(63 days)
The Intel® Health Guide PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel® Health Guide PHS6000 is not 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 PHS6000 is a communication tool that allows caregivers to remotely access vital sign measurements of patients at home. It collects measurements captured on commercially available wireless or tethered medical devices designed for home use, stores and displays the collected information on the LCD screen, and transmits the information to a secure host server. Caregivers can review the transmitted information and select education and reminders for patients using a caregiver software interface to the host server. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also optionally engage in video conferences with caregivers and answer the caregivers' questions by participating in surveys.
The Intel® Health Guide PHS6000 system consists of the:
- Intel® Health Guide PHS6000 hardware: The physical component of the Intel® Health Guide PHS6000 is an electronic device contained in a plastic enclosure with a touch screen, video camera with privacy screen, microphones, speakers and a reminder light which is mounted into the top of the case. On the back of the device is a power socket, a headphone socket, a Broadband (high-speed) internet socket for connection to a broadband network. The device has medical device sockets for connection to specific physiological monitors, and may optionally have a phone socket for modem connection to a standard phone line.
- Intel® Health Guide software application: The software application captures, stores, and transmits information to a secure website via a standard telephone line or a LAN/WAN connection.
- Intel® Care Management Suite software application: The application allows caregivers to review patient vital signs on the secure website. The Intel® Care Management Suite allows for predefining upper and lower limits and, when either limit is exceeded, the system emails and/or pages the caregiver.
- Processor software application: The processor software application manages the interface between the Intel® Health Guide PHS6000 software application and the secure website.
The Intel® Health Guide PHS6000 is not 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 device is contraindicated for patients requiring direct medical supervision or emergency intervention. The device 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 provided document is a 510(k) summary for a modification to the Intel® Health Guide PHS6000, a remote patient monitoring system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical performance through new studies.
Therefore, the document explicitly states: "The Intel® Health Guide PHS6000 does not rely on an assessment of clinical performance data."
Consequently, the information requested regarding acceptance criteria and a study proving the device meets those criteria cannot be found in this document. The submission relies on conformity to FDA recognized consensus standards to demonstrate safety and efficacy, and on the substantial equivalence to its predicate device (Intel® Health Guide PHS6000 - K080798 & K083115).
Here's why each specific point cannot be addressed by this document:
- A table of acceptance criteria and the reported device performance: Not provided. The device does not rely on clinical performance data for this submission.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
- 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: Not applicable. This device is a remote patient monitoring system, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or reported.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no clinical performance study demonstrating acceptance criteria was conducted or reported in this submission.
- The sample size for the training set: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of a new clinical performance study for this modification.
- How the ground truth for the training set was established: Not applicable as no machine learning algorithm requiring a training set is discussed or implied to be part of a new clinical performance study for this modification.
In summary, this 510(k) submission for the Intel® Health Guide PHS6000 modification relies on demonstrating substantial equivalence to a previously cleared device and conformity to recognized consensus standards, rather than presenting new clinical performance data or studies against specific acceptance criteria.
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).