(88 days)
No
The summary describes a remote patient monitoring system that collects vital signs and symptom data, provides reminders, and allows clinicians to review and manage patient information. There is no mention of AI or ML being used for data analysis, prediction, or any other function. The "alerts" are based on predefined limits set by the clinician, not on AI/ML algorithms.
No
Explanation: A therapeutic device is used for treating or curing a disease or condition. This device is primarily for remote monitoring, data collection, and communication between patients and clinicians, which are diagnostic and management functions, not therapeutic ones. While it aids in managing illness and medication adherence, it does not directly administer therapy.
No
Explanation: The device is designed for monitoring vital signs and patient-reported symptoms, as well as providing reminders and training. While it collects data relevant to a patient's health, its primary use is for "periodic remote monitoring" and "daily checkups" by professional clinicians, rather than providing a diagnosis itself. It facilitates data collection for clinicians to use, who then make diagnostic and treatment decisions.
No
The device description explicitly mentions the "Well@Home Monitor" which measures vital signs and interfaces with other medical devices via serial ports. This indicates the presence of hardware components beyond just software.
Based on the provided text, the Well@Home System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: An IVD device is used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for the diagnosis, prevention, or treatment of disease.
- Well@Home System Function: The Well@Home System primarily focuses on monitoring physiological vital signs (blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, ECG) and collecting self-reported symptoms. While it interfaces with a blood glucose meter (which is an IVD), the Well@Home System itself is not performing the in vitro diagnostic test. It's collecting and transmitting the results from an external IVD device.
- Intended Use: The intended use is for "home-based health care from professional clinicians" for "periodic remote monitoring of their vital signs... or self-reported symptoms," medication reminders, and training. This aligns with remote patient monitoring and data management, not in vitro diagnostic testing.
Therefore, the Well@Home System is a remote patient monitoring and data management system that integrates with some medical devices, including an IVD (the blood glucose meter), but it is not an IVD itself.
N/A
Intended Use / Indications for Use
The Well@Home System is intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility. The system is intended to guide patients through a set of scheduled activities whereby medical data (vital signs, symptoms, and medication compliance) is collected. The system is intended to transfer the collected data to a remote site where it is stored and reviewed by a clinician. The system is also intended to allow the clinician to modify the patient's scheduled activities in response to the collected medical data or other information available to the clinician. The intent is to provide clinicians caring for patients outside the hospital with a means for keeping track of how the patients are doing without requiring the patients to come in for a checkup or requiring the clinicians to go to the patients.
The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.
Product codes
MWI
Device Description
The Well@Home System consists of the home-based "Well@Home Monitor" and the office-based "Well@Home Clinician Application". Using the Well@Home System, clinicians can monitor theised at home or in another remote health care facility. The use model is "daily checkups", rather them continuous monitoring.
The Well@Home Monitor collects vital signs and symptom information on a periodic basis via a patientfriendly user interface. The user interface guides the patient through a schedule of activities using voice promots, instructional diagrams and large, easy-to-read buttons. The scheduled of doutinities can'nclude reminders to take medications or to take vital signs measurements. The schedule for these activities can be customized by the clinician according to the patient's medical condition. The user interface also provides opportunities for the patient to report symbons at any time, and to review training ontent related to managing the patient's illness.
The Well@Home monitor measures noninvasive blood pressure, oxygen saturation, pulse rate, temperation | President rate, heart rate, and ECG. The Well@Home Monitor is designed to interface to Other Medical Devices (OMD's) for the purpose of gathering physiological data from those devices. The interface is through the monitor's three OMD serial ports. These serial ports are electrically isoated from each other and from the monitor's own physiological front-end. The list of supported OMD's is as follows:
- . Fairbanks Digital Scale (private labeled and device listed as a Zoe Medical accessory)
- Lifescan One Touch Ultra Blood Glucose Meter (or compatible BGM from Lifescan) .
The OMD interface mechanism is designed to be expandable. Future OMD's may include a Spirometer or a PT/INR measurement device.
The Well@Home Monitor transmits the gathered information to a clinician over the patient's existing telephone line. This information is received and stored by the Well(@Home Clinican Application.
The Well@Home Clinician Application is essentially a patient data management and record keeping program that includes an interface to the Well@Home Monitor. The Well@Home Clinician Application stores information that is gathered from multiple Well@Home Monitors and allows a clinician to review a given patient's information. It also allows the clinician to make adjustments to a patient's schedule of activities as needed. These adjustments are sent back to the patient's Well@Home Monitor over the same telephone link.
