CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B

K073038 · Carematix, Inc. · DRG · Jan 11, 2008 · Cardiovascular

Device Facts

• Record ID: K073038
• Device Name: CAREMATIX WELLNESS SYSTEM, MODEL CWS-5000.1-B
• Applicant: Carematix, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jan 11, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2910
• Device Class: Class 2

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) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coagulation measurement 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 Story

System gathers/transmits patient data from home/remote locations to clinical caregivers. Components: wireless radiofrequency transmitter adapters, communication hub, internet server. Adapters connect to existing monitoring devices (blood pressure, pulse, glucose, SpO2, PT/INR, respiratory flow, weight). Hub collects/stores data from adapters; transmits to internet server. Server makes data available to caregivers for tracking, graphing, trending, and alert management. Caregivers use output to monitor patient status and adjust clinical decisions. Benefits: enables remote patient management, facilitates timely intervention for out-of-range parameters.

Clinical Evidence

Clinical performance testing conducted; results met acceptable criteria. Specific metrics, sample sizes, and study design details not provided in summary.

Technological Characteristics

System consists of RF transmitter adapters, communication hub, and internet server. Connectivity via common telephone lines. Operates as a physiological signal transmitter/receiver (21 CFR 870.2910).

Indications for Use

Indicated for patients requiring remote monitoring of vital signs and physiological data, including blood pressure, pulse, blood glucose, SpO2, PT/INR, respiratory flow (PEFR/FEV), and weight. Intended for home use with data transmission to clinical settings.

Regulatory Classification

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.

Predicate Devices

• Carematix™ Wellness System (K040966)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

# Carematix™ Wellness System

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### Submitter

Carematix™, Inc. 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606

#### Contact Person

Sukhwant Khanuia, Ph. D. Chief Executive Officer Carematix™, Inc. 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606

JAN 1 1 2008

Phone: [phone] e-mail: [e-mail]

#### Date Prepared:

October 23, 2007

#### Name of Device

Carematix™ Wellness System

#### Classification Names

Radiofrequency Physiological Signal Transmitters and Receivers

## Device Classification

| Regulatory Class: | Class II |
|-----------------------|-----------------------------|
| Product Code: | DRG |
| Classification Panel: | Cardiovascular Device Panel |
| Regulation Number: | 21 CFR 870.2910 |

## Predicate Devices

K040966 Carematix™ Wellness System

Carematix™, Inc.

## Description of Device

The Carematix™ Wellness System is intended to gather and transmit patient data from the home site or remote location to caregivers at a clinical facility where it provides supplemental information for the care of the patient.

The Carematix™ Wellness System consists of wireless radiofrequency transmitter adapters, a communication hub or receiving station, and an internet server:

- The radiofrequency transmitter adapter is connected, either wired directly or . to a serial port, of monitoring devices currently in distribution having capability to monitor patient parameters for blood pressure, pulse rate, blood sugar, blood oxygen saturation, PT/INR, and FEVR/PEF.
- The communications hub, or receiving station, collects and stores data . transmitted from each of the radiofrequency transmitter adapters and transmits patient data to the internet server at specified intervals.

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- . The internet server receives the patient data from the home setting or remote location where it is made available to the caregiver to track, graph, trend, note Page 1 of 2
- variances, set alert criteria, and receive alerts when parameters are outside . the criteria set.

## Indications For 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 qlucose level using a Glucometer:

Blood hemoglobin oxygen saturation (%SpO2) using a digital Pulse Oximeter;

Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an in-home coaqulation measurement 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.

## Nonclinical Performance

The Carematix™ Wellness System was tested and passed all required electrical and mechanical testing.

## Clinical Performance

The Carematix™ Wellness System performance was tested with clinical data and the results met the acceptable criteria.

## Conclusion

The Carematix™ Wellness System is substantially equivalent to the following 510(k) cleared devices:

Carematix™ Wellness System cleared under K040966 on June 2, 2004

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, composed of three curved lines, symbolizing health and well-being. The figure is positioned to the right of the department's name, which is arranged in a circular fashion around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

JAN 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Carematix Inc. c/o Sukhwant Khanuja, Ph.D. Chief Executive Officer 120 S. Riverside Plaza, Suite 2100 Chicago, IL 60606

Re: K073038

Trade/Device Name: Carematix™ Wellness System Model CWS-5000.1-B Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: December 11, 2007 Received: December 13, 2007

Dear Dr. Khanuja:

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 - 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 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/industry/support/index.html.

Sincerely yours.

Bymmermafr

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

K073038 510(k) Number

# Device Name: Carematix™ Wellness System

# Indications for 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) using a digital Pulse Oximeter; Prothrombin Time (PT) and International Normalized Ratio (INR) measurement using an inhome coagulation measurement 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.

Prescription Use (per 21 CFR 801.109)

and/or Over-the-counter Use

# PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bymmoma

Division of Caraio 510fk) Number