(75 days)
Intended for use in the data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. This device is indicated for use by health care providers whenever there is a need for generation of a patient record and computation of drug dosage.
As with the predicate device, the proposed IntelliVue Clinical Information Portfolio (ICIP) is a software only product used for charting and data management. The proposed updated device targets functionality needed for critical care, enhances the user experience, and provide necessary updates to meet hospital IT requirements, as is found in the Philips IntelliVue Clinical Information Portfolio device (K992636). Enhancements for the Critical Care market derived from customer feedback will be added to device in order to meet customer requirements for imoroved usability. The purpose of this submission is to formally document the renaming of the product to the Philips IntelliVue Clinical Information Portfolio (ICIP) as well as to update the 510(k) filing to include updated technologies needed to meet current hospital IT requirements and improve usability for clinicians
This FDA 510(k) premarket notification (K100272) is for the Philips IntelliVue Clinical Information Portfolio Release E.0. It is a software-only product used for charting and data management, and the submission primarily focuses on renaming the product, updating technologies to meet current hospital IT requirements, and improving usability.
Based on the provided documents, it is important to note that this submission does not involve a clinical study to prove the device meets specific performance criteria related to diagnostic accuracy or clinical outcomes. Instead, it relies on demonstrating substantial equivalence to a predicate device (HP CareVue 9000 Clinical Information System, K992636) through non-clinical testing.
Therefore, many of the requested sections (e.g., sample size for test sets, expert adjudication, MRMC study, standalone performance, ground truth types) are not applicable as they pertain to clinical or diagnostic performance studies, which were not conducted for this submission.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a software update and renaming submission, the "acceptance criteria" are related to maintaining the functionality, reliability, and safety of the previous version and meeting new IT and usability requirements. The reported performance is that these criteria were met through non-clinical testing.
| Acceptance Criteria Category | Description | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device (IntelliVue Clinical Information Portfolio Release E.0) must retain the core functionalities of the predicate device (HP CareVue 9000 Clinical Information System). | "ICIP Release E.0 contains all the main functionality of the predicate." |
| Intended Use Equivalence | The device must maintain the same intended use as the predicate device. | "The predicate device and the subject device are similar with respect to the intended use and indications for use." |
| Safety and Effectiveness | The updated device must not raise new issues of safety or effectiveness compared to the predicate device. | "In our opinion, given the substantial equivalence to the predicate devices, no new issues of safety or effectiveness are raised by this premarket notification." |
| Reliability and Performance Claims | The device must meet all reliability requirements and performance claims established for the device. Non-clinical testing (system level, performance, safety) demonstrated this. | "The results demonstrate that the Philips IntelliVue Clinical Information Portfolio Release E.0 meets all reliability requirements and performance claims and supports a determination of substantial equivalence." |
| Usability Enhancement | The new user interface and updated technologies should improve user experience and meet hospital IT requirements, making the product more user-friendly for clinicians, support, and scalability. | "There is a new user interface designed around more modern technologies, this makes the product more user friendly for clinicians, support and scalability." |
Regarding the study that proves the device meets the acceptance criteria:
The study that proves the device meets the acceptance criteria is described as Non-Clinical Testing.
- Type of Study: Verification, validation, and testing activities. This included system-level tests, performance tests, and safety testing from hazard analysis.
- Purpose: To establish the performance, functionality, and reliability characteristics of the subject device with respect to the predicate device.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This was a non-clinical software validation and verification study, not a study involving patient data or a specific "test set" of clinical cases in the way a diagnostic accuracy study would. The testing was against product specifications and the predicate device's performance.
- Data Provenance: Not applicable. No clinical data or patient data was involved in the testing described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth, in the context of clinical accuracy, was not established for this type of non-clinical software validation. The "ground truth" for this submission would be the functional and performance specifications of the software itself and the established performance of the predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No clinical test set or human interpretation requiring adjudication was involved.
5. 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
- MRMC Study: No. This submission does not involve AI or a diagnostic study requiring human reader assessment of cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No, not in the context of diagnostic or interpretive performance. The software's functionality was tested, but not its standalone performance in a clinical diagnostic sense. It is a clinical information management system, not a diagnostic algorithm.
7. The type of ground truth used
- Type of Ground Truth: The "ground truth" for this non-clinical testing was based on:
- The specifications cleared for the predicate device (HP CareVue 9000 Clinical Information System, K992636).
- The specifications of the subject device (Philips IntelliVue Clinical Information Portfolio Release E.0).
- Test results demonstrating adherence to these specifications and functional equivalence.
- Hazard analysis for safety testing.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set" of data in the conventional sense. The software development likely involved iterative testing and refinement, but not a distinct "training set" for model learning.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there was no training set in the context of AI/ML development. The "ground truth" for the software's development and verification would have been its functional requirements and design specifications.
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).