The Well@Home Clinician Application software was developed by Patient Care Technologies (PtCT) of Atlanta, Georgia, and is designed to run on standard Windows-based PC's. These PC's are typically installed at the office of a home care agency, and are referred to in this 510(k) as "Agency Servers". The Agency Servers may run other information management software developed by PtCT that is not part of the Well@Home System. The Well@Home System is product-branded to tie into PtCT's information management software product line.
Because of the remote-monitoring and spot check nature of the Well@Home System, there are no realtime "alarms" as in a hospital-style monitor. Rather, the clinician defines "alerts" that are to be generated (e.g., when a vital sign parameter exceeds set limits or when a particular symptom is reported). These alerts are part of the information package that is sent from the Well@Home Monitor to the Well@Home Clinician Application. The alerts are then visually highlighted when the clinician reviews the patient's information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
The Well@Home System is intended for use in adult and pediatric patients.
The Well@Home System is not intended for use on neonatal patients.
Intended User / Care Setting
Target customers for the Well@Home System are Home Health Care Providers, who will place the product in their patient's home. The system is intended for use in a patient's home or in another healthcare facility, with information reviewed by a clinician.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Internal engineering tests verified the performance of the Well@Home System in all functions that are similar to those that are performed by the HANC Network. The Well@Home System performed according to its functional requirements and passed all of these tests.
Bench tests using simulators were used to verify the performance of the Well@Home Monitor against the Nightingale PPM. These tests showed that on all physiological vital signs measured by the Nightingale PPM (noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, heart rate, and ECG), the performance of the Well@Home Monitor was substantially equivalent to the Nightingale PPM.
Internal engineering tests confirmed that the measurement results provided by the BGM (One Touch Ultra) were correctly collected and displayed by the Well@Home System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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040017-
Submitter
Zoe Medical Incorporated 460 Boston Street Topsfield, MA 01983-1223
Phone: (978) 887-1410 Fax: (978) 887-1406
Contact Name: Stephen Staats Contact Title: Quality System Manager
Date this Summary was Prepared: December 11, 2003
Trade Name
Well@Home System
Common Name
Noninvasive Blood Pressure Measurement System
Classification Name
Noninvasive Blood Pressure Measurement System (per 21 CFR 870.1130)
Predicate Devices
Overall Predicate Device:
HealthTech HANC (Home Assisted Nursing Care) Network 510(k) number K952979
Vital Signs Predicate Devices:
Zoe Medical Nightingale Monitoring System 510(k) number K001775
(for measuring noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate. heart rate, and ECG)
Lifescan One Touch Ultra
510(k) number K0241:94
(for measuring blood glucose level)
Zoe Medical, Incorporated 460 Boston Street Topsfield, MA 01983-1223 Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-2 of 7
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Medical
Well@Home Clinician Application
Device Description
Image /page/1/Figure/4 description: The image shows a diagram of a Well@Home Monitor system. The system includes a person with sensors attached to their body, a Well@Home Monitor device, and a computer running on an office-based Agency Server. The Well@Home Monitor device is connected to the person's sensors and to the computer via a telephone link. The text in the image indicates that the Well@Home Monitor is home-based.
The Well@Home System consists of the home-based "Well@Home Monitor" and the office-based "Well@Home Clinician Application". Using the Well@Home System, clinicians can monitor theised at home or in another remote health care facility. The use model is "daily checkups", rather them continuous monitoring.
The Well@Home Monitor collects vital signs and symptom information on a periodic basis via a patientfriendly user interface. The user interface guides the patient through a schedule of activities using voice promots, instructional diagrams and large, easy-to-read buttons. The scheduled of doutinities can'nclude reminders to take medications or to take vital signs measurements. The schedule for these activities can be customized by the clinician according to the patient's medical condition. The user interface also provides opportunities for the patient to report symbons at any time, and to review training ontent related to managing the patient's illness.
The Well@Home monitor measures noninvasive blood pressure, oxygen saturation, pulse rate, temperation | President rate, heart rate, and ECG. The Well@Home Monitor is designed to interface to Other Medical Devices (OMD's) for the purpose of gathering physiological data from those devices. The interface is through the monitor's three OMD serial ports. These serial ports are electrically isoated from each other and from the monitor's own physiological front-end. The list of supported OMD's is as follows:
- . Fairbanks Digital Scale (private labeled and device listed as a Zoe Medical accessory)
- Lifescan One Touch Ultra Blood Glucose Meter (or compatible BGM from Lifescan) .
