(23 days)
Indications for Use: Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Intended Use: For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility.
The names of the subject devices are the Philips SureSigns VM Series Patient Monitors, the SureSigns VS2 Vital Signs Monitor, and the SureSigns VS3 Vital Signs Monitor. The common usual name is multi-parameter patient monitor. The modification is to replace the currently cleared CAS NBP module with the picoNIBP(non invasive blood pressure) OEM Module (which was cleared in K051366) to the VS2 Vital Signs Monitor, the VS3 Vital Signs Monitor, and the VM Series (VM 4/6/8) Patient Monitors. In addition, this submission includes a change in plastics to Valox and the addition of new SP0- sensors and the disclosure of IPX1 rating for ingress protection to vertical water drops for all subject devices.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Philips SureSigns VM Series Patient Monitors, SureSigns VS2 Vital Signs Monitor, and SureSigns VS3 Vital Signs Monitor:
Based on the provided K090483 510(k) summary, much of the requested information regarding specific acceptance criteria, detailed device performance metrics, and study methodologies for the modified device is not explicitly stated. The submission focuses on demonstrating substantial equivalence to a predicate device (K052707) rather than providing a detailed de novo performance study with specific criteria.
The key takeaway is that the manufacturer states that "Pass/Fail criteria were based on the specifications cleared for the predicate device" and that testing showed "substantial equivalence." This implies that the acceptance criteria for the modified device are implicitly aligned with those established for the previously cleared predicate device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| General Performance | "Pass/Fail criteria were based on the specifications cleared for the predicate device." | "Testing involved system level tests, performance tests, and safety testing from hazard analysis. Pass/Fail criteria were based on the specifications cleared for the predicate device and test results showed substantial equivalence. The results demonstrate that the Philips SureSigns VM Series Patient Monitors, SureSigns VS2 Vital Signs Monitors and SureSigns VS3 Vital Signs Monitors meet all claims and support a determination of substantial equivalence." |
| Technological Equivalence | Same fundamental technological characteristics as the legally marketed predicate devices. Same design as the predicate device. | Modified devices have the same fundamental technological characteristics and use the same design as the predicate device (M3046B Compact Configurable Portable Patient Monitor, K052707). The modification is to replace the NBP module with picoNIBP module (cleared in K051366), change in plastics, and new SpO2 sensors. |
| Intended Use | Same intended use as the legally marketed predicate device. | "The modified devices have the same intended use as the legally marketed predicate device." For monitoring, recording, and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments and transport within a healthcare facility. |
| Safety | Safety testing from hazard analysis. Implicitly, to be as safe as the predicate device. | "Safety testing from hazard analysis" was performed. Results supported substantial equivalence. |
| Reliability | Reliability characteristics of the modified device with respect to the predicate. Implicitly, to be as reliable as the predicate device. | "Reliability characteristics of the modified device with respect to the predicate" were established. Results supported substantial equivalence. |
| Functionality | Functionality characteristics of the modified device with respect to the predicate. Implicitly, to be as functional as the predicate device. | "Functionality characteristics of the modified device with respect to the predicate" were established. Results supported substantial equivalence. |
Study Information Table
| Feature | Details from K090483 Document |
|---|---|
| Test Set Sample Size | Not explicitly stated. The document refers to "system level tests, performance tests, and safety testing," but does not provide specific sample sizes for these tests. |
| Test Set Data Provenance | Not explicitly stated. The testing appears to have been internal verification and validation activities conducted by Philips Medical Systems in Andover, MA, United States. It's likely prospective testing in a lab setting, given the nature of device modifications. |
| Number of Experts for Ground Truth (Test Set) | Not applicable/Not stated. The document describes engineering and performance testing against predicate device specifications, not a clinical study involving experts to establish a "ground truth" in the traditional sense of diagnostic accuracy. |
| Qualifications of Experts (Test Set) | Not applicable/Not stated. |
| Adjudication Method (Test Set) | Not applicable/Not stated. |
| Multi-Reader Multi-Case (MRMC) Study? | No. This submission describes modifications to patient monitors, not a diagnostic imaging or AI-assisted interpretation device that would typically undergo a MRMC study. |
| Effect Size of Human Readers (with/without AI assist) | Not applicable. This is not an AI-assisted diagnostic device. |
| Standalone Performance (Algorithm Only)? | Not applicable. This is a medical device (patient monitor) with integrated hardware and software components for physiological parameter monitoring. The "performance" described is the overall device performance, not a standalone algorithm. |
| Type of Ground Truth Used | The "ground truth" in this context refers to the established specifications and performance metrics of the predicate device (K052707) and the pre-cleared picoNIBP module (K051366), against which the modified device's performance was measured. It's based on engineering specifications and validated performance, not clinical outcomes or pathology from a patient cohort for diagnostic purposes. |
| Training Set Sample Size | Not applicable/Not stated. This device is not described as utilizing machine learning or AI that would require a "training set" in the common sense of the term for algorithm development. The development process would involve traditional engineering design, simulation, and testing. |
| How Ground Truth for Training Set was Established | Not applicable/Not stated. As above, this doesn't appear to be an AI/ML device requiring a training set with established ground truth. The "ground truth" for its development would be engineering principles, physiological models, and regulatory standards for vital signs monitoring. |
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).