CAREMATIX WELLNESS SYSTEM

K031840 · Carematix, Inc. · DXN · Oct 10, 2003 · Cardiovascular

Device Facts

• Record ID: K031840
• Device Name: CAREMATIX WELLNESS SYSTEM
• Applicant: Carematix, Inc.
• Product Code: DXN · Cardiovascular
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1130
• Device Class: Class 2

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.

Device Story

Carematix Wellness System (CWS) facilitates remote patient monitoring; collects physiological data (blood pressure, blood glucose, weight) via wireless sensors in home setting; transmits data to home hub; hub relays information to Carematix Internet server. Caregivers access data via web browser to track trends, graph results, annotate variances, and set alert criteria; alerts delivered via e-mail or pager. System enables clinical oversight of chronic conditions; supports physician decision-making through remote data visibility.

Clinical Evidence

Bench testing, electrical safety testing, FCC compliance testing, and user testing performed. No clinical trial data provided. Results indicate device is as safe and effective as predicate devices.

Technological Characteristics

System comprises wireless sensors (blood pressure cuff, weight scale, glucose meter adaptors) and a home hub. Uses wireless RF protocol for sensor-to-hub communication; transmits data via modem over telephone lines to a central server. Web-based interface for caregiver monitoring. Power provided by wall plug for hub and standard batteries for sensors.

Indications for Use

Indicated for home-based patients requiring remote monitoring of blood pressure, blood glucose, and weight. Prescription required.

Regulatory Classification

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.

Predicate Devices

• Philips Telemonitoring System (K023749)
• Hewlett Packard Company Model 3810A (K993169)
• AvidCare Series 100 Telemanagement System (K011779)
• AvidCare Corporation Home Health Monitoring System (K010029)

Submission Summary (Full Text)

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#### 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: [phone]

### 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
- 2. 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.
- 3. 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.
- 5. 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.

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| Feature | Avid Care K011779 | Philips K023749 | Carematix |
|------------------------------------------------|--------------------------------------------------------------------------------------|---------------------------------------------------|--------------------------------------------|
| Indications of<br>Use | Enables healthcare providers to<br>manage chronic conditions of<br>patients remotely | Same | Same |
| Intended use | Telemedicine System | Same | Same |
| Intended Users | Home users and Health care<br>provider | Same | Same |
| Site of Use | Home; clinic | Same | Same |
| Software | Patient Database | Same | Same |
| Types of<br>Sensors | Blood Pressure<br>Weight<br>Glucose levels<br>Oxygen Saturation<br>PT/INR<br>FEV/PEF | Blood Pressure<br>Weight<br>Glucose levels<br>ECG | Blood Pressure<br>Weight<br>Glucose levels |
| Power Source | Wall power plug for health<br>monitor (hub) and Standard<br>batteries in devices | Same | Same |
| Communication<br>method with<br>devices | Wired - over serial port | Wireless RF protocol | Wireless RF protocol |
| Communication<br>method with<br>central server | Via modem over telephone line | Same | Same |
| Display | On devices, and monitors<br>connected 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.

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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.

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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 [phone]. 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 [phone] or [phone] 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

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# 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)