The Carematix Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:
Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale. The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

Device Description

The Carematix Wellness System (CWS) provides easy monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.

AI/ML Overview

The Carematix Wellness System is a telemedicine system that collects, accumulates, and transmits patient vital signs and other physiological data from a patient at home to a healthcare practitioner. The device being cleared in K040966 is a modified version of the Carematix Wellness System (K031840). The modification is primarily related to the connectivity method between the hub and the sensor devices, changing from wired to wireless (RF protocol). The acceptance criteria and the study that proves the device meets these criteria are outlined below:

1. Acceptance Criteria and Reported Device Performance

The submission relies on a substantial equivalence comparison to predicate devices, rather than predefined quantitative performance acceptance criteria for the overall system. The implicit acceptance criteria are that the modified device remains "as safe and effective" as the predicate devices, despite the technological differences.

Feature	Acceptance Criteria (Implicit)	Reported Device Performance and Compliance
Safety & Effectiveness	Be as safe and effective as predicate devices.	"The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.""After analyzing bench, electrical safety, FCC, and user testing data, it is the conclusion of Carematix, Inc. that the Carematix Wellness System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices."
Functional Specifications	Meet product requirements and functional specifications.	Non-clinical testing demonstrates conformity to product requirements and functional specifications. The specific details of these requirements are not provided, but the conclusion states they were met.
Physiologic Data Storage	Physiologic data received by patient monitors must be stored properly.	Non-clinical testing verified that "the physiologic data received by the patient monitors are stored properly."
Data Transmission Security & Integrity	Data must be transmitted to the healthcare practitioner in a manner that maintains security and integrity.	Non-clinical testing verified that "the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the data."
Indications for Use	Have identical indications for use as the predicate device (K031840 and other earlier predicates).	The "Indications for Use" for the modified system are identical to those of the predicate Carematix Wellness System (K031840) and align with other predicates: "The modified Carematix Wellness System [...] has no new indications for use." The system collects, accumulates, and transmits physiological data including non-invasive blood pressure, pulse rate, blood glucose, %SpO2, PT/INR, body temperature, PEFR, FEV, and patient weight.
Technological Equivalence	The modification to the system (specifically, wireless connectivity for sensors) should not alter the fundamental scientific technology of the sensor devices and should be comparable to predicate devices.	The substantial equivalence chart clearly outlines the "Carematix Modified System" and its features, showing that fundamental aspects like data collection software functionality, communication method of hub with central server, and sensor software remain "Same" as predicates. The key technological difference, "Communication method of hub with devices" changed from "Wired - over serial port" in some predicates to "Wireless RF protocol" (915MHz FCC assigned channel) in the modified system, which is also present in other predicates (e.g., Philips K023749 and previous Carematix K031840). The application states: "The modification to the Carematix Wellness System approved under K031840 submitted for approval in this application does not alter the fundamental scientific technology of the sensor devices."

2. Sample Size for the Test Set and Data Provenance

The document describes "bench and user testing" as methods used to demonstrate safety and effectiveness. However, no specific sample size (number of participants or tests) for these "user testing" or "bench testing" activities is provided in the document.

The data provenance is not explicitly stated. Given the context of a 510(k) submission for a medical device aiming for the US market, it can be inferred that the testing would typically adhere to US regulatory standards. However, details like country of origin for user data or whether the studies were retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a test set in the traditional sense of clinical studies (e.g., radiologists interpreting images). The system relies on measurements from existing 510(k) cleared sensor devices. These sensor devices themselves would have undergone validation against established references or expert diagnoses during their own clearance processes.

For the Carematix Wellness System, the "ground truth" for the collected vital signs is implicitly assumed to be the accurate readings from the 510(k) cleared sensor devices. The system's role is to collect, store, and transmit these readings accurately, not to interpret or diagnose. Therefore, expert consensus or qualification of experts on the Carematix system's data collection and transmission wouldn't typically involve medical diagnostic experts but rather technical experts validating data integrity, security, and functionality.

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing focuses on the accurate collection, storage, and transmission of data from existing cleared sensors, rather than diagnostic interpretation requiring expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The device is a data collection and transmission system, not an AI-assisted diagnostic tool that would typically involve human readers. Therefore, there is no discussion of human readers improving with or without AI assistance.

6. Standalone Performance Study

A standalone performance evaluation of the system's ability to collect, store, and transmit data was conducted through "bench and user testing." The key outcomes verified were:

Meeting product requirements and functional specifications.
Proper storage of physiologic data received.
Secure and integral transmission of data.

These tests would represent the standalone (algorithm/system only, without human interpretation of the system's core function) performance of the Carematix Wellness System in its defined role.