The OMD interface mechanism is designed to be expandable. Future OMD's may include a Spirometer or a PT/INR measurement device.
The Well@Home Monitor transmits the gathered information to a clinician over the patient's existing telephone line. This information is received and stored by the Well(@Home Clinican Application.
Zoe Medical, Incorporated 460 Boston Street Topsfield, MA 01983-1223
Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-3 of 7
© 2003 Zoe Medical, Incorporated All Rights Reserved.
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The Well@Home Clinician Application is essentially a patient data management and record keeping program that includes an interface to the Well@Home Monitor. The Well@Home Clinician Application stores information that is gathered from multiple Well@Home Monitors and allows a clinician to review a given patient's information. It also allows the clinician to make adjustments to a patient's schedule of activities as needed. These adjustments are sent back to the patient's Well@Home Monitor over the same telephone link.
The Well@Home Clinician Application software was developed by Patient Care Technologies (PtCT) of Atlanta, Georgia, and is designed to run on standard Windows-based PC's. These PC's are typically installed at the office of a home care agency, and are referred to in this 510(k) as "Agency Servers". The Agency Servers may run other information management software developed by PtCT that is not part of the Well@Home System. The Well@Home System is product-branded to tie into PtCT's information management software product line.
Because of the remote-monitoring and spot check nature of the Well@Home System, there are no realtime "alarms" as in a hospital-style monitor. Rather, the clinician defines "alerts" that are to be generated (e.g., when a vital sign parameter exceeds set limits or when a particular symptom is reported). These alerts are part of the information package that is sent from the Well@Home Monitor to the Well@Home Clinician Application. The alerts are then visually highlighted when the clinician reviews the patient's information.
Zoe Medicał, Incorporated 460 Boston Street Topsfield, MA 01983-1223 Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-4 of 7
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Intended Use
The Well@Home System is intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility. The system is intended to guide patients through a set of scheduled activities whereby medical data (vital signs, symptoms, and medication compliance) is collected. The system is intended to transfer the collected data to a remote site where it is stored and reviewed by a clinician. The system is also intended to allow the clinician to modify the patient's scheduled activities in response to the collected medical data or other information available to the clinician. The intent is to provide clinicians caring for patients outside the hospital with a means for keeping track of how the patients are doing without requiring the patients to come in for a checkup or requiring the clinicians to go to the patients.
The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.
The Well@Home System is not an emergency response system. The device labeling advises patients to contact their caregiver, nurse, or doctor, or to call 911, or to go in to the Emergency Room, whenever they feel the need to do so. The device labeling refers patients to printed information they receive from their clinicians as their primary source of information. Furthermore, the Well@Home System does not analyze patient information nor does it offer medical advice.
The initial target customers for the Well@Home System are Home Health Care Providers, who will place the product in their patient's home. Target patient conditions include CHF, diabetes, COPD, and hypertension. While the Well@Home System is intended for use in adult and pediatric patients, the user interface is tailored for an adult operator. The Well@Home System is not intended for use on neonatal patients.
Zoe Medical, Incorporated 460 Boston Street Topsfield, MA 01983-1223 Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-5 of 7
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Medical
Technological Characteristics Compared to Predicate Devices
The Well@Home System incorporates technological characteristics that are very similar to three devices that have received 510(k) clearance.
For purposes of evaluating overall substantial equivalence, technological characteristics of the system related to the functions of scheduling patient activities, providing information, collecting vital sign and symptom data, transferring data to a remote nurse, and allowing clinicians to modify patient scheduled activities, are compared to the HeatthTech HANC (Home Assisted Nursing Care) Nework.
Technological characteristics related to the measurement of physiological vital signs (noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, heart rate, and ECG) are compared to the Zoe Medical Nightingale PPM (Personal Patient Monitor), part of the Nightingale Monitoring System.
Technological characteristics related to measuring blood glucose level are compared to the Lifescan One Touch Ultra.
Well@Home System in Comparison to the HANC (Home Assisted Nursing Care) Network
The Well@Home System and the HANC Network both have the same general intended use. Both systems provide means for remote monitoring of a patient's health status at home or in another healthcare facility.
Both systems have the overall function of collecting medical data about a patient (vital signs and Symptoms) and transferring the data to a remote site for storage and review purposes. The list of vital signs collected by both systems is similar: noninvasive blood pressure, temperature, oxygen saturation, pulse rate, respiration, and ECG.
