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.

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.

AI/ML Overview

The provided text describes the Zoe Medical Well@Home System, which is a noninvasive blood pressure measurement system for remote patient monitoring. However, it does not include detailed acceptance criteria or a specific study proving the device meets those criteria in the way a modern medical device submission typically would.

Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices through:

Technological Characteristics Comparison: Showing that the Well@Home System's design, functions, and principles of operation are similar to previously cleared devices.
Performance Testing: Stating that internal engineering tests were conducted to verify performance against functional requirements and to show substantial equivalence.

Given this, I will extract the information available and note where specific details (like numerical acceptance criteria, sample sizes for test sets, expert qualifications, etc.) are absent.

Acceptance Criteria and Device Performance (as inferred from the document)

Acceptance Criterion (Inferred)	Reported Device Performance
Overall System Functionality (compared to HANC Network)	The Well@Home System performed according to its functional requirements and passed all internal engineering tests, verifying performance in all functions similar to the HANC Network (scheduling activities, providing information, collecting vital sign/symptom data, transferring data, modifying schedules). The differences are described as "minor" and do not diminish the claim of substantial equivalence.
Vital Signs Measurement (compared to Nightingale PPM)	The Well@Home Monitor's performance for noninvasive blood pressure, oxygen saturation, pulse rate, temperature, respiration rate, heart rate, and ECG was shown to be "substantially equivalent" to the Nightingale PPM based on bench tests using simulators. This equivalence is attributed to using the same signal processing front-end hardware and software algorithms as the cleared Nightingale PPM.
Blood Glucose Measurement (compared to Lifescan One Touch Ultra)	Internal engineering tests confirmed that the measurement results provided by the Lifescan One Touch Ultra Blood Glucose Meter (BGM) were correctly collected and displayed by the Well@Home System when interfaced. The BGM's performance is stated to be "no different" whether connected to Well@Home or functioning as a standalone device.

Detailed Study Information (Based on Available Text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "internal engineering tests" and "bench tests using simulators" were conducted, but no numerical sample sizes for these tests are provided for either human subjects or simulated data points.
- Data Provenance: Not specified. The tests were "internal engineering tests," implying they were conducted by the manufacturer, Zoe Medical, but details on location or whether they involved human subjects are absent.
- Retrospective or Prospective: Not specified. The nature of "internal engineering tests" and "bench tests using simulators" suggests they were likely prospective tests conducted on the device hardware and software.
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/Not specified. The "ground truth" for the vital signs measurements appears to be established by the predicate devices themselves (Nightingale PPM and One Touch Ultra) and, for overall system functionality, by functional requirements. There is no mention of independent experts establishing ground truth for a test set in the context of clinical accuracy or interpretation that would require such expertise. "Bench tests using simulators" imply comparison against known simulator outputs.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. The document does not describe a clinical study design that would involve expert adjudication of results. The testing described is primarily technical and functional equivalence vs. predicate devices or simulators.
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 not an AI-assisted diagnostic tool for human readers. It is a remote monitoring system that collects and transmits vital signs and symptom data. Therefore, an MRMC study or AI-assistance effect size is not relevant to this submission.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The "internal engineering tests" and "bench tests using simulators" for vital signs measurement evaluate the device's capability to measure data and display it correctly. For the blood glucose meter, the BGM's performance is explicitly stated as "no different when it is connected to the Well@Home Monitor as when it functions as a standalone device," indicating a standalone performance assessment of the BGM component. The Well@Home System functions as an "information transfer technology" for the BGM.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For vital signs measurement (Nightingale PPM comparison): The ground truth was presumably the known accurate outputs from physiological simulators or the validated measurements from the predicate Nightingale PPM itself.
- For blood glucose measurement (One Touch Ultra comparison): The ground truth was the measurements provided by the standalone, predicate Lifescan One Touch Ultra Blood Glucose Meter.
- For overall system functionality (HANC Network comparison): The ground truth was likely defined by functional requirements derived from the predicate HANC Network's capabilities.
The sample size for the training set:
- Not applicable/Not specified. This document is for a medical device submission focused on substantial equivalence through hardware and software design, and functional testing. It does not describe a machine learning or AI model that would require a "training set" in the conventional sense. The software algorithms for vital signs measurement are stated to be "the same software algorithms" as the predicate Nightingale PPM, implying they were developed and validated previously, not newly trained for this specific application.
How the ground truth for the training set was established:
- Not applicable. As there is no described training set for an AI/ML model, this question is not relevant to the provided information.

Summary

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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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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.

. 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

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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 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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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

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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

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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

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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

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Indications for Use

510(k) Number (if known):

K040012

Well@Home System Device Name:

Indications For Use:

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

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510(k) Number_K 0 4 00 1 2

Regulation Number and Section

§ 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).