(8 days)
Health Buddy® with Device Connectivity 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 cuff, patient weight scale and peak flow meter). The Health Buddy with Device Connectivity retrieves data from a specific medical device and stores it for later transmission to a healthcare provider. The physiologic patient parameters available for retrospective display and evaluation include blood pressure, blood glucose level, and weight. In this submission, minor software changes are made in the Health Buddy ROM to allow it to connect to a Peak Flow Meter and monitor Peak Expiratory Flow (PEF) and FEV1 measurements. The Health Buddy has the ability to receive connections from optional, compatible devices, including those identified above, and others, such as digital thermometers, pulse oximeters and prothrombin/INR meters. The Health Buddy device has a data port that allows it to download readings from an identified attached device, activated only upon appropriate patient enrollment.
The Health Buddy with Device Connectivity is a simple, user-friendly device that connects to the patient's standard home telephone line. The device connects to the Data Center via a toll-free number to send patient responses from the previous day and to retrieve the current day's dialogue.
The screen displays the information or 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 information is sent to the patient's health care provider.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) premarket notification for a minor software modification, asserting substantial equivalence to previously cleared devices. It does not contain explicit performance acceptance criteria or a study with reported device performance metrics against such criteria.
The core of the submission is to demonstrate that the minor software changes to allow connection to a Peak Flow Meter do not alter the fundamental safety and effectiveness of the existing device. It relies on the concept of "substantial equivalence" rather than a de novo performance study.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A) – No specific test set to evaluate performance is described in this substantial equivalence submission.
- Data Provenance: Not applicable (N/A) – No new clinical data or data from a test set is presented. The submission relies on establishing equivalence to previously cleared devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable (N/A) – No new ground truth establishment for a test set is described.
- Qualifications of Experts: Not applicable (N/A)
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable (N/A) – No test set or ground truth adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This type of study is not mentioned or implied in the provided document. The device is a data collection and transmission accessory, not an AI diagnostic tool intended to assist human readers in image interpretation or similar tasks.
- Effect Size of Human Readers Improve with AI vs. Without AI Assistance: Not applicable (N/A)
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. The Health Buddy is described as a "communication tool" and an "accessory device" that collects and transmits historical data. It is not an algorithm that performs standalone diagnostic or interpretive functions.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable (N/A) – No ground truth is established or used in this submission. The device's function is to transmit existing physiological data, not to make a diagnosis or interpretation itself.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable (N/A) – The document does not describe a machine learning algorithm or a training set. The "software changes" mentioned are related to device connectivity for specific medical devices, not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable (N/A) – No training set or ground truth establishment for such a set is described.
Summary of Device's Approach to Meeting Requirements:
The document asserts that the modified Health Buddy® with Device Connectivity meets safety and effectiveness requirements by demonstrating substantial equivalence to predicate devices that have already received 510(k) clearance. The changes are described as "minor software changes" to allow connection to a Peak Flow Meter. The justification relies on the fact that the fundamental function of collecting and transmitting historical data for healthcare professionals (without providing automated treatment decisions) remains unchanged and aligns with the cleared functions of the predicate devices. Therefore, a new performance study with acceptance criteria and ground truth establishment was not deemed necessary for this specific submission.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).