Search Results
Found 1 results
510(k) Data Aggregation
(95 days)
INTEL CORPORATION DIGITAL HEALTH GROUP
The Intel® Health Guide Express is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel® Health Care Management Suite allows the caregiver to review patient data and initiate video conferencing with patients, or select and send educational and motivational content to patients.
The Intel® Health Guide Express is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.
The Intel® Health Guide Express is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
The Intel® Health Guide Express is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. The Intel® Health Guide Express is a software application running on a Commercial Off The Shelf (COTS) Personal Computer (PC). It collects measurements captured on commercially available wireless or tethered medical devices which are designed for home use and connection to a COTS PC. It displays the collected measurement on the PC, and securely stores the collected information locally on a memory device installed in the PC. The Intel® Health Guide Express also stores the information remotely on a host server, where the caregiver can view the measurement via the host server once synchronization between the host server and Intel® Health Guide Express has been completed. The Intel® Health Guide Express can be used to display educational and motivational content from the caregiver and can facilitate communication between the caregiver and patient via health wellness surveys and optional video conferencing.
The Intel® Health Guide Express is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required. It is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.
The Intel® Health Guide PHS Express system consists of the:
- Intel® Health Guide Express software application: (1)
The software application captures, stores, displays and transmits information to a secure database on a host server running the Intel® Health Care Management Suite software via a standard telephone line or internet connection. The Intel® Health Guide Express software runs on a Commercial Off The Shelf (COTS) Personal Computer (PC).
Intel® Health Care Management Suite software application: (2)
The software application runs on a host server and allows caregivers to review patient vital signs on the secure website. The Intel® Health Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
The Intel® Health Guide Express is a remote patient monitoring system. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting them in the way clinical studies for diagnostic accuracy often do.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" and "reported device performance" in the context of diagnostic accuracy or a specific performance study. Instead, it demonstrates substantial equivalence to a predicate device (Intel® Health Guide PHS6000) based on technological characteristics and functional similarities. The key performance aspect is the ability to collect, store, display, and transmit vital sign measurements, and this is compared to the predicate device's capabilities and compatibility with various peripherals.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (as presented in K103276) |
|---|---|
| Software Functionality: Capture, store, display, and transmit information to a secure database. | The Intel® Health Guide Express software application captures, stores, displays, and transmits information to a secure database on a host server. |
| Operating System: Compatible with standard PC operating system. | Compatible with Microsoft Windows 7 (32-bit versions). Predicate used Microsoft Windows XP embedded. |
| Communication Method: Standard telephone line or internet connection. | Uses standard telephone line or internet connection for transmission. |
| Sensor Interface: Ability to interface with commercially available wireless or tethered medical devices. | Interfaces with listed medical devices for Blood Pressure, Weight, Blood Glucose Level, Oxygen Saturation, and FEV/PEF. |
| Data Collection Implementation: Similar method to predicate device. | Claimed substantially equivalent to predicate in implementation method of collecting data from sensors. |
| Connectivity/Communication Protocol/Power Source/Display Method: Similar to predicate device. | Claimed substantially equivalent to predicate in these aspects. |
| Hardware Compatibility (COTS PC): Meets minimum specified hardware requirements. | Requires a COTS PC with minimum specifications for OS, CPU, Memory, Storage, Ports, Display, etc. (Table 2). |
| Safety Standard Compliance: Complies with relevant safety standards. | The device relies on conformity to FDA's recognized consensus standards to demonstrate safety and efficacy. COTS PC safety standard: UL 60950-1:2007. Predicate safety standard: ES60601-1:2005. Differences analyzed in risk analysis. |
| Patient Leakage Current: Within acceptable limits for a COTS PC. | For COTS PC, patient leakage current (from patient connection to earth) is 3.5mA (compared to 100μA for predicate, with differences covered in risk analysis). |
Essentially, the "acceptance criteria" here are that the new device performs its intended functions (collecting and transmitting data) and is at least as safe and effective as the predicate device, given its specific use case as a communication tool and not a diagnostic device.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a study involving patient data for performance evaluation in the context of diagnostic accuracy or a similar clinical measurement. The device is a "Remote Patient Monitoring System" that collects data from other commercially available medical devices.
The assessment is primarily a technical comparison and declaration of substantial equivalence to a predicate, not a clinical trial evaluating the performance on a patient cohort or a specific dataset. There is no mention of data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as there is no mention of a "test set" requiring ground truth established by experts for performance evaluation. The device's function is data capture and transmission, not interpretation or diagnosis.
4. Adjudication Method for the Test Set
This information is not applicable for the same reason as point 3. No test set requiring expert adjudication for ground truth establishing is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. The device is a data collection and communication tool, and its primary purpose is not to assist human readers in interpretation or diagnosis. Therefore, a study of improved human reader performance with AI assistance is not relevant to this type of device.
6. If a Standalone Study (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone study in the context of algorithmic performance for diagnosis/interpretation was not described. The device is a software application running on a COTS PC that interacts with other medical devices. Its performance is assessed in terms of its ability to correctly capture, store, transmit data, and its compatibility with hardware, rather than standalone diagnostic accuracy. The safety and efficacy claims "do not rely on an assessment of clinical performance data" but on conformity to recognized consensus standards.
7. The Type of Ground Truth Used
Not applicable. As stated earlier, the submission focuses on substantial equivalence based on technological characteristics and safety standards, not on evaluating diagnostic accuracy against a ground truth. The device itself is "not interpretive, nor is it intended for diagnosis."
8. The Sample Size for the Training Set
Not applicable. This device is a remote patient monitoring software system. There is no mention of a "training set" for an AI algorithm in the context of diagnosis or prediction.
9. How the Ground Truth for the Training Set was Established
Not applicable. For the same reasons as point 8, there is no mention of a training set or ground truth establishment relevant to an AI model's training.
Ask a specific question about this device
Page 1 of 1