(32 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 and peak flow meters). 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. In this submission, software changes are made to support hardware replacement to components no longer available in the Health Buddy. In addition, the operating system has changed. The Health Buddy device has data ports that allow it to download readings from identified attached devices, activated only upon appropriate patient enrollment.
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 from the previous day and to retrieve the current day's dialoque.
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.
The Health Buddy® is an accessory device, intended to be a communication tool to enable healthcare providers to receive historical patient information. The product is used in conjunction with Health Hero Network's Online Service, a communication tool to enable health care providers to educate, motivate, and receive patient information. Health Buddy Appliance is not intended to provide automated treatment decisions, nor is it to be used as a substitute for a professional healthcare judgment. All patient medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare professional.
The provided document is a 510(k) premarket notification for a modification to the Health Buddy® Appliance. This type of submission focuses on demonstrating "substantial equivalence" to a predicate device, rather than proving safety and efficacy through new, independent studies with acceptance criteria in the traditional sense.
Therefore, many of the requested categories (acceptance criteria, specific study design, sample sizes for test and training sets, ground truth establishment for novel algorithms, MRMC studies, and standalone performance) are not applicable to this type of submission.
Here's an breakdown based on the provided text, explaining why certain information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
- Not Applicable. This 510(k) is for modifications to an already cleared device (Health Buddy® Appliance) and focuses on demonstrating substantial equivalence to its predicates. It does not present new acceptance criteria or new performance metrics with specific thresholds that a study would aim to meet, as would be the case for a novel device or a device with new clinical indications. The "performance" here is primarily about maintaining the functionality and safety of the original device despite hardware and OS changes.
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. No explicit "test set" in the context of an algorithm's performance on a specific dataset is mentioned. The changes are to hardware components and the operating system of an existing communication device. The "testing" would have focused on ensuring the modified device continues to perform its intended functions (collecting and transmitting data from attached medical devices) as reliably as the original, in line with its cleared indications. This would likely involve engineering verification and validation, not a clinical study on a patient data set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. As there's no explicit "test set" involving diagnostic or interpretative tasks, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
- Not Applicable. No test set requiring expert adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. An MRMC study is typically conducted for diagnostic devices where human readers interpret medical images or data. The Health Buddy® Appliance is a data collection and transmission device, not an interpretive diagnostic tool. There is no AI component that would "assist" human readers in the way an MRMC study evaluates.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. The Health Buddy® Appliance acts as a communication tool and an accessory to other medical devices (blood glucose meters, blood pressure cuffs, etc.). It does not contain a standalone "algorithm" for making medical decisions or interpretations, nor does it perform any diagnostic functions independently. Its software updates are related to hardware compatibility and the operating system, not to a novel clinical algorithm.
7. Type of Ground Truth Used
- Not Applicable. Given the nature of the device (a data communication system), the concept of "ground truth" as it applies to diagnostic accuracy (e.g., pathology, clinical outcome) is not relevant. The device's function is to accurately transmit data, not to interpret it.
8. Sample Size for the Training Set
- Not Applicable. This device does not use machine learning algorithms that require a "training set" of data for learning or model development. The software changes are related to hardware drivers and the operating system.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As no training set is described (see point 8), there is no ground truth establishment for a training set.
Summary of the 510(k) Submission:
The provided document describes a Special 510(k) submission for modifications to the "Health Buddy® Appliance." The key points are:
- Device Type: A communication product that connects to a telephone line, used by patients to answer questions and transmit data from specific medical devices (blood glucose meters, blood pressure cuffs, scales, peak flow meters) to healthcare professionals.
- Modifications: Software changes to support hardware replacement due to components no longer being available, and an update to the operating system.
- Indication for Use: "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." It explicitly states it is not intended for automated treatment decisions or as a substitute for professional healthcare judgment.
- Predicate Devices: The submission claims substantial equivalence to previously cleared versions of the Health Buddy® (K042273, K040086, K993128) and other similar telehealth monitors/systems (CareMatix Wellness System K040966, Viterion 100 TeleHealth Monitor K030419).
- Conclusion: The changes maintain the technological features and indications for use, thus demonstrating substantial equivalence to cleared devices, assuring safety and effectiveness.
This 510(k) is a regulatory filing for a device modification, not a report on a clinical study establishing new performance metrics for a novel algorithm or diagnostic capability. The "study" here is essentially the demonstration that the modified device maintains its previously cleared functionality without raising new questions of safety or effectiveness.
§ 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).