Both systems employ the concept of connecting previously 510(k) cleared Original Equipment Manufacturer (OEM) components to measure certain vital signs parameters.
Both systems have similar features such as managing scheduled activities, medication reminders, coaching screens, and symptom reporting.
Both systems have similar principles of operation, combining a programmable device placed with the patient together with a device at the clinician's office that interacts with the patient device via a remote communications link.
Both systems have similar technological characteristics, combining touch screens, voice prompts, modems and PC technology.
The differences between the Well@Home System and the HANC Network are minor, and consist mainly of auxiliary, optional functions well be the Wellight and the Helwork are minior, and connecting to an intended use of sither with the woney follow are not central or even required for the intended use of either system, and thus do not diminish the claim of substantial equivalence.
Zoe Medical, Incorporated 460 Boston Street Topsfield, MA 01983-1223
Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-6 of 7
© 2003 Zoe Medical, Incorporated All Rights Reserved.
5
For all of the above-stated reasons, the Well@Home System is substantially equivalent to the HANC Network. Internal engineering tests verified the performance of the Well@Home System in all functions that are similar to those that are performed by the HANC Network. The Well@Home System performed according to its functional requirements and passed all of these tests.
Well@Home System in Comparison to the Nightingale PPM (For Vital Signs Measurement)
Both the Well@Home Monitor and the previously 510(k) cleared Nightingale PPM are designed and manufactured by Zoe Medical. The Well@Home monitor contains the same signal processing front-end hardware design as the Nightingale PPM, acquires the same physiological parameters, and uses the same software algorithms. For these reasons, bench tests using simulators were used to verify the performance of the Well@Home Monitor. These tests showed that on all physiological vital signs measured by the Nightingale PPM (noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, heart rate, and ECG), the performance of the Well@Home Monitor was substantially equivalent to the Nightingale PPM.
Well@Home System in Comparison to the One Touch Ultra (For Vital Signs Measurement)
The One Touch Ultra blood glucose meter (BGM) is a previously 510(k) cleared device that provides a measurement of the patient's blood ducose level. The manufacturer (Lifescan) provides a custom interface cable that allows remote access to the BGM from devices such as the Well@Home Monitor. In this capacity (regarding blood glucose level measurements), the Well@Horne Monitor functions as information transfer technology. The performance of the BGM is no different when it is connected to the Well@Home Monitor as when it functions as a standalone device. Internal engineering tests confirmed that the measurement results provided by the BGM were correctly collected and displayed by the Well@Home System.
Conclusions
Based on technological comparisons and performance testing results, in its overall intended use, functioning, safety and efficacy, the Well@Home System is substantially equivalent to the HealthTech HANC Network.
Based on technological comparisons and performance testing results, the vital signs measurement function of the Well@Home System is substantially equivalent to the vital signs measurement function of the Zoe Medical Nightingale PPM for measuring noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, heart rate, and ECG.
Based on technological comparisons and performance testing results, the vital signs measurement function of the Well@Home System is substantially equivalent to the vital signs measurement function of the Lifescan One Touch Ultra for measuring blood glucose level.
Zoe Medical, Incorporated 460 Boston Street Topsfield, MA 01983-1223 Phone: (978) 887-1410 FAX: (978) 887-1406 Page E-7 of 7
6
Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 2 2004
Zoe Medical, Incorporated c/o Mr. Stephen Staats Quality System Manager 460 Boston Street Topsfield, MA 01983-1223
K040012 Re:
Trade Name: Well@Home System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: December 30, 2003 Received: January 05, 2004
Dear Mr. Staats:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I·DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics with other requirements of the Act
7
Page 2 - Mr. Stephen Staats
or any Federal statutes and regulations administered by other Federal agencies. You must or car) 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. -This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will and my Jowe FDA finding of substantial equivalence of your device to a legally promated predicated with a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Danna R. Loines
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known):
Well@Home System Device Name:
Indications For Use:
The Well@Home System is indicated for use for patients who need home-based health care from professional clinicians. The system provides benefits for patients who need periodic remote monitoring of their vital signs (such as noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, weight, blood glucose level, heart rate, or ECG) or self-reported symptoms, who need reminders to take prescribed medications, or who need training about how to manage their illness.
Prescription Use
(Part 21 CFR 801 Subpart D)
✓
AND/OR
Over-The-Counter Use (21 CFR 807 Subpan C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Danna R. Vechner
(Division Sign-Off) Division of Cardiovascular Devices
ਦੀ Page 1 of
510(k) Number_K 0 4 00 1 2