The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; Measurement of blood glucose; 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. Prescription Device. Federal law (US) restricts this device to sale by or on the order of a physician.

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 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.

AI/ML Overview

The provided text describes the Carematix Wellness System and its 510(k) summary for substantial equivalence to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.

However, based on the provided information, we can infer some aspects and highlight what is not present.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics against those criteria. Instead, it relies on a comparison to predicate devices, claiming "substantial equivalence." The "performance" is implicitly defined by the functions of the predicate devices.

Feature / Criteria (Implied)	Carematix Reported Performance (Implied)
Indications of Use	Enables healthcare providers to manage chronic conditions of patients remotely (Same as predicates)
Intended Use	Telemedicine System (Same as predicates)
Intended Users	Home users and Healthcare provider (Same as predicates)
Site of Use	Home; clinic (Same as predicates)
Software	Patient Database (Same as predicates)
Types of Sensors Supported	Blood Pressure, Weight, Glucose levels (Subset of predicates, but sufficient for claimed indications)
Power Source	Wall power plug for health monitor (hub) and Standard batteries in devices (Same as predicates)
Communication method with devices	Wireless RF protocol (Differs from one predicate's wired, but same as another's wireless)
Communication method with central server	Via modem over telephone line (Same as predicates)
Display	On devices, and monitors connected to central server (Same as predicates)
Safety and Effectiveness	As safe and effective as the predicate devices (Claimed via bench and user testing)

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "bench and user testing" but does not specify:

The sample size of devices or users for any test set.
The data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The document refers to "user testing," but there's no mention of how "ground truth" for the performance of the system (e.g., accuracy of measurements) was established or by whom. The system transmits data from already cleared sensors, so the accuracy of those sensors themselves would have been established previously, but the system's performance in transmitting and displaying that data isn't detailed.

4. Adjudication Method:

This information is not provided.

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

This study type is not mentioned or implied. The Carematix Wellness System facilitates data collection and transmission, not interpretation by human readers. Therefore, an MRMC study comparing human reader performance with or without AI assistance is not applicable to the description of this device.

6. Standalone Performance Study:

A standalone performance study of the system's components (e.g., accuracy of the blood pressure unit, blood glucose meter, or weight scale) would have been conducted as part of their initial 510(k) clearances. However, for the Carematix Wellness System itself (the hub, transmission, and software functionality), the document mentions "bench and user testing." It does not provide specific data from a standalone study for the Carematix system's performance (e.g., data transmission accuracy, reliability of data display). The submission relies on the fact that it uses "sensor devices already cleared with 510(k) clearance" or provides "external adaptors for Blood glucose monitors having existing 510(k) clearances."

7. Type of Ground Truth Used:

For the Carematix system (as opposed to the individual sensors it connects to), the document does not explicitly state the type of ground truth used. "User testing" suggests qualitative feedback or verification of function, but no objective ground truth (like pathology, outcomes data, or expert consensus on system data accuracy) is specified. For the measurements themselves, the ground truth would have been established by the original 510(k) clearances of the individual sensor devices (e.g., comparison to a reference standard for blood pressure, glucose, or weight).

8. Sample Size for the Training Set:

This information is not applicable or provided. The Carematix Wellness System, as described, is a data collection and transmission system, not an AI/ML device that requires a training set.

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

This information is not applicable as the device is not described as using AI/ML requiring a training set.

Summary

{0}------------------------------------------------

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

June 13, 2003 Contact: Mr. Sukhwant Khanuja, Director

1. 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. The Carematix Wellness System only uses sensor devices already cleared with 510(k) clearance: OR provides external adaptors for Blood glucose monitors having existing 510(k) clearances. The Stand-on patient scale is exempt from pre-market notification as per 880.2700.
1. Indications for Use (intended use): The Carematix Wellness System is intended for patient home use for the following: Non-invasive blood pressure measurement; measurement of blood glucose, 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. 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 4. 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 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.
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}------------------------------------------------

Feature	Avid Care K011779	Philips K023749	Carematix
Indications ofUse	Enables healthcare providers tomanage chronic conditions ofpatients remotely	Same	Same
Intended use	Telemedicine System	Same	Same
Intended Users	Home users and Health careprovider	Same	Same
Site of Use	Home; clinic	Same	Same
Software	Patient Database	Same	Same
Types ofSensors	Blood PressureWeightGlucose levelsOxygen SaturationPT/INRFEV/PEF	Blood PressureWeightGlucose levelsECG	Blood PressureWeightGlucose levels
Power Source	Wall power plug for healthmonitor (hub) and Standardbatteries in devices	Same	Same
Communicationmethod withdevices	Wired - over serial port	Wireless RF protocol	Wireless RF protocol
Communicationmethod withcentral server	Via modem over telephone line	Same	Same
Display	On devices, and monitorsconnected to central server	Same	Same

6. Substantial Equivalence Chart

7. 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.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2003

Carematrix, Inc. c/o Mr. Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, IL 60015

Re: K031840

Trade Name: Carematrix Wellness System Regulation Number: 21 CFR 870.1130 and 870.2910 Regulation Name: Noninvasive Blood Pressure Measurement System and Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXN and DRG Dated: September 17, 2003 Received: September 22, 2003

Dear Mr. Kamm:

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.

{3}------------------------------------------------

Page 2 - Mr. Daniel Kamm, P.E.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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) 594-4646. 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.

Через Мар

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

K031840

j) Indications for Use

510(k) Number K031840

Device Name: Carematix Wellness System

Indications for Use: The Carematix Wellness System is intended for patient home use for the following:

Non-invasive blood pressure measurement; Measurement of blood glucose; 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.

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 K031840

Prescription Use X OR Over the Counter Use
(Per 21 CFR 801.109)

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).