7. Type of Ground Truth Used

The "ground truth" for the performance claims rests on the accurate readings provided by the integrated, pre-cleared sensor devices. The Carematix system's function is to relay these existing "truths" reliably. The testing verified the integrity of handling these known values rather than establishing new diagnostic ground truths. Specifically, the "ground truth" for the system's function is:

The known output from the 510(k)-cleared biometric devices.
The expected functional behavior as defined in product specifications.
Normative standards for electrical safety and FCC compliance.

8. Sample Size for the Training Set

This submission does not discuss a training set. The device is a system for collecting and transmitting physiological data, not an AI/machine learning algorithm that requires a training set for model development. The focus is on the functional performance and equivalence to predicate devices, using established engineering and verification methods rather than algorithm training.

9. How the Ground Truth for the Training Set Was Established

As there is no training set mentioned for an AI/ML algorithm, this question is not applicable.

Summary

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K040966

JUN - 2 2004

EXHIBIT 2 - 510(k) Summary of Safety and Effectiveness

Carematix, Inc. 2 N. LaSalle Street, Suite 1904 Chicago, IL 60602 Ph: 312-332-2444 Fax: 312-332-0100

April 05, 2004 Contact: Dr. Sukhwant Khanuja, Director

l. Identification of the Device:

Proprietary-Trade Name: Carematix Wellness System Classification Names: DXN: System, Measurement, Blood-Pressure, Non-Invasive DRG: Transmitters And Receivers, Physiological Signal, Radiofrequency Common/Usual Name: Telemedicine system

1. Equivalent legally marketed devices: This product is similar in function to the M3810a Philips Telemonitoring System, K023749 and Hewlett Packard Company Model 3810A, K993169; AvidCare Series 100 Telemanagement System, K011779; AvidCare Corporation Home Health Monitoring System, K010029; Viterion 100 Telehealth Monitor, K030419; Carematix Wellness System, K031840. The Carematix Wellness System only uses sensor devices already cleared with 510(k) approvals; OR provides adaptors for biometric measurement devices having existing 510(k) approvals. The Stand-on patient scale is exempt from pre-market notification as per 880.2700. Please refer to Exhibit 4: System Description for specific details on the sensor devices used with the Carematix Wellness Systems.
1. Indications for Use (intended use): The Carematix Wellness System is a physiological monitoring system. The system collects, accumulates and transmits patient vital signs and other physiological data from a patient who may be remote from the healthcare practitioner to the practitioner. It is intended for patient home use for the following and can record physiological information such as:

Non-invasive blood pressure measurement; Pulse rate measurement; Blood glucose level using a Glucometer; Blood hemoglobin oxygen saturation (%SpO2) and pulse rate using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio

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(INR) measurement using an in-home coagulation measurement system; Body temperature measurement using a digital thermometry device or system; Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements using an electronic peak flow meter; Patient weight using a stand-on electronic scale. The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

1. Prescription Device: Federal law (US) restricts this device to sale by or on the order of a physician.
Description of the Device: The Carematix Wellness System (CWS) provides easy 5. monitoring of the basic wellness parameters via a wireless connection between the monitoring device and a hub (receiving station) located in the home. The hub transmits the information to the Carematix Internet server where the data is added to the patient's chart. Using a web-browser, the caregiver can track the patient's data, graph the results, monitor trends, annotate variances, set alert criteria, and send reminders and receive alerts via e-mail or pager. The following monitoring devices are currently available from Carematix: Blood pressure unit (Arm cuff and Wrist cuff), Weight Scale, Blood Glucose Meter adaptors, Pulse Oximeter adaptors, Coagulation Measurement System adaptors, Digital Thermometer adaptors, Peak Flow Meter adaptors.
1. Safety and Effectiveness, comparison to predicate device. The results of bench and user testing indicate that the new device is as safe and effective as the predicate devices.
1. Substantial Equivalence Chart

Feature	Avid CareK011779 andK010029	PhilipsK023749	ViterionK030419	CarematixK031840	CarematixModifiedSystem
Indications ofUse	Enableshealthcareproviders tomanage chronicconditions ofpatients remotely	Same	Same	Same	Same
Intended use	TelemedicineSystem	Same	Same	Same	Same
IntendedUsers	Home users andHealth careprovider	Same	Same	Same	Same
Site of Use	Home; clinic	Same	Same	Same	Same
Data	Avid Care	Philips	Viterion	Carematix	Carematix

