intended function (remote upgrades, backups, scheduled downloads) accurately and reliably.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the medical/diagnostic sense. The "ground truth" for the RSM feature would be the successful execution of its defined functional and performance requirements (e.g., a software package is correctly installed, system settings are retained, the system remains operational after an upgrade).
7. The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm in the context of diagnostic interpretation that requires a "training set" of patient data.
8. How the ground truth for the training set was established:
- Not applicable as there is no training set for a diagnostic algorithm.
Summary of the Study and Equivalence Argument:
The "study" described in K250177 for the Remote Software Management (RSM) feature primarily consisted of non-clinical performance testing and software verification/validation.
- Approach: Philips evaluated the RSM feature against internal procedures, adhering to software lifecycle processes (IEC 62304) and risk management (ISO 14971).
- Comparison Basis: The proposed RSM feature was compared to the predicate device's existing, more limited RSM capabilities (which only supported bug fixes and patch upgrades). The new feature expands this to include major software releases, OS components, drivers, BIOS/UEFI versions, application packages, service application packages, and automatic backup/restore.
- Conclusion of Testing: "All software verification tests met the acceptance criteria." and "Results of these tests show that the proposed Remote Software Management software feature meets the intended use."
- Substantial Equivalence Argument: The document argues that this enhancement is substantially equivalent to the predicate device because it does not introduce new questions of safety or effectiveness. The core function of the ultrasound system (diagnostic imaging) remains unchanged, and the RSM feature is purely a workflow enhancement for system maintenance. No hardware changes are required, and existing transducers are used. The comparison table directly addresses the differences and highlights how the improved RSM capabilities are an extension of the predicate's feature, not a fundamentally new diagnostic function.
§ 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.