(272 days)
EveryWare is indicated to support clinicians by managing data of patients who are prescribed compatible therapy devices in accordance with the intended use of those therapy devices. EveryWare provides remote patient data collection & viewing and is intended to be used by healthcare representatives in conjunction with compatible non-life support therapy devices to adjust prescription and/or performance settings. EveryWare is intended to be used in hospital, institutional, provider, and home care settings.
EveryWare is a platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system. The data from ventilator is sent over a cellular modem through a cellular network to a cloud-hosted secure data storage system. The authenticated users access this cloud hosted system from a browser in their computer.
EveryWare securely connects compatible medical devices located at the point of patient care to the cloud, and provides authorized healthcare representatives the means to manage patient and device information and settings. EveryWare does NOT alter the intended use of connected medical devices or provide functions to automate diagnosis or therapy.
This document is a 510(k) clearance letter for the medical device "EveryWare." It focuses on establishing substantial equivalence to previously cleared predicate devices. Therefore, it does not contain the detailed study information typically found in a clinical trial report or a performance validation study for a novel device.
Based on the provided text, here's what can be extracted and what is NOT available:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics (e.g., "sensitivity $\ge 90%$"). The document primarily focuses on demonstrating that EveryWare's functionalities and technical characteristics are similar to its predicates, and that its differences "do not raise new questions of safety and effectiveness."
- Reported Device Performance: Instead of performance metrics, the document lists functional and technological characteristics and states their similarity or difference compared to predicates. Performance is broadly assessed through "non-clinical testing" listed below.
| Characteristic | Acceptance Criterion (Implied) | EveryWare Performance (Reported) |
|---|---|---|
| Intended Use | Must be within or similar to predicate devices. | "EveryWare is indicated to support clinicians by managing data of patients... provides remote patient data collection & viewing and is intended to be used by healthcare representatives... to adjust prescription and/or performance settings." Similar to predicates. |
| Environment of Use | Must be similar to predicate devices. | "EveryWare is intended to be used in hospital, institutional provider, and home care settings." Similar to predicates. |
| User Population | Must be similar to predicate devices. | "EveryWare is intended to be used by... Prescribing physicians, nurses, respiratory therapists, physiotherapists and technicians - Durable Medical Equipment (DME)/Homecare providers (HCPs)/Home Medical Equipment providers (HMPs)." Similar to predicates. |
| Application Type | Must be similar to predicate devices. | "Web-based application." Same as predicates. |
| Product Codes Supported by Remote Prescription Change Functionality | Must support relevant product codes, with differences not raising new safety/effectiveness questions. | MNS, MNT. Similar to K152356 (which supports MNS, MNT, BZD), but EveryWare does not support BZD. This difference is not presented as raising safety/effectiveness concerns. |
| Product Codes NOT Supported by Remote Prescription Change Functionality | Must align with predicates or have justified differences. | NOU, CBK. Similar to predicates. |
| Data Transfer Technology | Must be robust and achieve remote data transfer. | Wireless (cellular modem), SD Card, File upload/Internet. Uses iLink cellular modem. Similar to predicates. |
| Functionality | Must include core features of data management and settings. | Centralized database, Patient Management, Display therapy data, Generate reports, Settings management for non-life supporting devices. Same as predicates. |
| Therapy Mode Change (for non-life support devices) | Justified difference from predicates if not raising new safety/effectiveness questions. | No. Predicates Yes. Different, but "The absence of Therapy Mode Change does not raise new questions of safety and effectiveness." |
| Target Volume Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| IPAP & EPAP Settings | Must be present if offered by predicates. | Yes. Same as predicates. |
| Breath Rate and Insp. Time Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| Rise Time & Ramp Pressure Setting | Must be present if offered by predicates. | Yes. Same as predicates. |
| Humidifier Setting | Justified difference from predicates if not raising new safety/effectiveness questions. | No. Predicates Yes. Different, but "The absence of Humidifier Setting does not raise new questions of safety and effectiveness." |
| High Minute Volume, Disconnection & Apnea alarm | Must be present if offered by a predicate and relevant. | Yes. Similar to K152356. |
| Mask Resistance & Mask Resistance Lock | Must align with predicates or have justified differences. | No. Similar to K151901. |
| View Optional Screen | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Tubing Type & Tubing Type Lock | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Automated Airway Management | Must align with predicates or have justified differences. | No. Similar to K151901. |
| Reports | Must provide compliance reports. | Detailed report (includes compliance information). Same as predicates. |
| Labeling | Must include online help. | Online help file within the application. Same as predicates. |
| Viewing of data | Must allow interactive viewing based on date range. | Interactive viewing of data based on user selected date range. Same as predicates. |
| Safety and Effectiveness | Must be demonstrated through compliance with recognized standards and lack of new safety/effectiveness questions. | EveryWare was designed and subjected to performance testing in accordance with listed non-clinical standards (e.g., Software, Cybersecurity, Human Factors, EMC). "EveryWare, by itself, is not intended for diagnosis and treatment of disease or medical condition. EveryWare does not change the performance specification of the connected therapeutic devices. Therefore, no further performance data is required to demonstrate substantial equivalence." |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the clearance letter. The document mentions "performance testing" and adherence to various standards but does not detail a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective nature). The focus is on software and system validation rather than clinical dataset performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. As the device is primarily a data management and remote settings platform aiming for "substantial equivalence" based on functional and technical characteristics, and not for diagnostic or therapeutic AI, there is no mention of experts establishing a clinical ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the device and the presented documentation, it's unlikely an adjudication method for a clinical test set would be applicable or detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
A MRMC study was not performed nor mentioned. EveryWare is a data management and settings adjustment platform, not an AI-assisted diagnostic or therapeutic tool that would typically involve human readers interpreting AI output.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a "platform that gathers treatment information from Breas respiratory devices in a secure cloud-based system" and allows "authorized healthcare representatives the means to manage patient and device information and settings." It does not involve a "standalone algorithm" in the typical sense of a diagnostic or predictive AI. Its performance is tied to its functionality in securely collecting, displaying, and allowing modification of therapy data, which relies on system integrity rather than algorithmic output interpretation. Therefore, a standalone algorithmic performance study in the context of AI was not done or reported.
7. The Type of Ground Truth Used
For EveryWare, the "ground truth" relates to:
- The accurate and secure transmission, storage, and display of patient data from compatible devices.
- The correct implementation of remote prescription/performance settings onto compatible devices.
- Compliance with various software, cybersecurity, human factors, and electromagnetic compatibility standards.
This is fundamentally different from a clinical ground truth (e.g., pathology, outcomes data, or expert consensus for disease detection). The ground truth for this type of device would be defined by technical specifications, data integrity, security protocols, and successful functional validation against a known correct behavior.
8. The Sample Size for the Training Set
This information is not provided. EveryWare is described as a data management platform rather than a machine learning model that would require a "training set" in the context of AI. The development would involve software engineering and validation practices.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" mentioned in the context of an AI/ML model for this device. The development process would have involved establishing requirements and validating the software against those requirements, rather than training against a ground-truth dataset.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).