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Collection	Proprietarysoftware	ProprietarySoftware	Proprietarysoftware	Proprietarysoftware	Proprietarysoftware
DataCollectionSoftwareFunctionality	Transmit datafrom Sensordevices to Centraldatabase	Transmitdata fromSensordevices toCentraldatabase	Transmit datafrom Sensordevices toCentraldatabase	Transmitdata fromSensordevices toCentraldatabase	Transmit datafrom Sensordevices toCentraldatabase
Communication method ofhub withcentral server	Via modem overtelephone line	Same	Same	Same	Same
Types ofsensors whichcan beinterfaced(wired orwirelessly) toreceiver hub	• BloodPressure• Weight• Glucoselevels• OxygenSaturation• PT/INR• FEV/PEF	• BloodPressure• Weight• Glucoselevels• ECG	• BloodPressure• Weight• Glucoselevels• OxygenSaturation• Temperature• FEV/PEF	• BloodPressure• Weight• Glucoselevels	• BloodPressure• Weight• Glucoselevels• OxygenSaturation• PT/INR• Temperature• FEV/PEF
Implemen-tation-method ofcollectingdata fromsensors	Modify off-theshelf sensors withprevious 510(k)clearance by addingcommunicationsinterface. Basicsensors unchanged.	Same	Same	Same	Same
SensorSoftware	Sensorsoftwareunchanged	Sensorsoftwareunchanged	Sensorsoftwareunchanged	Sensorsoftwareunchanged	Sensorsoftwareunchanged
Connectivity	Wired to hub	Wired orWireless tohub	Wired to hub	Wireless tohub	Wireless tohub
Communi-cation methodof hub withdevices	Wired - overserial port	Wireless RFprotocol	Wired - overserial port	WirelessRF protocol	Wireless RFprotocol
Communications protocol	Serial protocol	Proprietaryprotocol	Serialprotocol	Proprietaryprotocol	Proprietaryprotocol
Communication frequency	Wired	915MHzFCC assignedchannel	Wired	915 MHzFCC assignedchannel	915 MHzFCC assignedchannel
Power Source	Wall power plugfor hub (120VAC/50-60~) andbatteries in devices	Same	Same	Same	Same
Display	On devices andhub, and monitorsconnected tocentral server	On devicesand hub, andmonitorsconnected tocentral server	On devicesand hub, andmonitorsconnected tocentral server	On devices,and monitorsconnected tocentral server	On devices,and monitorsconnected tocentral server

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TC-0966

8. Non-clinical Testing

Similar to the predicate device Viterion 100 (K030419) which further refers to Panasonic Telehomecare system (K004050), the Carematix Wellness System utilizes patient sensors that have already received 510(k) clearance. The testing to demonstrate substantial equivalence for this product similarly to the predicates relies on:

. Testing to meet the product requirements and functional specifications
Verification that the physiologic data received by the patient monitors are stored . properly; and
. Verification that the data is transmitted to the healthcare practitioner in a manner that maintains the security and integrity of the data.

9. Conclusion

After analyzing bench, electrical safety, FCC, and user testing data, it is the conclusion of Carematix, Inc. that the Carematix Wellness System is as safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate devices. The modification to the Carematix Wellness System approved under K031840 submitted for approval in this application does not alter the fundamental scientific technology of the sensor devices.

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Image /page/4/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and wings at the top.

UN = 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carematix, Inc. c/o Sukhwant Khanuja, Ph. D. CEO 2 N Lasalle St., Suite 1805 Chicago, IL 60602

Re: K040966

Trade Name: Carematix Wellness System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: II (two) Product Code: DRG Dated: April 12, 2004 Received: April 14, 2004

Dear Dr. Khanuja:

We have reviewed your Section 510(k) premarket notification of intent to market the device wt nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimeres processified in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). and Costiere rece (110.) that to nevice, subject to the general controls provisions of the Act. The 1 ou may, mereleve, include requirements for annual registration, listing of general controls provision 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 If your device 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.

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Page 2 - Sukhwant Khanuja, Ph. D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your deviee complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny I 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 OF I ratt 0077, accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic reral in and quinn control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product in the low you to begin marketing your device as described in your Section 510(k) rms let notification. The FDA finding of substantial equivalence of your device to a legally premated predicated. The 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 in you t 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 other Economic 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,

Nél R.P. Ogden

B.Zucker, M.D., S.C.

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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j) Indications for Use

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Device Name: Carematix Wellness System

Indications for Use:

Non-invasive blood pressure measurement; .
Blood glucose level using a Glucometer; .
Patient weight using a stand-on electronic scale .
Pulse rate measurement; .
Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter; .
Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an . in-home coagulation measurement system;
Body temperature measurement using a digital thermometer; .
Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV) measurements . using an electronic peak flow meter;

The results of these measurements are transmitted to a computer monitoring station in a clinical setting via common telephone lines from the patient's home setting.

Prescription Device.

Federal law (US) restricts this device to sale by or on the order of a physician.

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number	K040966

Prescription Use X OR Over the Counter Use ______

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).