(23 days)
Health Buddy® Appliance is indicated for use in non-clinical settings to collect and transmit historical medical information to healthcare professionals to help support effective management of their patients.
The Health Buddy appliance is a communications product that connects to a telephone line. It is used by patients in conjunction with the Health Hero Online service to answer questions and furnish information to their healthcare professional(s) between office visits. The Health Buddy appliance contains software that can be activated to function with specific medical devices (including blood glucose meters, non-invasive blood pressure cuffs, patient weight scales, peak flow meters and pulse oximeters). The Health Buddy appliance retrieves data from a specific medical device and stores it for transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, weight, and Peak Expiratory Flow (PEF) and FEV1 (forced expiratory volume) measurements, and blood oxygen saturation (%SpO₂) and pulse rate using a digital pulse oximeter. The Health Buddy receives connections from these medical devices, and through the data port, downloads readings from the identified attached device and, at predetermined times, transmits the responses over the phone lines to the patient's health care professional.
The Health Buddy appliance is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to a Data Center via a toll-free number to send patient responses since the previous data transfer and to retrieve the new dialoque.
The screen displays information and asks questions about vital signs, symptoms and behaviors sent by the patient's healthcare provider, and allows the patient to respond via four large buttons. The Health Buddy will respond to the patient's answers with education, reinforcement and messages that prompt patient action. The patient responses are sent to the patient's health care provider.
The provided text describes a 510(k) submission for modifications to the Health Buddy® Appliance. However, it does not contain any information about acceptance criteria or a study designed to prove the device meets those criteria.
The document focuses on:
- Regulatory Authority and Company Information
- Device Name and Classification
- Predicate Devices: Identifying previously cleared devices that the modified device is substantially equivalent to.
- Device Description: Explaining what the Health Buddy appliance is and how it functions as a communication tool for collecting and transmitting physiological data from various medical devices.
- Indication for Use Statement: Defining the intended purpose of the device.
- Substantial Equivalence Comparison: Arguing that the modified device is substantially equivalent to existing cleared devices.
- Conclusion: Stating that safety and effectiveness are reasonably assured due to substantial equivalence.
- FDA Correspondence: The FDA's letter granting 510(k) clearance based on substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria or a study that proves the device meets them because this information is not present in the provided text.
In a real-world scenario for a medical device requiring performance testing, the requested information would typically be found in a separate section detailing verification and validation activities, including test protocols, acceptance criteria, and specific study results. This document bypasses such a detailed study by asserting substantial equivalence to previously cleared devices for modifications that are primarily software-related to support additional medical device connections.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).